[Federal Register Volume 83, Number 240 (Friday, December 14, 2018)]
[Notices]
[Pages 64393-64397]
[FR Doc No: 2018-27081]

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SECURITIES AND EXCHANGE COMMISSION

[Release No 34-84771; File No. SR-NSCC-2018-012]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing and Immediate Effectiveness of a Proposed
Rule Change To Amend Certain Fees Relating to Mutual Fund Services, and
Insurance and Retirement Processing Services

December 10, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 26, 2018, National Securities Clearing Corporation
(``NSCC'') 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 clearing agency.
NSCC filed the proposed rule change pursuant to Section 19(b)(3)(A) of
the Act \3\ and Rules 19b-4(f)(2) and (f)(4) thereunder.\4\ 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).
    \4\ 17 CFR 240.19b-4(f)(2) and (f)(4).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of modifications to Addendum A
(Fee Structure) (``Addendum A'') of NSCC's Rules & Procedures
(``Rules'') in order to make certain adjustments and clarifications in
the fee provisions for NSCC's Mutual Fund Services (``MFS'') and
Insurance and Retirement Processing Services (``I&RS''), as described
below.\5\
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    \5\ Capitalized terms used herein and not otherwise defined
shall have the meaning assigned to such terms in the Rules,
available at http://dtcc.com/~/media/Files/Downloads/legal/rules/
nscc_rules.pdf.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The purpose of this proposed rule change is to reduce certain fees
for MFS and I&RS set forth in Addendum A as described below, in order
to better align fees with the costs of services provided by NSCC by
reducing the fees so that the revenue received by NSCC would be closer
to the costs of providing the services. In addition, certain fee
reductions as described below are also intended to incentivize greater
use of certain MFS and I&RS products. The proposed rule change would
also clarify the description of certain fees as described below to
improve clarity and transparency of the Rules. NSCC expects the
proposed rule change would result in a decrease in revenue of

approximately 9.5% for each of the MFS and I&RS services.
(i) Background
    NSCC has undertaken a strategic review of its pricing structure,
and developed a revenue and pricing strategy with the goal of among
other things, reducing pricing complexity in Addendum A and aligning
pricing with costs.\6\ As a result of the review, NSCC has determined
that certain fees in MFS and I&RS have over time become misaligned with
the costs of services. Such fees are misaligned because the revenue
that NSCC has been receiving for such services has increased over time
more than the costs to provide the services. NSCC believes that this is
a result of streamlined processes in such services which have resulted
in the reduction of processing costs for NSCC for such services. NSCC
believes it is reasonable and appropriate to assess Members and Limited
Members (collectively, ``NSCC Members'') fees that are commensurate
with the costs of services provided to NSCC Members. Accordingly, the
proposed changes would adjust certain fees in MFS and I&RS so that
revenue for NSCC would better align with the costs of the services by
reducing the revenue that NSCC receives so that it is closer to the
costs of providing the services by NSCC. NSCC believes that the
proposed fee reductions would allow NSCC to lower the costs for
services to NSCC Members while still providing adequate funding to
enable NSCC to recover its costs in providing the services.
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    \6\ NSCC is also proposing changes to fees for NSCC services
that are not MFS and I&RS services in a separate proposal. In
addition, NSCC's affiliates, The Depository Trust Company and Fixed
Income Clearing Corporation are proposing changes to their
respective fees.
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    NSCC is also proposing certain fee changes as described below to
incentivize greater use of certain MFS and I&RS products.
    In addition, NSCC is proposing certain clarifying changes to the
description of certain fees in Addendum A as described below to enhance
clarity and transparency of the Rules.
(ii) Proposed Rule Changes

A. Networking Omni/SERV[supreg] Fee Reductions

    Omni/SERV, which is a feature of the MFS Networking service,
provides a streamlined communication platform for the transmission of
files for fund accounts held in omnibus.\7\ NSCC is proposing to reduce
the monthly fee for Omni/SERV file transmissions in Section IV.H.3. of
Addendum A from $2,500 per month to $1,500 per month. As discussed
below, NSCC believes that the proposed fee reduction would better align
the fees with the costs of providing Omni/SERV.
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    \7\ An omnibus fund account is a fund account held by a
financial intermediary on behalf of multiple underlying investors.
Omni/SERV allows NSCC Members to communicate information relating to
the underlying investors' sub-accounts.
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B. Profile Phases I and II Fee Reductions

    NSCC is proposing to reduce the monthly fee for Phases I and II of
the Mutual Fund Profile Service (``Profile'') in Section IV.J.b. of
Addendum A from $2,000 per month to $1,250 per month.\8\ In addition,
NSCC is proposing to change the credit that Profile II users (with 25
or fewer Funds) receive in footnote 1 of Addendum A from $1,150 to
$1,000. Together, with the reduction in the monthly fee from $2,000 to
$1,250, this proposed change would reduce the overall net fee for such
users from $850 to $250.
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    \8\ NSCC offers two levels of service through Profile, which are
referred to in NSCC's fee schedule as ``Phase I'' and ``Phase II.''
Phase I is used by NSCC Members to transmit price and rate
information for mutual funds and pooled investment entities (each a
``Fund'' and collectively, ``Funds''). Phase II consists of three
databases, (i) the participant profile database, (ii) the security
issue profile database, and (iii) the distribution declaration
information profile database. Through these three databases, NSCC
offers a centralized repository for prospectus and operational
information for securities of Funds, Fund distributions and Fund
processing capabilities. The current fee to use both Phase I and
Phase II is $2,000 per month. See Section IV.J.b. of Addendum A,
supra note 5.
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    As discussed below, NSCC believes that the proposed fee reduction
would better align the fees with the costs of providing Phases I and
II.
    In addition, NSCC believes that the proposed reduction in the fees
and the credit for smaller firms for Phases I and II would incentivize
more firms to use the service. NSCC believes that more firms using the
service would increase the value of the service by providing greater
access to more Fund data to NSCC Members.

C. Positions Fee Reductions

    NSCC is proposing to reduce the fees in three tiers for Positions
(Full, New and Retirement Plans) in Section IV.K.2.a.(i) of Addendum A
as follows: (i) Reduce fees for 0 to 500,000 items/month from $8 to $6
per 1,000 items, (ii) reduce fees for 500,001 to 2,000,000 items/month
from $4 to $3.50 per 1,000 items, and (iii) reduce fees for 4,000,001
or more items/month from $2 to $1.25 per 1,000 items. NSCC is not
proposing to reduce the fees for 2,000,001 to 4,000,000 items/month.\9\
As discussed below, NSCC believes that the proposed fee reduction would
better align the fees with the costs of providing Positions (Full, New
and Retirement Plans).
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    \9\ NSCC has determined that, based on the average number of
users and revenues generated for each tier, the intended overall
revenue decrease for the service could be accomplished by reducing
the three tiers as indicated without reducing the fees for the tier
for 2,000,001 to 4,000,000 items/month. In addition, NSCC determined
that the proposed tier structure following the Fee Reductions would
continue to incentivize NSCC Members to increase their use of the
service which NSCC believes increases efficiency in sending contract
details. All NSCC Members using the service would benefit from the
proposed fee reductions because the NSCC Members who reach the tier
for 2,000,001 to 4,000,000 items/month would benefit from the fee
reductions in the lower two tiers.
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D. IFT Tiered Pricing Program Fee Reductions and Revised Description

    NSCC proposes to restructure the current In Force Transactions
(``IFT'') \10\ tiered pricing program, including certain fee reductions
and certain clarifications as described below.
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    \10\ IFT is an I&RS offering that automates data processing with
respect to transactions relating to ``in-force'' contracts among
participating NSCC Members. ``In-force'' contract transactions are
transactions that occur after the underlying insurance contract has
become effective.
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(1) IFT Fee Reductions
    Currently, NSCC Members engaged in IFTs are required to choose an
Activity Level (Level 1, Level 2 or Level 3) based on their projected
activity. Each Activity Level has a corresponding minimum monthly fee.
NSCC Members that choose Level 2 and Level 3 benefit from discounted
fees per transaction after the amount of fees incurred for the month
reaches the amount of the minimum monthly fee. Once the respective
amount of the monthly fee is met, the discount for Level 2 is 20%
(i.e., from $1.25/$.35 per transaction to $1.00/$.28 per transaction)
and the discount for Level 3 is 40% (i.e., from $1.25/$.35 per
transaction to $.75/$.21 per transaction). The discounts are set forth
in an IFT Chart in Addendum A.
    NSCC is proposing to decrease the overall price of certain IFTs in
Section IV.K.3. of Addendum A from $1.25 per request to $.65 per
request, increase the number of levels in the IFT tiered pricing
program from three to four, set new monthly minimum fees for each level
and apply new discount percentages for the proposed Level 2, Level 3
and Level 4.
    As discussed below, NSCC believes that the proposed fee reduction
would better align the fees with the costs of providing the IFT
service.
    In addition, the IFT tiered pricing program is intended to
incentivize greater use of the IFT product by discounting transaction
fees once the minimum monthly fee has been met for

higher Activity Level designations. The proposed changes are intended
to further incentivize greater use by reducing transaction pricing for
IFTs generally and increasing the number of minimum monthly fee
thresholds, and thus discounts, from which NSCC Members may choose.
(2) IFT Clarifications
    NSCC is proposing to change the description of the IFT chart in
Addendum A to clarify when the discounts are applied and update the
description in the chart for readability, including changing ``Activity
Level'' to ``Threshold Level'' and stating the discounts as a
percentage rather than a dollar amount for each Level and revising the
description of the discount in the table. Below is the proposed updated
chart:

                      * In Force Transactions Chart
------------------------------------------------------------------------
                                                        Discount for
                                        Minimum      transactions after
          Threshold level             monthly fee    fees exceed minimum
                                                     monthly fee amount
------------------------------------------------------------------------
Level 1...........................            $250  No Discount
                                                    (pay base price of
                                                     $0.65/$0.35 for
                                                     Requests/
                                                     Inquiries).
Level 2...........................             500  5%.
Level 3...........................           1,000  10%.
Level 4...........................           3,000  20%.
------------------------------------------------------------------------

    NSCC is also proposing to move the fees for the IFTs that are
currently listed in TIER 5 ($1.25) to TIER 4 ($0.65) in Section IV.K.3.
of Addendum A with other transactions that are $0.65 per request to
reflect the proposed fee reductions set forth above. In addition, NSCC
is proposing to move the description of the fee for Producer Management
Portal (per inquiry), which is currently in TIER 5 in Section IV.K.3.
of Addendum A, to Section IV.K.2.h. of Addendum A so that the fee is in
the same section as other Producer Management Portal fees and to re-
number the items in Section IV.K.2.h. of Addendum A to reflect the
addition of the fee in this Section. NSCC is also proposing to remove
TIER 5 in Section IV.K.3. of Addendum A since there would no longer be
any fees in that TIER following the proposed changes described above.
In addition, NSCC is proposing to rename the Producer Management Portal
fee to ``Distributor Subscription Fee'' to clarify that the $1.25 fee
is for distributor inquiries for Producer Management Portal and to add
a provision clarifying that the maximum fee paid by Distributors is
$6,000 per month. There is a $6,000 per month maximum because if the
number of inquiries would result in more than $6,000 in fees in a
month, the distributor could pay the $6,000 Distributor Batch Service
Fee for the month rather than pay on a per inquiry basis.
    NSCC is proposing to revise the description of the * In Force
Transaction Chart as described above, move the IFT transaction fees to
TIER 4 with other transaction fees that are $0.65, delete TIER 5, move
and rename the Producer Management Portal fee, re-number the items in
Section IV.K.2.h. of Addendum A and add language relating to a $6,000
maximum per month for the Distributor Subscription Fee for enhanced
clarity and transparency of the Rules.

E. Decimals

    In Section IV.H. through Section IV.K. of Addendum A, where a
dollar amount is less than one and where there is not currently a zero
in front of the decimal point, NSCC is proposing to place a zero before
the decimal point for enhanced clarity and consistency with other
decimals contained in Addendum A.
    The proposed changes set forth in items II(A)(1)(ii)(A), (B), (C)
and (D)(1) above are proposed fee reductions and are referred to herein
as ``Fee Reductions.'' For each of the services for which Fee
Reductions are being proposed, NSCC has determined that the revenue has
increased over time more than the overall costs to provide the service.
Since implementation of the current fees, revenues have increased for
each of the services due to existing NSCC Members increasing their use
of the services and new NSCC Members using the services. In addition,
costs to provide the services are lower as a result of streamlined
processes which increase efficiency in such services to allow NSCC to
provide the services for lower costs than when the current fees were
implemented. NSCC has determined that the revenue that it would receive
for each of the services above following the proposed Fee Reductions
would be closer to the costs of providing the services and sufficient
to enable NSCC to recover costs to NSCC to provide the services. As
such, NSCC believes that the proposed Fee Reductions would better align
the fees with the costs of providing each of the services for which Fee
Reductions are being proposed.
    The proposed changes set forth herein in items II(A)(1)(ii)(D)(2)
and (E) are proposed clarifying changes to the description of the fees
and are referred to herein as ``Clarifications.'' Each of the
Clarifications are being proposed in order to improve the clarity and
transparency of the Rules.
(iii) Implementation Timeframe
    NSCC expects to implement the proposed rule changes on January 1,
2019. As proposed, a legend would be added to Addendum A stating there
are changes that became effective upon filing with the Commission but
have not yet been implemented. The proposed legend also would include
January 1, 2019, as the date on which such changes would be implemented
and the file number of this proposal, and state that, once this
proposal is implemented, the legend would automatically be removed from
Addendum A.
2. Statutory Basis
    NSCC believes this proposal is consistent with the requirements of
the Act and the rules and regulations thereunder applicable to a
registered clearing agency. Specifically, NSCC believes this proposal
is consistent with Sections 17A(b)(3)(D) \11\ and 17A(b)(3)(F) \12\ of
the Act and Rule 17Ad-22(e)(23)(ii),\13\ as promulgated under the Act,
for the reasons described below.
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    \11\ 15 U.S.C. 78q-1(b)(3)(D).
    \12\ 15 U.S.C. 78q-1(b)(3)(F).
    \13\ 17 CFR 240.17Ad-22(e)(23)(ii).
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    Section 17A(b)(3)(D) of the Act \14\ requires, in part, that the
Rules provide for the equitable allocation of reasonable dues, fees,
and other charges among its participants.
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    \14\ 15 U.S.C. 78q-1(b)(3)(D).
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    The proposed Fee Reductions set forth above are consistent with
17A(b)(3)(D) of the Act \15\ because the proposed fees would be
allocated equitably among the NSCC Members

that subscribe for those services based on each NSCC Member's use of
such services. In addition, NSCC believes that the proposed Fee
Reductions are reasonable because they would enable NSCC to better
align its revenue with the costs and expenses required for NSCC to
provide the services to NSCC Members. Specifically, NSCC has determined
that based on the current usage and projected revenue for each of the
services listed above for which Fee Reductions are proposed, the
decrease in fees would result in revenues for those services that would
be closer to the costs of providing such services. Therefore, by
establishing fees that align with the costs of delivery of these
products and services and allocating those fees equitably among the
subscribing NSCC Members, the proposed Fee Reductions are consistent
with the requirements of Section 17A(b)(3)(D) of the Act.\16\
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    \15\ Id.
    \16\ Id.
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    NSCC also believes that the proposed Clarifications above are
consistent with 17A(b)(3)(D) of the Act \17\ because each of the
proposed Clarifications would clarify the meaning of the fees in the
Rules without affecting the amount of the existing fee for such line
item. The amounts of the existing fees would continue to be equitably
allocated among the subscribing NSCC Members in accordance with their
utilization of the services. Therefore, NSCC believes that the proposed
Clarifications would not affect the allocation or amount of fees, and
would thereby continue to provide for the equitable allocation of
reasonable fees, consistent with Section 17A(b)(3)(D) of the Act.\18\
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    \17\ Id.
    \18\ Id.
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    Section 17A(b)(3)(F) of the Act \19\ requires, in part, that the
Rules promote the prompt and accurate clearance and settlement of
securities transactions. NSCC believes that the proposed Clarifications
set forth above would enhance NSCC Members' ability to understand the
fees associated with the MFS and I&RS services. Specifically, the
proposed Clarifications would clarify the meaning of certain provisions
of Addendum A relating to the IFT tiered pricing program and Producer
Management Portal and revise certain decimals to be consistent with
other decimals in the Rules and enhance clarity and transparency in the
Rules in this regard. As such, the proposed Clarifications would allow
NSCC Members to have a better understanding of the Rules in relation to
their activities and thereby assist in promoting the requirements of
Section 17A(b)(3)(F) of the Act.\20\
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    \19\ 15 U.S.C. 78q-1(b)(3)(F).
    \20\ Id.
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    Rule 17Ad-22(e)(23)(ii) under the Act \21\ requires NSCC to
establish, implement, maintain and enforce written policies and
procedures reasonably designed to provide sufficient information to
enable participants to identify and evaluate the risks, fees, and other
material costs they incur by participating in the covered clearing
agency. The proposed Clarifications set forth above would help ensure
that the fees set forth in Addendum A are clear and transparent to NSCC
Members. Having a clear and transparent Addendum A would help NSCC
Members to better understand NSCC's fees and help provide NSCC Members
with increased predictability and certainty regarding the fees they
incur in participating in NSCC. As such, by improving the clarity and
transparency of the Rules, NSCC believes the proposed Clarifications
are consistent with Rule 17Ad-22(e)(23)(ii) under the Act.\22\
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    \21\ 17 CFR 240.17Ad-22(e)(23)(ii).
    \22\ Id.
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(B) Clearing Agency's Statement on Burden on Competition
    NSCC does not believe that the proposed Fee Reductions would have
an adverse impact, or impose any burden, on competition because, in
each case, the proposed Fee Reductions would be a reduction in fees as
currently set forth in the Rules that would not disproportionally
impact any NSCC Members. As a reduction to the fees currently in the
Addendum A for these services, the proposed Fee Reductions would not
impede any NSCC Members from engaging in the services or have an
adverse impact on any NSCC Members.
    Moreover, the proposed Fee Reductions may promote competition
because, in each case, the proposed Fee Reductions would allow NSCC
Members to engage in a greater number of transactions with lower costs
than they would incur today for the same transactions. In addition, as
described above, NSCC believes that the proposed fee changes to the
Profile Phase I and Phase II and the proposed fee reductions and
increased discount levels for the IFT tiered pricing program would
incentivize greater use of those services by NSCC Members. NSCC
believes that increased use of the NSCC services as a result of the fee
reductions would enhance participation in the marketplace by providing
all NSCC Members that use the services more data which would increase
the value of the services and promote competition among NSCC Members
that use the services.
    NSCC does not believe that the proposed Clarifications would have
any impact on competition because such changes are clarifications of
the Rules that would not affect the rights or obligations of NSCC
Members.
(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others
    NSCC has not received or solicited any written comments relating to
this proposal. NSCC will notify the Commission of any written comments
received by NSCC.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \23\ and paragraph (f) of Rule 19b-4
thereunder.\24\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \23\ 15 U.S.C 78s(b)(3)(A).
    \24\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NSCC-2018-012 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NSCC-2018-012. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's

internet website (http://www.sec.gov/rules/sro.shtml). Copies of the
submission, all subsequent amendments, all written statements with
respect to the proposed rule change that are filed with the Commission,
and all written communications relating to the proposed rule change
between the Commission and any person, other than those that may be
withheld from the public in accordance with the provisions of 5 U.S.C.
552, will be available for website viewing and printing in the
Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of NSCC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). 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-NSCC-2018-012 and should be submitted on
or before January 4, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
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    \25\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2018-27081 Filed 12-13-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 210 (Monday, October 31, 2011)]
[Notices]
[Pages 67178-67179]
[FR Doc No: 2011-28105]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14169-000]

Riverbank Hydro No. 15 LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On May 2, 2011, Riverbank Hydro No. 15 LLC (Riverbank) filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of a
hydropower project at the U.S. Army Corps of Engineers' (Corps) Hugo
Dam, located on the Kiamichi River, in Choctaw County, Oklahoma. The
sole purpose of a preliminary permit, if issued, is to grant the permit
holder

priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    The proposed project would consist of: (1) A bifurcation from the
existing outlet structure; (2) a 16-foot-diameter, 165-foot-long
penstock; (3) a powerhouse containing one generating unit with a total
capacity of 8.6 megawatts (MW); (4) a tailrace structure; and (5) a
2.8-mile-long, 25 kilo-volt (kV) transmission line. The project would
have an estimated average annual generation of 21.8 gigawatt-hours
(GWh), and operate run-of-river utilizing surplus water from the Hugo
Dam, as directed by the Corps.
    Applicant Contact: Mr. Kuo-Bao Tong, Riverbank Power Corporation,
Royal Bank Plaza, South Tower, P.O. Box 166, 200 Bay Street, Suite
3230, Toronto, ON, Canada M5J2J4.<PHONE_NUMBER> x 154.
    FERC Contact: Michael Spencer<EMAIL_ADDRESS>(202) 502-
6093.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-(866) 208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14169-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: October 25, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-28105 Filed 10-28-11; 8:45 am]
BILLING CODE 6717-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement, and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request 2. OMB control number b. X None EPA/ OAQPS a. B 2 0 6 0 3. Type of information collection ( check one) 4. Type of review requested ( check one)

a. X New collection a. X Regular b. Revision of a currently approved collection b. Emergency  Approval requested by: / /

c. Extension of a currently approved collection c. Delegated d. Reinstatement, without change, of a previously 5. Small entities approved collection for which approval has expired Will this information collection have a significant economic impact on a e. Reinstatement, with change, of a previously substantial number of small entities? Yes X No approved collection for which approval has expired f. Existing collection in use without OMB control 6. Requested expiration date number a. X Three years from approval date For b B f, note Item A2 of Supporting Statement Instructions b. Other Specify: /

7. Title NESHAP for Primary Magnesium Refining ( Proposed Rule)

8. Agency form number( s) ( if applicable)

2098.01 9. Keywords Environmental protection, Air pollution control, Hazardous substances, Primary magnesium refining, Recordkeeping and reporting requirements 10. Abstract Owners or operators of primary magnesium refining plants would comply with recordkeeping and reporting requirements of the NESHAP General Provisions ( 40 CFR Part 63, Subpart A) and maintain records of specific information needed by EPA to determine if compliance has been achieved.

11. Affected public 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. Farms a. Voluntary b. P Business or other for profit e. Federal Government b. Required to obtain or retain benefits c. Not for profit institutions f. X State, Local or Tribal c. P Mandatory Government 13. Annual reporting and recordkeeping hour burden 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Number of respondents 1 a. Total annualized capital/ startup costs 0 b. Total annual responses 6 b. Total annual costs ( O& M) 0 1. Percentage of these responses c. Total annualized cost requested 0 collected electronically 10 % d. Current OMB inventory 0 c. Total annual hours requested 1 e. Difference 0 d. Current OMB inventory 0 f. Explanation of difference e. Difference 1 1. Program change 0 f. Explanation of difference 2. Adjustment 0 1. Program change 1 2. Adjustment 0 15. Purpose of information collection 16. Frequency of recordkeeping or reporting ( check all that apply)

( Mark primary with " P" and all others that apply with " X") a. X Recordkeeping b. Third party disclosure a. Application for benefits e. Program planning or c. X Reporting b. Program evaluation management 1. On occasion 2. Weekly c. General purpose statistics f. Research 3. Monthly 4. Quarterly d. Audit g. P Regulatory or compliance 5. X Semi annually 6. Annually compliance 7. Biennially 8. Other ( describe)

17. Statistical methods 18. Agency contact ( person who can best answer questions regarding the Does this information collection employ statistical methods? content of this submission)

Yes X No Name: Lula Melton, EPA/ OAQPS/ MG Phone: ( 919) 541 2910 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers: ( a) It is necessary for the proper performance of agency functions; ( b) It avoids unnecessary duplication; ( c) It reduces burden on small entities; ( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; ( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; ( f) It indicates the retention periods for recordkeeping requirements; ( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number; ( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions); ( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Date Director, Collection Strategies Division ( OEI)

OMB 83 I 10/ 95


[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Rules and Regulations]
[Pages 18810-18815]
[FR Doc No: 2014-07563]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0164; FRL-9903-11]

Proquinazid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
proquinazid in or on grape and raisin. DuPont Crop Protection requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective April 4, 2014. Objections and
requests for hearings must be received on or before June 3, 2014, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0164, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West

Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
OPP Docket is<PHONE_NUMBER>. Please review the visitor instructions
and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0164 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 3, 2014. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0164, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 2, 2012 (77 FR 25954) (FRL-9346-1),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7972)
by DuPont Crop Protection, Stine Haskell Research Center, P.O. Box 30,
Newark, DE 19714-0030. The petition requested that 40 CFR 180.674 be
amended by establishing tolerances for residues of the fungicide
proquinazid, 6-Iodo-2-propoxy-3-propyl-3H-quinazolin-4-one, in or on
imported commodities to include grape at 0.5 parts per million (ppm)
and raisin at 1.0 ppm. That document referenced a summary of the
petition prepared by DuPont Crop Protection., the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
changed one of the requested commodity names from raisin; to grape,
raisin; and added a significant figure to the numerical grape
tolerance. The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Proquinazid has no significant acute toxicity via the oral, dermal,
or inhalation routes of exposure. It is not an eye or skin irritant and
does not cause skin sensitization. Based on the results of a 28-day
dermal study in rats (as well as the dermal lethal dose (LD) study),
proquinazid is poorly absorbed through the skin.

    The liver and thyroid are the primary target organs for
proquinazid. In rodents, body weight/body weight gain reductions,
increased liver and thyroid organ weights, hypertrophy/hyperplasia,
liver enzyme induction, and thyroid hormone changes were seen across
varying durations and routes of exposure in rodents but not in dogs. In
the 90-day oral rat study, the low dose effects of proquinazid are
characterized primarily by altered thyroid hormones and associated
follicular cell hypertrophy in the thyroid. Decrements in body weight
and nutritional parameters, as well as histopathological changes in the
liver (including hypertrophy) were observed at higher doses. In a 28-
day oral rat study, hypertrophy of the thyroid and liver was completely
reversible after a 6 week recovery period. In chronic rodent studies,
non-neoplastic effects in both mice and rats included thyroid
follicular hyperplasia and hypertrophy, with associated thyroid hormone
changes (only investigated in rats), and some marked hepatic lesions,
i.e., necrosis and hyperplasia (including oval cell hyperplasia in
rats). In addition, chronic exposure in rats led to increases in the
incidence of liver and thyroid tumors. The mode of action for the
thyroid tumors in rats involves early changes in liver enzyme
regulation that lead to dis-regulation of thyroid hormone homeostasis
thyroid follicular hypertrophy/hyperplasia, and thyroid follicular
adenoma formation. Mode of action data were submitted on the thyroid
follicular cell tumors observed in male rats and the
cholangiocarcinomas observed in female rats. The hypothesized mode of
action (i.e., non-genotoxic) for each tumor type (i.e, the thyroid and
cholangiocarcinoma) was supported by adequate studies that clearly
identified the sequence of key events, dose-response concordance, and
temporal relationship to the tumor types. No treatment-related tumors
were observed in male or female mice. The overall weight-of-evidence
was considered sufficient to demonstrate that proquinazid thyroid
follicular tumors are the result of an anti-thyroidal mode of action
and that a carcinogenic response would not be expected at doses below
the threshold for changes in liver enzyme regulation leading to dis-
regulation of thyroid hormone homeostasis. The data also shows that
rats are substantially more sensitive than humans to the development of
thyroid follicular cell tumors in response to thyroid hormone
imbalance. Proquinazid induced cholangiocarcinomas in female rats only
at doses that produced marked liver toxicity and oval cell hyperplasia
microscopically. In contrast, in both male and female rats, doses that
produced less severe or no hepatotoxicity or oval cell proliferation
did not produce chlolangiocarcinomas. Therefore, at high enough doses,
proquinazid can cause these biochemical and histopathological effects
in livers of rodents but is unlikely to be carcinogenic at doses below
those causing these changes. In contrast, in both male and female rats,
doses that produced less severe or no hepatoxicity or oval cell
proliferation did not produce cholangiocarcinomas. Therefore, at high
enough doses, proquinazid can cause these biochemical and
histopathological effects in livers of rodents but is unlikely to be
carcinogenic at doses below those causing these changes. Therefore, the
Agency determined that quantification of risk using a non-linear
approach (i.e., reference dose (RfD) will adequately protect for all
chronic toxicity, including carcinogenicity, that could result from
exposure to proquinazid.
    There is no mutagenicity concerns from in vivo or in vitro genetic
toxicity assays. Proquinazid was not found to be immunotoxic. No
evidence of increased quantitative or qualitative susceptibility was
seen following in utero exposure to proquinazid with rats or rabbits in
the prenatal developmental studies or in young rats in the 2-generation
reproduction study. The 2-generation rat reproduction study resulted in
no effects on reproduction or fertility. The offspring effects
(decreases in F1 pup weight during lactation) occurred at
the same dose which caused parental effects (thyroid hypertrophy,
reduced body weight gain, and food consumption). Evidence of
developmental delays were observed in developmental toxicity studies in
rabbits and rats and were characterized by reduced fetal weight and an
increased incidence of retarded ossification and patent ductus
arteriosus, respectively. These developmental effects occurred in the
presence of maternal toxicity and were considered of equal toxicity.
    There is limited evidence for neurotoxicity following oral
exposures to proquinazid. Following a single exposure, evidence for
neurotoxicity at the lowest observed adverse effect level (LOAEL) was
limited to decreased motor activity in both sexes with no behavioral or
neuropathology changes. At doses above the study LOAEL other effects
including decreased grip strength and food splay were observed.
Following repeated (dietary) exposures, there were no treatment-related
clinical signs of neurotoxicity, behavioral changes or neuropathology.
Specific information on the studies received and the nature of the
adverse effects caused by proquinazid as well as the no observed
adverse effect level (NOAEL) and the LOAEL from the toxicity studies
can be found at http://www.regulations.gov in document ``Proquinazid:
Human Health Risk Assessment for the Tolerance on Imported Grapes''
dated September 2013 at pages 23 through 35 in docket ID number EPA-HQ-
OPP-2012-0164.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a RfD--and a safe margin of exposure
(MOE). For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
expected in a lifetime. For more information on the general principles
EPA uses in risk characterization and a complete description of the
risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for proquinazid used for
human risk assessment is shown in Table 1. of this unit. Because only
oral exposure are anticipated for imported grapes, no other endpoints
are relevant such as dermal and inhalation exposures.

  Table 1--Summary of Toxicological Doses and Endpoints for Proquinazid for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 50 mg/kg/bw   Acute RfD = aPAD =   Acute Neurotoxicity Study-Rat.
 including infants and children).   UFA = 10x.            0.050 mg/kg/bw.     LOAEL = 100 mg/kg/bw based on
                                   UFH = 10x...........                        decreased motor activity seen in
                                   FQPA SF = 10x.......                        females on day 1.
                                   UFDB................
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 1.2 mg/kg/day  Chronic RfD = cPAD   Chronic Toxicity/Carcinogenicity
                                   UFA = 13x...........   = 0.004 mg/kg/day.   Study-Rat.
                                   UFH = 10x...........                       LOAEL = 12 mg/kg/day based on
                                   FQPA SF = 10x.......                        increases in non-neoplastic liver
                                   UFDB................                        lesions and changes in thyroid
                                                                               hormones and thyroid pathology.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  A non linear approach (i.e., RfD will adequately protect for all chronic
                                    toxicity, including carcinogenicity, that could result from exposure to
                                    proquinazid. The cPAD for proquinazid will protect for carcinogenic effects
                                    because it is below the level that caused changes in liver enzyme regulation
                                    and liver toxicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. mg/kg/bw =
  milligram/kilogram/body weight. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a =
  acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation
  in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to proquinazid, EPA considered exposure under the petitioned-
for tolerances as well as all existing proquinazid tolerances in 40 CFR
180.674. EPA assessed dietary exposures from proquinazid in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for proquinazid. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWIA). As
to residue levels in food, EPA used tolerance level residues and 100%
percent crop treated (PCT). Default processing factors were used for
grape juice. The Agency considers these to be highly conservative
assessments.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA used tolerance level
residues and 100% PCT.
    iii. Cancer. Quantification of risk using a non-linear approach
(i.e., RfD will adequately protect for all chronic toxicity, including
carcinogenicity, which could result from exposure to proquinazid.
Cancer risk was assessed using the same exposure estimates as discussed
in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for proquinazid. Tolerance level residues and/or 100% CT were assumed
for all food commodities.
    2. Dietary exposure from drinking water. There is no drinking water
exposure in the U.S. associated with the establishment of an import
tolerance.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Proquinazid is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found proquinazid to share a common mechanism of
toxicity with any other substances, and proquinazid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
proquinazid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. No evidence of increased
quantitative or qualitative susceptibility was seen following in utero
exposure to proquinazid with rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. The 2-generation rat reproduction study resulted in no effects
on reproduction or fertility. The

offspring effects (decreases in F1 pup weight during
lactation) occurred at the same dose which caused parental effects
(thyroid hypertrophy, reduced body weight gain, and food consumption).
Evidence of developmental delays were observed in developmental
toxicity studies in rabbits and rats were characterized by reduced
fetal weight and an increased incidence retarded ossification and paten
ductus arteriosus, respectively. These developmental effects occurred
in the presence of maternal toxicity. For the rats, the developmental
effects were seen in the presence of clear maternal toxicity, including
a marked reduction in body weight gain after adjustment for uterine
contents and were considered to be of equal severity.
    3. Conclusion. In determining whether there are reliable data to
amend or remove the presumptive 10X FQPA safety factor, EPA considered
the following factors:
    i. The toxicity database for proquinazid required by 40 CFR Part
158 is complete. However, there remains some uncertainty regarding the
potential for proquinazid effects on the thyroid in the young. Effects
on the thyroid (manifested as changes in hormones, weight, and
histopathology) following proquinazid exposure were consistently
observed in adult animals (rats) following subchronic and chronic
exposures. Thyroid effects, however, were not assessed in studies
involving neo- or postnatal animals, and EPA is lacking data showing
the comparative effect of proquinazid on the thyroid in adult and neo-
and postnatal animals.
    ii. There is only limited evidence that proquinazid is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity. There is limited
evidence for neurotoxicity following oral exposures to proquinazid.
Following a single exposure, evidence for neurotoxicity at the LOAEL
was limited to decreased motor activity in both sexes with no
behavioral or neuropathology changes. At doses above the study LOAEL
other effects including decreased grip strength and foot splay were
observed. Following repeated (dietary) exposures, there were no
treatment-related clinical signs of neurotoxicity, behavioral changes,
or neuropathology.
    iii. As discussed in Unit III.D.2., there is no evidence that
proquinazid results in increased susceptibility with in utero rats or
rabbits in the prenatal developmental studies or in young rats in the
2-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. Drinking water is not a factor
because this is an import tolerance assessment. These assessments will
not underestimate the exposure and risks posed by proquinazid.
    Despite the lack of any indication of sensitivity in the young and
the very conservative exposure assessment, EPA has determined that it
lacks reliable data to choose a FQPA safety factor other than the
default value of 10X given (1) the absence of data on thyroid effects
on the young, including comparative thyroid data on adults and the
young, and (2) the fact that thyroid effects were the most sensitive
effect seen in adult animals. At the same time, after considering all
of the data on proquinazid toxicity and exposure, EPA has also
determined that application of a FQPA safety factor of 10X, in
conjunction with inter- and intraspecies safety factors, will result in
a risk assessment that protects the safety of infants and children.
Although there is some uncertainty as to whether the young might have
greater sensitivity to proquinazid's thyroid effects due to the absence
of comparative thyroid data, two developmental studies and a
reproduction study have otherwise shown no indication of sensitivity in
the young to proquinazid. Additionally, the exposure assessment
provides an extra margin of safety given that it is based on the
conservative assumption that all grapes, and all food products derived
from grapes (e.g., raisins, grape juice, wine), consumed in the United
States bear residues of proquinazid at the appropriate tolerance level.
This assumption is particularly conservative here because proquinazid
is not registered for use in the United States. Taking into account all
of these considerations, EPA concludes that no safety factor in
addition to the inter- and intraspecies factors, and the default FQPA
safety factor is needed to protect the safety of infants and children.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute dietary exposure from food to proquinazid will occupy
18% of the aPAD for children 1-2 years old, the population group
receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
proquinazid from food will utilize 47% of the cPAD for children 1-2
years old the population group receiving the greatest exposure. There
are no residential uses for proquinazid. Based on the explanation in
Unit III.C.3., regarding residential use patterns, chronic residential
exposure to residues of proquinazid is not expected.
    3. Aggregate cancer risk for U.S. population. The cPAD of 0.004 mg/
kg/day will be protective of both non-cancer and cancer effects,
including rat tumors (liver, thyroid, and cholangiocarcinomas). As
discussed in Unit III.E., aggregate exposure to proquinazid is below
the cPAD.
    4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to proquinazid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with electron
capture detection) is available to enforce the proposed tolerances for
residues of proquinazid on grape commodities.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health

Organization food standards program, and it is recognized as an
international food safety standards-setting organization in trade
agreements to which the United States is a party. EPA may establish a
tolerance that is different from a Codex MRL; however, FFDCA section
408(b)(4) requires that EPA explain the reasons for departing from the
Codex level.
    The Codex has not established a MRL for proquinazid. However, the
tolerances established in this rule are harmonized with Canadian MRLs.

C. Revisions to Petitioned-For Tolerances

    The Agency is changing the proposed commodity definition for
raisins from raisin to grape, raisin. The change in the commodity
definition is to make the tolerance consistent with Agency naming-
conventions for commodities and crop groups. No changes are recommended
for the proposed tolerance levels, but the grape tolerance is being
revised from 0.5 to 0.50 to correct the number of significant figures.

V. Conclusion

    Therefore, tolerances are established for residues of proquinazid
in or on grape at 0.50 ppm and grape, raisin 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: March 25, 2014.
Marty Marnell,
Acting Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Add Sec.  180.674 to read as follows:

Sec.  180.674  Proquinazid; tolerances for residues.

    (a) General. Tolerances are established for residues of the
fungicide, proquinazid, including its metabolites and degradates, in or
on the commodities listed in the following table. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only proquinazid, [6-Iodo-2-propoxy-3-propyl-3H-
quinazolin-4-one), in or on the following commodities:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Grape \1\...............................................            0.50
Grape, raisin \1\.......................................            1.0
------------------------------------------------------------------------
\1\ No U.S. registrations for Proquinazid.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2014-07563 Filed 4-3-14; 8:45 am]
BILLING CODE 6560-50-P


From: David Word [ mailto: d_ word@ src ncasi. org] Sent: Thursday, April 22, 2004 2: 50 PM To: Katie Hanks Cc: Tim Hunt Subject: Method 29 Metals Laboratory Methods and Appendix B Katie:

I have been looking into the lab methods associated with metals and believe I have a better handle on it than I did when we last talked about this issue. My understanding is that a number of analytical techniques are used for metals and that the detection limits vary considerably by method and to some extent by individual metals.

Four techniques are commonly used AA ( AAS), ICP ( ICAP), GFAA, and ICP MS ( ICAP MS). There are other techniques as well, such as ICP Axial, CVAAS, etc.

AA is often referred to as flame atomic adsorption ( also AAS, atomic adsorption spectroscopy). This is an older technology that is used less frequently as time progresses. ( In fact, we gave away our AA when we moved to our new office about a year ago, because the equipment was considered outdated.) AA has relatively high detection levels.

ICP, iductively coupled plasma, ( or ICAP) is the metals measurement technique that has largely replaced AA. My understanding is that the detection limits are generally a little better than AA, but detection limits vary somewhat by individual metal.

GFAA ( GFAAS) is graphite furnace atomic adsorption. This method has significantly greater sensitivity than flame AA.

ICP MS ( or ICAP MS) is inductively coupled plasma mass spectroscopy, which has greater sensitivity than ' plain' ICP. ICP MS and GFAA are both enhancements with lower detection limits than ICP and AA.

The above is mostly based on conversations with Jeff Louch at our West Coast Center and Jim Stainfield in our Southern Regional Center. But, Method 29 also discusses the various detection limits in Section 2.1 and in more depth in Section 13.2. In section 13.2 Method 29 states that ICP MS detection limits are generally lower by a factor of 10 compared to ICP. The method does not provide a similar statement for GFAA, but does show low GFAA ( GFAAS) detection limits in Section 13.2.4.

Table 29 1 in Method 29 shows GFAAS and ICAP values  not AAS and ICAP values. The values in parentheses are GFAAS values and thus are much lower than ICAP ( ICP) values. ( The footnote was not written very well and is not real clear.)

The industry as well as most laboratories would like to be able to use GFAAS and ICP MS since these techniques are the more ' modern' and accurate and have lower detection limits. The way Appendix B, Section 5 ( f)( 2) is written, mills will not be able to consider non detects as zero unless AAS is used. It would be much better if this section of the PCWP MACT rule was written as follows:

( 2) For pollutants measured using Method 29 in appendix A to 40 CFR part 60, you analyze samples using atomic adsorption spectroscopy ( AAS) or another laboratory method with detection limits lower than or equal to AAS. This rephrasing of the rule would allow mills to use methods with lower detection limits but still consider non detects as zero for the purposes of Appendix B.

I plan on calling you later today or early tomorrow, but thought it best to write this down and give you a little time to digest it before we talk.

Thanks for your consideration.

DW David Word, Ph. D. Program Manager NCASI 402 SW 140th Terrace Newberry, FL 32669 ( 352) 331 1745 x241 ( Phone) ( 352) 331 1766 ( FAX)


[Federal Register Volume 88, Number 167 (Wednesday, August 30, 2023)]
[Notices]
[Pages 59900-59901]
[FR Doc No: 2023-18744]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2607-016]

Spencer Mountain Hydropower, LLC; Notice of Application Accepted
for Filing and Soliciting Motions To Intervene and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Subsequent License.
    b. Project No.: 2607-016.
    c. Date filed: June 26, 2023.
    d. Applicant: Spencer Mountain Hydropower, LLC.
    e. Name of Project: Spencer Mountain Hydroelectric Project (Spencer
Mountain Project).
    f. Location: On the South Fork Catawba River, near the town of
Gastonia, in Gaston County, North Carolina.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Kevin Edwards and Mrs. Amy Edwards,
Spencer Mountain Hydropower, LLC, 916 Comer Rd, Stoneville, NC 27048;
Phone at<PHONE_NUMBER>, or [email protected].
    i. FERC Contact: Michael Spencer at<PHONE_NUMBER>, or
[email protected].
    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. For assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY).
    In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. All filings must clearly identify the project name and
docket number on the first page: Spencer Mountain Project (P-2607-016).
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted but is not ready for
environmental analysis at this time.
    l. The existing Spencer Mountain Project consists of the following
existing facilities: (1) a 12-foot-high, 636-foot-long masonry and
rubble dam with a crest elevation of 634.7 feet mean sea level (msl);
(2) a 68-acre reservoir with a storage capacity of 166 acre-feet; (3) a
58.9-foot-long canal headwork, consisting of four 6-foot-wide gates;
(4) a 53.8-foot-long canal spillway connected to the downstream side of
the canal headwork; (5) a 30-foot-wide, 10-foot-deep, 3,644-foot-long
open earthen canal; (6) a 32-foot-wide trashrack at the powerhouse
forebay with a 2.5-inch

clear bar-space; (7) a 36-inch-diameter bypass pipe; (8) a 22.5-foot-
high, 49.5-foot-long, 48.75-foot-wide powerhouse containing two
Francis-type generating units with a total capacity of 0.64 megawatts;
(9) a concrete lined tailrace discharging flows back into the South
Fork Catawba River; (10) a substation containing a 2.3/44-kilovolt (kV)
transformer and interconnection to Duke Energy's 44 kV transmission
line; and (11) appurtenant facilities.
    The project operates in a run-of-river mode with a minimum bypass
flow of 76 cubic feet per second. Spencer Mountain Hydropower, LLC
proposes no changes to the project facilities or operations. The
project has an average annual generation of 4,064 megawatt-hours.
    m. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room. For assistance, contact FERC Online Support at
[email protected] or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    You may also register online at https://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests filed, but
only those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any protests
or motions to intervene must be received on or before the specified
deadline date for the particular application.
    All filings must (1) bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (2) set forth in the heading
the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application.
    o. Procedural schedule: The application will be processed according
to the following schedule. Revisions to the schedule will be made as
appropriate.

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

------------------------------------------------------------------------
Issue Scoping Document 1 for comments.....  September 2023.
Scoping Document 1 comments due...........  October 2023.
Request Additional Information (if          November 2023.
 necessary).
Issue Scoping Document 2 (if necessary)...  November 2023.
Issue Notice of Ready for Environmental     January 2024.
 Analysis.
------------------------------------------------------------------------

    Dated: August 24, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-18744 Filed 8-29-23; 8:45 am]
BILLING CODE 6717-01-P