[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Page 78691]
[FR Doc No: 2022-27883]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0417]

Request for Nominations of Voting Members on a Public Advisory
Committee; National Mammography Quality Assurance Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the National Mammography
Quality Assurance Advisory Committee in the Center for Devices and
Radiological Health. Nominations will be accepted for current and
upcoming vacancies effective February 1, 2023, with this notice. FDA
seeks to include the views of women and men, members of all racial and
ethnic groups, and individuals with and without disabilities on its
advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.

DATES: Nominations received on or before February 21, 2023, will be
given first consideration for membership on the National Mammography
Quality Assurance Advisory Committee. Nominations received after
February 21, 2023, will be considered for nomination to the committee
as later vacancies occur.

ADDRESSES: All nominations for membership should be submitted
electronically by logging into the FDA Advisory Nomination Portal at
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member on an
FDA advisory committee can also be obtained by visiting FDA's website
at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership: James P. Swink, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5211, Silver Spring, MD 20993,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members to fill upcoming vacancies on the National Mammography Quality
Assurance Advisory Committee.

I. General Description of the Committee Duties

    The National Mammography Quality Assurance Advisory Committee
advises the Commissioner of Food and Drugs (the Commissioner) or
designee on: (1) developing appropriate quality standards and
regulations for mammography facilities; (2) developing appropriate
standards and regulations for bodies accrediting mammography facilities
under this program; (3) developing regulations with respect to
sanctions; (4) developing procedures for monitoring compliance with
standards; (5) establishing a mechanism to investigate consumer
complaints; (6) reporting new developments concerning breast imaging
that should be considered in the oversight of mammography facilities;
(7) determining whether there exists a shortage of mammography
facilities in rural and health professional shortage areas and
determining the effects of personnel on access to the services of such
facilities in such areas; (8) determining whether there will exist a
sufficient number of medical physicists after October 1, 1999; and (9)
determining the costs and benefits of compliance with these
requirements.

II. Criteria for Voting Members

    The committee consists of a core of 15 members, including the
Chair. Members and the Chair are selected by the Commissioner or
designee from among physicians, practitioners, and other health
professionals, whose clinical practice, research specialization, or
professional expertise includes a significant focus on mammography.
Almost all non-Federal members of this committee serve as Special
Government Employees. Members will be invited to serve for terms of up
to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified persons
for membership on the advisory committee. Self-nominations are also
accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address, telephone number, and email address if
available, and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Nomination Portal (see ADDRESSES).
Nominations must specify the advisory committee for which the nominee
is recommended. Nominations must also acknowledge that the nominee is
aware of the nomination unless self-nominated. FDA will ask potential
candidates to provide detailed information concerning such matters
related to financial holdings, employment, and research grants and/or
contracts to permit evaluation of possible sources of conflict of
interest.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27883 Filed 12-21-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Notices]
[Pages 24265-24269]
[FR Doc No: 2013-09654]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69394; File No. SR-ISE-2013-33]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend the Schedule of Fees

April 18, 2013.
    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 April 12, 2013, the International Securities Exchange, LLC (the
``Exchange'' or the

``ISE'') filed with the Securities and Exchange Commission the proposed
rule change, as described in Items I, II, and III below, which items
have been prepared by the self-regulatory organization. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 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 ISE proposes to amend its Schedule of Fees. The text of the
proposed rule change is available on the Exchange's Web site (http://www.ise.com), at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the 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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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 Exchange currently assesses per contract transaction fees and
provides rebates to market participants that add or remove liquidity
from the Exchange (``maker/taker fees and rebates'') in all symbols
that are in the Penny Pilot program (``Select Symbols''). The
Exchange's maker/taker fees and rebates are applicable to regular and
complex orders executed in the Select Symbols. The fee changes
discussed below apply to both standard options and mini options traded
on the Exchange. The Exchange's Schedule of Fees has separate tables
for fees and rebates applicable to standard options and mini options.
The Exchange notes that while the discussion below notes the fees and
rebates for standard options, the fees and rebates for mini options,
which are not discussed below, are and shall continue to be \1/10\th of
the fees and rebates for standard options.\3\
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    \3\ See Securities Exchange Act Release No. 69270 (April 2,
2013), 78 FR 20988 (April 8, 2013) (SR-ISE-2013-28).
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    For regular orders that remove liquidity in the Select Symbols, the
Exchange currently charges a taker fee of: (i) $0.32 per contract for
Market Maker \4\ and Market Maker Plus \5\ orders, (ii) $0.36 per
contract for Non-ISE Market Maker \6\ orders, (iii) $0.33 per contract
for Firm Proprietary/Broker-Dealer and Professional Customer \7\
orders, and (iv) $0.25 per contract for Priority Customer \8\ orders.
The Exchange now proposes to increase the taker fee for: (i) Market
Maker and Market Maker Plus orders in the Select Symbols from $0.32 per
contract to $0.34 per contract, (ii) Non-ISE Market Maker orders in the
Select Symbols from $0.36 per contract to $0.38 per contract, (iii)
Firm Proprietary/Broker-Dealer and Professional Customer orders in the
Select Symbols from $0.33 per contract to $0.35 per contract, and (iv)
Priority Customer orders in the Select Symbols from $0.25 per contract
to $0.28 per contract.
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    \4\ The term ``Market Makers'' refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively. See ISE Rule
100(a)(25).
    \5\ In order to promote and encourage liquidity in the Select
Symbols, the Exchange currently offers a $0.10 per contract rebate
to Market Makers if the quotes they send to the Exchange qualify the
Market Maker to become a Market Maker Plus. A Market Maker Plus is a
Market Maker who is on the National Best Bid or National Best Offer
80% of the time for series trading between $0.03 and $5.00 (for
options whose underlying stock's previous trading day's last sale
price was less than or equal to $100) and between $0.10 and $5.00
(for options whose underlying stock's previous trading day's last
sale price was greater than $100) in premium in each of the front
two expiration months and 80% of the time for series trading between
$0.03 and $5.00 (for options whose underlying stock's previous
trading day's last sale price was less than or equal to $100) and
between $0.10 and $5.00 (for options whose underlying stock's
previous trading day's last sale price was greater than $100) in
premium for all expiration months in that symbol during the current
trading month. A Market Maker's single best and single worst overall
quoting days each month, on a per symbol basis, is excluded in
calculating whether a Market Maker qualifies for this rebate, if
doing so will qualify a Market Maker for the rebate. The Exchange
provides Market Makers a report on a daily basis with quoting
statistics so that Market Makers can determine whether or not they
are meeting the Exchange's stated criteria.
    \6\ A Non-ISE Market Maker, or Far Away Market Maker
(``FARMM''), is a market maker as defined in Section 3(a)(38) of the
Securities Exchange Act of 1934 registered in the same options class
on another options exchange.
    \7\ A Professional Customer is a person who is not a broker/
dealer and is not a Priority Customer.
    \8\ A Priority Customer is defined in ISE Rule 100(a)(37A) as a
person or entity that is not a broker/dealer in securities, and does
not place more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s).
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    For regular orders in Non-Select Symbols,\9\ the Exchange currently
charges an execution fee of: (i) $0.18 per contract for Market Maker
orders; (ii) $0.20 per contract for Market Maker (for orders sent by
Electronic Access Members), Firm Proprietary/Broker-Dealer and
Professional Customer orders; (iii) $0.45 per contract for Non-ISE
Market Maker orders; and (iv) $0.00 per contract for Priority Customer
orders (for Singly Listed Symbols, this fee is $0.20 per contract). The
Exchange now proposes to increase the execution fee for Firm
Proprietary/Broker-Dealer and Professional Customer orders, from $0.20
per contract to $0.30 per contract. The Exchange is not proposing any
change to the execution fee for other market participants.
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    \9\ ``Non-Select Symbols'' are options overlying all symbols
excluding Select Symbols.
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    For Responses to Crossing Orders in Non-Select Symbols, the
Exchange currently charges a fee of: (i) $0.18 per contract for Market
Maker orders; (ii) $0.20 per contract for Market Maker (for orders sent
by Electronic Access Members), Firm Proprietary/Broker-Dealer and
Professional Customer orders; (iii) $0.45 per contract for Non-ISE
Market Maker orders; and (iv) $0.20 per contract for Priority Customer
and Priority Customer (Singly Listed Symbols) orders. The Exchange now
proposes to increase the Fee for Responses to Crossing Orders for Firm
Proprietary/Broker-Dealer and Professional Customer orders, from $0.20
per contract to $0.30 per contract. The Exchange is not proposing any
change to the Fee for Responses to Crossing Orders for other market
participants.
    For FX Options, the Exchange currently charges an execution fee of:
(i) $0.18 per contract for Market Maker and Priority Customer orders;
(ii) $0.20 per contract for Market Maker (for orders sent by Electronic
Access Members), Firm Proprietary/Broker-Dealer and Professional
Customer orders; (iii) $0.45 per contract for Non-ISE Market Maker
orders; (iv) $0.40 per contract for Priority Customer orders in Early
Adopter FX Option Symbols; and (v) $0.00 per contract for Early Adopter
Market Maker orders. The Exchange now proposes to increase the
execution fee for Firm Proprietary/Broker-Dealer and Professional
Customer orders, from $0.20 per contract to $0.30 per contract. The
Exchange is not proposing any change to the execution fee for other
market participants.
    For Responses to Crossing Orders in FX Options, the Exchange
currently charges a fee of: (i) $0.18 per contract for

Market Maker orders; (ii) $0.20 per contract for Market Maker (for
orders sent by Electronic Access Members), Firm Proprietary/Broker-
Dealer, Professional Customer and Priority Customer orders; (iii) $0.45
per contract for Non-ISE Market Maker orders; (iv) $0.40 per contract
for Priority Customer in Early Adopter FX Option Symbols; and (v) $0.00
per contract for Early Adopter Market Maker orders. The Exchange now
proposes to increase the Fee for Responses to Crossing Orders for Firm
Proprietary/Broker-Dealer and Professional Customer orders, from $0.20
per contract to $0.30 per contract. The Exchange is not proposing any
change to the Fee for Responses to Crossing Orders for other market
participants.
    Since the rate changes to the Schedule of Fees pursuant to this
proposal will be effective upon filing, for the transactions occurring
in April 2013 prior to the effective date of this filing members will
be assessed the rates in effect immediately prior to those proposed by
this filing. For transactions occurring in April 2013 on and after the
effective date of this filing, members will be assessed the rates
proposed by this filing.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Schedule of
Fees is consistent with Section 6(b) of the Securities and Exchange Act
of 1934 (the ``Act'') \10\ in general, and furthers the objectives of
Section 6(b)(4) of the Act \11\ in particular, in that it is an
equitable allocation of reasonable dues, fees and other charges among
Exchange members and other persons using its facilities.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4).
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    The Exchange has determined to charge fees and provide rebates for
regular orders in mini options at a rate that is \1/10\th the rate of
fees and rebates the Exchange currently provides for trading in
standard options. The Exchange believes it is reasonable and equitable
and not unfairly discriminatory to assess lower fees and rebates to
provide market participants an incentive to trade mini options on the
Exchange. The Exchange believes the proposed fees and rebates are
reasonable and equitable in light of the fact that mini options have a
smaller exercise and assignment value, specifically \1/10\th that of a
standard option contract, and, as such, levying fees that are \1/10\th
of what market participants pay today.
    The Exchange believes that its proposal to assess a $0.34 per
contract taker fee for regular Market Maker and Market Maker Plus
orders in the Select Symbols is reasonable and equitably allocated
because the fee is within the range of fees assessed by other exchanges
employing similar pricing schemes. For example, NASDAQ Options Market
(``NOM'') currently charges a taker fee of $0.48 per contract to NOM
Market Maker orders in Penny Pilot options in its regular order
book.\12\ The Exchange also notes that with this proposed rule change,
the fee charged to regular Market Maker and Market Maker Plus orders in
the Select Symbols will remain lower than the fee currently charged by
the Exchange to certain other market participants.
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    \12\ See NOM fee schedule at http://nasdaq.cchwallstreet..com/
NASDAQ.Tools/.Platform.Viewer.asp?.selectednode=chp.--1.--1.--
15&.manual=%2Fnasdaq.%2Fmain.%2Fnasdaq.-optionsrules%2F.
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    The Exchange also believes that its proposal to assess a $0.35 per
contract taker fee for regular Firm Proprietary/Broker-Dealer and
Professional Customer orders and $0.38 per contract taker fee for
regular Non-ISE Market Maker orders in the Select Symbols is reasonable
and equitably allocated because the fee is also within the range of
fees assessed by other exchanges employing similar pricing schemes. By
comparison, the proposed fees assessed to regular Firm Proprietary/
Broker-Dealer and Professional Customer orders and to regular Non-ISE
Market Maker orders are lower than the rates assessed by NOM for
similar orders. NOM currently charges a taker fee of $0.48 per contract
for equivalent orders in its regular order book.\13\
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    \13\ Id.
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    The Exchange also believes that its proposal to assess a $0.28 per
contract taker fee for all regular Priority Customer orders in the
Select Symbols is reasonable and equitably allocated because the fee is
within the range of fees assessed by other exchanges employing similar
pricing schemes. The proposed fee is substantially lower than the $0.45
per contract taker fee currently charged by NOM for Customer orders in
its regular order book.\14\ Therefore, while ISE is proposing a fee
increase, the resulting fee remains lower than the fee currently
charged by NOM. The Exchange also notes that with this proposed rule
change, the fee charged to regular Priority Customer orders will remain
lower (as it historically has always been) than the fee currently
charged by the Exchange to other market participants.
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    \14\ Id.
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    The Exchange believes it is reasonable and equitable to charge a
fee of $0.30 per contract for regular Firm Proprietary/Broker-Dealer
orders and regular Professional Customer orders in Non-Select Symbols
and in FX Options and also when such members are responding to crossing
orders because the fee is also within the range of fees assessed by
other exchanges employing similar pricing schemes. By comparison, the
proposed fees assessed to regular Firm Proprietary/Broker-Dealer and
Professional Customer orders are lower than the rates assessed by NOM
for similar orders. NOM currently charges a taker fee of $0.89 per
contract in Non-Penny Pilot options in its regular order book.\15\ The
Exchange notes that an execution resulting from a response to a
crossing order is akin to an execution and therefore its proposal to
establish execution fees and fees for responses to crossing orders that
are identical is reasonable and equitable. The Exchange believes its
proposal to increase the execution fee and fee for responses to
crossing orders for regular orders in Non-Select Symbols and FX Options
is not unfairly discriminatory because the proposed fees would apply
uniformly to all regular Firm Proprietary/Broker-Dealer and
Professional Customer orders in the same manner.
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    \15\ Id.
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    The Exchange believes that the price differentiation between the
various market participants is justified. As for Priority Customers,
for the most part, the Exchange does not charge Priority Customers a
fee (Priority Customers have traditionally traded options on the
Exchange without a fee) and to the extent they pay a transaction fee,
those fees are lower than fees charged to other market participants.
The Exchange believes charging lower fees, or no fees, to Priority
Customer orders attracts that order flow to the Exchange and thereby
creates liquidity to the benefit of all market participants who trade
on the Exchange. With respect to fees to Non-ISE Market Maker orders,
the Exchange believes that charging Non-ISE Market Maker orders a
higher rate than the fee charged to Market Maker, Firm Proprietary/
Broker-Dealer and Professional Customer regular orders is appropriate
and not unfairly discriminatory because Non-ISE Market Makers are not
subject to many of the non-transaction based fees that these other
categories of membership are subject to, e.g., membership fees, access
fees, API/Session fees, market data fees, etc. Therefore, the Exchange
believes it

is appropriate and not unfairly discriminatory to assess a higher
transaction fee to Non-ISE Market Makers because the Exchange incurs
costs associated with these types of orders that are not recovered by
non-transaction based fees paid by members. With respect to fees for
Market Maker orders, the Exchange believes that the price
differentiation between the various market participants is appropriate
and not unfairly discriminatory because Market Makers have different
requirements and obligations to the Exchange that the other market
participants do not (such as quoting requirements and paying
membership-related non-transaction fees). The Exchange believes that it
is equitable and not unfairly discriminatory to assess a higher fee to
market participants that do not have such requirements and obligations
that Exchange Market Makers do.
    Moreover, the Exchange believes that the proposed fees are fair,
equitable and not unfairly discriminatory because the proposed fees are
consistent with price differentiation that exists today at other
options exchanges. Additionally, the Exchange believes it remains an
attractive venue for market participants to direct their order flow in
the symbols that are subject to this proposed rule change as its fees
are competitive with those charged by other exchanges for similar
trading strategies. The Exchange operates in a highly competitive
market in which market participants can readily direct order flow to
another exchange if they deem fee levels at a particular exchange to be
excessive. For the reasons noted above, the Exchange believes that the
proposed fees are fair, equitable and not unfairly discriminatory.

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

    ISE 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. The Exchange believes the
proposed fee change does not impose a burden on competition because the
proposed taker fee increase for regular orders in Select Symbols is
consistent with fees charged by other exchanges. The Exchange believes
the proposed new taker fees for regular orders in Select Symbols does
not impose a burden on competition because the rate increase applies to
all market participants on the Exchange. Further, by raising the
proposed taker fee for regular orders in Select Symbols by similar
amounts (with the exception for Priority Customers, who have
historically paid lower or no fees and will continue to pay lower fees
with this proposed rule change), the proposed new taker fees for
regular orders in Select Symbols does not impose a burden on
competition because all participants are affected to the same extent.
    Similarly, the proposed increase to the execution fee and the fee
for responses to crossing orders is not a burden on competition because
it will uniformly apply to all Firm Proprietary/Broker-Dealer and
Professional Customer orders that transact in regular orders in Non-
Select Symbols and in FX Options. The Exchange believes the proposed
execution fee and the proposed new fee for responses to crossing orders
for regular orders in Non-Select Symbols and FX Options does not impose
a burden on competition because it sets the same rate for all Firm
Proprietary/Broker Dealer and Professional Customer orders. Further, by
raising the proposed execution fee and the proposed fee for responses
to crossing orders for regular orders in Non-Select Symbols and FX
Options by similar amounts, the proposed execution fee and the proposed
fee for responses to crossing orders for regular orders in Non-Select
Symbols and FX Options does not impose a burden on competition because
all Firm Proprietary/Broker-Dealer and Professional Customer orders are
affected to the same extent.
    The Exchange notes that it operates in a highly competitive market
in which market participants can readily direct their order flow to
competing venues. In such an environment, the Exchange must continually
review, and consider adjusting, its fees and rebates to remain
competitive with other exchanges. For the reasons described above, the
Exchange believes that the proposed fee change reflects this
competitive environment.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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)(ii) of the Act \16\ and subparagraph (f)(2) of Rule 19b-4
thereunder,\17\ because it establishes a due, fee, or other charge
imposed by ISE.
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    \16\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \17\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    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. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2013-33 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-ISE-2013-33. 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 10:00 a.m. and 3:00 p.m. Copies of
such filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; 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-ISE-2013-33, and should be submitted on or before May
15, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-09654 Filed 4-23-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3762-3763]
[FR Doc No: 2012-1462]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR12-7-000]

Magellan Pipeline Company, L.P.; Notice of Petition for
Declaratory Order

    Take notice that on December 29, 2011, pursuant to Rule 207(a)(2)
of the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a)(2)(2011), Magellan Pipeline
Company, L.P. (Magellan) filed a petition for a declaratory order that
approves priority committed space and the overall rate structure
involving the proposed partial reversal and expansion of Magellan's
refined petroleum products pipeline system in Texas to move refined
petroleum products from Houston to El Paso, Texas.
    Any person desiring to intervene or to protest in this proceeding
must file in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214 (2011)) on
or before 5 p.m. Eastern time on the specified comment date. Protests
will be considered by the Commission in determining the appropriate
action to be taken, but will not serve to make protestants parties to
the proceeding. Anyone filing a motion to intervene or protest must
serve a copy of that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's

eLibrary system by clicking on the appropriate link in the above list.
They are also available for review in the Commission's Public Reference
Room in Washington, DC. There is an eSubscription link on the web site
that enables subscribers to receive email notification when a document
is added to a subscribed docket(s). For assistance with any FERC Online
service, please email<EMAIL_ADDRESS>or call (866) 208-
3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Monday, February 13, 2012.

    Dated: January 19, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-1462 Filed 1-24-12; 8:45 am]
BILLING CODE 6717-01-P


9660 Federal Register / Vol. 68, No. 40 / Friday, February 28, 2003 / Notices intended to restate its commitment to cost share with Task Force I or to make an offer to cost share with Task Force II. In any case, Prochimie's letter at most shows that Prochimie made an offer to cost share, which was an option it emphasized that it had not selected. Prochimie did not provide any evidence that it had selected the option of offer to pay or that any such offer had been accepted. In order to support the option Prochimie selected to address the data requirements, it must provide evidence that any such offer had been accepted. Prochimie did not do that. Although Prochimie paid Task Force II for the use of several specific studies which are not involved in this Notice, those payments do not provide any evidence that a cost share agreement has been reached with respect to any other studies required by the 1991 DCI for nonresidential turf use that Task Force II submitted or has committed to submit. In fact, Mr. Rockwell, the chairman of Task Force II, stated in an affidavit dated May 2, 2000, that `` No written offer to pay or any offer to jointly develop any data as required by and identified in the 1991 DCI has ever been received by Thiram Task Force II. . . from Prochimie.'' Since Task Force II does not believe that it has ever received an offer to cost share from Prochimie, it is unlikely that a cost share agreement has been reached between Prochimie and Task Force II. Without adequate proof of such an agreement, Prochimie may not claim an ownership interest in Task Force II's data for which Prochimie has not paid and hence may not claim that such data satisfies Prochimie's obligations. Consequently, the Agency considers that Prochimie is in noncompliance with certain data requirements for nonresidential turf use imposed by the 1991 DCI irrespective of Task Force II's actions to address those data requirements. Those data requirements are identified in Appendix II to this Notice and are as follows: EPA Guideline Nos. 71   4( b), 83   4, 85   1, and 122   2. Moreover, prior to its dissolution, Task Force I failed to satisfy certain 1984 DCI data requirements for nonresidential turf use that were also imposed by the 1991 DCI. Because Prochimie was a member of Task Force I and has not independently submitted data or otherwise addressed these requirements, Prochimie is in noncompliance with these requirements. These data requirements are identified in Appendix II to this Notice and are as follows: EPA Guideline Nos. 161   1, 161   2, 162   1, 163   1, and 164   1. In a letter dated December 21, 1998, EPA informed Prochimie that the data required under the 1991 DCI were long overdue and that Prochimie had satisfied only those data requirements that had been satisfied by Task Force I prior to its dissolution. In a letter dated January 12, 1999, Prochimie informed EPA that `` Prochimie cost shared/ co owned several studies submitted by Task Force II.'' However, Prochimie did not provide the evidence required by the 1991 DCI that Prochimie and Task Force II have agreed to cost share in the development of any other data required by the 1991 DCI for nonresidential turf use. Prochimie's letter also restated Prochimie's commitment to satisfy certain data requirements that neither Task Forces committed to fulfill. However, Prochimie did not submit any studies or proof required by the 1991 DCI of a cost share agreement with any party obligated to satisfy these data requirements. In a letter dated June 29, 1999, Prochimie requested data waivers ( or determination of nonapplicability or no need for additional data) for, among others, the following data requirements: Guideline Nos. 82   2, 83   4, 122   2, 161   1, 161   2, 163   1, and 164   1, and 165   4. After careful consideration of Prochimie's requests, EPA denied the request for waiver of the above mentioned data requirements in letters dated May 21, 2001 and August 31, 2001. In a letter dated August 31, 2001, EPA informed Prochimie of its failure to demonstrate that it had taken appropriate steps to secure data required by the 1991 DCI. In an attachment to the letter, EPA identified all of the data requirements for nonresidential turf use under the 1991 DCI and the names of the parties who submitted studies for those requirements. As shown in that attachment, UCB Chemicals Corporation, Inc. (`` UCB''), not Task Force I or II, satisfied a number of data requirements under the 1991 DCI for nonresidential turf use. The letter notified Prochimie of the Agency's intent to issue a Notice of Intent to Suspend Prochimie's technical thiram registration unless, within 30 calendar days of its receipt of the letter, EPA received from Prochimie certain required data or proof of an agreement or offer to cost share with UCB. In its October 4, 2001 response, Prochimie did not provide any of the data/ information that the Agency required, but instead requested a re   evaluation of the Agency's determination not to waive certain environmental fate studies, clarification of applicable existing data, and a determination of data requirements applicable to the nonresidential turf use. To date, Prochimie has failed to take appropriate steps to secure certain data required by the 1991 DCI applicable to nonresidential turf use and remains in noncompliance with those data requirements, which are set forth in Appendix II to this Notice. Accordingly, the Agency is issuing this Notice of Intent to Suspend.

V. What is the Agency's Authority for Taking this Action?

The Agency's authority for taking this action is section 6( f)( 2) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), 7 U. S. C. 136 et seq.

List of Subjects Environmental protection.

Dated: February 4, 2003. Richard Colbert, Director, Agriculture Division, Office of Compliance, Office of Enforcement and Compliance Assurance. [ FR Doc. 03   4776 Filed 2   27   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0006; FRL   7288   9]

Cymoxanil; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0006, must be received on or before March 31, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   9354; e mail address: waller. mary@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in OPP   2003   0006. If you have any questions regarding the applicability of VerDate Jan< 31> 2003 18: 05 Feb 27, 2003 Jkt 200001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 28FEN1. SGM 28FEN1 9661 Federal Register / Vol. 68, No. 40 / Friday, February 28, 2003 / Notices this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket ID number OPP   2003   0006. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA dockets. You may use EPA dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also, include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2003   0006. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID number OPP   2003   0006. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington,

VerDate Jan< 31> 2003 18: 05 Feb 27, 2003 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 28FEN1. SGM 28FEN1 9662 Federal Register / Vol. 68, No. 40 / Friday, February 28, 2003 / Notices DC 20460   0001, Attention: Docket ID number OPP   2003   0006. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID number OPP   2003   0006. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking? EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time, or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: February 10, 2003. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition The petitioner summary of the pesticide petition is printed below as required by FFDCA section 408( d)( 3). The summary of the petition was prepared by E. I. du Pont de Nemours and Company and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues, or an explanation of why no such method is needed.

E. I. du Pont de Nemours and Company PP 0F6072 EPA has received a pesticide petition ( 0F6072) from E. I. du Pont de Nemours and Company, DuPont Agricultural Products, Barley Mill Plaza, Wilmington, DE 19880   0038 proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR 180.503 by establishing tolerances for residues of the fungicide, cymoxanil; 2 cyano N( ethylamino) carbonyl l 2 ( methoxyimino) acetamide in or on the raw agricultural commodities cucurbit vegetables at 0.05 parts per million ( ppm), fruiting vegetables at 0.2 ppm, and head lettuce at 4.0 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. The plant metabolism of cymoxanil is adequately understood in three diverse crops: potatoes, tomatoes, and lettuce. The results of these plant metabolism studies indicate that cymoxanil degrades extensively to primarily the amino acid glycine, with subsequent reincorporation into other naturallyoccurring products, such as glucose. 2. Analytical method. An analytical enforcement method is available for determining these plant residues by high performance level chromotography ( HPLC) with ultraviolet ( UV) detection. The limit of quantitation allows monitoring of crops with cymoxanil residues at or above the levels proposed in these tolerances. 3. Magnitude of residues   i. Cucurbit vegetables. The magnitude and decline of residues of cymoxanil was determined on cucumber, cantaloupe and summer squash, the representative commodities for the cucurbit vegetable crop group as follows:   Cucumber. DPX KP481 50DF, containing 25% cymoxanil and 25% famoxadone, was applied as a water dispersible granule to six test sites in Florida, Georgia, Minnesota, Ohio, Virginia, and Texas. DPX KP481 50DF was applied as seven broadcast applications at the maximum rate of 0.1875 lb cymoxanil acre for a maximum seasonal use rate of 1.31 lb cymoxanil/ acre. Applications were made approximately 5 days apart. The target pre harvest interval ( PHI) was 3 days. Residues of cymoxanil were less than 0.05 ppm.   Cantaloupe. DPX KP481 50DF, containing 25% cymoxanil and 25% famoxadone, was applied as a water dispersible granule to six test sites in Florida, Georgia, Minnesota, Ohio, Virginia, and Texas. DPX KP481 50DF was applied as seven broadcast applications at the maximum rate of 0.1875 lb cymoxanil/ acre for a maximum seasonal use rate of 1.31 lb cymoxanil/ acre. Applications were made approximately 5 days apart. The target PHI was 3 days. Residues of cymoxanil were less than 0.05 ppm.   Summer squash. DPX KP481 50DF, containing 25% cymoxanil and VerDate Jan< 31> 2003 18: 05 Feb 27, 2003 Jkt 200001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 28FEN1. SGM 28FEN1 9663 Federal Register / Vol. 68, No. 40 / Friday, February 28, 2003 / Notices 25% famoxadone, was applied as a water dispersible granule to five test sites in Florida, Pennsylvania, Minnesota, North Carolina and California. DPX KP481 50DF was applied as seven broadcast applications at the maximum rate of 0.1875 lb cymoxanil/ acre for a maximum seasonal use rate of 1.31 lb cymoxanil/ acre. Applications were made approximately 5 days apart. The target PHI was 3 days. Residues of cymoxanil were less than 0.05 ppm. ii. Fruiting vegetables. The magnitude and decline of residues of cymoxanil was determined on tomato and pepper, the representative commodities for the fruiting vegetable crop group as follows:   Pepper. Bell and non bell DPXKP481 50DF, containing 25% cymoxanil and 25% famoxadone, was applied as a water dispersible granule to nine test sites in Georgia, Florida, Ohio, Texas, Arizona, California, and New Mexico. DPX KP481 50DF was applied as nine broadcast applications at a maximum seasonal use rate of 1.12 lb cymoxanil/ acre. Applications were made approximately 5 days apart. The target PHI was 3 days. Residues of cymoxanil at the target PHI of 3 days ranged from less than 0.05   0.12 ppm in peppers ( bell and non bell).   Tomato. DPX KP481 50DF, containing 25% cymoxanil and 25% famoxadone was applied as a water dispersible granule to 12 test sites in Florida, Maryland, Pennsylvania, California and Indiana. DPX KP481 50DF was applied as nine broadcast applications at a maximum seasonal use rate of 1.12 lb cymoxanil/ acre. Applications were made approximately 5 days apart. The target PHI was 3 days. Residues of cymoxanil at the target PHI of 3 days were less than 0.05 ppm in tomatoes.   Tomato, process fractions. DPXKP481 50DF, containing 25% cymoxanil and 25% famoxadone, was applied as a water dispersible granule to one site in California to determine the magnitude of residue in tomato and the extent to which the residue concentrated in tomato processed fractions. DPX KP481 50DF was applied in nine broadcast applications at 1X and 5X the proposed maximum rate of 1.12 lb cymoxanil/ acre. Applications were made approximately 5 days apart. The target PHI was 3 days. When applied at 5X the maximum use rate residues did not concentrate in tomato washed, unwashed, paste or puree. iii. Head lettuce. DPX KP481 50DF, containing 25% cymoxanil and 25% famoxadone, was applied as a water dispersible granule to eight test sites in Arizona, California, Florida, New York, and New Mexico. DPX KP481 50DF was applied as seven broadcast applications at the maximum rate of 0.1875 lb cymoxanil/ acre for a maximum seasonal use rate of 1.31 lb cymoxanil/ acre. Applications were made approximately 5 days apart. The target PHI was 3 days. Residues of cymoxanil in head lettuce ranged from less than 0.05   2.8 ppm ( wrapper leaves attached) and less than 0.05   1.1 ppm ( wrapper leaves removed).

B. Toxicological Profile 1. Acute toxicity. A battery of acute toxicity tests on technical cymoxanil places it in the following Toxicity Categories:

TABLE 1.   ACUTE TOXICITY RESULTS ON TECHNICAL CYMOXANIL Oral LD50 Rat 960 mg/ kg Category III Dermal LD50 Rabbit > 2,000 mg/ kg Category III Inhalation LC50 Rat > 5.06 mg/ L Category IV Eye irritation Rabbit Slight irritant Category IV Dermal irritation Rabbit Not an irritant Category IV Dermal sensitization Guinea pig Not a sensitizer An acute neurotoxicity study was not required with cymoxanil and no acute neurotoxicity has been observed in short term or subchronic studies. 2. Genotoxicty. Cymoxanil was tested in a battery of assays to evaluate genotoxicity and chromosome aberrations with the following results. Based on the weight of evidence, cymoxanil is not considered to be genotoxic or clastogenic.

TABLE 2.   GENOTOXICITY AND CHROMOSOME ABERRATIONS ASSAY RESULTS Bacterial gene mutation Salmonella typhimurium Negative Mammalian gene mutation in vitro CHO/ HGPRT Negative Mammalian chromosome aberrations in vitro CHO Positive Mammalian chromosome aberrations in vitro Mouse micronucleus Negative Unscheduled DNA synthesis in vitro Primary rat hepatocytes Negative Unscheduled DNA synthesis in vitro Primary rat hepatocytes and Spermatocytes Negative VerDate Jan< 31> 2003 18: 05 Feb 27, 2003 Jkt 200001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 28FEN1. SGM 28FEN1 9664 Federal Register / Vol. 68, No. 40 / Friday, February 28, 2003 / Notices 3. Reproductive and developmental toxicity. The results of a series of studies indicated that there were no reproductive, developmental, or teratogenic hazards associated with cymoxanil. In a 2 generation cymoxanil rat reproduction study, the no observed effect level ( NOEL) for both parents and offspring was approximately 7 milligrams/ kilogram/ day ( mg/ kg/ day), based on decreased body weight, weight gain and food consumption in adults and decreased pup weight in offspring at 32 mg/ kg/ day. There were no reproductive or fertility effects. Since offspring effects occurred only in the presence of maternal toxicity, it is considered a secondary effect to the health effects on the dam. With cymoxanil, developmental studies conducted in rats demonstrated a NOEL of 10 mg/ kg/ day and a lowest observed effect level ( LOEL) of 25 mg/ kg/ day for both adult and developmental effects. Maternal effects in rats included decreased weight, weight gain, and food consumption. Developmental effects were increases in fetal variations, which were the result of generalized delays in ossification, and overall malformations, although malformations detected were not doserelated In rabbits, several developmental toxicity studies were conducted with cymoxanil. Based on the weight of evidence of all three studies, EPA considered there was no unique sensitivity of perinatal animals to the effects of cymoxanil, nor any anomalies of the fetal nervous system at maternally toxic doses up to and including 32 mg/ kg/ day ( Cymoxanil Agency Risk Assessment, February 18, 1998). 4. Subchronic toxicity. Subchronic ( 90   day) feeding studies were conducted with rats, mice, and dogs. In addition, the following subchronic feeding studies were conducted: A 90   day in rats to evaluate neurotoxicity and 28   day feeding studies in rats and mice to evaluate immunotoxicity. A 28   day dermal study was conducted in rats. In a subchronic toxicity/ neurotoxicity study in rats with cymoxanil, the NOEL of 47.6 mg/ kg/ day in males was based on decreased body weights and minimal to mild testicular and epididymal effects at higher concentrations. In females, the NOEL of 59.9 mg/ kg/ day was based on effects on body weight, weight gain, and food efficiency at higher levels. The subchronic NOEL for male mice administered cymoxanil was 8.25 mg/ kg/ day based on body weight and weight gain effects at 82.4 mg/ kg/ day and above. The NOEL for females was 121 mg/ kg/ day based on increases in spleen and liver weights at 433 mg/ kg/ day and above. For cymoxanil, dogs were the most sensitive species in subchronic studies. Reduced body weight gain and/ or food consumption was observed at 3 mg/ kg/ day or greater in females and 5 mg/ kg/ day and above in males. Both sexes had red blood cells ( RBC) changes decreased RBC counts, hemaglobin ( Hb), and/ or hematocrit ( Hct) and increased incidence of ketonuria at the intermediate and high concentration, and changes in serum chemistry ( decreases in various electrolytes and proteins) at the high dose. Males had testicular and epididymal effects at the highest concentration, 11 mg/ kg/ day ( raised from 5 mg/ kg/ day at week 3); this was considered to be retardation of development due to markedly reduced body weight in this group. The NOEL for males was 3 mg/ kg/ day. There was no NOEL in female dogs in the 90   day study. Although, a NOEL was not established in the dog subchronic study, 3 mg/ kg/ day was found to be a NOEL in a subsequent chronic study in dogs. Subchronic 28   day studies were conducted in rats and mice to evaluate the immunotoxicity potential of cymoxanil. Cymoxanil was not immunotoxic up to and including the highest dose tested which was 1,600 ppm in rats ( 108 and 117 mg/ kg/ day in males and females, respectively), 1,200 ppm ( 218 mg/ kg/ day) in male mice, and 2,400 ppm ( 552 mg/ kg/ day) in female mice. Cymoxanil was applied to the skin of rats 6   hours/ day for 28 days at doses of 0, 50, 500, and 1,000 mg/ kg/ day. There were no effects at any dose tested. The 28   day dermal NOEL was 1,000 mg/ kg/ day, the highest dose tested. 5. Chronic toxicity. Chronic studies with cymoxanil were conducted on rats, mice, and dogs to determine oncogenic potential and/ or chronic toxicity of the compound. Effects generally similar to those observed in the 90   day studies were seen in the chronic studies. Cymoxanil was not oncogenic. The chronic NOEL for cymoxanil in male rats was 4.08 mg/ kg/ day based on decreased body weight, weight gain, food efficiency, and non neoplastic lesions in several organs including lung inflammation, spermatid degeneration, and retinal atrophy at 30.3 mg/ kg/ day or higher. In addition, male rats in the two highest groups displayed increased aggressiveness and hyperreactivity consistent with the compromised general health status ( i. e. systemic toxicity) of those groups. In females, the NOEL of 5.36 mg/ kg/ day was based on decreased body weight, weight gain, food efficiency, and non neoplastic lesions in several organs including lungs, liver, intestines, mesenteric lymph nodes, sciatic nerve, and retina at 38.4 mg/ kg/ day or higher. Retinal atrophy and sciatic lesions are common spontaneous lesions associated with aging. These effects observed in cymoxanil test animals were considered aging related effects. Spermatid degeneration occurs spontaneously in rats. While the incidence was increased in cymoxanil treated rats, most were mild or minimal and none were more than moderate. Thus, the effects are considered a mild exacerbation of a spontaneously occurring lesion. In mice, the chronic NOELs for cymoxanil were 4.19 and 5.83 mg/ kg/ day for males and females, respectively, based on changes in organ weights, gastrointestinal effects in females and liver, testes and epididymal effects in males at the LOEL. Similar to the rat, the testicular effects were considered an exacerbation of a spontaneous lesion, that occurred in one quarter of the control mice. The LOELs were 42.0 and 58.1 mg/ kg/ day for males and females, respectively. The chronic cymoxanil NOEL for male dogs was 3.0 mg/ kg/ day based on a temporary decrease in body weight and food consumption, and lower RBC count, hemoglobin, and hematocrit at 5.7 mg/ kg/ day. In female dogs the only finding was a transient effect on body weight, food consumption, and food efficiency at the highest dose tested, 3.1 mg/ kg/ day, only during the first week of the study. EPA considered the NOEL in females to be 3.1 mg/ kg ( Cymoxanil Agency Risk Assessment, February 18, 1998). 6. Animal metabolism. When administered by gavage to rats, cymoxanil was readily absorbed and eliminated. Absorption reached maximum concentrations in whole blood within 4 hours post dosing. A rapid and almost complete elimination was observed in the urine and feces. The majority of radioactivity was recovered within 96 hours, mainly in urine but also in feces. Radioactivity in the tissues and carcass was less than 1%. In the urine and feces, the majority of the radioactivity was free and/ or conjugated glycine. 2 Cyano 2 methoxyimino acetic acid was also found in low levels in the urine and trace levels in the feces. Intact cymoxanil was less than 1% in feces and not detected in the urine. The metabolite profile in urine and feces was similar between sexes, among dose groups, and between dosing regimens ( single vs. multiple).

VerDate Jan< 31> 2003 18: 05 Feb 27, 2003 Jkt 200001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 28FEN1. SGM 28FEN1 9665 Federal Register / Vol. 68, No. 40 / Friday, February 28, 2003 / Notices 7. Metabolite toxicology. There are no metabolites of toxicological significance to mammals. 8. Endocrine disruption. Chronic, lifespan, and multi generational bioassays in mammals and acute and subchronic studies on aquatic organisms and wildlife did not reveal endocrine effects. Any endocrine related effects would have been detected in this definitive array of required tests. The probability of any such effect due to agricultural uses of cymoxanil is negligible.

C. Aggregate Exposure 1. Dietary exposure. Cymoxanil is a fungicide currently registered in the United States for use on potatoes. In addition, tolerances have been for cymoxanil on imported tomatoes and grapes. This tolerance petition proposes the following new uses in the United States: Cucurbit vegetables, fruiting vegetables and head lettuce. There are no residential uses. i. Food   a. Chronic dietary exposure assessment. The chronic RfD of 0.041 mg/ kg/ day is based on a NOEL of 4.08 mg/ kg/ day from the 1 year rat feeding study and an uncertainty factor of 100. The acute NOEL of 4.0 mg/ kg/ day is based upon maternal clinical signs and weight effects at higher levels in a rat developmental study. Chronic dietary cymoxanil exposure risks resulting from the proposed use of DPX KP481 50DF on cucurbits, fruiting vegetables, head lettuce, potatoes and imported grapes were estimated using the Dietary Exposure Evaluation Model ( DEEM, Novigen Sciences, Inc., 1999 Version 6.74). The analysis conservatively assumed that 30% of the crops on the proposed label would be treated with DPX KP481 50DF and used field trial residue data. The chronic dietary risk estimate for cymoxanil shows that an adequate margin of safety exists for all population subgroups and that no effects would result from dietary exposure to cymoxanil. The following table presents the analysis which indicate large margins of safety for each population subgroup and very low probability of effects resulting from chronic exposure to cymoxanil in DPX KP481 50DF. No sensitive subpopulations were identified. For the general populations and all subpopulations 0.2% or less of the chronic RfD used.

TABLE 3.   RESULTS OF CHRONIC DIETARY ANALYSIS WITH CYMOXANIL Population Group Maximum Dietary Exposure ( mg/ kg/ day) % RfD U. S. population 0.000063 0.2 Non nursing infants (< 1 yr.) 0.000016 < 0.1 Children ( 1   6 yr.) 0.000074 0.2 Children ( 7   12 yr.) 0.000068 0.2 Females ( 13+) 0.000074 0.2 b. Acute dietary exposure. Results of the Tier 3 acute dietary exposure analysis show that an adequate margin of safety exists for all population subgroups and that no acute effects would result from dietary exposure to cymoxanil. The analysis conservatively assumed that 30% of the crops on the proposed label would be treated with DPX KP481 50DF and used field trial residue data. The results of the acute dietary exposure analysis for cymoxanil are given in the table below. The percentages of acute reference dose ( aRFD) for cymoxanil were calculated based on an acute NOEL of 4 mg/ kg/ day from the rabbit developmental study based on maternal clinical signs and weight effects at the higher levels and an uncertainty factor of 100. The results of the acute dietary exposure analysis for cymoxanil indicate that the predicted exposures, expressed as a percentage of the aRFD are well below 100%, showing cymoxanil clearly meets the Food Quality Protection Act ( FQPA) standard of reasonable certainty of no harm and presents much lower acute dietary risk than many of its competitors. At the 99.9th percentile, the percentage of the aRFD was 4.47% for the general population and 5.72% for the most sensitive subpopulation, nursing females.

TABLE 4.   RESULTS OF ACUTE DIETARY ANALYSIS WITH CYMOXANIL Population Group 99th Percentile of Exposure 99th Percentile of Exposure Exposure ( mg/ kg/ day) % aRfD Exposure ( mg/ kg/ day) % aRfD U. S. population 0.000475 1.19 0.001789 4.47 Non nursing infants (< 1 yr.) 0.000184 0.46 0.000599 1.50 Children ( 1   6 yr.) 0.000576 1.44 0.002096 5.24 Children ( 7   12 yr.) 0.000485 1.21 0.001936 4.84 Females ( 13+ nursing) 0.000635 1.59 0.002287 5.72 ii. Drinking water. Surface water exposure was estimated using the Generic Expected Environmental Concentration ( GENEEC) model. Ground water exposure was estimated using SCI GROW. These are screening level VerDate Jan< 31> 2003 18: 05 Feb 27, 2003 Jkt 200001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 28FEN1. SGM 28FEN1 9666 Federal Register / Vol. 68, No. 40 / Friday, February 28, 2003 / Notices models used for determining upper bound concentrations of pesticides in surface water and ground water. The acute drinking water levels of concern ( DWLOCs) are 1.3 parts per million ( ppm) for the U. S. population, and 0.38 ppm for the most exposed population subgroup, children ( 1   6 years). The estimated maximum concentration of cymoxanil in surface water ( 8.15 ppb) derived from GENEEC is much lower than the acute DWLOC. Therefore, one can conclude with reasonable certainty that residues of cymoxanil in drinking water will not contribute significantly to the aggregate acute human health risk. The chronic DWLOCs are 1.4 ppm for the U. S. population and 0.4 ppm for the most sensitive subgroup, children ( 1   6 years). The DWLOCs are substantially higher than the GENEEC 56   day estimated environmental concentration of 0.37 ppb for cymoxanil in surface water. Therefore, one can conclude with reasonable certainty that residues of cymoxanil in drinking water do not contribute significantly to the aggregate chronic human health risk. 2. Non dietary exposure. Cymoxanil products are not labeled for residential non food uses, thereby eliminating the potential for residential exposure. Nonoccupational non dietary exposure for cymoxanil has not been estimated because the proposed products are limited to commercial crop production. Therefore, the potential for nonoccupational exposure is insignificant.

D. Cumulative Effects EPA's consideration of a common mechanism of toxicity is not necessary at this time because there is no indication that toxic effects of cymoxanil should be cumulative with those of any other chemical compounds or with each other. Cymoxanil is a unique cyanoacetamide and is chemically unrelated to any other commercial plant disease control agent. Its biochemical mode of action on fungi appears to be unique; it is theorized to act through inhibition of multiple cellular processes, but a definitive mechanism has not been completely elucidated. Similarly, the mechanism of action underlying observed toxicological effects in mammals is not fully characterized and there is no reliable information to suggest that cymoxanil has a mechanism of toxicity in common with any other compound. Given the distinct chemical and toxicological profile of cymoxanil, its low acute toxicity, absence of genotoxic, oncogenic, developmental, or reproductive effects, and low exposure potential, the expression of cumulative human health effects with any other natural or synthetic pesticide is not anticipated.

E. Safety Determination 1. U. S. population. Dietary and occupational exposure will be the major routes of exposure to the U. S. population for cymoxanil, and ample margins of safety have been demonstrated for both. For cymoxanil, assuming 30% crop treated and residues estimated based on field trial results, the chronic dietary exposure for the overall U. S. population is estimated to be 0.000063 mg/ kg/ day, using 0.2 percent of the RfD. For acute dietary exposure, the estimated exposure is 0.000475 and 0.001789 at the 99th and 99.9th percentiles, which will utilize 1.19 and 4.47%, respectively, of the RfD for the overall U. S. population. The ground application margin of exposure ( MOE) was 7,814 for mixers/ loaders and 1,430 for applicators. The aerial application MOE was 3,907 for mixers/ loaders and 38,763 for applicators. The MOE for flaggers was 10,916. Based on the completeness and reliability of the toxicity data and the conservative exposure assessments, there is reasonable certainty that no harm will result from the aggregate exposure of residues of cymoxanil including all anticipated dietary exposure and all other non occupational exposures. 2. Infants and children. Chronic dietary exposure of cymoxanil for the most highly exposed children's subpopulations are: 0.000074 mg/ kg/ day for children 1   6 years and 0.000068 mg/ kg/ day for children 7   12 years, representing 0.2% of the chronic reference dose ( cRfD) for each subpopulation. Exposure for all infant subpopulations was negligible. For acute dietary exposure of cymoxanil, the % RfD for children 1   6 years is 1.44 at the 99th percentile and 5.24 at the 99.9th percentile. For non nursing infants (> 1 yr.), the % RfD is 0.46 at the 99th percentile and 1.50 at the 99.9th percentile. There are no residential uses of cymoxanil; it is extremely unlikely that drinking water will be contaminated. Based on the completeness and reliability of the toxicity data base, the lack of toxicological endpoints of special concern, the lack of any indication that children are more sensitive than adults to cymoxanil, and the conservative exposure assessment, there is a reasonable certainty that no harm will result to infants and children from the aggregate exposure of residues of cymoxanil, including all anticipated dietary exposure and all other nonoccupational exposures. Accordingly, there is no need to apply an additional safety factor for infants and children.

F. International Tolerances To date, no international tolerances exist for cymoxanil. [ FR Doc. 03   4257 Filed 2   27   03; 8: 45 am]

BILLING CODE 6560   50   S FEDERAL EMERGENCY MANAGEMENT AGENCY [ FEMA   1445   DR]

Alaska; Amendment No. 3 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency ( FEMA). ACTION: Notice.

SUMMARY: This notice amends the notice of a major disaster declaration for the State of Alaska, ( FEMA   1445 DR), dated December 4, 2002, and related determinations.

EFFECTIVE DATE: February 12, 2003. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Response and Recovery Directorate, Federal Emergency Management Agency, Washington, DC 20472, ( 202) 646   2705 or Magda. Ruiz@ fema. gov.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of Alaska is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of December 4, 2002:

Kodiak Island Borough for Public Assistance ( already designated for Individual Assistance). Alaska Railroad right of way between Milepost 79 and Milepost 102 along the Turnagain Arm and state highway Milepost 4 Power Creek Road highway in the Cordova area for Public Assistance. ( The following Catalog of Federal Domestic Assistance Numbers ( CFDA) are to be used for reporting and drawing funds: 83.537, Community Disaster Loans; 83.538, Cora Brown Fund Program; 83.539, Crisis Counseling; 83.540, Disaster Legal Services Program; 83.541, Disaster Unemployment Assistance ( DUA); 83.556, Fire Management Assistance; 83.558, Individual and Household Housing; 83.559, Individual and Household Disaster Housing Operations; 83.560 Individual and Household Program   Other Needs, 83.544, Public Assistance Grants; 83.548, Hazard Mitigation Grant Program.)

Joe M. Allbaugh, Director. [ FR Doc. 03   4723 Filed 2   27   03; 8: 45 am]

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