[Federal Register Volume 77, Number 43 (Monday, March 5, 2012)]
[Notices]
[Pages 13165-13166]
[FR Doc No: 2012-5278]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66487; File No. SR-C2-2012-007]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Amend the Fees Schedule of Market Data Express, LLC

February 28, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 15, 2012, C2 Options Exchange, Incorporated (the
``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been substantially
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Fee Schedule of Market Data
Express, LLC (``MDX''), an affiliate of C2. The text of the proposed
rule change is available on the Exchange's Web site (http://www.c2exchange.com/Legal/), at the Exchange's Office of the Secretary,
and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to establish a monthly
fee of $500 per data port that MDX will charge for access to certain
market data with respect to the trading of options on C2's market.\3\
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    \3\ The Commission notes that the MDX Fee Schedule is available
at https://www.cboe.org/MDX/CSM/OBOOKMain.aspx.
---------------------------------------------------------------------------

    C2 currently collects and processes market data with respect to
options quotes and orders and the prices of trades that are executed on
the Exchange. This market data includes the ``best bid and offer,'' or
``BBO'', consisting of all outstanding quotes and standing orders at
the best available price level on each side of the market, with
aggregate size (``BBO data,'' sometimes referred to as ``top of book
data''). Data with respect to executed trades is referred to as ``last
sale'' data. C2 formats its BBO data and last sale data according to
Options Price Reporting Authority (``OPRA'') specifications and sends
the data to OPRA for redistribution to the public.
    MDX provides to ``Customers'' \4\ a real-time, low latency data
feed that includes the C2 BBO data and last sale data. (This data feed
is sometimes referred to in this filing as the ``BBO Data Feed''). The
BBO and last sale data contained in the BBO Data Feed is identical to
the data that C2 sends to OPRA.\5\ In addition, the BBO Data Feed
includes certain data that is not included in the data sent to OPRA,
namely, totals of customer versus non-customer contracts at the BBO,
All-or-None contingency orders priced better than or equal to the BBO,
and BBO data and last sale data for complex strategies (e.g., spreads,
straddles, buy-writes, etc.).
---------------------------------------------------------------------------

    \4\ A ``Customer'' is any entity that receives the BBO Data Feed
directly from MDX's system and then distributes it either internally
or externally to Subscribers. A ``Subscriber'' is a person (other
than an employee of a Customer) that receives the BBO Data Feed from
a Customer for its own internal use.
    \5\ The Exchange notes that MDX makes available to Customers the
BBO data and last sale data that is included in the BBO Data Feed no
earlier than the time at which the Exchange sends that data to OPRA.
The Exchange also notes that it also makes the BBO data and last
sale data that is included in the BBO Data Feed available directly
to its Trading Permit Holders, and permits them to redistribute the
data to their customers.
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    MDX currently charges Customers a ``direct connect fee'' of $1,000
per connection per month as well as a ``per user fee'' of $25 per month
per ``Authorized User'' or ``Device'' for receipt of the BBO Data Feed
by Subscribers. An ``Authorized User'' is defined as an individual user
(an individual human being) who is uniquely identified (by user ID and
confidential password or other unambiguous method reasonably acceptable
to MDX) and authorized by a Customer to access the BBO Data Feed
supplied by the Customer. A ``Device'' is defined as any computer,
workstation or other item of equipment, fixed or portable, that
receives, accesses and/or displays data in visual, audible or other
form. Either a C2 Trading Permit Holder or a non-C2 Trading Permit
Holder may be a Customer. All Customers are assessed the same fees.
    MDX provides ports that allow Customers to direct connect to MDX to
receive the data feed. Currently, such ports are provided to Customers
free of charge. However, MDX recently made an investment to upgrade the
equipment involved in the ports, and maintenance and upkeep of such
ports has gotten costly, as well. As such, MDX proposes to assess a
monthly fee of $500 per data port in order to recoup such costs and
maintain such equipment in the future, as well as cover other
administrative costs. This amount is similar to the amount of fees
assessed by other exchanges for access to similar data feed ports.\6\
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    \6\ See Securities Exchange Act Release No. 64964 (July 26,
2011) (SR-EDGA-2011-22) and Securities Exchange Act Release No.
64963 (July 26, 2011) (SR-EDGX-2011-21) (in which EDGA Exchange,
Inc. (``EDGA'') and EDGX Exchange, Inc. (``EDGX'') each assess a
monthly fee of $500 per port for access to logical ports used to
receive market data) and also Rule 7015(g) of the NASDAQ Stock
Market LLC (``NASDAQ'') (in which NASDAQ assesses a monthly fee of
$600 per Internet port that is used to deliver market data).
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    The proposed fees would be implemented on March 1, 2012.

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\7\ Specifically, the Exchange also believes the proposed rule
change is consistent with Section 6(b)(4) of the Act,\8\ which provides
that Exchange rules may provide for the equitable allocation of
reasonable dues, fees, and other charges among its Trading Permit
Holders and other persons using its facilities. The proposed adoption
of the monthly $500 per port fee is reasonable because the fee is
within the same range as those assessed on other exchanges, and because
MDX must recoup the costs of upgrading and maintaining the equipment
involved in the ports, as well as cover other administrative costs.\9\
The proposed adoption of the port fee is equitable and not unfairly
discriminatory because it will be assessed to all market participants
equally.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
    \9\ See footnote 6.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    C2 does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) \10\ of the Act and paragraph (f) of Rule 19b-4 \11\
thereunder. At any time within 60 days of the filing of such 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.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
    Send an email to<EMAIL_ADDRESS>Please include File Number
SR-C2-2012-007 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-C2-2012-007. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet 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 Web site 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 the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; 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-C2-2012-007 and should be
submitted on or before March 26, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-5278 Filed 3-2-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Pages 14307-14308]
[FR Doc No: 2022-05250]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94376; File No. SR-CBOE-2022-008]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Its Fees Schedule

March 8, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 1, 2022, Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to amend its Fees Schedule. The text of the proposed rule change is
provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend its fee schedule by removing certain
fee codes related to routed XSP options orders in light of the recent
delisting of XSP options on the Exchange's affiliate Cboe BZX Exchange,
Inc. (``BZX Options''), effective March 1, 2022.
    The Exchange assesses various fees for orders that are routed and
executed on away markets.\3\ The proposed rule change removes fees
codes RX, RY, TX and TY from the Routing Fees table, all of which apply
specifically to XSP orders that are routed away. The Exchange proposes
to eliminate these fee codes as XSP is a proprietary product and the
only other exchange that listed XSP (i.e., BZX Options) has now
delisted it. As such, XSP currently trades exclusively on the Exchange
and therefore cannot route to any other market. Accordingly, the
Exchange proposes to eliminate the now obsolete fee codes and
corresponding fees.
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    \3\ See Cboe Options Fees Schedule, Routing Fees.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\4\ in general, and
furthers the objectives of Section 6(b)(4),\5\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Trading Permit Holders and issuers and
other persons using its facilities. The Exchange also believes that the
proposed rule change is consistent with the objectives of Section
6(b)(5) \6\ requirements that the rules of an exchange be designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, 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, particularly, is not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes the proposed rule change is reasonable,
equitable and not unfairly discriminatory as it does not change the
fees or rebates assessed by the Exchange, but rather updates the Fee
Schedule to remove fee codes associated with routed orders in XSP
options because the only other exchange that listed XSP options (and
that such options could therefore route to) no longer lists XSP options
for trading. Therefore, the proposed rule change is reasonably designed
to update the Fee Schedule to accurately reflect classes available for
routing and is designed to reduce any potential confusion regarding the
availability of XSP options on an exchange other than the Exchange. The
Exchange also believes that the proposed rule change is equitable and
not unfairly discriminatory because all Trading

Permit Holders are equally unable to route orders in XSP, and the
removal of references to routed XSP orders merely updates the Fee
Schedule to reflect this.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act because the proposed rule
change merely updates the Fee Schedule to reflect that a product (i.e.,
XSP options) can no longer be routed to another options exchange and is
designed to reduce any potential confusion without having any impact on
competition.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \7\ and paragraph (f) of Rule 19b-4 \8\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CBOE-2022-008 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to File Number SR-CBOE-2022-008. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2022-008 and should be submitted on
or before April 4, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-05250 Filed 3-11-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Rules and Regulations]
[Pages 19413-19415]
[FR Doc No: 2013-07294]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket Nos. FDA-2011-C-0344 and FDA-2011-C-0463]

Listing of Color Additives Exempt From Certification; Reactive
Blue 246 and Reactive Blue 247 Copolymers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the safe use of additional
copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone
(C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2-
hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester
(C.I. Reactive Blue 247) as color additives in contact lenses. This
action is in response to two color additive petitions (CAPs) filed by
CooperVision, Inc.

DATES: This rule is effective May 2, 2013. See section VII for related
information on the filing of objections. Submit either electronic or
written objections and requests for a hearing by May 1, 2013.

ADDRESSES: You may submit either electronic or written objections and
requests for a hearing, identified by Docket No. FDA-2011-C-0344 (C.I.
Reactive Blue 246) or FDA-2011-C-0463 (C.I. Reactive Blue 247), by any
of the following methods:

Electronic Submissions

    Submit electronic objections in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and the appropriate docket number (FDA-2011-C-0344 for C.I. Reactive
Blue 246 or FDA-2011-C-0463 for C.I. Reactive Blue 247) for this
rulemaking. All objections received will be posted without change to
http://www.regulations.gov, including any personal information
provided. For detailed instructions on submitting objections, see the
``Objections'' heading of the SUPPLEMENTARY INFORMATION section.
    Docket: For access to the dockets to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket numbers, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding CAP 1C0291 (C.I. Reactive
Blue 246): Judith Kidwell, Center for Food Safety and Applied Nutrition
(HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740-3835,<PHONE_NUMBER>.
    Regarding CAP 1C0292 (C.I. Reactive Blue 247): Teresa Croce, Center
for Food Safety and Applied Nutrition (HFS-265), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835,
240-402-1281.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of June 28, 2011 (76
FR 37690), we announced that CooperVision, Inc., 6150 Stoneridge Mall
Rd., suite 370, Pleasanton, CA 94588 (petitioner) had filed two color
additive petitions (CAP 1C0291 and CAP 1C0292). The petitions proposed
to amend the color additive regulations in 21 CFR part 73, subpart D,
Medical Devices, to provide for the safe use of additional copolymers
of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-
propenoic)ester (C.I. Reactive Blue 247) and additional copolymers of
1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive
Blue 246) as color additives in contact lenses. The color additives are
produced by copolymerizing the reactive dyes with various vinyl and/or
acrylic monomers such that the dyes are bound covalently and cross-
linked in the resulting polymer matrix.\1\
---------------------------------------------------------------------------

    \1\ According to the International Union of Pure and Applied
Chemistry (IUPAC), a vinyl polymer is prepared from a monomer
containing the vinyl group -CH=CH2. Acrylic polymers are
one subclass of vinyl polymers; however, not all acrylic polymers
(e.g., methacrylic polymers) are vinyl polymers using the IUPAC
definition (Ref. 1). The term ``vinyl and/or acrylic monomers''
includes monomers that form vinyl polymers, monomers that form
acrylic polymers (e.g., acrylate, methacylate, acrylamide, etc.), or
any combination thereof.

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

    Current regulations for C.I. Reactive Blue 246 and C.I. Reactive
Blue 247 copolymers (21 CFR 73.3106 and 73.3100, respectively) list the
reaction products of these reactive dyes with specific vinyl and/or
acrylic monomers for use in coloring contact lenses.\2\ The petitions
sought to expand the list of permitted monomers to include any suitable
vinyl and/or acrylic monomer capable of forming a contact lens. The
petitions were filed under section 721 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 379e). In Sec.  73.3100,
Reactive Blue 247 is identified as 1,4-bis[(2-hydroxyethyl)amino]-9,10-
anthracenedione bis(2-propenoic)ester. As part of this final rule, we
are correcting the nomenclature for Reactive Blue 247 by inserting ``2-
methyl'' before ``2-propenoic.''
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    \2\ 21 CFR 73.3106 originally allowed for the safe use of 1,4-
bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone (C.I. Reactive
Blue 246) copolymerized with hydroxyethyl methacrylate monomer or a
blend of hydroxyethyl methacrylate and N-vinyl pyrrolidone monomers
(58 FR 17506, April 5, 1993). The regulation was later amended to
also allow for the safe use of C.I. Reactive Blue 246 copolymerized
with a blend of 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate
and N-vinyl pyrrolidone monomers (60 FR 10495, February 27, 1995).
    21 CFR 73.3100 allows for the safe use of 1,4-bis[ (2-
hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester (C.I.
Reactive Blue 247) copolymerized either with glyceryl methacrylate,
methyl methacrylate, and ethylene glycol dimethacrylate monomers, or
with N,N-dimethyl acrylamide, methyl methacrylate, and ethylene
glycol dimethacrylate monomers (61 FR 51584, October 3, 1996).
---------------------------------------------------------------------------

II. Safety Evaluation

    Under section 721(b)(4) of the FD&C Act, a color additive may not
be listed for a particular use unless the data available to FDA
establishes that the color additive is safe for that use. Our color
additive regulations at 21 CFR 70.3(i) define safe to mean that there
is ``convincing evidence that establishes with reasonable certainty
that no harm will result from the intended use of the color additive.''
    As part of our safety evaluation of the color additives, we
considered exposure to unreacted C.I. Reactive Blue 246 and 247 and any
impurities (e.g., reaction byproducts) from the petitioned use of the
color additives. We also considered results from skin sensitization,
ocular irritation, and cytotoxicity studies with either representative
lens materials or extracts from the lens materials (i.e., the color
additives that are the subjects of the petitions).\3\
---------------------------------------------------------------------------

    \3\ Both the petitioner's representative formulations and
currently regulated formulations consist of either C.I. Reactive
Blue 246 or C.I. Reactive Blue 247 copolymerized with various vinyl
and/or acrylic monomers.
---------------------------------------------------------------------------

A. C.I. Reactive Blue 246

    We calculated an exposure estimate for C.I. Reactive Blue 246 from
its proposed use in three representative contact lens formulations
using vinyl and/or acrylic monomers based on results from a
leachability study that was conducted by the petitioner. This study
demonstrated that there was no detectable migration of C.I. Reactive
Blue 246 at the limit of detection (LOD) of an appropriate analytical
method for any of the lens formulations evaluated. We estimated the
potential exposure to any one impurity using the maximum amount of
total impurities determined in C.I. Reactive Blue 246.
    The average daily exposure to C.I. Reactive Blue 246 from its
proposed use would be no greater than 13 nanograms (ng)/person/day (p/
d) and the maximum exposure to any one impurity will not exceed 0.6 ng/
p/d. These estimates represent worst-case exposure, and the actual
exposure to C.I. Reactive Blue 246 and its impurities from the use of
the color additive in contact lenses is expected to be significantly
lower. Based on data submitted in the petitions, as well as other
relevant information, we note that it is highly unlikely that either
C.I. Reactive Blue 246 or its components would migrate from the contact
lens into the aqueous environment of the eye because the reactive dye
is covalently bound and cross-linked during polymerization such that
any migration from the resulting copolymer matrix as a result of the
proposed uses will be negligible. Therefore, we conclude that the
exposure to the color additive, including any impurities that may be
present in it, from the petitioned use would be negligible (Ref. 2).
    The petitioner submitted data from 24 toxicology studies on either
representative lens materials or extracts from representative lens
materials with and without C.I. Reactive Blue 246 to establish the
safety of the copolymerized color additives of C.I. Reactive Blue 246.
Studies included guinea pig maximization studies, in vivo ocular
irritation studies in rabbits, and cytotoxicity studies. Based on our
review of these studies, we conclude that there is no evidence of
toxicity (Ref. 3).

B. C.I. Reactive Blue 247

    We calculated an exposure estimate for C.I. Reactive Blue 247 from
its proposed use in three representative contact lens formulations
using vinyl and/or acrylic monomers based on results from a
leachability study that was conducted by the petitioner. This study
demonstrated that there was no detectable migration of C.I. Reactive
Blue 247 at the LOD of an appropriate analytical method for any of the
lens formulations evaluated. We estimated the potential exposure to any
one impurity using the maximum amount of total impurities determined in
C.I. Reactive Blue 247.
    The average daily exposure to C.I. Reactive Blue 247 from its
proposed use would be no greater than 10 ng/p/d and the maximum
exposure to any one impurity will not exceed 0.5 ng/p/d. These
estimates represent worst-case exposure, and the actual exposure to
C.I. Reactive Blue 247 and its impurities from the use of the color
additive in contact lenses is expected to be significantly lower. Based
on data submitted in the petitions, as well as other relevant
information, we note that it is highly unlikely that either C.I.
Reactive Blue 247 or its components would migrate from the contact lens
into the aqueous environment of the eye because the reactive dye is
covalently bound and cross-linked during polymerization such that any
migration from the resulting copolymer matrix as a result of the
proposed uses will be negligible. Therefore, we conclude that the
exposure to the color additive, including any impurities that may be
present in it, from the petitioned use would be negligible (Ref. 4).
    The petitioner submitted data from 24 toxicology studies on either
representative lens materials or extracts from representative lens
materials with and without C.I. Reactive Blue 247 to establish the
safety of the copolymerized color additives of C. I. Reactive Blue 247.
Studies included guinea pig maximization studies, in vivo ocular
irritation studies in rabbits, and cytotoxicity studies. Based on our
review of these studies, we conclude that there is no evidence of
toxicity (Ref. 5).

III. Conclusion

    Based on the data contained in the two petitions and other
available relevant material, we conclude that the petitioned use of the
reaction products formed by copolymerizing either C.I. Reactive Blue
246 or C.I. Reactive Blue 247 with vinyl and/or acrylic-monomers to
form colored contact lenses is safe and that the color additives will
achieve their intended technical effect. We further conclude that there
is no need for imposing a limitation on the amount of color additive to
be used, beyond the limitation that reactants may be used in amounts
not to exceed the minimum reasonably required to accomplish the
intended technical effect. Therefore, we

are amending the regulations in part 73 (21 CFR part 73) as set forth
in this document. In addition, based upon the factors listed in Sec.
71.20(b) (21 CFR 71.20(b)), we have determined that batch certification
of these color additives is not necessary for the protection of the
public health.

IV. Public Availability of Documents

    In accordance with Sec.  71.15 (21 CFR 71.15), the petition and the
documents that we considered and relied upon in reaching our decision
to approve the petition will be made available for public disclosure
(see FOR FURTHER INFORMATION CONTACT). As provided in Sec.  71.15, we
will delete from the documents any materials that are not available for
public disclosure.

V. Environmental Impact

    We previously considered the environmental effect of this rule, as
stated in the June 28, 2011, Federal Register notice of petitions for
CAP 1C0291 and CAP 1C0292 (76 FR 37690). We stated that we had
determined, under 21 CFR 25.32(l), that this action ``is of a type that
does not individually or cumulatively have a significant effect on the
human environment'' such that neither an environmental assessment nor
an environmental impact statement is required. We have not received any
new information or comments that would affect our previous
determination.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

VII. Objections

    This rule is effective as shown in the DATES section; except as to
any provisions that may be stayed by the filing of proper objections.
Any person who will be adversely affected by this regulation may file
with the Division of Dockets Management (see ADDRESSES) either
electronic or written objections regarding this document. Each
objection shall be separately numbered, and each numbered objection
shall specify with particularity the provisions of the regulation to
which objection is made and the grounds for the objection. Each
numbered objection on which a hearing is requested shall specifically
so state. Failure to request a hearing for any particular objection
shall constitute a waiver of the right to a hearing on that objection.
Each numbered objection for which a hearing is requested shall include
a detailed description and analysis of the specific factual information
intended to be presented in support of the objection in the event that
a hearing is held. Failure to include such a description and analysis
for any particular objection shall constitute a waiver of the right to
a hearing on the objection. It is only necessary to send one set of
documents. Identify documents with the appropriate docket number found
in brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will
publish notice of the objections that we have received or lack thereof
in the Federal Register.

VIII. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

    1. Bar[oacute]n, M., K.-H. Hellwich, M. Hess, K. Horie, et al,
``Glossary of Class Names of Polymers Based on Chemical Structure
and Molecular Architecture (IUPAC Recommendations 2009)'', Pure and
Applied Chemistry, 81(6), pp. 1131-1186, 2009.
    2. Memorandum from H. Lee, Division of Petition Review,
Chemistry Review Team, to J. Kidwell, Division of Petition Review,
Regulatory Group I, FDA, July 26, 2011.
    3. Memorandum from S. Park, Division of Petition Review,
Toxicology Review Team, to M.Harry, Division of Petition Review,
Regulatory Group I, FDA, November 30, 2011.
    4. Memorandum from H. Lee, Division of Petition Review,
Chemistry Review Team, to T.Croce, Division of Petition Review,
Regulatory Group II, FDA, August 16, 2011.
    5. Memorandum from T.Walker, Division of Petition Review,
Toxicology Review Team, to T.Croce, Division of Petition Review,
FDA, January 13, 2012.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for part 73 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.

0
2. Amend Sec.  73.3100 by revising the section heading and paragraph
(a) to read as follows:

Sec.  73.3100  1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione
bis(2-methyl-2-propenoic)ester copolymers.

    (a) Identity. The color additives are the copolymers formed as the
reaction product of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione
bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) (CAS Reg. No.
109561-07-1) with one or more vinyl and/or acrylic monomers to form the
contact lens material.
* * * * *

0
3. Amend Sec.  73.3106 by revising paragraph (a) to read as follows:

Sec.  73.3106  1,4-Bis[4-(2-methacryloxyethyl)
phenylamino]anthraquinone copolymers.

    (a) Identity. The color additives are the copolymers formed as the
reaction product of 1,4-bis[4- (2-
methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246)
(CAS Reg. No. 121888-69-5) with one or more vinyl and/or acrylic
monomers to form the contact lens material.
* * * * *

    Dated: March 25, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2013-07294 Filed 3-29-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 192 (Tuesday, October 4, 2011)]
[Notices]
[Pages 61447-61450]
[FR Doc No: 2011-25528]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65438; File No. SR-CBOE-2011-087]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Proposed Rule Change Related to Market-Wide
Circuit Breakers

September 28, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 27, 2011, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II, below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend Exchange Rule 6.3B to revise the
current methodology for determining when to halt trading in all stock
options trading on CBOE and in all stocks trading on the CBOE Stock
Exchange, LLC (``CBSX,'' the CBOE's stock trading facility), due to
extraordinary market volatility. The text of the rule proposal is
available on the Exchange's Web site (http://www.cboe.org/legal), at
the Exchange's Office of the Secretary, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend its rules to revise the current
methodology for determining when to halt trading in all stocks and
stock options due to extraordinary market volatility. The Exchange is
proposing this rule change in consultation with other equity, options,
and futures markets, the Financial Industry Regulatory Authority, Inc.
(``FINRA''), and staffs of the Commission and the Commodity Futures
Trading Commission (``CFTC'').
    Since May 6, 2010, when the markets experienced excessive
volatility in an abbreviated time period, i.e., the ``flash crash,''
the exchanges and FINRA have implemented market-wide measures designed
to restore investor confidence by reducing the potential for excessive
market volatility. Among the measures adopted include pilot plans for
stock-by-stock trading pauses \3\ and related changes to the stock
market clearly erroneous execution rules \4\ and more stringent stock
market maker quoting requirements.\5\ In addition, on April 5, 2011,
the equities exchanges and FINRA filed a plan pursuant to Rule 608 of
Regulation NMS to address extraordinary market volatility (the ``Limit
Up-Limit Down Plan'').\6\ As proposed, the Limit Up-Limit Down Plan is
designed to prevent trades in individual NMS stocks from occurring
outside specified price bands.
---------------------------------------------------------------------------

    \3\ Exchange Rule 6.3C.
    \4\ Exchange Rule 52.4.
    \5\ Exchange Rules 53.23.01 and 53.56.01.
    \6\ See Securities Exchange Act Release No. 64547 (May 25,
2011), 76 FR 31647 (June 1, 2011).
---------------------------------------------------------------------------

    The Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues
(``Committee'') has recommended that, in addition to the initiatives
already adopted or proposed, the markets should consider reforming the
existing market-wide circuit breakers. Among other things, the
Committee noted that the interrelatedness of today's highly electronic
markets warrants the need to review the present operation of the
system-wide circuit breakers now in place. Specifically, the Committee
recommended that the markets consider replacing the Dow Jones
Industrial Average (``DJIA'') with the S&P 500[supreg] Index (``S&P
500''), revising the 10%, 20%, and 30% decline percentages, reducing
the length of trading halts, and allowing halts to be

triggered up to 2:30 p.m. (all times herein are Central).\7\
---------------------------------------------------------------------------

    \7\ See Summary Report of the Committee, ``Recommendations
Regarding Regulatory Responses to the Market Events of May 6, 2010''
(Feb, 18, 2011). The Exchange notes that CBOE submitted a comment
letter to the Committee that recommended, among other things, reform
of the market-wide circuit breaker rules. See Letter to Mary
Schapiro, Chairman, Commission, and Gary Gensler, Chairman, CFTC,
from Edward J. Joyce, President and Chief Operating Officer, CBOE
(August 3, 2010). The proposed reforms set forth in this rule
proposal differ slightly from the changes recommended in that
comment letter, and represent consensus among the markets of how to
address reform of the market-wide circuit breakers.
---------------------------------------------------------------------------

    The exchanges and FINRA have taken into consideration the
Committee's recommendations, and with some modifications, have proposed
changes to market-wide circuit breakers that the Exchange believes will
provide for a more meaningful measure in today's faster, more
electronic markets, of when to halt stocks and stock options on a
market-wide basis as a result of rapid market declines.
Background
    The Exchange adopted is its rule on market-wide trading halts in
October 1988 as part of an effort by the securities and futures markets
to implement a coordinated means to address potentially destabilizing
market volatility.\8\ The rule, currently reflected in Exchange Rule
6.3B, provides for market-wide halts in trading at specified levels in
order to promote stability and investor confidence during a period of
significant stress.\9\ As the Commission noted in the 1987 approval
order, the rule was intended to enable market participants to establish
an equilibrium between buying and selling interest and to ensure that
market participants have an opportunity to become aware of and respond
to significant price movements. Importantly, the market-wide circuit
breakers were not intended to prevent markets from adjusting to new
price levels; rather, they provide for a speed bump for extremely rapid
market declines.\10\
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 26198 (Oct. 19,
1988).
    \9\ Exchange Rule 6.3B does not currently contain any reference
to the specific levels of decline in the DJIA that would trigger a
market-wide trading halt. Instead, the rule was amended in 1997 to
provide that a market-wide halt will be triggered on the Exchange
whenever a market-wide halt is in effect on the New York Stock
Exchange (``NYSE''). See Securities Exchange Act Release No. 38221
(January 31, 1997), 62 FR 5871 (February 7, 1997)(SR-CBOE-96-78).
    \10\ See note 8, supra.
---------------------------------------------------------------------------

    In its current form,\11\ the rule provides for Level 1, 2, and 3
declines and specified trading halts following such declines. The
values of Levels 1, 2 and 3 are calculated at the beginning of each
calendar quarter, using 10%, 20% and 30%, respectively, of the average
closing value of the DJIA for the month prior to the beginning of the
quarter. Each percentage calculation is rounded to the nearest fifty
points to create the Levels' trigger points. The NYSE distributes new
trigger levels quarterly to the media and via an NYSE Information Memo,
and the new trigger levels are also available on the NYSE Web site.\12\
The values then remain in effect until the next quarterly calculation,
notwithstanding whether the DJIA has moved and a Level 1, 2, or 3
decline is no longer equal to an actual 10%, 20%, or 30% decline in the
most recent closing value of the DJIA.
---------------------------------------------------------------------------

    \11\ The methodology for calculating market-wide trading halts
was last amended in 1998, when declines based on specified point
drops in the DJIA were replaced with the current methodology of
using a percentage decline that is recalculated quarterly. See
Securities Exchange Act Release No. 39846 (April 9, 1998), 63 FR
18477 (April 15, 1998) (SR-NYSE-98-06, SR-Amex-98-09, SR-BSE-98-06,
SR-CHX-98-08, SR-NASD-98-27, and SR-Phlx-98-15).
    \12\ See, e.g., NYSE Regulation Information Memos 11-19 (June
30, 2011) and 11-10 (March 31, 2011).
---------------------------------------------------------------------------

    Once a market-wide circuit breaker is in effect, trading in all
securities on the Exchange, including stock options on CBOE and stocks
on CBSX, halt for the time periods specified below:
Level 1 Halt
    Anytime before 2 p.m.--one hour;
    At or after 2 p.m. but before 2:30 p.m.--30 minutes;
    At or after 2:30 p.m.--trading shall continue, unless there is a
Level 2 Halt.
Level 2 Halt
    Anytime before 1 p.m.--two hours;
    At or after 1 p.m. but before 2 p.m.--one hour;
    At or after 2 p.m.--trading shall halt and not resume for the rest
of the day.
Level 3 Halt
    At any time--trading shall halt and not resume for the rest of the
day.
Proposed Amendments
    As noted above, the Exchange, other equities, options, and futures
markets, and FINRA propose to amend the market-wide circuit breakers to
take into consideration the recommendations of the Committee, and to
provide for more meaningful measures in today's markets of when to halt
trading in all stocks and stock options. Accordingly, the Exchange
proposes to amend Rule 6.3B as follows: (i) Replace the DJIA with the
S&P 500; (ii) replace the quarterly calendar recalculation of Rule 6.3B
triggers with daily recalculations: (iii) replace the 10%, 20%, and 30%
market decline percentages with 7%, 13%, and 20% market decline
percentages; (iv) modify the length of the trading halts associated
with each market decline level; and (v) modify the times when a trading
halt may be triggered. The Exchange believes that these proposed
amendments update the rule to reflect today's high-speed, highly
electronic trading market while still meeting the original purpose of
the market-wide circuit breaker rules: to ensure that market
participants have an opportunity to become aware of and respond to
significant price movements.
    First, the Exchange proposes to replace the DJIA with the S&P 500.
The Exchange believes that because the S&P 500 is based on the trading
prices of 500 stocks, as compared to the 30 stocks that comprise the
DJIA, the S&P 500 represents a broader base of stocks against which to
measure whether extraordinary market-wide volatility is occurring. In
addition, as noted by the Committee, using an index that correlates
closely with derivative products, such as the E-Mini and SPY, will
allow for a better cross-market measure of market volatility.
    Second, the Exchange proposes to change the recalculation of the
trigger values from once every calendar quarter to daily. The Exchange
believes that updating the trigger values daily will better reflect
current market conditions. In particular, a daily recalculation will
ensure that the percentage drop triggers relate to current market
conditions, and are not compared to what may be stale market
conditions. As noted in the proposed rule, the daily calculations of
the trigger values will be published before the trading day begins.\13\
---------------------------------------------------------------------------

    \13\ The Exchange and other markets will advise via Circular (or
Trader Alert or similar notice) the specific methodology for
publishing the daily calculations, as well as the manner by which
the markets will halt trading in all stocks and stock options should
a Rule 6.3B trading halt be triggered.
---------------------------------------------------------------------------

    Third, the Exchange proposes to decrease the current Level 1, 2,
and 3 declines of 10%, 20%, and 30% to a Level 1 Market Decline of 7%,
a Level 2 Market Decline of 13%, and Level 3 Market Decline of 20%. In
particular, as demonstrated by the May 6, 2010 flash crash, the current
Level 1 10% decline may be too high a threshold before determining
whether to halt trading across all securities. In fact, since adoption,
the markets have halted only once, on October 27, 1997.\14\
Accordingly, to reflect the potential that a lower, yet still
significant decline may

warrant a market-wide trading halt, the Exchange proposes to lower the
market decline percentage thresholds.
---------------------------------------------------------------------------

    \14\ At that time, the triggers were based on absolute declines
in the DJIA (350 point decrease for a Level 1 halt and 550 point
decrease for a Level 2 halt).
---------------------------------------------------------------------------

    As further proposed, the Exchange would halt trading based on a
Level 1 or Level 2 Market Decline only once per day. For example, if a
Level 1 Market Decline were to occur and trading were halted, following
the reopening of trading, the Exchange would not halt the market again
unless a Level 2 Market Decline were to occur. Likewise, following the
reopening of trading after a Level 2 Market Decline, the Exchange would
not halt trading again unless a Level 3 Market Decline were to occur,
at which point, trading in all stocks and stock options would be halted
until the next trading day.
    Fourth, to correspond with the lower percentages associated with
triggering a trading halt, the Exchange also proposes to shorten the
length of the market-wide trading halts associated with each Level. As
proposed, a Level 1 or 2 Market Decline occurring after 8:30 a.m. and
up to and including 2:25 p.m. or, in the case of an early scheduled
close, 11:25 a.m., would result in a trading halt in all stocks and
stock options for 15 minutes.
    The Exchange believes that by reducing the percentage threshold,
coupled with the reduced length of a trading halt, the proposed rule
would allow for trading halts for serious market declines, while at the
same time, would minimize disruption to the market by allowing for
trading to continue after the proposed more-abbreviated trading halt.
The Exchange believes that in today's markets, where trading
information travels in micro-second speed, a 15-minute trading halt
strikes the appropriate balance between the need to halt trading for
market participants to assess the market, while at the same time
reducing the time that the market is halted.
    Finally, because the proposed Level 1 and Level 2 trading halts
will now be 15 minutes, the Exchange proposes amending the rule to
allow for a Level 1 or 2 Market Decline to trigger a trading halt up to
2:25 p.m. (or, in the case of an early scheduled close, 11:25 a.m.)
Under the current rule, a trading halt cannot be triggered after 1:30
p.m., and this time corresponds to the need for the markets both to
reopen following a 30-minute halt and to engage in a fair and orderly
closing process. However, as the markets experienced on May 6, 2010,
even if the Level 1 decline had occurred that day, because the market
decline occurred after 1:30 p.m., it would not have triggered a halt
under the current rule. The Committee recommended that trading halts be
triggered up to 2:30 p.m. The Exchange agrees that the proposed
amendments must strike the appropriate balance between permitting
trading halts as late in the day as feasible without interrupting the
closing process.
    Accordingly, to accommodate certain existing exchange rules
concerning closing procedures, including, for example, the publication
of imbalance information beginning at 2:45 p.m. and the restrictions on
entry and cancellation of market on close (``MOC'') and limit on close
(``LOC'') orders after 2:45 p.m.,\15\ the Exchange proposes that the
last Level 1 or Level 2 Market Decline trading halt should be 2:25 p.m.
(or, in the case of an early scheduled close, 11:25 a.m.). The Exchange
proposes 2:25 p.m. as the cut-off time so that there is time following
the 15-minute trading halt for the markets to reopen before the 2:45
cut-off for entry and cancellation of MOC and LOC orders under exchange
rules.
---------------------------------------------------------------------------

    \15\ See, e.g., NYSE Rule 123C.
---------------------------------------------------------------------------

    As with current Level 3 declines, under the proposed rule, a Level
3 Market Decline would halt trading for the remainder of the trading
day, including any trading that may take place after 3 p.m., and would
not resume until the next trading day.
    In addition to these proposed changes, the Exchange proposes to add
to Rule 6.3B how the markets will reopen following a 15-minute trading
halt.\16\ For stocks, similar to the reopening procedures set forth in
Rule 6.3C, the Exchange proposes that if a circuit breaker is initiated
in all stocks, all markets will halt trading in those stocks until the
primary listing market has resumed trading in the stock or notice has
been provided by the primary listing market that trading may resume. As
further proposed, if the primary listing market does not reopen a stock
within 15 minutes following the end of the trading halt, other markets
may resume trading in that stock. For options overlying stocks, similar
to the reopening procedures set forth in Rule 6.3.06, the Exchange
proposes that if a circuit breaker is initiated in all stocks, all
markets will halt trading in the options on those stocks until the
primary listing market has resumed trading in the stock or notice has
been provided by the primary listing market that trading may resume. If
the primary listing market does not reopen a stock within 15 minutes
following the end of the trading halt, other markets may resume trading
in the options on that stock if at least one market has resumed traded
[sic] in the stock. For all other stock options, e.g., stock index
options, the Exchange proposes that if a circuit breaker is initiated
in all stocks, all markets shall halt trading in such other stock
options and may resume trading in such options anytime after the 15-
minute halt period.\17\
---------------------------------------------------------------------------

    \16\ Upon reopening, a rotation shall be held in each class of
options and stock in accordance with the Exchange's opening
procedures, see, e.g., Rules 6.3B and 51.3, unless the Exchange
concludes that a different method of reopening is appropriate under
the circumstances, including but not limited to, no rotation, an
abbreviated rotation or any other variation in the manner of the
rotation.
    \17\ The Exchange understands that other markets are submitting
similar rule changes and revising procedures to address market-wide
circuit breakers and reopenings for stocks, options and futures. The
Exchange believes it is integral that the markets have consistent
procedures for market-wide circuit breakers and reopenings (e.g.,
our intention is to have [sic] same ability to reopen trading in
stock index options when futures markets reopen). As a result, to
the extent it may be necessary, the Exchange reserves the right to
modify its proposed rule change in order to conform its procedures
based on a review of the rule change filings and procedures of the
other equities, options and futures markets.
---------------------------------------------------------------------------

2. Statutory Basis
    The basis under the Act for these proposed rule changes are [sic]
the requirement under Section 6(b)(5) \18\ that an Exchange have rules
that are 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. Specifically, this rule proposal
supports the objectives of perfecting the mechanism of a free and open
market and the national market system because it promotes uniformity
across markets concerning when and how to halt trading in all stocks
and stock options as a result of extraordinary market volatility.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    The Exchange neither solicited nor received comments on the
proposal.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i)

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed
changes to the market-wide circuit breaker regime are consistent with
the Act. The Commission specifically requests comment on the following:
     As discussed above, the proposed rule change would narrow
the percentage market declines that would trigger a market-wide halt in
trading. How would the proposed changes interact with the existing
single-stock circuit breaker pilot program \19\ or, if approved, the
proposed NMS Plan to establish a limit-up/limit-down mechanism for
individual securities? \20\
---------------------------------------------------------------------------

    \19\ See Securities Exchange Act Release No. 64735 (June 23,
2011), 76 FR 38243 (June 29, 2011) (SR-BATS-2011-016; SR-BYX-2011-
011; SR-BX-2011-025; SR-CBOE-2011-049; SR-CHX-2011-09; SR-EDGA-2011-
15; SR-EDGX-2011-14; SR-FINRA-2011-023; SR-ISE-2011-028; SR-NASDAQ-
2011-067; SR-NYSE-2011-21; SR-NYSEAmex-2011-32; SR-NYSEArca-2011-26;
SR-NSX-2011-06; SR-Phlx-2011-64) (approving the ``Phase III Pilot
Program''). The Phase III Pilot Program has been extended through
January 2012. See, e.g., Securities Exchange Act Release 65094
(August 10, 2011), 76 FR 50779 (August 16, 2011) (SR-NASDAQ-2011-
011).
    \20\ See Securities Exchange Act Release No. 64547 (May 25,
2011), 76 FR 31647 (June 1, 2011).
---------------------------------------------------------------------------

     To what extent could the concurrent triggering of single
stock circuit breakers in many S&P 500 Index stocks lead to
difficulties in calculating the index? Would the triggering of many
single stock circuit breakers in a general market downturn cause the
index calculation to become stale and thereby delay the triggering of
the market-wide circuit breaker?
     Should the market-wide circuit breaker be triggered if a
sufficient number of single-stock circuit breakers or price limits are
triggered, and materially affect calculations of the S&P 500 Index?
     Should market centers implement rules that mandate
cancellation of pending orders in the event a market-wide circuit
breaker is triggered? If so, should such a rule require cancellation of
all orders or only certain order types (e.g., limit orders)? Should all
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     Should some provision be made to end the regular trading
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     In the event of a Level 3 Market Decline, should some
provision be made for the markets to hold a closing auction?
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trading resumes in other venues?
     In the event of a Level 3 Market Decline, should the
markets wait for the primary market to reopen trading in a particular
security on the next trading day before trading in that security
resumes?
    Comments may be submitted by any of the following methods:

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     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
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     Send paper comments in triplicate to Elizabeth M. Murphy,
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All submissions should refer to File Number SR-CBOE-2011-087. This file
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    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-25528 Filed 10-3-11; 8:45 am]
BILLING CODE 8011-01-P


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EUROPEAN COMMISSION
HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL
Scientific Steering Committee
OPINION on :
NECROPHAGOUS BIRDS AS POSSIBLE TRANSMITTERS OF TSE/BSE
ADOPTED BY
THE SCIENTIFIC STEERING COMMITTEE
AT ITS MEETING OF 7-8 NOVEMBER 2002

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OPINION
BACKGROUND AND MANDATE
Concern has been raised to the theoretical risk that carrion or necrophagous birds could play a
1
role in the spread of TSE and exposure to TSE of humans by contracting the disease, by
spreading the agent passively in waste from their food or by exposure of persons involved in
handling the birds and the direct release of the agent in the environment.
On  9  October  2001
the CMIEET (Multidisciplinary
Scientific Committee for Research into Transmissible
Spongiform Encephalopathies, Spain), adopted a scientific opinion and report on Carrion birds
as possible vectors of bovine spongiform encephalopathy and on possible alternatives to the use
of ruminant carcasses as food for these animals. The Scientific Steering Committee was
subsequently requested to:
(1)
Evaluate the opinion of the Spanish Scientific Committee on TSEs in relation to
necrophagous birds being possible transmitters of BSE and
(2)  Advise on the safety with regard to TSE risks for the use of dead ruminants containing
specified risk material (SRM) for the feeding of necrophagous birds and, if appropriate,
suggest examples of conditions under which such feeding can be carried out safely.
The opinion hereafter pays special attention to the above mentioned spanish report and is based
on the discussions held by the TSE/BSE ad hoc Group at its meetings of 25 July and 5
September 2002 (rapporetur: Dr.E.Vanopdenbosch),
as well as contributions from
Prof.Dr.L.Bolis, Dr.P.Brown and Dr.R.Bradley.
OPINION
1.
Necrophagous birds as possible transmitters of BSE.
The SSC considers that the evaluation  of necrophagous birds as possible transmitters of
BSE, should theoretically
be approached from a broader perspective of mammals and
birds which prey on, or are carrion eaters (scavengers) of mammalian species. Thus,
carnivorous and omnivorous mammals, birds of prey (vultures,  falcons, eagles, hawks
etc.), carrion eating birds (crows, magpies etc.) in general could be considered possible
vectors of transmission and/or spread of TSE infectivity in the environment. In view also
of the occurrence of Chronic Wasting Disease (CWD) in various deer species it should not
be accepted that domestic cattle and sheep are necessarily the only source of TSE agent
exposure for carnivorous species. While some information is available on the susceptibility
of wild/exotic/zoo animals to natural or experimental infection with certain TSE agents,
nothing is known of the possibility of occurrence of TSE in wild animal populations, other
than among the species of deer affected by CWD in the USA.
1
The carrion birds are animals whose diet regularly or occasionally includes the consumption of carcasses,
including possibly TSE infected ruminant carcasses.

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The SSC therefore took, in addition to the opinion of the Spanish CMIEET, also the
following publications into account :
2
-
SSC Opinion (1999) on the risks of non conventional transmissible agents,
conventional infectious agents or other hazards such as toxic substances entering the
human food or animal feed chains via raw material from fallen stock and dead animals
(including also: ruminants, pigs, poultry, fish, wild/exotic/zoo animals, fur animals,
cats, laboratory animals and fish) or via condemned materials.
-
SSC Opinion (1999) on the risk born by recycling animal by-products as feed with
regard to propagating TSE in non-ruminant farmed animals.
-
SSC Opinion (2000) on the Scientific basis for import bans proposed by 3 member
states with regard to BSE risks in France and the Republic of Ireland; on the Scientific
basis for several measures proposed by France with regard to BSE risks and on the
Scientific basis for banning animal protein from feed for all farmed animals, including
pig, poultry, fish and pet animals.
-
Scrimgeour, E. M., et al., 1996. Disposal of rendered offal. The Veterinary Record,
August 31, 219-220. This paper raises the issue of birds as uninfected vectors of
infectivity from landfill carcass sites in 1996.
-
Tella,  J.L., 2001. Action is needed now, or BSE crisis could wipe out endangered
birds of prey. Nature, 410: 408.
The SSC analysed the above literature from the following perspectives:
-
The risk of TSE infection and agent replication in birds in general and in necrophagous
birds in particular;
-
Risk of passive spread of TSE
-
Human exposure risk
It concluded as follows:
-
The scientific basis (both literature and field data) for advising on the safety with
regard to TSE risks, of the use of dead ruminants containing specified risk material
(SRM) as bird feed, is very limited. As far as birds are concerned, most data relate to
the domestic fowl. No literature could be found on aspects such as microscopic brain
examinations in zoo carnivorous/omnivorous birds (often fed on waste bovine material
that in the past may have been infected with BSE) nor on the epidemiology of TSEs as
possibly influenced by the role of prey animals and carrion eaters (scavengers) .
3
2
The opinion of 9 October 2001 of the CMIEET was originally prepared in Spanish and a translation of the
opinion into English is therefore attached to this opinion for ease of reference. At certain places, comments made
by the TSE/BSE ad hoc Group at its meeting of 25 July 2002 have been introduced and they are highlighted.
3
It would hardly be possible to analyse this possible role with an epidemiological design.

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-
The possibility of active replication of PrP
Sc
in birds is remote, if existing at all.
(Necrophagous and omnivorous) birds are nevertheless able to ingest BSE infectious
material and to spread the ingested infectious material through dissemination of faeces
because it is unlikely that the pathological prion protein would be completely
destroyed in the digestive tract. Moreover, plumage, claws and beak may also be
contaminated with infectious material, which is then released into the environment.
-
Although there is no data on TSE epidemiology indicating any significant role of any
such pathways in the spread of scrapie, it cannot be excluded that they could play a
part in the transportation of TSE infected materials, given that these birds can cover
great distances and may also migrate.
2
safety with regard to TSE risks of the use of dead ruminants containing specified risk
material (SRM) for the feeding of necrophagous birds; examples of conditions under
which such feeding can be carried out safely.
One could theoretically consider implementing rigorous health measures to prevent birds
from having access to carcasses of animal species susceptible to TSE, but in view of the
very limited human exposure risk this may bring about changes to the ecology created by
the traditional practices and could jeopardise the conservation of certain animal species.
On the other hand, feeding practices should not lead to an artificial increase of the number
of  potential TSE transmission sources, and their possible spread. Whereas it is recognised
that the removal of fallen animals from remote wild areas is not a realistic option under all
circumstances, the SSC considers that feeding programmes of wild species such as
necrophagous birds should thus not become an alternative way of disposal of fallen
ruminant stock posing a TSE risk nor of specified risk materials.
The SSC considers that the above recommendations are for the time being also valid for
other prey animals and carrion eaters (scavengers), for which even less literature is
available.
3.
The above conclusions are consistent with the opinion of 9 October 2001 of the CMIEET and with
its main conclusions.

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Annex:
CMIEET
Multidisciplinary Scientific Committee for Research into
Transmissible Spongiform Encephalopathies
Ministry of Science and Technology
SCIENTIFIC OPINION:
REPORT ON CARRION BIRDS AS POSSIBLE VECTORS OF BOVINE SPONGIFORM
ENCEPHALOPATHY
(POSSIBLE ALTERNATIVES TO THE USE OF RUMINANT CARCASSES AS FOOD
FOR THESE ANIMALS)
Adopted by CMIEET during its meeting held in Madrid on 9 October 2001
-----------------------
Translation into English of:
OPINIÓN CIENTÍFICA:
INFORME SOBRE LAS AVES CARROÑERAS COMO POSIBLES VECTORES DE LA
ENCEFALOPATÍA ESPONGIFORME BOVINA
(POSIBLES ALTERNATIVAS AL USO DE CADÁVERES DE RUMIANTES PARA EL
ABASTECIMIENTO DE ESTOS ANIMALES)
Adoptada por el Comité Científico Multidisciplinar para la Investigación en
Encefalopatías Espongiformes Transmisibles (CMIEET),   Ministerio de Ciencia y
Tecnología, en su reunión celebrada en Madrid, el 9 de Octubre de 2001
Note:
When producing this report CMIEET concentrated on analysing and discussing
information published in scientific reviews. Other technical documents, such as
compilations of existing legislation and documents provided by organisations and
persons involved in natural resources management, were also taken into consideration.
Please note that opinions expressed by CMIEET are not necessarily binding on the
Ministry of Science and Technology.

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INDEX
Page
I.
Executive Summary
3
II.
Subject matter
4
III.
Definitions and Abbreviations
4
IV.
Background
4
V.
Analysis of Scientific Evidence and Discussion
V.1.
Information on TSEs in necrophagous birds
V.2.
Information on TSEs in birds in general
V.3.
Digestive physiology of necrophagous birds with possible effects
on the viability of the agent
V.4. Evaluation of uncertainties surrounding the possibility of
necrophagous birds becoming infected by or spreading the BSE agent
V.5.
Practical proposals for action regarding the use of carcasses
from other species to feed these birds
V.6.
The potential role of other wild species in the spread of TSEs
5
5
5
6
7
9
11
VI.
Conclusions
13
VII.
References
14
VIII.
Annexes
VIII.1. Annex I.   Carrion bird numbers
VIII.2. Annex II. Specific information required
16
17

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I.
EXECUTIVE SUMMARY
The eradication of TSEs will require the removal of potential sources of the agent, such as
bovine (and ovine) carcasses, from the natural environment. This will result in the elimination, or
at least the reduction, of food sources for necrophagous species, for the conservation of which
Spain has responsibilities unique in Europe.
There are no studies on the presence of TSE in necrophagous birds, nor is there any solid
evidence that such processes affect birds in general. In fact, it has not even been possible to
demonstrate birds’ sensitivity to BSE under test conditions. This absence of observations can
theoretically be explained by the low level of similarity — only 30% — between prion protein
sequences of birds and mammals.
The possibility of necrophagous birds’ digestive systems being somehow adapted to breaking
down and extracting nutrients from prion proteins could be of great importance, not only in the
interests of ensuring environmental biosafety but also as a potential final stage in the elimination
of TSE risks: there is therefore a case for research into this issue.
There are two alternatives to deal with the immediate problem of food for necrophagous birds: a)
keep using bovine carcasses, but on the condition that rapid test results are negative b) replacing
them by other species not susceptible to BSE. The first alternative will not result in any
substantial increase in costs since tests on all dead bovines have been obligatory since 1 July
2001 (Order of 26 July 2001). The second could create complex logistical problems and be
considerably more expensive in regions where numbers of such species are low.
Consideration should be given to a moratorium on the use of sheep carcasses until it can be
demonstrated that any cases of scrapie emerging in this country are unrelated to processes caused
by the BSE agent.
If we take the global view of the issue of prions in the environment, we should also pay special
attention to the possible problems related to other wild species documented as being susceptible
to TSEs, such as mustelids (occasional carrion eaters) and cervids. We must also not lose sight of
the potential for disaster if the Iberian lynx, a unique and endangered species, were to become
involved in a possible wild BSE cycle.
We must also draw attention to the need for detailed studies of costs and of the uncertainties
surrounding the numbers of domestic species and carrion animals, and for research into their
susceptibility to TSEs and into the role which other wild species may play in the survival and
spread of TSEs in the natural environment.

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II.
SUBJECT MATTER
Carrion birds as possible vectors of bovine spongiform encephalopathy. Possible alternatives to
the use of ruminant carcasses as food for such animals
III.
DEFINITIONS AND ABBREVIATIONS
Carrion or necrophagous animals: Carnivorous or omnivorous animals whose diet regularly or
occasionally includes the consumption of carcasses. Annex I contains a list of the specific
carrion birds referred to in this report.
AC: Autonomous Community
TSE: Transmissible spongiform encephalopathy
BSE: bovine spongiform encephalopathy
SRM: specific risk materials
PrP: Prion protein
PrP : normal prion cellular protein
C
PrP
SC
: Resistant or pathological prion protein associated with scrapie and considered to be
responsible for transmissible spongiform encephalopathies
SEO: Sociedad Española de Ornitología (Spanish Ornithological Society)
CNS: Central Nervous System
IV.
BACKGROUND
The European programme for the eradication of transmissible spongiform encephalopathies in
animals requires all sources of contagion to be monitored and destroyed. This implies that
carcasses of animals which may potentially have been infected should be removed from the
environment and destroyed under the correct conditions. This measure, which is of primary
importance for TSE control, has an unwanted side effect – namely, the disappearance of
traditional sources of food for necrophagous species. This group includes mammals and birds,
although the latter have received more public attention because of their higher visibility and
because some of them are endemic species in danger of extinction (Directives 79/409/EEC and
91/244/EEC, Law 4/1989). In this connection we must point out that Spain is the main reserve
for carrion birds in Europe since it is home to more than 80-90% of the populations of these birds
(Annex I), plus one unique species, the lammergeier or bearded vulture. Implementing rigorous
health measures to remove animal carcasses would bring about changes to the traditional semi-
natural equilibrium and could jeopardise the conservation of an irreplaceable part of our natural
heritage.

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In this context of biological conservation, we must draw attention to the potential problem of
circulation of TSE agents in wild species since some of these species, such as mustelids and
cervids, have proven susceptible to TSE. As far as the former are concerned, we must stress that
even though these animals rarely feed on carrion they cannot be discounted as possible carriers
of TSEs given our lack of knowledge of TSE epidemiology. It should also be borne in mind that
there are other land species apart from carrion birds which feed on animal carcasses and whose
role has gone ignored until now. These species, some of which are of immense biological value,
could also be affected if this food source were to disappear. Finally, although cervids may not
appear to present an immediate problem they should be taken into consideration as part of a
complete analysis of the issue of TSEs in the natural environment.
V.
ANALYSIS OF SCIENTIFIC EVIDENCE AND DISCUSSION
V.1. Information on TSE in necrophagous birds
There is no information of any kind on the presence of TSE in necrophagous birds. This situation
does not necessarily mean that they are not affected, since, first, it would be difficult to observe
infected birds and, second, no post-mortem studies have been carried out to date. We must not
forget that these types of birds are not present in Great Britain, which has seen the highest
number of cases, and that so far the Spanish situation cannot be considered very serious. Even
so, and if such birds were susceptible to the scrapie agent, one would expect to see over time a
higher mortality rate related to the consumption of sheep, which has not so far been recorded.
Thus, if the source of BSE were an ovine strain or a pre-existent and very rare process, we could
even accept that these species might be resistant to such processes, or at least that they would not
play a major role in their spread, since they certainly could have been exposed to these agents at
any time.
[Note: At its meetings of 25 July and 5 September 2002, The TSS/BSE ad hoc Group noticed that there is
no scientific information available on the presence of TSE in necrophagous birds, and agrees that
this absence of evidence does not necessarily mean that they cannot be affected. The Group
further considered While vultures do not occur in several other Community countries, carrion
eaters do, and so if a wider consideration is to given to the possibility of such species providing
transport of TSE agents, even as mechanical vectors, a broader perspective of the issue is
required.]
V.2. Information on TSE in birds in general
Various bibliographical searches have only discovered two works describing suspected clinical
symptoms, where a confirming diagnosis was not obtained, and one experimental attempt at
infection, where transmission was not demonstrated.
In 1991, Schoon et al. described three cases where symptoms compatible with spongiform
encephalopathies were observed in ostriches in two zoos in northern Germany, in 1986, 1988 and
1989. The birds displayed symptoms of a nervous disorder with ataxia, changes to balance,
uncoordinated movements during feeding and microscopic lesions on the brain stem and medulla
oblongata similar to those observed in cases of TSE described in mammals. One notable aspect is
that the birds’ feed included meat from livestock animals which had been the subject of

DRAFT
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emergency slaughter. However, no conclusive diagnosis could be made since it was not possible
to rule out toxic or nutritional aetiology. The authors referred to the existence of other animals, in
both zoos, which died displaying the same symptoms but could not be examined post-mortem.
In 1996, on a farm in Kent (UK) with cases of BSE in its livestock, a 30-month old hen (allowed
the free run of the farm) displayed symptoms of behavioural change: the animal had trouble
entering the coop and became panicked and lost its balance in stressful situations. The process
lasted at least 10 weeks and during the final phase it displayed noticeable weight loss,
progressive ataxia and violent trembling of the body and limbs. The histological lesions observed
correspond to neuronal death, more obvious in the Purkinje cells, and minimal vacuolation.
Consequent immunohistochemical studies did not shed any light on the aetiology of this process,
due to the differences of opinion between the teams which had studied the case (Cawthorne,
1997; Narang, 1997).
Dawson et al. in 1991 carried out an experiment on domestic birds, hamsters, pigs and cows,
which were intravenously administered with a homogenised preparation of BSE-infected brain
tissue. The preparation was also administered, orally, to the pigs and birds. Results confirmed
that the disease spread to the cattle and pigs. It was not demonstrated that it had spread to
hamsters and birds although tests on these species had not been completed when the results were
published. No further references from these authors clarifying these data have been found.
[Note:  On the basis of the above and of previous opinions of the SSC, the TSE/BSE ad hoc Group
concluded at its meetings of 25 July and 5 September 2002 that there is no evidence from the
world literature that a natural TSE exists in poultry. Unpublished, but completed experimental
studies, of the transmissibility of the BSE agent to the domestic fowl have not detected evidence
of transmission.  These studies included primary parenteral and oral exposures of domestic fowl
chicks to BSE affected brain tissue and subpassage of nervous systems tissue (into further
chicks, intracerebrally and into a panel of inbred mice) from selected survivors of both primary
exposure experiments (G. A. H. Wells, personal communication). .  The possibility that poultry,
under field conditions, could after oral exposure,act as healthy carriers in the spread of TSE-
agents is l hypothetical and no results of experiments conducted as yet are available to support
this hypothesis.]
V.3. Digestive physiology of necrophagous birds with possible effects on the viability of the
agent
The fact that necrophagous birds are now able to ingest highly infectious materials suggests that
they may over time have developed resistance to many infectious agents  (Houston and Cooper,
1975) and may even be able to extract nutrients from them. TSEs documented over the past 200
years could be included in this adaptation. Although the capacity for individual immune response
may be an important mechanism for the species as a whole, a highly efficient digestive
physiology which destroyed pathogenic agents would be much more significant in the interests
of the environment, since this would prevent the passive spread of these agents to sensitive
species.
The digestive system of carrion birds presents conditions of extreme acidity, around pH 1-1.2 in
the stomach (Houston and Cooper, 1975; Farner, 1967), capable of dissolving bone calcium

DRAFT
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completely. Faecal matter, moreover, is mixed in the cloaca with products consisting almost
exclusively of uric acid excreted by the kidneys. While these conditions ensure a high level of
sterilisation in respect of the vast majority of biological pathogenic agents, their effect on prions
has not been fully confirmed, since prion proteins are more sensitive to alkalinity (pH > 10
quickly deactivates them) than to acidity. It is for this exact reason — this possibility of
deactivation by alkalis such as NaOH or sodium hypochlorite — that the effects of acid pH do
not appear to have been investigated. The bibliographical research carried out for this report
found only references to slight deactivation of the scrapie prion at pH 2-10 (Mould et al., 1965)
and even at pH 0.1 for one hour in hydrochloric acid (Brown et al., 1986). However, these
observations contradict the widely recommended practice when handling of material for
histology, namely that it should be deactivated using formic acid (Brown et al., 1990, Taylor,
1995, Taylor et al., 1997). This last point suggests that levels of deactivation in acid media may
vary depending on other factors. In this connection, one could extrapolate that conditions in the
digestive tract of carrion birds probably provide these helpful factors both as a means to extract
nutritious proteins and as a form of protection against biological agents.
As far as proteolytic enzymes of the digestive system such as trypsin and pepsin are concerned,
these do not appear to be capable of effectively destroying prions under test conditions (Taylor,
2000), although it cannot be ruled out that under the specific conditions of a combination of
proteolytic factors in carrion birds’ digestive system their activity could be completely efficient.
No specific information has been found concerning these points, so any studies on this subject
should be considered as being of great interest. If the existence of such a mechanism with an
effect on pathological prion proteins were to be confirmed it would be of great relevance as it
would offer a complementary ecological and low-cost alternative for the destruction of SRM.
V.4. Evaluation of uncertainties surrounding the possibility of necrophagous birds
becoming infected by or spreading the BSE agent
As far as carrion birds are concerned there are principally three types of risks associated with
TSE: a) the risk that they contract the disease, b) the risk of spreading the agent passively in
waste from their food, and c) exposure of persons involved in handling carrion and the direct
release of the agent into the natural environment.