MEMORANDUM

DATE:		7/31/2015

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Mike Gordon, EPA Region 3

SUBJECT:	6/12/15 Meeting with Region 3 State Secretaries --------------------------------------------------------------------------------

SUMMARY

      On June 12, 2015 EPA attended a meeting with the State Secretaries or representatives from Region 3 to discuss the proposed Clean Power Plan for Existing Power Plants. The Clean Power Plan for Existing Power Plants was proposed on June 2, 2014.               ATTENDEES

Mike Gordon, EPA Region 3 Dave Arnold, EPA Region 3 Shawn Garvin, EPA Region 3


[Federal Register Volume 86, Number 182 (Thursday, September 23, 2021)]
[Notices]
[Pages 52937-52940]
[FR Doc No: 2021-20552]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93045; File No. SR-BOX-2021-22]

Self-Regulatory Organizations; BOX Exchange LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee
Schedule on the BOX Options Market LLC Facility To Reduce the Amount of
the Options Regulatory Fee (``ORF'')

September 17, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 14, 2021, BOX Exchange LLC (``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been prepared by the Exchange. The Exchange filed the proposed rule
change pursuant to Section 19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-
4(f)(2) thereunder,\4\ which renders the proposal 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)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange is filing with the Securities and Exchange Commission
(``Commission'') a proposed rule change to amend the Fee Schedule on
the BOX Options Market LLC (``BOX'') options facility. The text of the
proposed rule change is available from the principal office of the
Exchange, at the Commission's Public Reference Room and also on the
Exchange's internet website at http://boxexchange.com.

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
    Currently, the Exchange assesses ORF in the amount of $0.0038 per
contract side. The Exchange proposes to reduce the amount of ORF from
$0.0038 per contract side to $0.00295 per contract side in order to
help ensure that revenue collected from the ORF, in combination with
other regulatory fees and fines, does not exceed the Exchange's total
regulatory costs. The Exchange's proposed change to the ORF should
balance the Exchange's regulatory revenue against the anticipated
regulatory costs.
Collection of ORF
    Currently, the Exchange assesses the per-contract ORF to each
Participant \5\ for all options transactions, including Mini Options,
cleared or ultimately cleared by the Participant, which are cleared by
the Options Clearing Corporation (``OCC'') in the ``customer''
range,\6\ regardless of the exchange on which the transaction occurs.
The ORF is collected by OCC on behalf of the Exchange from either: (1)
A Participant that was the ultimate clearing firm for the transaction;
or (2) a non-Participant that was the ultimate clearing firm where a
Participant was the executing clearing firm for the transaction. The
Exchange uses reports from OCC to determine the identity of the
executing clearing firm and ultimate clearing firm.
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    \5\ The term ``Participant'' or ``Options Participant'' means a
firm, or organization that is registered with the Exchange pursuant
to the Rule 2000 Series for purposes of participating in trading on
a facility of the Exchange. See BOX Rule 100(a)(41).
    \6\ Exchange Participants must record the appropriate account
origin code on all orders at the time of entry in order. The
Exchange represents that it has surveillances in place to verify
that Participants mark orders with the correct account origin code.
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    To illustrate how the Exchange assesses and collects ORF, the
Exchange provides the following set of examples. For a transaction that
is executed on the Exchange and the ORF is assessed, if there is no
change to the clearing account of the original transaction, then the
ORF is collected from the Participant that is the executing clearing
firm for the transaction (the Exchange notes that, for purposes of the
Fee Schedule, when there is no change to the clearing account of the
original transaction, the executing clearing firm is deemed to be the
ultimate clearing firm). If there is a change to the clearing account
of the original transaction (i.e., the executing clearing firm ``gives-
up'' or ``CMTAs'' \7\ the transaction to another clearing firm), then
the ORF is collected from the clearing firm that ultimately clears the
transaction--the ``ultimate clearing firm.'' The ultimate clearing firm
may be either a Participant or non-Participant of the Exchange. If the
transaction is executed on an away exchange and the ORF is assessed,
then the ORF is collected from the ultimate clearing firm for the
transaction. Again, the ultimate clearing firm may be either a
Participant or non-Participant of the Exchange. The Exchange notes,
however, that when the transaction is executed on an away exchange, the
Exchange does not assess the ORF when neither the executing clearing
firm nor the ultimate clearing firm is a Participant (even if a
Participant is ``given-up'' or ``CMTAed'' and then such Participant
subsequently ``gives-up'' or ``CMTAs'' the transaction to another non-
Participant via a CMTA reversal). Finally, the Exchange does not assess
the ORF on outbound linkage trades, whether executed at the Exchange or
an away exchange. ``Linkage trades'' are tagged in the Exchange's
system, so the Exchange can readily tell them apart from other trades.
A customer order routed to another exchange results in two customer
trades, one from the originating exchange and one from the recipient
exchange. Charging ORF on both trades could result in double-billing of
ORF for a single customer order; thus, the Exchange does not assess ORF
on outbound linkage trades in a linkage scenario.
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    \7\ ``CMTA'' or Clearing Member Trade Assignment is a form of
``give-up'' whereby the position will be assigned to a specific
clearing firm at OCC.
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    As a practical matter, when a transaction that is subject to the
ORF is not executed on the Exchange, the Exchange lacks the information
necessary to identify the order-entering market participant for that
transaction. There are a multitude of order-entering market
participants throughout the industry, and such participants can make
changes to the market centers to which they connect, including dropping
their connection to one market center and establishing themselves as
participants on another. For these reasons, it is not possible for the

Exchange to identify, and thus assess fees such as ORF, on order-
entering participants on away markets on a given trading day. Clearing
members, however, are distinguished from order-entering participants
because they remain identified to the Exchange on information the
Exchange receives from OCC regardless of the identity of the order-
entering participant, their location, and the market center on which
they execute transactions. Therefore, the Exchange believes it is more
efficient for the operation of the Exchange and for the marketplace as
a whole to collect the ORF from clearing members.
ORF Revenue and Monitoring of ORF
    The Exchange monitors the amount of revenue collected from the ORF
to ensure that it, in combination with other regulatory fees and fines,
does not exceed regulatory costs. In determining whether an expense is
considered a regulatory cost, the Exchange reviews all costs and makes
determinations if there is a nexus between the expense and a regulatory
function. The Exchange notes that fines collected by the Exchange in
connection with a disciplinary matter offset ORF.
    As discussed below, the Exchange believes it is appropriate to
charge the ORF only to transactions that clear as customer at the OCC.
The Exchange believes that its broad regulatory responsibilities with
respect to a Participant's activities supports applying the ORF to
transactions cleared but not executed by a Participant. The Exchange's
regulatory responsibilities are the same regardless of whether a
Participant enters a transaction or clears a transaction executed on
its behalf. The Exchange regularly reviews all such activities,
including performing surveillance for position limit violations,
manipulation, front-running, contrary exercise advice violations and
insider trading. These activities span across multiple exchanges.
    Revenue generated from ORF, when combined with all of the
Exchange's other regulatory fees and fines, is designed to recover a
material portion of the regulatory costs to the Exchange of the
supervision and regulation of Participants' customer options business
including performing routine surveillances, investigations,
examinations, financial monitoring, and policy, rulemaking,
interpretive, and enforcement activities. Unlike other options
exchanges, all of the Exchange's expenses support the regulatory
function as BOX Exchange LLC (the ``Exchange'') is a fully separate
legal entity from BOX Options Market LLC, the equity options facility
of the Exchange. The Exchange fulfills the regulatory functions and
responsibilities as a national securities exchange registered with the
SEC under Section 6 of the Securities Exchange Act of 1934, and
oversees the BOX Options Market. Exchange expenses are solely
regulatory in nature because, due to the unique structure between the
Exchange and the BOX Options Market facility, the Exchange expenses are
separate from the BOX Options Market facility expenses and there can be
no commingling of the funds. Put another way, all of the Exchange's
expenses support the regulatory function of BOX Exchange because the
Exchange expenses are completely separate from the BOX Options Market
facility expenses. The ORF is designed to recover a material portion of
these regulatory costs to the Exchange, including the supervision and
regulation of its participants, including performing routine
surveillances, investigations, examinations, financial monitoring, and
policy, rulemaking, interpretive, and enforcement activities.
Proposal
    Based on the Exchange's most recent review, the Exchange proposes
to reduce the amount of ORF that will be collected by the Exchange from
$0.0038 per contract side to $0.00295 per contract side. The Exchange
issued an Informational Circular detailing the Options Regulatory Fee
Announcement on July 27, 2021, indicating the proposed rate change for
September 1, 2021.\8\
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    \8\ See https://boxoptions.com/assets/IC-2021-32-Options-Regulatory-Fee-Announcement.pdf.
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    The proposed decrease is based on recent options volumes, which
included an increase in retail investors. With respect to options
volume, the Exchange, and the options industry as a whole, experienced
a significant increase between 2020 and 2021. For example, total
options contract volumes in April, May and June 2021 were 29.7%, 32.7%
and 25.6% higher than the total options contract volumes in April, May
and June 2020, respectively.\9\
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    \9\ See data from OCC at: OCC April 2021 Total Volume Up 29.7
Percent from a Year Ago [bond]Business Wire, OCC May 2021 Total
Volume Up 32.7 Percent from a Year Ago [bond] Business Wire, and OCC
June 2021 Total Volume Up 25.6 Percent from a Year Ago (apnews.com).
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    There can be no assurance that the Exchange's final costs for 2021
will not differ materially from these expectations, nor can the
Exchange predict with certainty whether options volume will remain at
the current level going forward. The Exchange notes however, that when
combined with regulatory fees and fines, the revenue being generated
utilizing the current ORF rate may result in revenue that will run in
excess of the Exchange's estimated regulatory costs for the year.\10\
Particularly, as noted above, the options market has seen a substantial
increase in volume throughout 2020 and 2021, due in large part to the
extreme volatility in the marketplace as a result of the COVID-19
pandemic. This unprecedented spike in volatility resulted in
significantly higher volume than was originally projected by the
Exchange (thereby resulting in substantially higher ORF revenue than
projected). The Exchange therefore proposes to decrease the ORF in
order to ensure it does not exceed its regulatory costs for the year.
Particularly, the Exchange believes that decreasing the ORF when
combined with all of the Exchange's other regulatory fees and fines,
would allow the Exchange to continue covering a material portion of its
regulatory costs, while lessening the potential for generating excess
revenue that may otherwise occur using the current rate.\11\
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    \10\ The Exchange notes that notwithstanding the potential
excess ORF revenue the Exchange anticipates it would collect
utilizing the current rate, it has not used such revenue for non-
regulatory purposes.
    \11\ The Exchange notes that its regulatory responsibilities
with respect to Participant compliance with options sales practice
rules have been allocated to the Financial Industry Regulatory
Authority (``FINRA'') under a 17d-2 Agreement. The ORF is not
designed to cover the cost of options sales practice regulation.
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    The Exchange will continue to monitor the amount of revenue
collected from the ORF to ensure that it, in combination with its other
regulatory fees and fines, does not exceed the Exchange's total
regulatory costs. The Exchange will continue to monitor BOX regulatory
costs and revenues at a minimum on a semi-annual basis. If the Exchange
determines regulatory revenues exceed or are insufficient to cover a
material portion of its regulatory costs, the Exchange will adjust the
ORF by submitting a fee change filing to the Commission. The Exchange
will notify Participants of adjustments to the ORF via Informational
Circular at least 30 days prior to the effective date of the change.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act, in general, and Section
6(b)(4) and 6(b)(5)of the Act,\12\ in particular, in that

it provides for the equitable allocation of reasonable dues, fees, and
other charges among BOX Participants and other persons using its
facilities and does not unfairly discriminate between customers,
issuers, brokers or dealers.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes the proposed fee change is reasonable because
customer transactions will be subject to a lower ORF fee than the
current rate. Moreover, the proposed reduction is necessary in order
for the Exchange to not collect revenue in excess of its anticipated
regulatory costs, in combination with other regulatory fees and fines,
which is consistent with the Exchange's practices.
    The ORF is designed to recover a material portion of the costs of
supervising and regulating Participants' customer options business
including performing routine surveillances and investigations, as well
as policy, rulemaking, interpretive and enforcement activities. The
Exchange will monitor the amount of revenue collected from the ORF to
ensure that it, in combination with its other regulatory fees and
fines, does not exceed the Exchange's total regulatory costs. The
Exchange has designed the ORF to generate revenues that, when combined
with all of the Exchange's other regulatory fees, will be less than or
equal to the Exchange's regulatory costs, which is consistent with the
Commission's view that regulatory fees be used for regulatory purposes
and not to support the Exchange's business side. In this regard, the
Exchange believes that the proposed decrease to the fee is reasonable.
    The Exchange believes that continuing to limit changes to the ORF
to twice a year on specific dates with advance notice is reasonable
because it gives participants certainty on the timing of changes, if
any, and better enables them to properly account for ORF charges among
their customers. The Exchange believes that continuing to limit changes
to the ORF to twice a year on specific dates is equitable and not
unfairly discriminatory because it will apply in the same manner to all
Participants that are subject to the ORF and provide them with
additional advance notice of changes to that fee.
    The Exchange believes that collecting the ORF from non-Participants
when such non-Participants ultimately clear the transaction (that is,
when the non-Participant is the ``ultimate clearing firm'' for a
transaction in which a Participant was assessed the ORF) is an
equitable allocation of reasonable dues, fees, and other charges among
its participants and issuers and other persons using its facilities.
The Exchange notes that there is a material distinction between
``assessing'' the ORF and ``collecting'' the ORF. The ORF is only
assessed to a Participant with respect to a particular transaction in
which it is either the executing clearing firm or ultimate clearing
firm. The Exchange does not assess the ORF to non-Participants. Once,
however, the ORF is assessed to a Participant for a particular
transaction, the ORF may be collected from the Participant or a non-
Participant, depending on how the transaction is cleared at OCC. If
there was no change to the clearing account of the original
transaction, the ORF would be collected from the Participant. If there
was a change to the clearing account of the original transaction and a
non-Participant becomes the ultimate clearing firm for that
transaction, then the ORF will be collected from that non-Participant.
The Exchange believes that this collection practice continues to be
reasonable and appropriate, and was originally instituted for the
benefit of clearing firms that desired to have the ORF be collected
from the clearing firm that ultimately clears the transaction.
    The Exchange designed the ORF so that revenue generated from the
ORF, in combination with its other regulatory fees and fines, does not
exceed regulatory costs, which is consistent with the view of the
Commission that regulatory fees be used for regulatory purposes and not
to support the Exchange's business operations. As discussed above,
however, after review of its regulatory costs and regulatory revenues,
which includes revenues from ORF and other regulatory fees and fines,
the Exchange determined that absent a reduction in ORF, it may be
collecting revenue in excess of its regulatory costs. Indeed, the
Exchange notes that when taking into account the recent options volume,
which included an increase in customer options transactions, it
estimates the ORF will generate revenues that may cover more than the
approximated Exchange's projected regulatory costs. Moreover, when
coupled with the Exchange's other regulatory fees and revenues, the
Exchange estimates ORF to generate over 100% of the Exchange's
projected regulatory costs. As such, the Exchange believes it is
reasonable and appropriate to decrease the ORF amount from $0.0038 to
$0.00295 per contract side.
    The Exchange also believes the proposed fee change is equitable and
not unfairly discriminatory in that it is charged to all Participants
on all their transactions that clear in the customer range at the
OCC,\13\ with an exception.\14\ The Exchange believes the ORF ensures
fairness by assessing higher fees to those Participants that require
more Exchange regulatory services based on the amount of customer
options business they conduct. Regulating customer trading activity is
much more labor intensive and requires greater expenditure of human and
technical resources than regulating non-customer trading activity,
which tends to be more automated and less labor intensive. For example,
there are costs associated with main office and branch office
examinations (e.g., staff expenses), as well as investigations into
customer complaints and the terminations of registered persons. As a
result, the costs associated with administering the customer component
of the Exchange's overall regulatory program are materially higher than
the costs associated with administering the non-customer component
(e.g., participant proprietary transactions) of its regulatory program.
Moreover, the Exchange notes that it has broad regulatory
responsibilities with respect to activities of its Participants,
irrespective of where their transactions take place. Many of the
Exchange's surveillance programs for customer trading activity may
require the Exchange to look at activity across all markets, such as
reviews related to position limit violations and manipulation. Indeed,
the Exchange cannot effectively review for such conduct without looking
at and evaluating activity regardless of where it transpires. In
addition to its own surveillance programs, the Exchange also works with
other SROs and exchanges on intermarket surveillance related issues.
Through its participation in the Intermarket Surveillance Group
(``ISG'') \15\ the Exchange shares

information and coordinates inquiries and investigations with other
exchanges designed to address potential intermarket manipulation and
trading abuses. Accordingly, there is a strong nexus between the ORF
and the Exchange's regulatory activities with respect to customer
trading activity of its Participants.
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    \13\ The BOX ORF is collected by OCC on behalf of BOX from
either (1) a Participant that was the ultimate clearing firm for the
transaction or (2) a non-Participant that was the ultimate clearing
firm where a Participant was the executing clearing firm for the
transaction. The Exchange uses reports from OCC to determine the
identity of the executing clearing firm and ultimate clearing firm.
    \14\ When a transaction is executed on an away exchange, the
Exchange does not assess the ORF when neither the executing clearing
firm nor the ultimate clearing firm is a Participant (even if a
Participant is ``given-up'' or ``CMTAed'' and then such Participant
subsequently ``gives-up'' or ``CMTAs'' the transaction to another
non-Participant via a CMTA reversal).
    \15\ ISG is an industry organization formed in 1983 to
coordinate intermarket surveillance among the SROs by cooperatively
sharing regulatory information pursuant to a written agreement
between the parties. The goal of the ISG's information sharing is to
coordinate regulatory efforts to address potential intermarket
trading abuses and manipulations.
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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 not necessary or appropriate in
furtherance of the purposes of the Act. This proposal does not create
an unnecessary or inappropriate intra-market burden on competition
because the ORF applies to all customer activity, thereby raising
regulatory revenue to offset regulatory expenses. It also supplements
the regulatory revenue derived from non-customer activity. The Exchange
notes, however, the proposed change is not designed to address any
competitive issues. Indeed, this proposal does not create an
unnecessary or inappropriate inter-market burden on competition because
it is a regulatory fee that supports regulation in furtherance of the
purposes of the Act. The Exchange is obligated to ensure that the
amount of regulatory revenue collected from the ORF, in combination
with its other regulatory fees and fines, does not exceed regulatory
costs.

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

    No written comments were either solicited or received.

III. 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 Exchange Act \16\ and Rule 19b-4(f)(2)
thereunder,\17\ because it establishes or changes a due, or fee.
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    \16\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \17\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend the rule
change if it appears to the Commission that the action is necessary or
appropriate in the public interest, for the protection of investors, or
would otherwise further 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-BOX-2021-22 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BOX-2021-22. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BOX-2021-22, and should be submitted on
or before October 14, 2021.

    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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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-20552 Filed 9-22-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 28, 2005 (Volume 70, Number 208)]
[Notices]
[Page 62130]
[DOCID:fr28oc05-57]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1604-DR]

Mississippi; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, Emergency Preparedness and
Response Directorate, Department of Homeland Security

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster for the
State of Mississippi (FEMA-1604-DR), dated August 29, 2005, and related
determinations.

EFFECTIVE DATE: October 14, 2005.

FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal
Emergency Management Agency, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this disaster is closed effective October 14, 2005.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services Program; 97.034,
Disaster Unemployment Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and Households Housing; 97.049,
Individuals and Households Disaster Housing Operations; 97.050
Individuals and Households Program--Other Needs, 97.036, Public
Assistance Grants; 97.039, Hazard Mitigation Grant Program.)

R. David Paulison,
Acting Under Secretary, Emergency Preparedness and Response, Department
of Homeland Security.
[FR Doc. 05-21502 Filed 10-27-05; 8:45 am]

BILLING CODE 9110-10-P


 Written to:  Greg Nudd (EPA), Stephen Edgerton (ECR)        Date: August 28, 2012 Written By:  Gary Mirich

Regarding:  Hawaii Low Sulfur Fuel Model  -  Avoided Cost Impact for HELCO

It came to our attention that the original LSF modeling we had completed for EPA did not address an avoided cost issue relative to HELCO.  Specifically, we came to understand that the cost paid by MELCO for IPP renewables was based on an avoided cost calculation, and that any change in avoided cost in our modeling (i.e. increased fuel costs driven by a change in fuel from LSFO to LSIFO) would need to address the impact on avoided costs paid for the QF purchases.

This memo discusses the changes incorporated into the MS Excel workbook titled "C-5-g Fuel Cost Screening - r0 - 08_15_12 ESLC Edits" made to address the impact of avoided costs on the total utility fuel cost and electric rate impact outputs from the model.

Modeling Modification

Based on research on the HI rules and discussion with the HI staff we learned that the HI avoided cost calculations are derived from a production cost model revised annually, but run monthly to create both on and off peak avoided cost rates for those hours.  The avoided cost actually paid to generators is, therefore, a function of their on and off peak production (MWh) and the calculated on and off peak prices.  Although some key components of the historical avoided costs are published online, those readily available do not include the year 2009  -  the year in our fuel impact model.   Even so, had that data been available we are not confident that we could recreate the calculations without considerably more data and access to all assumptions in the production cost model employed at the time.

To address the avoided cost issue in light of the constraints on information and data, we modified the LSF model as described.  Avoided costs are derived from an approved stipulation in a case concluded before the HI PUC in 2002.  The stipulation approved the general methodology for calculation of avoided cost and calls the method a "QF in /QF out" approach  -  where avoided cost is driven by cost differential that occurs when MWh production of existing fossil resources are replaced by MWh from a QF resource.  In this case the qualifying resources are the renewables that HELCO purchases.

   1. The original LSF fuel impact model estimated 2009 costs for QF renewable plant purchased based on averages of the prior three years costs  -  data that was available online.  This data also included the MWh of production purchased from each facility, thus an estimated 2009 MWh of QF production was calculated using the average of 2006-2008 data.  The estimated 2009 QF MWh production for each plant totaled 340,604 MWh.  The revision in the model to address avoided costs therefore seeks to determine what cost was avoided from fossil plant production (QF out) because 340,604 MWh of energy was supplied by QFs (QF in).

   2. Seeking to balance with the QF MWh production described above, thermal plant output was increased by changing the capacity factor of individual units. Any fossil plant production that was increased in order to reach the targeted MWh (340,604) was not allowed to run more than 85% capacity factor in a year.

   3. Plant capacity factors were increased on the highest heat rate unit first, then the next highest, and so on, until the total MWh produced by the adjustment equaled the QF MWh production described above.

   4. The MWh adjustments were made for both the base case and the alternative case, then the difference in fuel cost between the two cases was calculated  -  this represented the incremental avoided cost as a result of the higher fuel cost in the alternative case.

   5. This incremental avoided cost was added to the cost of each QF plant price for the year to give the adjusted total impact.  That impact flows through to the Dashboard page in the model.


[Federal Register: May 6, 2009 (Volume 74, Number 86)]
[Rules and Regulations]
[Page 20874-20877]
[DOCID:fr06my09-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2008-0668; FRL-8780-1]

Revisions to the California State Implementation Plan, North
Coast Unified Air Quality Management District.

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve revisions to the
North Coast Unified Air Quality Management District (NCUAQMD) portion
of the California State Implementation Plan (SIP). This action revises
and adds various definitions of terms used by the NCUAQMD. Under
authority of the Clean Air Act as amended in 1990 (CAA or the Act), we
are approving local rules that are administrative and address changes
for clarity and consistency.

DATES: This rule is effective on July 6, 2009 without further notice,
unless EPA receives adverse comments by June 5, 2009. If we receive
such comments, we will publish a timely withdrawal in the Federal
Register to notify the public that this direct final rule will not take
effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2008-0668, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://
www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://
www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-mail directly to EPA, your e-mail address will be
automatically captured and included as part of the public comment.

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.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available in either location
(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed in the
FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Cynthia Allen, EPA Region IX, (415)
947-4120<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we'', ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rule revision?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules we are approving with the dates that they
were adopted by the local air agency and submitted by the California
Air Resources Board (CARB).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
              Local agency                  Rule No.              Rule title              Adopted     Submitted
----------------------------------------------------------------------------------------------------------------
NCAQMD..................................          100  General Provisions.............     05/19/05     07/18/08
NCAQMD..................................          101  Definitions....................     05/15/08     07/18/08
NCAQMD..................................          108  Severability of Rules and           05/19/05     07/18/08
                                                        Regulations.
----------------------------------------------------------------------------------------------------------------

    On August 22, 2008, these rules were found to meet the completeness
criteria in 40 CFR Part 51 Appendix V, which must be met before formal
EPA review.

B. Are there other versions of these rules?

    We approved a version of Rule 100 into the SIP on December 5, 1984
(49 FR 47490). There is no previous version of Rules 101 and 108 in the
SIP although we approved Rule 130 in February 9, 1999 (64 FR 6223),
which is now being replaced by Rule 101.

C. What is the purpose of the submitted rule revisions?

    Section 110(a) of the CAA requires states to submit regulations
that control volatile organic compounds, oxides of nitrogen,
particulate matter, and other air pollutants which harm human health
and the environment. These rules were developed as part of the local
agency's program to control these pollutants.
    NCUAQMD Rule 100 has been re-codified and added to Regulation I,
Air Quality Rules. This revision simply re-codifies existing
requirements. Rule 100 defines NCUAQMD and sets its purpose to protect,
maintain and achieve State and Federal Air Quality Standards. The rule
lists the procedures and immediate action the Air Pollution Control
Officer should follow in the event of atmospheric conditions causing a
dangerous or potentially hazardous concentration of air contaminants.
The rule also defines which documents in the NCUAQMD's possession are
considered public records and gives the authority of the regulations
and how the regulations are to be interpreted.
    NCUAQMD Rule 101 was amended to include new definitions, eliminate
definitions that were no longer needed and change some existing
definitions. Rule 101 has been re-codified and added to Regulation I,
Air Quality Rules. This revised rule provides definitions for terms
used in the NCUAQMD rules and regulations document.
    This re-codification includes incorporating in Rule 101 the
substantive definitions of various terms found throughout the four
NCUAQMD Regulations (I, II, III, and IV). Where multiple definitions of
the same term exist, a single ``consistent'' definition is included in
Rule 101.
    NCUAQMD Rule 108, Severability of Rules and Regulations, is a new
rule and has been added to establish legal severability among the rules
and regulations. Legal severability references the notion that if one
part of a rule, or one rule, or one regulation is found to be
unenforceable, that does not ``contaminate'' the enforceability of the
other provisions, rules or regulations.
    EPA's technical support document (TSD) has more information about
these rules.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    These rules describe administrative provisions and definitions that
support emission controls found in other local agency requirements. In
combination with the other requirements, these rules must be
enforceable (see section 110(a) of the Act) and must not relax existing
requirements (see sections 110(l) and 193). EPA policy that we used to
help evaluate enforceability requirements consistently includes the
Bluebook (``Issues Relating to VOC Regulation Cutpoints, Deficiencies,
and Deviations,'' EPA, May 25, 1988) and the Little Bluebook
(``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001).

B. Do the rules meet the evaluation criteria?

    We believe these rules are consistent with the relevant policy and
guidance regarding enforceability and SIP relaxations. The TSD has more
information on our evaluation.

C. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, EPA is fully
approving the submitted rules because we believe they fulfill all
relevant requirements. We do not think anyone will object to this
approval, so we are finalizing it without proposing it in advance.
However, in the Proposed Rules section of this Federal Register, we are
simultaneously proposing approval of the same submitted rules. If we
receive adverse comments by June 5, 2009, we will publish a timely
withdrawal in the Federal Register to notify the public that the direct
final approval will not take effect and we will address the comments in
a subsequent final action based on the proposal. If we do not receive
timely adverse comments, the direct final approval will be effective
without further notice on July 6, 2009. This will incorporate these
rules into the federally enforceable SIP.

    Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

III. Statutory and Executive Order Reviews

A. Executive Order 12866, Regulatory Planning and Review

    The Office of Management and Budget (OMB) has exempted this
regulatory action from Executive Order 12866, entitled ``Regulatory
Planning and Review.''

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b).

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and small governmental
jurisdictions.
    These rules will not have a significant impact on a substantial
number of small entities because SIP approvals under section 110 and
subchapter I, part D of the Clean Air Act do not create any new
requirements but simply approve requirements that the State is already
imposing. Therefore, because the Federal SIP approval does not create
any new requirements, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
    Moreover, due to the nature of the Federal-State relationship under
the Clean Air Act, preparation of flexibility analysis would constitute
Federal inquiry into the economic reasonableness of state action. The
Clean Air Act forbids EPA to base its actions concerning SIPs on such
grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976);
42 U.S.C. 7410(a)(2).

D. Unfunded Mandates Reform Act

    Under sections 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
    EPA has determined that the approval action promulgated does not
include a Federal mandate that may result in estimated costs of $100
million or more to either State, local, or tribal governments in the
aggregate, or to the private sector. This Federal action approves pre-
existing requirements under State or local law, and imposes no new
requirements. Accordingly, no additional costs to State, local, or
tribal governments, or to the private sector, result from this action.

E. Executive Order 13132, Federalism

    Federalism (64 FR 43255, August 10, 1999) revokes and replaces
Executive Orders 12612 (Federalism) and 12875 (Enhancing the
Intergovernmental Partnership). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects 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.'' Under Executive Order 13132, EPA may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or EPA
consults with State and local officials early in the process of
developing the proposed regulation. EPA also may not issue a regulation
that has federalism implications and that preempts State law unless the
Agency consults with State and local officials early in the process of
developing the proposed regulation.
    These rules will not have substantial direct effects 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, as specified in Executive Order 13132, because it
merely approves a state rule implementing a federal standard, and does
not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. Thus, the
requirements of section 6 of the Executive Order do not apply to this
rule.

F. Executive Order 13175, Coordination With Indian Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This final rule does not have
tribal implications, as specified in Executive Order 13175. It will not
have substantial direct effects on tribal governments, on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes. Thus, Executive Order 13175 does not
apply to this rule.

G. Executive Order 13045, Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation.
These rules are not subject to Executive Order 13045, because it
approves a state rule implementing a Federal standard.

H. Executive Order 13211, Actions That Significantly Affect Energy
Supply, Distribution, or Use

    These rules are not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12 of the National Technology Transfer and Advancement Act
(NTTAA) of 1995 requires Federal

agencies to evaluate existing technical standards when developing a new
regulation. To comply with NTTAA, EPA must consider and use ``voluntary
consensus standards'' (VCS) if available and applicable when developing
programs and policies unless doing so would be inconsistent with
applicable law or otherwise impractical.
    The EPA believes that VCS are inapplicable to this action. Today's
action does not require the public to perform activities conducive to
the use of VCS.

J. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. section 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing these
rules and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
section 804(2). These rules will be effective July 6, 2009.

K. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 6, 2009. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of these rules for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: February 10, 2009.
Jane Diamond,
Acting Regional Administrator, Region IX.

0
Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52 [AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraph (c)(359)(i)(A)(3), (4)
and (5) to read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (359) * * *
    (i) * * *
    (A) * * *
    (3) Rule 100, ``General Provisions,'' originally adopted on
November 3, 1982 and amended on May 19, 2005.
    (4) Rule 101, ``Definitions,'' originally adopted on November 3,
1982 and amended on May 19, 2005 and May 15, 2008.
    (5) Rule 108, ``Severability of Rules and Regulations,'' originally
adopted on May 19, 2005.
* * * * *
[FR Doc. E9-10509 Filed 5-5-09; 8:45 am]

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[Federal Register Volume 85, Number 4 (Tuesday, January 7, 2020)]
[Notices]
[Pages 705-706]
[FR Doc No: 2020-00014]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL20-12-000]

CPV Fairview, LLC; Notice of Institution of Section 206
Proceeding and Refund Effective Date

    On December 30, 2019, the Commission issued an order in Docket No.
EL20-12-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2018), instituting an investigation into whether CPV
Fairview, LLC's rate schedule is unjust, unreasonable, unduly
discriminatory or preferential, or otherwise unlawful. CPV Fairview,
LLC, 169 FERC 61,261 (2019).

    The refund effective date in Docket No. EL20-12-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL20-12-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426, in accordance with Rule 214 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2019),
within 21 days of the date of issuance of the order.

    Dated: December 31, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-00014 Filed 1-6-20; 8:45 am]
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[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3776-3777]
[FR Doc No: 2012-1489]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0592]

Yuri Izurieta: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
debarring Yuri Izurieta for a period of 20 years from importing
articles of food or offering such articles for importation into the
United States. FDA bases this order on a finding that Mr. Izurieta was
convicted of six felony counts under Federal law for conduct relating
to the importation into the United States of an article of food. Mr.
Izurieta was given notice of the proposed debarment and an opportunity
to request a hearing within the timeframe prescribed by regulation. As
of November 10, 2011 (30 days after receipt of the notice), Mr.
Izurieta had not responded. Mr. Izurieta's failure to respond
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is effective January 25, 2012.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance
Policy (HFC-230), Food and Drug Administration, 12420 Parklawn Dr.,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article for import into the United States if FDA
finds, as required by Section 306(b)(3)(A) of the FD&C Act (21 U.S.C.
335a(b)(3)(A)), that the individual has been convicted of a felony for
conduct relating to the importation into the United States of any food.
    On May 11, 2011, in the United States District Court for the
Southern District of Florida, Mr. Izureita was convicted of one count
of conspiracy to smuggle goods into the United States, in violation of
18 U.S.C. 371, and five counts of smuggling goods into the United
States, in violation of 18 U.S.C. 545. The United States District Court
for the Southern District of Florida entered judgment against Mr.
Izurieta on July 29, 2011.
    FDA's finding that debarment is appropriate is based on the felony
conviction's referenced herein for conduct relating to the importation
into the United States of any food. The factual basis for these
convictions is as follows: As alleged in the indictment that was filed
against Mr. Izurieta, beginning on or about April 18, 2007, and
continuing through about December 23, 2010, in violation of 18 U.S.C.
371, Mr. Izurieta knowingly, and with the intent to further the object
of the conspiracy, conspired with others to commit an offense against
the United States--to fraudulently and knowingly import and bring into
the United States merchandise contrary to law, in violation of 18
U.S.C. 545. Specifically, Mr. Izurieta conspired to distribute and sell
imported dairy products that FDA had detained after receiving notice
from FDA that the dairy products were suspected to be adulterated.
    Mr. Izurieta worked at Naver Trading Corp., a registered Florida
corporation engaged in the business of importing and distributing food,
including dairy products, in local and interstate commerce. While
working there, Mr. Izurieta caused dairy products and other food to be
imported from Honduras and Nicaragua. Despite requests from FDA, Mr.
Izurieta failed to disclose the location of shipments of dairy products
after learning that FDA had slated specific shipments for examination
due to concerns of adulteration with Escherichia coli, Staphylococcus
aureus, and Salmonella. Mr. Izurieta also distributed shipments of
dairy products after learning that FDA had slated specific shipments
for examination due to concerns of adulteration with E. coli, S.
aureus, and Salmonella. Mr. Izurieta failed to redeliver for
destruction and exportation shipments of dairy products that FDA had
determined to be adulterated with E. coli, S. aureus, and Salmonella,
and that were not authorized for entry into the United States. Mr.
Izurieta then imported and distributed dairy products that were
adulterated and not authorized for entry into the United States. This
conduct was in violation of 18 U.S.C. 545.
    From approximately April 18, 2007, and continuing to approximately
December 7, 2010, Mr. Izurieta fraudulently and knowingly imported and
brought into the United States merchandise contrary to law. Further,
Mr. Izurieta failed to redeliver, export, and destroy with FDA
supervision the dairy products and other food products contained in
these shipments after receiving notice from FDA regarding concerns
about the adulteration of these products with E. coli, S. aureus, and/
or Salmonella.
    As a result of his conviction, on September 28, 2011, FDA sent Mr.
Izurieta a notice by certified mail proposing to debar him for a period
of 20 years from importing articles of food or offering such articles
for import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Mr. Izurieta was
convicted of six felony counts under Federal law for conduct relating
to the importation into the United States of an article of food because
he conspired to commit offenses related to the importation of dairy
products into the United States and imported and brought into the
United States merchandise contrary to law. It was also based on a
determination, after consideration of the factors set forth in section
306(c)(3) of the FD&C Act (21 U.S.C. 335a(c)(3)) that Mr. Izurieta
should be subject to a 20-year period of debarment. The proposal also
offered Mr. Izurieta an opportunity to request a hearing, providing him
30 days from the date of receipt of the letter in which to file the
request, and advised him that failure to request a hearing constituted
a waiver of the opportunity for a hearing and of any contentions
concerning this action. Mr. Izurieta failed to respond within the
timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and waived any contentions concerning his
debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(b)(1)(C) of the FD&C Act, and
under authority delegated to the Director (Staff Manual Guide 1410.35),
finds that Mr. Yuri Izurieta has been convicted of six felony counts
under Federal law for conduct relating to the importation of an article
of food into the United States and that he is subject to 20 years of
debarment.
    As a result of the foregoing finding, Mr. Izurieta is debarred for
a period of 20 years from importing articles of food or offering such
articles for import into the United States, effective (see DATES).
Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the United States of an article
of food by, with the assistance of, or at the direction of Mr. Izurieta
is a prohibited act.

    Any application by Mr. Izurieta for termination of debarment under
section 306(d)(1) (21 U.S.C. 335a(d)(1)) of the FD&C Act should be
identified with Docket No. FDA-2011-N-0592 and sent to the Division of
Dockets Management (see ADDRESSES). All such submissions are to be
filed in four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 11, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-1489 Filed 1-24-12; 8:45 am]
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