[Federal Register: December 7, 2005 (Volume 70, Number 234)]
[Notices]
[Page 72867-72870]
[DOCID:fr07de05-133]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52860; File No. SR-CBOE-2005-100]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Obligations of Designated Primary Market Makers
During the Implementation of the PAR Official Program

November 30, 2005.
    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 November 22, 2005, 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.
CBOE has designated this proposal as non-controversial under section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\
which renders the proposed rule change effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to issue a regulatory circular that will
subject certain Designated Primary Market Makers (``DPMs'') to
obligations that were removed upon the approval of the Exchange's PAR
Official proposal.\5\ The text of the proposed regulatory circular is
attached hereto as Exhibit A.
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    \5\ See infra note 6 and accompanying text.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the 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
    On November 18, 2005, the Commission approved CBOE's proposal to
remove a DPM's obligation to execute orders as an agent, including as a
floor broker, in its allocated securities on the Exchange in any
trading station and to allow the Exchange to appoint an Exchange
employee or independent contractor (``PAR Official'') to assume many of
the functions and obligations that DPMs previously held (``PAR Official
proposal'').\6\ A specific provision of rules approved in connection
with the PAR Official proposal gives the Exchange up to ninety days to
implement the PAR Official proposal.\7\ Because this ninety-day
implementation provision could mean that some DPMs will continue to be
required to represent orders as agents in their allocated securities,
those DPMs must still be subject to the same obligations that governed
DPM operations prior to the approval of the PAR Official proposal. As
such, the Exchange has incorporated those obligations into a regulatory
circular that will govern the operations of those DPMs that were not
immediately included in the PAR Official conversion as of November 18,
2005. These rules and obligations, as provided in the regulatory
circular attached hereto as Exhibit A, were adopted directly from the
now-former DPM rules.
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    \6\ See Securities Exchange Act Release No. 52798 (November 18,
2005), 70 FR 71344 (November 28, 2005).
    \7\ See Interpretation and Policy .01 to CBOE Rule 7.12.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b) \8\ of the Act in general, and furthers the
objectives of section 6(b)(5) \9\ in particular, in that it is designed
to promote just and equitable principles of trade, to prevent
fraudulent and manipulative acts, and, in general, to protect investors
and the public interest.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

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

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

    The foregoing proposed rule change has become effective pursuant to
section 19(b)(3)(A) of the Act \10\ and Rule 19b-4(f)(6) thereunder
\11\ because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; or (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate. In addition, the Exchange provided the
Commission with written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of the filing of
the proposed rule change as required by Rule 19b-4(f)(6).\12\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ Id.
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    Pursuant to Rule 19b-4(f)(6)(iii) under the Act,\13\ the proposal
does not become operative until 30 days after the date of its filing,
or such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest. The Exchange has
requested that the Commission waive the 30-day operative delay so that
the proposed rule change becomes effective immediately. The Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest. The Commission notes
that granting this waiver will ensure that DPMs not immediately subject
to the new rules approved recently in connection with the PAR Official
proposal will continue to be subject to appropriate regulation.
Therefore, the Commission has determined to waive the 30-day delay

and to allow the proposed rule change to become operative
immediately.\14\
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    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ For purposes only of waiving the operative delay of this
proposal, the Commission notes that it has considered the proposed
rule's impact on efficiency, competition, and capital formation. 15
U.S.C. 78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.\15\
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    \15\ 15 U.S.C. 78s(b)(3)(C).
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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 e-mail to<EMAIL_ADDRESS>Please include

File No. SR-CBOE-2005-100 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.
    All submissions should refer to File Number SR-CBOE-2005-100. 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 Commissions Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the CBOE. 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-CBOE-2005-100 and should be submitted on or before
December 28, 2005.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Jonathan G. Katz,
Secretary.

Exhibit A--Chicago Board Options Exchange, Incorporated Regulatory
Circular RG05-xx

    Date: November 18, 2005.
    To: Members and Member Firms.
    From: Legal Division; Regulatory Division; Trading Operations
Division
    Re: DPM Obligations Until the Implementation of the PAR Official
Program
    On November 18, 2005, the Securities and Exchange Commission
(``SEC'') approved a CBOE rule change, SR-CBOE-2005-46 (``rule change''
or ``PAR Official rule change''), that, among other things, (1)
prohibits a DPM from executing orders as an agent or Floor Broker in
its allocated option classes and (2) eliminates the authority of a DPM
to act in any other way as a Floor Broker in those classes.\17\ Rule
8.8 and Rule 8.85(b) now prevent a DPM from representing or executing
orders for other persons in the DPM's assigned option classes. Once the
rule change goes into effect in a particular options class, the DPM
assigned to that option class will lose the ability to take custody of
or handle orders for other persons in that option class, including
through operation of the PAR terminal. The rule change authorizes the
Exchange to assign to an Exchange employee or subcontractor known as a
PAR Official, the responsibility, among other things, to operate the
PAR workstation for designated option classes, to maintain the book in
those classes, to represent orders to be sent via Intermarket Option
Linkage in those classes, and to effect executions of agency orders
placed with the PAR Official in those classes.
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    \17\ Please refer to the rule change and the SEC order approving
the rule change, which both can be found on the Exchange's Web site
at http://www.cboe.org/Legal/filings.aspx.

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    The rule change allows the Exchange to put PAR Officials in place
in DPM trading crowds during a 90-day period after the SEC approves the
rule change. This provision is intended to insure a smooth roll-out of
the PAR Official program. Therefore, until a PAR Official is put in
place in a particular DPM trading crowd during this 90-day transition
period, the DPM in that trading crowd will continue to be responsible
to operate the PAR workstation and will continue to be subject to the
same agency obligations as set forth under former Rule 8.85(b) and to
other obligations applicable to DPMs under current and former Exchange
rules. These rules and regulations are provided below:
* * * * *

DPM Obligations

    (a) General Obligations. Each DPM shall fulfill all of the
obligations of a Floor Broker or Order Book Official (to the extent
that the DPM acts as a Floor Broker) under the Rules, and shall satisfy
each of the requirements contained in this paragraph, in respect of
each of the securities allocated to the DPM. To the extent that there
is any inconsistency between the specific obligations of a DPM set
forth in subparagraphs (b) through (i) of this Rule and the general
obligations of a Floor Broker or of an Order Book Official under the
Rules, subparagraphs (b) through (i) of this Rule shall govern.
    (b) Display Obligation. Each DPM shall display immediately the full
price and size of any customer limit order that improves the price or
increases the size of the best disseminated CBOE quote. ``Immediately''
means, under normal market conditions, as soon as practicable but no
later than 30-seconds after receipt (``30-second standard'') by the
DPM. The term ``customer limit order'' means an order to buy or sell a
listed option at a specified price that is not for the account of
either a broker or dealer; provided, however, that the term customer
limit order shall include an order transmitted by a broker or dealer on
behalf of a customer. The following are exempt from the Display
Obligation as set forth under this provision:
    (A) An order executed upon receipt;
    (B) An order where the customer who placed it requests that it not
be displayed, and upon receipt of the order, the DPM announces in
public outcry the information concerning the order that would be
displayed if the order were subject to being displayed;
    (C) An order for which immediately upon receipt a related order for
the principal account of a DPM reflecting the terms of the customer
order is routed to another options exchange that is a participant in
the Intermarket Options Linkage Plan;
    (D) The following orders as defined in Rule 6.53: contingency
orders; One-cancels-the-other orders; all or none

orders; fill or kill orders; immediate or cancel orders; complex orders
(e.g., spreads, straddles, combinations); and stock-option orders;
    (E) Orders received before or during a trading rotation (as defined
in Rule 6.2, 6.2A, and 6.2B), including Opening Rotation Orders as
defined in Rule 6.53(l), are exempt from the 30-second standard,
however, they must be displayed immediately upon conclusion of the
applicable rotation; and
    (F) Large Sized Orders: Orders for more than 100 contracts, unless
the customer placing such order requests that the order be displayed.
    (c) A DPM shall not remove from the public order book any order
placed in the book unless (A) the order is canceled, expires, or is
executed or (B) the DPM returns the order to the member that placed the
order with the DPM in response to a request from that member to return
the order;
    (d) A DPM shall accord priority to any customer order which the DPM
represents as agent over the DPM's principal transactions, unless the
customer who placed the order has consented to not being accorded such
priority;
    (e) A DPM shall not charge any brokerage commission with respect
to:
    (1) The execution of any portion of an order for which the DPM has
acted as both agent and principal, unless the customer who placed the
order has consented to paying a brokerage commission to the DPM with
respect to the DPM's execution of the order while acting as both agent
and principal; or
    (2) Any portion of an order for which the DPM was not the executing
floor broker, including any portion of the order that is automatically
executed through an Exchange system; or
    (3) Any portion of an order that is automatically cancelled, or;
    (4) Any portion of an order that is not executed and not cancelled.
    (f) A DPM shall act as a Floor Broker to the extent required by the
MTS Committee.
    (g) A DPM shall not represent discretionary orders as a Floor
Broker or otherwise.
    (h) Autobook Pilot. A DPM shall maintain and keep active on the
DPM's PAR workstation at all times the automated limit order display
facility (``Autobook'') provided by the Exchange. The appropriate
Exchange Floor Procedure Committee will determine the Autobook timer in
all classes under that Committee's jurisdiction. A DPM may deactivate
Autobook as to a class or classes provided that Floor Official approval
is obtained. The DPM must obtain such approval no later than three
minutes after deactivation.
    (i) The Exchange may make personnel available to assist a DPM in
the DPM's performance of the obligations of an Order Book Official, for
which the Exchange may charge the DPM a reasonable fee.
* * * * *

RAES Operations

    DPMs will still be responsible for non-automated handling of orders
routed to the PAR workstation pursuant to Rule 6.8(d)(vi) and
Interpretation and Policy .02(b) of Rule 6.8.
* * * * *

Priority of Bids and Offers and Priority of Allocation of Trades

    DPMs shall be required to comply with those provisions of Rule
6.45, 6.45A, and 6.45B, that are now assigned to PAR Officials.
* * * * *

Timing of Firm Quote Obligations in a DPM Trading Crowd With Respect to
Firm Disseminated Market Quotes

    In Non-Hybrid classes, for purposes of determining when the firm
quote obligations under Rule 8.51 attach in respect of orders received
at a PAR workstation in a DPM trading crowd and how the exemptions to
that obligation provided in paragraph (e) of that Rule apply, the
responsible broker or dealer shall be deemed to receive an order, and
an order shall be deemed to be presented to the responsible broker or
dealer, at the time the order is received on the DPM's PAR workstation.
    In Hybrid classes, for purposes of determining when the firm quote
obligations under Rule 8.51 attach with respect to orders received at a
PAR workstation in a DPM trading crowd and how the exemptions to that
obligation provided in paragraph (e) of that rule apply, the
responsible broker or dealer shall be deemed to receive an order, and
an order shall be deemed presented to the responsible broker or dealer:
    (i) At the time the order is announced to the trading crowd with
respect to each responsible broker or dealer that is not the DPM for
the class; and
    (ii) At the time the order is received on PAR with respect to the
DPM as the responsible broker or dealer.
    As such, firm quote obligations for an order received on a PAR
workstation may attach at two separate times for different responsible
broker or dealers: at the time of receipt with respect to the DPM as a
responsible broker or dealer and at the time of announcement with
respect to non-DPM members of the trading crowd as responsible brokers
or dealers.
* * * * *

Linkage Rules

    Only with respect to any DPM continuing to represent and execute
orders as agent pursuant to this Regulatory Circular, Rule 6.80
(``Definitions'') paragraph (12)(i) shall read as follows:
    ``Principal Acting as Agent (`P/A') Order,'' which is an order for
the principal account of a Market-Maker (or equivalent entity on
another Participant Exchange that is authorized to represent Customer
orders) reflecting the terms of a related unexecuted Customer order for
which the Market-Maker is acting as agent.
* * * * *

DPM Designees

    The DPM must continue to maintain the requisite number of approved
DPM Designees, as defined under Rule 8.81. Additionally, these DPM
Designees must continue to be registered as a Floor Broker pursuant to
Rule 6.71. A DPM Designee also shall continue to be restricted from
trading as a Floor Broker in securities allocated to the DPM unless
acting on behalf of the DPM in its capacity as a DPM.
    Finally, when acting on behalf of a DPM in its capacity as a DPM,
the DPM Designee is exempt from the provisions of Rule 8.8
(``Restriction on Acting as Market-Maker and Floor Broker''). (See
former Rule 8.81(e)).
* * * * *

Rule 17.50. Imposition of Fines for Minor Rule Violations

    DPMs shall be subject to a fine for failure to promptly book and
display limit orders that would improve the disseminated quote or for
failure to use due diligence in the execution of orders for which the
DPM maintains an agency obligation.
* * * * *

Summary

    After the rule change has been approved and until the end of the
90-day trading period, neither a DPM assigned to a trading crowd nor
the Exchange shall be subject to the provisions of the rule change with
respect to the operation of that trading crowd until a PAR Official has
been assigned to that trading crowd.
    Questions pertaining to this Regulatory Circular should be directed
to Jim Flynn at<PHONE_NUMBER>; Doug

Beck at<PHONE_NUMBER>; or John Johnston at<PHONE_NUMBER>.

 [FR Doc. E5-6986 Filed 12-6-05; 8:45 am]

BILLING CODE 8010-01-P


MEMORANDUM Eastern Research Group, Inc. 110 Hartwell Avenue Lexington, MA 02421 Date: July 29, 2003 To: James Covington, EPA From: Cal Franz, ERG Re: MPP Industry Cost Effectiveness Analysis for Small Processors in Subcategories A through D, and K ERG estimated the cost effectiveness of pollutant removals for small processors in subcategories A through D and K based on costs received from Tetra Tech on June 27 and August 6, 2003, and loads received from Tetra Tech on July 3 and August 7, 2003. The attached tables show the results of these analyses. All results are presented by subcategory.

This analysis only examines impact to small processors: those that produce less than 50 million pounds of meat products per year in Subcategory A through D, and those that produce less than 10 million pounds of meat products per year in Subcategory K. In all respects, the methodology for analyzing small processors in these two subcategories is identical to the methodology for analyzing large processors in the same subcategories. EPA did, however, examine the cost effectiveness of Option 1 for small processors; this option was not analyzed for nonsmall processors in these two subcategories.

To interpret these tables, an option is considered   dominated  if, in total, facilities:   incur costs but have zero removals,   incur costs that are higher than the previous option, but have lower removals, or   incur costs that are higher than the previous option, but have no additional removals.

In subcategory A through D: C incremental cost reasonableness ranges from $ 12 per pound ( Option 2.5) to $ 283 per pound ( Option 4), C the most cost effective option for removing conventional pollutants is Option 1 ($ 67 per pound), C the most cost effective option for removing total nutrients is Option 2.5 ($ 27 per pound).

In subcategory K: C incremental cost reasonableness ranges from $ 200 per pound ( Option 2.5) to $ 378 per pound ( Option 1), C the most cost effective option for removing conventional pollutants is Option 1 ($ 163 per pound), C the most cost effective option for removing total nutrients is Option 4 ($ 218 per pound).

1 Table 1 Total Compliance Costs by Subcategory ($ 1999)

Small Facilities: Subcategory A through D and Subcategory K One Time Capital O& M Non capital Post tax Pre tax Option Costs Costs Costs Annualized Annualized Subcategory A through D Option 1 CBI CBI CBI CBI $ 400  $ 700 Option 2 CBI CBI CBI CBI $ 500  $ 750 Option 2+ P CBI CBI CBI CBI $ 1,000  $ 2,500 Option 2.5 CBI CBI CBI CBI $ 750  $ 1,500 Option 2.5+ P CBI CBI CBI CBI $ 2,000  $ 4,000 Option 4 CBI CBI CBI CBI $ 2,500  $ 5,000 Subcategory K Option 1 CBI CBI CBI CBI $ 750  $ 1,000 Option 2 CBI CBI CBI CBI $ 1,000  $ 2,500 Option 2+ P CBI CBI CBI CBI $ 2,500  $ 5,000 Option 2.5 CBI CBI CBI CBI $ 1,000  $ 2,500 Option 2.5+ P CBI CBI CBI CBI $ 2,500  $ 5,000 Option 4 CBI CBI CBI CBI $ 3,000  $ 6,000 Table 2 Incremental Cost Effectiveness of Pollution Control Options: Toxics and Nonconventionals Small Facilities: Subcategory A through D and Subcategory K Average Incremental Pre tax Pounds Cost Cost Pre tax Pounds Cost Cost Annualized Equivalent Effectiveness Effectiveness Annualized Equivalent Effectiveness Effectiveness Option Costs ($ 1999) Removed ( PE) ($ 1999/ PE) ($ 1981/ PE) Costs ($ 1999) Removed ( PE) ($ 1999/ PE) ($ 1981/ PE)

Subcategory A through D Baseline $ 0 0 NA NA NA NA NA NA Option 1 CBI CBI Undefined Undefined DOM DOM DOM DOM Option 2 CBI CBI $ 247,296 $ 144,280 CBI CBI $ 247,296 $ 144,280 Option 2+ P CBI CBI $ 697,228 $ 406,783 DOM DOM DOM DOM Option 2.5 CBI CBI $ 215,962 $ 125,998 CBI CBI $ 185,709 $ 108,348 Option 2.5+ P CBI CBI $ 436,975 $ 254,944 DOM DOM DOM DOM Option 4 CBI CBI $ 477,163 $ 278,391 CBI CBI $ 3,080,008 $ 1,796,968 Subcategory K Baseline $ 0 0 NA NA NA NA NA NA Option 1 CBI CBI Undefined Undefined DOM DOM DOM DOM Option 2 CBI CBI $ 818,347 $ 477,448 CBI CBI $ 818,347 $ 477,448 Option 2+ P CBI CBI $ 1,901,965 $ 1,109,663 DOM DOM DOM DOM Option 2.5 CBI CBI $ 847,776 $ 494,618 CBI CBI $ 955,528 $ 557,483 Option 2.5+ P CBI CBI $ 1,698,921 $ 991,201 DOM DOM DOM DOM Option 4 CBI CBI $ 1,441,533 $ 841,033 CBI CBI $ 2,577,471 $ 1,503,773 DOM: Option is dominated; it either has ( 1) higher cost than following option, resulting in a negative incremental CE, or ( 2) it has higher cost than the previous option but no additional removals, resulting in an undefined incremental CE. Table 3 Incremental Cost Reasonableness of Pollution Control Options: BOD, Total Phosphorus, & Total Nitrogen Small Facilities: Subcategory A through D and Subcategory K Average Incremental Pre tax Cost Pre tax Cost Annualized Pounds Effectiveness Annualized Pounds Effectiveness Option Costs ($ 1999) Removed ($ 1999/ pound) Costs ($ 1999) Removed ($ 1999/ pound)

Subcategory A through D Baseline $ 0 0 NA NA NA NA Option 1 CBI CBI $ 102 CBI CBI $ 102 Option 2 CBI CBI $ 103 DOM DOM DOM Option 2+ P CBI CBI $ 290 DOM DOM DOM Option 2.5 CBI CBI $ 24 CBI CBI $ 12 Option 2.5+ P CBI CBI $ 48 DOM DOM DOM Option 4 CBI CBI $ 51 CBI CBI $ 283 Subcategory K Baseline $ 0 0 NA NA NA NA Option 1 CBI CBI $ 378 CBI CBI $ 378 Option 2 CBI CBI $ 529 DOM DOM DOM Option 2+ P CBI CBI $ 1,228 DOM DOM DOM Option 2.5 CBI CBI $ 268 CBI CBI $ 200 Option 2.5+ P CBI CBI $ 538 DOM DOM DOM Option 4 CBI CBI $ 228 CBI CBI $ 208 DOM: Option is dominated; it either has ( 1) higher cost than following option, resulting in a negative incremental CE, or ( 2) it has higher cost than the previous option but no additional removals, resulting in an undefined incremental CE. Table 4 Incremental Cost Effectiveness of Pollution Control Options: Conventional Pollutants Small Facilities: Subcategory A through D and Subcategory K Average Incremental Pre tax Cost Pre tax Cost Annualized Pounds Effectiveness Annualized Pounds Effectiveness Option Costs ($ 1999) Removed ($ 1999/ pound) Costs ($ 1999) Removed ($ 1999/ pound)

Subcategory A through D Baseline $ 0 0 NA NA NA NA Option 1 CBI CBI $ 67 CBI CBI $ 67 Option 2 CBI CBI $ 68 DOM DOM DOM Option 2+ P CBI CBI $ 191 DOM DOM DOM Option 2.5 CBI CBI $ 120 DOM DOM DOM Option 2.5+ P CBI CBI $ 243 DOM DOM DOM Option 4 CBI CBI $ 244 CBI CBI $ 1,122 Subcategory K Baseline $ 0 0 NA NA NA NA Option 1 CBI CBI $ 163 CBI CBI $ 163 Option 2 CBI CBI $ 228 DOM DOM DOM Option 2+ P CBI CBI $ 530 DOM DOM DOM Option 2.5 CBI CBI $ 301 DOM DOM DOM Option 2.5+ P CBI CBI $ 602 DOM DOM DOM Option 4 CBI CBI $ 537 CBI CBI $ 1,369 DOM: Option is dominated; it either has ( 1) higher cost than following option, resulting in a negative incremental CE, or ( 2) it has higher cost than the previous option but no additional removals, resulting in an undefined incremental CE. Table 5 Incremental Nutrient Cost Effectiveness of Pollution Control Options: Total Nutrients Small Facilities: Subcategory A through D and Subcategory K Average Incremental Pre tax Cost Pre tax Cost Annualized Pounds Effectiveness Annualized Pounds Effectiveness Option Costs ($ 1999) Removed ($ 1999/ pound) Costs ($ 1999) Removed ($ 1999/ pound)

Subcategory A through D Baseline $ 0 0 NA NA NA NA Option 1 CBI CBI Undefined DOM DOM DOM Option 2 CBI CBI Undefined DOM DOM DOM Option 2+ P CBI CBI Undefined DOM DOM DOM Option 2.5 CBI CBI $ 27 CBI CBI $ 27 Option 2.5+ P CBI CBI $ 55 DOM DOM DOM Option 4 CBI CBI $ 58 CBI CBI $ 291 Subcategory K Baseline $ 0 0 NA NA NA NA Option 1 CBI CBI Undefined DOM DOM DOM Option 2 CBI CBI Undefined DOM DOM DOM Option 2+ P CBI CBI Undefined DOM DOM DOM Option 2.5 CBI CBI $ 436 CBI CBI $ 436 Option 2.5+ P CBI CBI $ 874 DOM DOM DOM Option 4 CBI CBI $ 271 CBI CBI $ 218 DOM: Option is dominated; it either has ( 1) higher cost than following option, resulting in a negative incremental CE, or ( 2) it has higher cost than the previous option but no additional removals, resulting in an undefined incremental CE. Table 6 Incremental Nutrient Cost Effectiveness of Pollution Control Options: Total Phosphorus Small Facilities: Subcategory A through D and Subcategory K Average Incremental Pre tax Cost Pre tax Cost Annualized Pounds Effectiveness Annualized Pounds Effectiveness Option Costs ($ 1999) Removed ($ 1999/ pound) Costs ($ 1999) Removed ($ 1999/ pound)

Subcategory A through D Baseline $ 0 0 NA NA NA NA Option 1 CBI CBI Undefined DOM DOM DOM Option 2 CBI CBI Undefined DOM DOM DOM Option 2+ P CBI CBI Undefined DOM DOM DOM Option 2.5 CBI CBI Undefined DOM DOM DOM Option 2.5+ P CBI CBI Undefined DOM DOM DOM Option 4 CBI CBI Undefined DOM DOM DOM Subcategory K Baseline $ 0 0 NA NA NA NA Option 1 CBI CBI Undefined DOM DOM DOM Option 2 CBI CBI Undefined DOM DOM DOM Option 2+ P CBI CBI Undefined DOM DOM DOM Option 2.5 CBI CBI Undefined DOM DOM DOM Option 2.5+ P CBI CBI Undefined DOM DOM DOM Option 4 CBI CBI $ 25,324 CBI CBI $ 25,324 DOM: Option is dominated; it either has ( 1) higher cost than following option, resulting in a negative incremental CE, or ( 2) it has higher cost than the previous option but no additional removals, resulting in an undefined incremental CE. Table 7 Incremental Nutrient Cost Effectiveness of Pollution Control Options: Total Nitrogen Small Facilities: Subcategory A through D and Subcategory K Average Incremental Pre tax Cost Pre tax Cost Annualized Pounds Effectiveness Annualized Pounds Effectiveness Option Costs ($ 1999) Removed ($ 1999/ pound) Costs ($ 1999) Removed ($ 1999/ pound)

Subcategory A through D Baseline $ 0 0 NA NA NA NA Option 1 CBI CBI Undefined DOM DOM DOM Option 2 CBI CBI Undefined DOM DOM DOM Option 2+ P CBI CBI Undefined DOM DOM DOM Option 2.5 CBI CBI $ 27 CBI CBI $ 27 Option 2.5+ P CBI CBI $ 55 DOM DOM DOM Option 4 CBI CBI $ 58 CBI CBI $ 291 Subcategory K Baseline $ 0 0 NA NA NA NA Option 1 CBI CBI Undefined DOM DOM DOM Option 2 CBI CBI Undefined DOM DOM DOM Option 2+ P CBI CBI Undefined DOM DOM DOM Option 2.5 CBI CBI $ 436 CBI CBI $ 436 Option 2.5+ P CBI CBI $ 874 DOM DOM DOM Option 4 CBI CBI $ 274 CBI CBI $ 222 DOM: Option is dominated; it either has ( 1) higher cost than following option, resulting in a negative incremental CE, or ( 2) it has higher cost than the previous option but no additional removals, resulting in an undefined incremental CE. Table 8A Pollutant Removals by Option, Subcategory A through D Small Facilities: Subcategory A through D and Subcategory K Removals ( Pounds per Year) Toxic Removals ( Pounds Equivalent per Year)

Weighting Pollutant Option 1 Option 2 Option 2+ P Option 2.5 Option 2.5+ P Option 4 Factor Option 1 Option 2 Option 2+ P Option 2.5 Option 2.5+ P Option 4 Toxics Ammonia as Nitrogen 0 CBI CBI CBI CBI CBI 1.83E 003 0.0 CBI CBI CBI CBI CBI Barium 0 0 0 0 0 0 1.99E 003 0.0 0.0 0.0 0.0 0.0 0.0 Carbaryl 0 0 0 0 0 0 2.80E+ 002 0.0 0.0 0.0 0.0 0.0 0.0 Chromium 0 0 0 0 0 0 7.57E 002 0.0 0.0 0.0 0.0 0.0 0.0 Cis permethrin 0 0 0 0 0 0 4.54E+ 000 0.0 0.0 0.0 0.0 0.0 0.0 Copper 0 0 0 0 0 0 6.27E 001 0.0 0.0 0.0 0.0 0.0 0.0 Manganese 0 0 0 0 0 0 7.04E 002 0.0 0.0 0.0 0.0 0.0 0.0 Molybdenum 0 0 0 0 0 0 2.01E 001 0.0 0.0 0.0 0.0 0.0 0.0 Nickel 0 0 0 0 0 0 1.09E 001 0.0 0.0 0.0 0.0 0.0 0.0 Nitrate/ Nitrite 0 0 0 CBI CBI CBI 6.20E 005 0.0 0.0 0.0 CBI CBI CBI Titanium 0 0 0 0 0 0 2.93E 002 0.0 0.0 0.0 0.0 0.0 0.0 Trans permethrin 0 0 0 0 0 0 4.54E+ 000 0.0 0.0 0.0 0.0 0.0 0.0 Vanadium 0 0 0 0 0 0 6.22E 001 0.0 0.0 0.0 0.0 0.0 0.0 Zinc 0 0 0 0 0 0 4.67E 002 0.0 0.0 0.0 0.0 0.0 0.0 Total 0 CBI CBI CBI CBI CBI 0.0 CBI CBI CBI CBI CBI Pollutants for Cost Reasonableness Test 5 Day Biochemical Oxygen Demand CBI CBI CBI CBI CBI CBI NA Total Phosphorus 0 0 0 0 0 0 NA Total Nitrogen 0 0 0 CBI CBI CBI NA Total CBI CBI CBI CBI CBI CBI Conventionals 5 Day Biochemical Oxygen Demand CBI CBI CBI CBI CBI CBI NA Oil & Grease ( HEM) 0 0 0 0 0 0 NA Total Suspended Solids CBI CBI CBI CBI CBI CBI NA Total CBI CBI CBI CBI CBI CBI Nutrients Total Phosphorus 0 0 0 0 0 0 NA Total Nitrogen 0 0 0 CBI CBI CBI NA Total 0 0 0 CBI CBI CBI Table 8B Pollutant Removals by Option, Subcategory K Small Facilities: Subcategory A through D and Subcategory K Removals ( Pounds per Year) Toxic Removals ( Pounds Equivalent per Year)

Weighting Pollutant Option 1 Option 2 Option 2+ P Option 2.5 Option 2.5+ P Option 4 Factor Option 1 Option 2 Option 2+ P Option 2.5 Option 2.5+ P Option 4 Toxics Ammonia as Nitrogen 0 CBI CBI CBI CBI CBI 1.83E 003 0.0 CBI CBI CBI CBI CBI Barium 0 0 0 0 0 0 1.99E 003 0.0 0.0 0.0 0.0 0.0 0.0 Carbaryl 0 0 0 0 0 0 2.80E+ 002 0.0 0.0 0.0 0.0 0.0 0.0 Chromium 0 0 0 0 0 0 7.57E 002 0.0 0.0 0.0 0.0 0.0 0.0 Cis permethrin 0 0 0 0 0 0 4.54E+ 000 0.0 0.0 0.0 0.0 0.0 0.0 Copper 0 0 0 0 0 0 6.27E 001 0.0 0.0 0.0 0.0 0.0 0.0 Manganese 0 0 0 0 0 0 7.04E 002 0.0 0.0 0.0 0.0 0.0 0.0 Molybdenum 0 0 0 0 0 0 2.01E 001 0.0 0.0 0.0 0.0 0.0 0.0 Nickel 0 0 0 0 0 0 1.09E 001 0.0 0.0 0.0 0.0 0.0 0.0 Nitrate/ Nitrite 0 0 0 CBI CBI CBI 6.20E 005 0.0 0.0 0.0 CBI CBI CBI Titanium 0 0 0 0 0 0 2.93E 002 0.0 0.0 0.0 0.0 0.0 0.0 Trans permethrin 0 0 0 0 0 0 4.54E+ 000 0.0 0.0 0.0 0.0 0.0 0.0 Vanadium 0 0 0 0 0 0 6.22E 001 0.0 0.0 0.0 0.0 0.0 0.0 Zinc 0 0 0 0 0 0 4.67E 002 0.0 0.0 0.0 0.0 0.0 0.0 Total 0 CBI CBI CBI CBI CBI 0.0 CBI CBI CBI CBI CBI Pollutants for Cost Reasonableness Test 5 Day Biochemical Oxygen Demand CBI CBI CBI CBI CBI CBI NA Total Phosphorus 0 0 0 0 0 CBI NA Total Nitrogen 0 0 0 CBI CBI CBI NA Total CBI CBI CBI CBI CBI CBI Conventionals 5 Day Biochemical Oxygen Demand CBI CBI CBI CBI CBI CBI NA Oil & Grease ( HEM) 0 0 0 0 0 0 NA Total Suspended Solids CBI CBI CBI CBI CBI CBI NA Total CBI CBI CBI CBI CBI CBI Nutrients Total Phosphorus 0 0 0 0 0 CBI NA Total Nitrogen 0 0 0 CBI CBI CBI NA Total 0 0 0 CBI CBI CBI Appendix: Table 1 Removals of Specified Pollutants by Option Small Facilities: Subcategory A through D and Subcategory K Removals ( Pounds per Year)

Pollutant Option 1 Option 2 Option 2+ P Option 2.5 Option 2.5+ P Option 4 Subcategory A through D 5 Day Biochemical Oxygen Demand CBI CBI CBI CBI CBI CBI Total Suspended Solids CBI CBI CBI CBI CBI CBI Chemical Oxygen Demand 0 0 0 0 0 0 Carbonaceous Biochemical Oxygen Demand CBI CBI CBI CBI CBI CBI Ammonia as Nitrogen 0 CBI CBI CBI CBI CBI Total Nitrogen 0 0 0 CBI CBI CBI Total Phosphorus 0 0 0 0 0 0 Nitrate/ Nitrite 0 0 0 CBI CBI CBI Total Kjeldahl Nitrogen 0 CBI CBI CBI CBI CBI Oil & Grease ( HEM) 0 0 0 0 0 0 Subcategory K 5 Day Biochemical Oxygen Demand CBI CBI CBI CBI CBI CBI Total Suspended Solids CBI CBI CBI CBI CBI CBI Chemical Oxygen Demand CBI CBI CBI CBI CBI CBI Carbonaceous Biochemical Oxygen Demand CBI CBI CBI CBI CBI CBI Ammonia as Nitrogen 0 CBI CBI CBI CBI CBI Total Nitrogen 0 0 0 CBI CBI CBI Total Phosphorus 0 0 0 0 0 CBI Nitrate/ Nitrite 0 0 0 CBI CBI CBI Total Kjeldahl Nitrogen 0 CBI CBI CBI CBI CBI Oil & Grease ( HEM) 0 0 0 0 0 0


Meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to Consider and Review Scientific Issues Associated with the
 Proposed Endocrine Disruptor Screening Program (EDSP) Tier Ecotoxicity Tests

                               June 25-28, 2013

Docket Number: EPA-HQ-OPP-2013-0182				OPP Docket Tel:<PHONE_NUMBER>

                  Please note that all times are approximate
                      (See note at the end of the Agenda)

--------------------------------------------------------------------------------
Tuesday, June 25, 2013

9:00 A.M.	Opening of Meeting and Administrative Procedures  -  Sharlene Matten, Ph.D., Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M. 	Introduction and Identification of Panel Members  -  Martha Sandy, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

9:15 A.M.	Opening Remarks  -  Steven Knott, Deputy Director, Office of Science Coordination and Policy and Steven Bradbury, Ph.D. Director, Office of Pesticide Programs, EPA

9:25 A.M. 	Overview of EDSP and Proposed Tier 2 Ecotoxicity Tests  -  Mary Manibusan, Director, Exposure Assessment Coordination and Policy Division, Office of Science Coordination and Policy, EPA

10:00 A.M.	Break

10:10 A.M.	Japanese Quail Two-generation Toxicity Test  -  Leslie Touart, Ph.D., Exposure Assessment Coordination and Policy Division, Office of Science Coordination and Policy, EPA

11:10 A.M.	Medaka Multigeneration Toxicity Test  -  Rodney Johnson, Ph.D., Mid-Continent Ecology Division, National Health and Environmental Effects Research Laboratory  -  Duluth, Office of Research and Development, EPA

12:10 P.M.	Lunch

1:10 P.M.	Larval Amphibian Growth and Development Assay  - Sigmund Degitz, Ph.D., Mid-Continent Ecology Division, National Health and Environmental Effects Research Laboratory  -  Duluth, Office of Research and Development, EPA

2:30 P.M.	Break

2:40 P.M.	Mysid Two-generation Toxicity Test and Harpacticoid Copepod Development & Reproduction Test  -  Leslie Touart, Ph.D., Exposure Assessment Coordination and Policy Division, Office of Science Coordination and Policy, EPA

3:40 P.M.	Break

3:45 P.M.	Public Comments

5:45 P.M.	Adjournment
--------------------------------------------------------------------------------
Wednesday, June 26, 2013
9:00 A.M.	Opening of Meeting and Administrative Procedures  -  Sharlene Matten, Ph.D., Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M.	Introduction and Identification of Panel Members  -  Martha Sandy, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

9:10 A.M.	Follow-up from Previous Day's Meeting  -  Mary Manibusan, Director, Exposure Assessment Coordination and Policy Division, Office of Science Coordination and Policy, EPA

9:20 A.M.	Additional Public Comments (if needed)

10:20 A.M.	Break

10:30 A.M.	Panel Discussion of Charge Questions

                   JAPANESE QUAIL TWO-GENERATION TEST (JQTT)

JQTT Question 1
A rationale for the test method should be available, including a clear statement of scientific basis and the regulatory purpose and need for the test method. The EDSTAC described the Tier 2 tests as having the purpose to "characterize the nature, likelihood, and dose-response relationship of endocrine disruption of estrogen, androgen, and thyroid in humans and wildlife." Tier 2 tests were designed to be definitive tests that generate sufficient data to characterize the specific hazard of the substance and provide sufficient information on dose-response and adverse effects to permit risk decisions.

Please comment on the rationale and purpose of the assay as part of the Tier 2 testing in the EDSP, as described in Sections 2.5 and 2.6 of the JQTT ISR.

JQTT Question 2
Test methods and their associated endpoint(s) should be scientifically relevant to the biological processes of interest and should be demonstrated to be responsive to the specific type of effect/toxicity of interest. Each species presents unique characteristics from a biological perspective and allows for specialized endpoints to address a specific toxicological mode of action.
Please comment on the biological and toxicological relevance of the assay in regards to the stated purpose of characterizing endocrine disruptors, as described in Sections 3 and 4 of the JQTT ISR.

JQTT Question 3

   JQTT Question 3.1 The test protocol should be sufficiently detailed and should include a description of what is measured and how it is measured. The selection of endpoints within the assay should be reflective of the biological processes of interest and the endpoints should be intrinsically relevant and have established sensitivity. The test protocol should demonstrate the ability to measure the endpoints and provide adequate performance criteria for evaluation.
   Please comment on the selection, optimization and demonstration of the assay endpoints, as outlined in Sections 4 and 5 of the JQTT ISR.

   JQTT Question 3.2 Pathological evaluation of histological tissue preparations is an established, sensitive and integral endpoint in the assessment of effects in long term in vivo assays. The tissues targeted for histopathological evaluation should be shown to be sensitive to exposure and relevant to a mode of action or pathway determination. Tissue samples from several organs or glands (e.g., kidney, liver, thyroid, gonads) underwent histopathological examination in the JQTT inter-laboratory validation and a discussion of histopathology as an endpoint is provided in Section 4.1.13 of the JQTT ISR.
   Please comment on the value of histopathological analyses in the JQTT assay for each of the tissue types examined and what (if any) critical information is gained from their inclusion or would be lost if histology were not examined.

12:00 P.M.	Lunch

1:00 P.M.	JQTT Charge Questions (cont'd)

JQTT Question 4
Demonstration of the test method performance should be based on the testing of reference chemicals representative of the types of substances for which the test method will be used. Test substances should adequately represent an appropriate range of responses and physical/chemical properties for which the test method is proposed to be appropriate. The selection of the most appropriate statistical approaches depends in part on the nature of the data and also on the design of the validation study. Statistical and non-statistical methods used to analyze should be described.
Please comment on the selection of test substances and methods (analytical and statistical where appropriate) chosen for the demonstration and validation of the JQTT assay.

JQTT Question 5
Considering the variability inherent in biological and chemical test methods, a test method needs to be repeatable and reproducible. A test is robust and reliable if the results are repeatable and reproducible within a laboratory and between different laboratories, respectively. A test protocol should provide sufficient guidance to ensure proper and consistent performance across labs and chemicals.
Please comment on the test method robustness and reliability and the repeatability and reproducibility of the results obtained with the JQTT assay.

JQTT Question 6
The test protocol should be descriptive enough to be fully transferable to a competent laboratory. The protocol should describe the methodology of the assay in a clear and concise manner so that a laboratory could comprehend the objective, conduct the assay, observe and measure prescribed endpoints, compile and prepare data for statistical analyses, and report the results. Section 6 of the JQTT ISR outlines the process of and challenges experienced in the inter-laboratory studies.
Please comment on the transferability across labs and provide any suggestions or recommendations for improvement of the JQTT assay.

2:45 P.M.	Break

3:00 P.M.	JQTT Charge Questions (cont'd)

JQTT Question 7
The purpose of the validation process is to determine the readiness of a test for inclusion in a testing program. A component of readiness of a test is the evaluation of the usefulness and limitations of the test, including the classes and types of test substances that can and cannot be tested.
Please comment on the strengths and/or limitations of the JQTT assay, as described in Section 7 of the JQTT ISR.

JQTT Question 8
There is sufficient evidence to indicate that EDCs can disrupt normal development and reproductive success, however the sensitivity of the F2 generation compared to the P0 or F1 is less clearly defined. In the JQTT, there is an increase in endpoint CVs with each subsequent generation (JQTT ISR Table 6-4), which indicates decreased power of discrimination. Please comment from a scientific and risk assessment perspective on the value added of multiple generations in the JQTT assay.

3:55 P.M.	Break

4:00 P.M.	Panel Discussion of Charge Questions (cont'd)

                  MEDAKA MULTIGENERATION TOXICITY TEST (MMT)

Section 5 of the MMT ISR outlines the EPA proposed Medaka Reproduction Test (MRT) assay which utilizes the culmination of knowledge and experience gained from many successive U.S. and Japanese studies over multiple years.

MMT Question 1
A rationale for the test method should be available, including a clear statement of scientific basis and the regulatory purpose and need for the test method. The EDSTAC introduced the Tier 2 tests as having the purpose to "characterize the nature, likelihood, and dose-response relationship of endocrine disruption of estrogen, androgen, and thyroid in humans and wildlife." Tier 2 tests were designed to be definitive tests which generate sufficient data to characterize the specific hazard of the substance and provide sufficient information on dose-response and adverse effects to permit risk decisions.
Please comment on the rationale and purpose of the assay as part of the Tier 2 testing in the EDSP, as described in Sections 2.1 and 2.2 of the MMT ISR.

MMT Question 2
Test methods and their associated endpoint(s) should be scientifically relevant to the biological processes of interest and should be demonstrated to be responsive to the specific type of effect/toxicity of interest. Each species presents unique characteristics from a biological perspective and allows for specialized endpoints to address a specific toxicological mode of action.
Please comment on the biological and toxicological relevance of the assay in regards to the stated purpose of characterizing endocrine disruptors, as described in Section 3 of the MMT.

MMTQuestion 3
The test protocol should be sufficiently detailed and should include a description of what is measured and how it is measured. The selection of endpoints within the assay should be reflective of the biological processes of interest and the endpoints should be intrinsically relevant and have established sensitivity. The test protocol should demonstrate the ability to measure the endpoints and provide adequate performance criteria for evaluation.
Please comment on the selection, optimization and demonstration of the assay endpoints, as outlined in Section 3 of the MMT ISR.

5:30 P.M.  	Adjournment

--------------------------------------------------------------------------------
Thursday, June 27, 2013
9:00 A.M.	Opening of Meeting and Administrative Procedures  -  Sharlene Matten, Ph.D., Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M.	Introduction and Identification of Panel Members  -  Martha Sandy, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

9:10 A.M.	Follow-up from Previous Day's Meeting  -  Mary Manibusan, Director, Exposure Assessment Coordination and Policy Division, Office of Science Coordination and Policy, EPA

9:20 A.M.	MMT Test Charge Questions (cont'd)

MMT Question 4
Demonstration of the test method performance should be based on the testing of reference chemicals representative of the types of substances for which the test method will be used. Test substances should adequately represent an appropriate range of responses and physical/chemical properties for which the test method is proposed to be appropriate. The selection of the most appropriate statistical approaches depends in part on the nature of the data and also on the design of the validation study. Statistical and non-statistical methods used to analyze should be described.
Please comment on the selection of test substances and methods (analytical and statistical where appropriate) chosen for the demonstration and validation of the MMT and MRT assays.

MMT Question 5
Considering the variability inherent in biological and chemical test methods, a test method needs to be repeatable and reproducible. A test is robust and reliable if the results are repeatable and reproducible within a laboratory and between different laboratories, respectively. A test protocol should provide sufficient guidance to ensure proper and consistent performance across labs and chemicals.
Please comment on the test method robustness and reliability and the repeatability and reproducibility of the results obtained with the MTT and MRT assays.

10:20 A.M.	Break

10:30 A.M.	MMT Test Charge Questions (cont'd)

MMT Question 6
The test protocol should be descriptive enough to be fully transferable to a functional laboratory. The protocol should describe the methodology of the assay in a clear and concise manner so that a laboratory could comprehend the objective, conduct the assay, observe and measure prescribed endpoints, compile and prepare data for statistical analyses, and report the results. Section 4 of the MMT ISR outlines the process of and challenges experienced in the inter-laboratory studies and Section 5 presents the optimization and proposed Medaka Reproduction Test (MRT) protocol.
Please comment on the transferability across labs and provide any suggestions or recommendations for improvement of the.MMT and MRT assays.

MMT Question 7
The purpose of the validation process is to determine the readiness of a test for inclusion in a testing program. A component of readiness of a test is the evaluation of the usefulness and limitations of the test, including the classes and types of test substances that can and cannot be tested.
Please comment on the strengths and/or limitations of the MMT and MRT assays.

MMT Question 8
There is sufficient evidence to indicate that EDCs can disrupt normal development and reproductive success, however the value added of the F2 generation compared to the P0 or F1 is less clearly defined. The EPA is proposing the Medaka Reproduction Test (MRT) as an EDSP Tier 2 assay. The MRT test terminates after the F2 embryo hatch, and a rationale for the proposed protocol is provided in Section 5 of the MMT ISR.
Please comment on the Agency's rationale that the value added by the F2 generation is not sufficient to warrant its inclusion in the Tier 2 fish test protocol.

MMT Question 9
It is the Agency's opinion that the outcomes of the various MMT trials have provided enough information to recommend a medaka reproduction test (MRT) for use as the fish test in Tier 2 of the EDSP. Two major changes from the MMT are proposed, i.e., an increase in the number of replicates per treatment for evaluating effects on reproduction, and terminating the test after the embryos hatch in F2. Other proposed changes include minimizing the collection of endpoint data from F0, and evaluating pathology in only the F1 adults sampled after the assessment of reproduction.

Overall, the authors conclude that both the MMT and the MRT are transferable methods and are capable of adequately characterizing potential disruption of the endocrine system by putative endocrine disrupting chemicals. However, the MRT is recommended as the preferred EDSP Tier 2 test method for fish because it is less resource intensive with improved statistical power, appears to be as sensitive, and is better able to ensure consistent findings when performed routinely by testing laboratories.
Please comment on the scientific rationale of the Agency's proposed Tier 2 fish test, the MRT, with respect to statistical power, sensitivity, and consistency in performance across laboratories. In addition, please comment on the adequacy of the MRT to characterize potential endocrine disruption, a requirement of Tier 2 of the EDSP.

12:15 P.M. 	Lunch

1:15 P.M.	Panel Discussion of Charge Questions

             LARVAL AMPHIBIAN GROWTH AND DEVELOPMENT ASSAY (LAGDA)

LAGDA Question 1
A rationale for the test method should be available, including a clear statement of scientific basis and the regulatory purpose and need for the test method. The EDSTAC introduced the Tier 2 tests as having the purpose to "characterize the nature, likelihood, and dose-response relationship of endocrine disruption of estrogen, androgen, and thyroid in humans and wildlife." Tier 2 tests were designed to be definitive tests which generate sufficient data to characterize the specific hazard of the substance and provide sufficient information on dose-response and adverse effects to permit risk decisions.
Please comment on the rationale and purpose of the assay as part of the Tier 2 testing in the EDSP, as described in Section 3 of the LAGDA ISR.

LAGDA Question 2
Test methods and their associated endpoint(s) should be scientifically relevant to the biological processes of interest and should be demonstrated to be responsive to the specific type of effect/toxicity of interest. Each species presents unique characteristics from a biological perspective and allows for specialized endpoints to address a specific toxicological mode of action. Please comment on the biological and toxicological relevance of the assay in regards to the stated purpose of characterizing endocrine disruptors, as described in Sections 3 and 4 of the LAGDA ISR.

LAGDA Question 3

   LAGDA Question 3.1
   The test protocol should be sufficiently detailed and should include a description of what is measured and how it is measured. The selection of endpoints within the assay should be reflective of the biological processes of interest and the endpoints should be intrinsically relevant and have established sensitivity. The test protocol should demonstrate the ability to measure the endpoints and provide adequate performance criteria for evaluation.
   Please comment on the selection, optimization and demonstration of the assay endpoints, as outlined in Sections 3 and 4 of the LAGDA ISR.

   LAGDA Question 3.2
   Three of the four labs in the inter-laboratory validation of the LAGDA were unsuccessful in properly performing the thyroxine (T4) analyses using commercially available enzyme-linked Immunosorbent assay (ELISA) kits with antibodies specific for human or canine T4. Subsequently, the EPA developed an extraction method (Section 5.3.2) and presents a revised ELISA method for measuring T4 in amphibian samples in Appendix 7 of the LAGDA ISR.
   Please comment on the technical feasibility, reproducibility, and accuracy of the revised ELISA T4 measurement method. Provide any recommendations regarding additional guidance to ensure the reproducibility of T4 measurements.

2:45 P.M.	Break

3:00 P.M.	LAGDA Charge Questions (cont'd)

   LAGDA Question 3.3
   Vitellogenin (VTG) is an established biomarker of estrogenic exposure and is used as a key endpoint in endocrine disruptor testing. There is currently not a standardized commercial source for Xenopus laevis VTG antibodies for an ELISA.
   Please comment on the protocol for measuring and reporting VTG levels. Provide any recommendations regarding additional guidance to ensure the consistency, repeatability and reproducibility of VTG measurements.
LAGDA Question 4
Demonstration of the test method performance should be based on the testing of reference chemicals representative of the types of substances for which the test method will be used. Test substances should adequately represent an appropriate range of responses and physical/chemical properties for which the test method is proposed to be appropriate. The selection of the most appropriate statistical approaches depends in part on the nature of the data and also on the design of the validation study. Statistical and non-statistical methods used to analyze should be described.
Please comment on the selection of test substances and methods (analytical and statistical where appropriate) chosen for the demonstration and validation of the LAGDA assay.

LAGDA Question 5
Considering the variability inherent in biological and chemical test methods, a test method needs to be repeatable and reproducible. A test is robust and reliable if the results are repeatable and reproducible within a laboratory and between different laboratories, respectively. A test protocol should provide sufficient guidance to ensure proper and consistent performance across labs and chemicals.
Please comment on the test method robustness and reliability and the repeatability and reproducibility of the results obtained with the LAGDA assay.

LAGDA Question 6
The test protocol should be descriptive enough to be fully transferable to a functional laboratory. The protocol should describe the methodology of the assay in a clear and concise manner so that a laboratory could comprehend the objective, conduct the assay, observe and measure prescribed endpoints, compile and prepare data for statistical analyses, and report the results. Sections 5 and 6 of the LAGDA ISR outline the process of and challenges experienced in the inter-laboratory studies.
Please comment on the transferability across labs and provide any suggestions or recommendations for improvement of the LAGDA assay.

LAGDA Question 7
The purpose of the validation process is to determine the readiness of a test for inclusion in a testing program. A component of readiness of a test is the evaluation of the usefulness and limitations of the test, including the classes and types of test substances that can and cannot be tested.
Please comment on the strengths and/or limitations of the LAGDA assay.

5:30 P.M.	Adjournment

--------------------------------------------------------------------------------
Friday, June 28, 2013

9:00 A.M.	Opening of Meeting and Administrative Procedures  -  Sharlene Matten, Ph.D., Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M.	Introduction and Identification of Panel Members  -  Martha Sandy, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

9:10 A.M.	Follow-up from Previous Day's Meeting  -  Mary Manibusan, Director, Exposure Assessment Coordination and Policy Division, Office of Science Coordination and Policy, EPA

9:20 A.M.	Panel Discussion of Charge Questions (cont'd)

MYSID TWO-GENERATION TOXICITY TEST (MTTT) AND HARPACTICOID COPEPOD DEVELOPMENT & REPRODUCTION TEST (HCDRT)

MTTT Question 1
A rationale for the test method should be available, including a clear statement of scientific basis and the regulatory purpose and need for the test method. The EDSTAC introduced the Tier 2 tests as having the purpose to "characterize the nature, likelihood, and dose-response relationship of endocrine disruption of estrogen, androgen, and thyroid in humans and wildlife." Although the hormones produced and used by invertebrates are not directly analogous to those of vertebrates (e.g., estrogen, androgen, and thyroid), growth, reproduction, development, and other aspects of invertebrate physiology and life cycle are known to be under endocrine control. EDSTAC went on to note that "chemicals that affect these vertebrate hormones may also affect invertebrate hormones resulting in altered reproduction, development, and growth." Tier 2 tests were designed to be definitive tests which generate sufficient data to characterize the specific hazard of the substance and provide sufficient information on dose-response and adverse effects to permit risk decisions.
Please comment on the rationale and purpose of the assay as part of the Tier 2 testing in the EDSP, as described in Sections 2.1 and 2.2 of the MTTT ISR.

MTTT Question 2
Test methods and their associated endpoint(s) should be scientifically relevant to the biological processes of interest and should be demonstrated to be responsive to the specific type of effect/toxicity of interest. Each species presents unique characteristics from a biological perspective and allows for specialized endpoints to address a specific toxicological mode of action.
Please comment on the biological and toxicological relevance of the assay in regards to the stated purpose of characterizing endocrine disruptors, as described in Section 2 of the MTTT ISR.

10:20 A.M.	Break

10:30 A.M.	MTTT and HCDRT Charge Questions (cont'd)
MTTT Question 3
The test protocol should be sufficiently detailed and should include a description of what is measured and how it is measured. The selection of endpoints within the assay should be reflective of the biological processes of interest and the endpoints should be intrinsically relevant and have established sensitivity. The test protocol should demonstrate the ability to measure the endpoints and provide adequate performance criteria for evaluation.
Please comment on the selection, optimization and demonstration of the assay endpoints, as outlined in Sections 3 and 4 of the MTTT ISR.

MTTT Question 4

   MTTT Question 4.1
   Demonstration of the test method performance should be based on the testing of reference chemicals representative of the types of substances for which the test method will be used. Test substances should adequately represent an appropriate range of responses and physical/chemical properties for which the test method is proposed to be appropriate. The selection of the most appropriate statistical approaches depends in part on the nature of the data and also on the design of the validation study. Statistical and non-statistical methods used to analyze should be described.
   Please comment on the selection of test substances and methods (analytical and statistical where appropriate) chosen for the demonstration and validation of the MTTT assay.
   MTTT Question 4.2
   The proposed MTTT study design uses three replicates per control and treatment group and additional replicates require greater resources.
   Please comment on the proposed level of replication and the subsequent statistical analysis of the data.

MTTT Question 5
Considering the variability inherent in biological and chemical test methods, a test method needs to be repeatable and reproducible. A test is robust and reliable if the results are repeatable and reproducible within a laboratory and between different laboratories, respectively. A test protocol should provide sufficient guidance to ensure proper and consistent performance across labs and chemicals.
Please comment on the test method robustness and reliability and the repeatability and reproducibility of the results obtained with the MTTT assay.

12:00 P.M.	Lunch

1:00 P.M	MTTT and HCDRT Charge Questions (cont'd)

MTTT Question 6

   MTTT Question 6.1
   The test protocol should be descriptive enough to be fully transferable to a functional laboratory. The protocol should describe the methodology of the assay in a clear and concise manner so that a laboratory could comprehend the objective, conduct the assay, observe and measure prescribed endpoints, compile and prepare data for statistical analyses, and report the results. Section 5 of the MTTT ISR outlines the process of and challenges experienced in the inter-laboratory studies. Please comment on the transferability across labs and provide any suggestions or recommendations for improvement of the MTTT assay.

   MTTT Question 6.2
   Based on the validation results using the two different invertebrate species, mysid (MTTT) and copepod (HCDRT), the EPA is proposing the mysid protocol as the preferred Tier 2 assay.
   Please comment on the rationale to recommend the mysid protocol as the preferred Tier 2 invertebrate assay, as described in Section 6.4 of the MTTT ISR.

MTTT Question 7
The purpose of the validation process is to determine the readiness of a test for inclusion in a testing program. A component of readiness of a test is the evaluation of the usefulness and limitations of the test, including the classes and types of test substances that can and cannot be tested.
Please comment on the strengths and/or limitations of the assay, as described in Section 6 of the MTTT ISR.

MTTT Question 8
There is sufficient evidence to indicate that EDCs can disrupt normal development and reproductive success, however the sensitivity of the F1 generation compared to the F0 is less clearly defined.
Please comment from a scientific and risk assessment perspective on the value added of multiple generations in the MTTT assay.

3:00 P.M.	Adjournment

Please be advised that agenda times are approximate; when the discussion for one topic is completed, discussions for the next topic will begin.  For further information, please contact the Designated Federal Official for this meeting, Dr. Sharlene Matten, telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>, or email<EMAIL_ADDRESS>


[Federal Register Volume 77, Number 211 (Wednesday, October 31, 2012)]
[Rules and Regulations]
[Pages 65812-65815]
[FR Doc No: 2012-26192]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0719; Directorate Identifier 2011-NM-240-AD;
Amendment 39-17235; AD 2012-21-19]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Model A330-200 freighter series airplanes; Model A330-200 and -
300

series airplanes; and Model A340-200 and -300 series airplanes. This AD
was prompted by reports of ram air turbine (RAT) pump failure. This AD
requires inspecting the RAT pump anti-stall valve for correct setting,
re-identifying the RAT pump, performing a functional ground test of the
RAT, and replacing the RAT pump or the RAT assembly with a serviceable
part if necessary. We are issuing this AD to detect and correct
malfunction of the RAT pump, which could lead to in-flight loss of the
RAT-pump pressurization, possibly resulting in reduced control of the
airplane.

DATES: This AD becomes effective December 5, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of December 5,
2012.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1138; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on July 11, 2012 (77 FR
40830). That NPRM proposed to correct an unsafe condition for the
specified products. The Mandatory Continuing Airworthiness Information
(MCAI) states:

    During a test flight before delivery from production, an A330
aeroplane experienced a RAT [ram air turbine] pump failure, as a
result of which, the green hydraulic system could not be fully
pressurized.
    Investigations concluded that this malfunction was due to poor
installation of the anti-stall valve sleeve, causing a shift in the
anti-stall speed setting and leading to an inability of the
hydraulic pump Part Number (P/N) 5909522 to provide enough hydraulic
pressure.
    This condition, if not detected and corrected, could lead to the
in-flight loss of the RAT-Pump pressurization which, in case of a
total engine flame out, could have consequences for the hydraulic
circuits, possibly resulting in reduced control of the aeroplane.
A340-500/-600 series aeroplanes are not affected by this issue
because they are fitted with a different hydraulic pump P/N.
    For the reasons described above, this [European Aviation Safety
Agency] AD requires a check to ensure correct setting of the RAT
anti-stall valve in the pump housing, followed by a RAT functional
ground test, and accomplishment of the applicable corrective
actions, depending on findings.

Corrective actions include replacing the RAT pump or the RAT assembly
with a serviceable part. Required actions include reporting the
findings of the inspection. You may obtain further information by
examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (77 FR 40830, July 11,
2012) or on the determination of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed--except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 40830, July 11, 2012) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 40830, July 11, 2012).

Costs of Compliance

    We estimate that this AD will affect 59 products of U.S. registry.
We also estimate that it will take about 4 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $20,060, or $340 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 7 work-hours and require parts costing up to $405,143, for a
cost of up to $405,738 per product. We have no way of determining the
number of products that may need these actions.

Authority for This Rulemaking

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

Regulatory Findings

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

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (77 FR 40830, July 11, 2012),
the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2012-21-19 Airbus: Amendment 39-17235. Docket No. FAA-2012-0719;
Directorate Identifier 2011-NM-240-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective December 5,
2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A330-201, -202, -203, -223, -
243, -223F, -243F, -301, -302, -303, -321, -322, -323, -341, -342,
and -343 airplanes; and Airbus Model A340-211, -212, -213, -311, -
312, and -313 airplanes; certificated in any category; all
manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 29: Hydraulic
Power.

(e) Reason

    This AD was prompted by reports of ram air turbine (RAT) pump
failure. We are issuing this AD to detect and correct malfunction of
the RAT pump, which could lead to in-flight loss of the RAT-pump
pressurization, possibly resulting in reduced control of the
airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Actions

    (1) Within the applicable compliance time specified in table 1
to paragraph (g)(1) of this AD, as applicable, check the RAT pump
anti-stall valve for correct setting, re-identify the RAT pump, and
do a functional ground test of the RAT, except as provided by
paragraph (g)(3) of this AD; in accordance with the Accomplishment
Instructions of the applicable service bulletin specified in
paragraph (g)(1)(i) or (g)(1)(ii) of this AD.

        Table 1 to Paragraph (g)(1) of This AD--Compliance Times
------------------------------------------------------------------------
         Affected airplanes                    Compliance time
------------------------------------------------------------------------
For airplanes on which Airbus A330   Within 3,000 flight hours or 7
 certification maintenance            months, whichever occurs first
 requirements (CMR) Task 292000-      after the effective date of this
 00001-1-C, or Airbus A340-200/-300   AD.
 CMR Task 292000-A0001-1-C, or
 Airbus A330/A340 maintenance
 review board report (MRBR) Task
 29.20.00/06, as applicable to the
 airplane type, has not been
 accomplished as of the effective
 date of this AD.
For airplanes on which the Airbus    Within 24 months after the last
 A330 CMR Task<PHONE_NUMBER>1-1-C, or   accomplishment of Airbus A330 CMR
 Airbus A340-200/-300 CMR Task        Task<PHONE_NUMBER>1-1-C, or Airbus
 292000-A0001-1-C, or Airbus A330/    A340-200/-300 CMR Task 292000-
 A340 MRBR Task 29.20.00/06, as       A0001-1-C, or Airbus A330/A340
 applicable to the airplane type,     MRBR Task 29.20.00/06, applicable
 has already been accomplished as     to the airplane type, or 30 days
 of the effective date of this AD.    after the effective date of this
                                      AD, whichever occurs later.
------------------------------------------------------------------------

     (i) Airbus Mandatory Service Bulletin A330-29-3117, dated July
19, 2011 (for Model A330 series airplanes).
    (ii) Airbus Mandatory Service Bulletin A340-29-4090, dated July
19, 2011 (for Model A340 series airplanes).
    (2) If the functional ground test of the RAT, as required by
paragraph (g)(1) of this AD, is not successful (as defined by the
Accomplishment Instructions of the applicable service bulletin
specified in paragraph (g)(1)(i) or (g)(1)(ii) of this AD): Before
further flight, replace the RAT pump or the RAT assembly with a
serviceable part, in accordance with the Accomplishment Instructions
of the applicable service bulletin specified in paragraph (g)(1)(i)
or (g)(1)(ii) of this AD.
    (3) Any airplane equipped with a RAT hydraulic pump marked with
an ``X'' or a date (month/year) in the amendment cell C of the
identification plate, which has been successfully tested (as defined
by the Accomplishment Instructions of the applicable service
bulletin specified in paragraph (g)(1)(i) or (g)(1)(ii) of this AD)
in accordance with the Accomplishment Instructions of the applicable
service bulletin specified in paragraph (g)(1)(i) or (g)(1)(ii) of
this AD prior to the effective date of this AD, is considered
compliant with the requirements of paragraphs (g)(1) and (g)(2) of
this AD.

(h) Parts Installation Limitations

    As of the effective date of this AD, no person may install any
RAT hydraulic pump or RAT assembly on any airplane unless it has
been inspected, corrected, and successfully tested (as defined by
the Accomplishment Instructions of the applicable service bulletin
specified in paragraph (g)(1)(i) or (g)(1)(ii) of this AD) in
accordance with the requirements of paragraph (g) of this AD, on any
airplane.

(i) Definition

    A serviceable part is a RAT hydraulic pump or RAT assembly that
has been inspected, corrected, and successfully tested (as defined
by the Accomplishment Instructions of the applicable service
bulletin specified in paragraph (g)(1)(i) or (g)(1)(ii) of this AD),
in accordance with the Accomplishment Instructions of the applicable
service bulletin specified in paragraph (g)(1)(i) or (g)(1)(ii) of
this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(k) Related Information

    Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2011-0197, dated October 10, 2011, and the service
bulletins specified in paragraphs (k)(1) and (k)(2) of this AD, for
related information.
    (1) Airbus Mandatory Service Bulletin A330-29-3117, dated July
19, 2011.
    (2) Airbus Mandatory Service Bulletin A340-29-4090, dated July
19, 2011.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this

paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Airbus Mandatory Service Bulletin A330-29-3117, dated July
19, 2011.
    (ii) Airbus Mandatory Service Bulletin A340-29-4090, dated July
19, 2011.
    (3) For service information identified in this AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (4) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on October 12, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-26192 Filed 10-30-12; 8:45 am]
BILLING CODE 4910-13-P