[Federal Register Volume 79, Number 19 (Wednesday, January 29, 2014)]
[Notices]
[Pages 4786-4788]
[FR Doc No: 2014-01662]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71378; File No. SR-NYSEArca-2013-137]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a
Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To List
and Trade Shares of the Merk Gold Trust Pursuant to NYSE Arca Equities
Rule 8.201

January 23, 2014.

I. Introduction

    On November 27, 2013, NYSE Arca, Inc. (``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to list and trade shares
(``Shares'') of Merk Gold Trust (``Trust'') pursuant to NYSE Arca
Equities Rule 8.201. On December 11, 2013, the Exchange filed Amendment
No. 1 to the proposed rule change.\3\ The proposed rule change, as
modified by Amendment No. 1 thereto, was published for comment in the
Federal Register on December 17, 2013.\4\ The Commission received no
comment letters regarding the proposal. This order approves the
proposed rule change, as modified by Amendment No. 1 thereto.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, the Exchange clarified certain
statements in the filing with respect to: (1) The Custodian's (as
defined below) information barriers between itself and its broker-
dealer affiliate; (2) the use of unallocated gold accounts by other
gold trusts; and (3) the Trustee's role in valuing the Trust's
physical gold holdings.
    \4\ See Securities Exchange Act Release No. 71038 (December 11,
2013), 78 FR 76367 (December 17, 2013) (``Notice'').
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II. Description of the Proposal

    The Exchange proposes to list and trade the Shares under NYSE Arca
Equities Rule 8.201, which governs the listing and trading of
Commodity-Based Trust Shares.\5\ Each Share will represent a fractional
undivided beneficial interest in the Trust's net assets.\6\ The
Exchange represents that the Shares satisfy the requirements of NYSE
Arca Equities Rule 8.201 and thereby qualify for listing on the
Exchange.\7\ The Exchange deems the Shares to be equity securities and
therefore subject to the Exchange's rules governing the trading of
equity securities.\8\
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    \5\ Commodity-Based Trust Shares are securities issued by a
trust that represent investors' discrete identifiable and undivided
beneficial ownership interest in the commodities deposited into the
trust.
    \6\ See Notice, supra note 4, at 76368.
    \7\ See Notice, supra note 4, at 76368.
    \8\ See Notice, supra note 4, at 76373.
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    The sponsor of the Trust is Merk Investments LLC (``Sponsor'').\9\
The trustee for the Trust is The Bank of New York Mellon
(``Trustee'').\10\ The custodian is JPMorgan Chase Bank, N.A. (the
``Custodian'').\11\
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    \9\ The Sponsor is a Delaware limited liability company. The
Sponsor generally oversees the performance of the Trustee and the
Trust's principal service providers, but does not exercise day-to-
day oversight of the Trustee or such service providers. See Notice,
supra note 4, at 76367. Additional details regarding the Trust are
set forth in the Registration Statement for the Trust on Form S-1,
filed with the Commission on April 8, 2013 (No. 333-180868) (as
amended, the ``Registration Statement'').
    \10\ The Trustee will be responsible for the day-to-day
administration of the Trust and is responsible, among other things,
for valuing the Trust's holdings and calculating net asset value
(``NAV'') per Share of the Trust. See Notice, supra note 4, at
76367.
    \11\ The Custodian is affiliated with a broker-dealer. The
Custodian has represented that it has policies and procedures in
place to enable it to comply with its regulatory obligations in
relation to appropriate information barriers and controls to
safeguard client confidentiality, including, but not limited to,
information barriers and controls between itself and its broker-
dealer affiliate so that its broker-dealer affiliate will not have
access to information concerning the composition of and/or changes
to the Trust's holdings that are not available on the Trust's Web
site. See Notice, supra note 4, at 76367-68.
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    The Exchange states that the objective of the Trust is to provide
investors with an opportunity to invest in gold and be able to take
delivery of physical gold in exchange for their Shares; the Trust's
secondary objective is for the Shares to reflect the performance of the
price of gold less the expenses of the Trust's operations.\12\
According to the Exchange, the Trust is not actively managed and does
not engage in any activities designed to obtain a profit from, or to
compensate investors for losses caused by, changes in the price of
gold.
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    \12\ See Notice, supra note 4, 78 FR at 76368. The Trust is
neither an investment company registered under the Investment
Company Act of 1940 nor a commodity pool for purposes of the
Commodity Exchange Act. See Notice, supra note 4, at 76368.
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    Shareholders may redeem their Shares by submitting to the Sponsor a
delivery application and payment for the applicable: (1) Processing
fees; and (2) delivery fees to cover the cost of preparing and
transporting physical gold to the shareholder.\13\ The number of shares
to be redeemed must: (1) Correspond to at least one Fine Ounce \14\ of
physical gold; and (2) have a minimum dollar value in an amount that is
specified by the Sponsor from time to time on the Trust's Web site.\15\
If the Sponsor approves the delivery application,\16\ the shareholder
would submit his/her Shares to the Trustee and receive physical gold
and, if applicable, cash in return.\17\
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    \13\ See Notice, supra note 4, at 76370.
    \14\ Fine Ounce is defined in the Registration Statement as an
ounce of 100% pure gold.
    \15\ See Notice, supra note 4, at 76371.
    \16\ See Notice, supra note 4, at 76370-71 (explaining the
process the Sponsor will follow to review and approve delivery
applications).
    \17\ See Notice, supra note 4, at 76371.
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    Additional information regarding the Trust, including NAV
calculation, operation of the Trust, restrictions, risks, expenses, and
creation and redemption of Shares can be found in the Notice and/or
Registration Statement.

III. Discussion and Commission's Findings

    After careful review, the Commission finds that the Exchange's
proposal to list and trade the Shares is consistent with the Exchange
Act and the rules and regulations thereunder applicable to a national
securities exchange.\18\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b)(5) of the Exchange
Act,\19\ which requires, among other things, that the Exchange's rules
be designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest.
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    \18\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \19\ 15 U.S.C. 78f(b)(5).
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    The Exchange states it is able, pursuant NYSE Arca Equities Rule
8.201(g), to obtain information regarding trading in the Shares and the
underlying gold, gold futures contracts, options on gold futures, or
any other gold derivative through Equity Trading Permit Holders (``ETP
Holders'') acting as registered Market Makers, in connection with their
proprietary or customer trades. More generally, the Exchange states
that it has regulatory jurisdiction over its ETP Holders and their
associated persons, which include any person or entity controlling an
ETP Holder. With respect to a subsidiary or affiliate of an ETP Holder
that does business only in commodities or futures contracts, the
Exchange states that it could obtain information regarding the
activities of such subsidiary or affiliate through surveillance sharing
agreements with regulatory organizations of which such subsidiary or
affiliate is a member. The Exchange also states that it may obtain
trading information via the

Intermarket Surveillance Group (``ISG'') from other exchanges that are
members of the ISG, including the COMEX.\20\ Commentary .04 of NYSE
Arca Equities Rule 6.3 requires an ETP Holder acting as a registered
Market Maker in the Shares, and its affiliates, to establish, maintain,
and enforce written policies and procedures reasonably designed to
prevent the misuse of any material nonpublic information with respect
to such products, any components of the related products, any physical
asset or commodity underlying the product, applicable currencies,
underlying indexes, related futures or options on futures, and any
related derivative instruments (including the Shares).\21\ NYSE Arca
Equities Rule 8.201(g) and Commentary .04 of NYSE Arca Equities Rule
6.3 may help to prevent fraudulent and manipulative acts and practices
by facilitating the Exchange's surveillance of trading in the Shares.
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    \20\ See Notice, supra note 4, at 76374.
    \21\ See Notice, supra note 4, at 76373-74.
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    The Commission also finds that the proposal to list and trade the
Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of
the Exchange Act,\22\ which sets forth Congress's finding that it is in
the public interest and appropriate for the protection of investors and
the maintenance of fair and orderly markets to assure the availability
to brokers, dealers, and investors of information with respect to
quotations for, and transactions in, securities. Last sale, quotation
information, trading volume, closing prices and NAV for the Shares from
the previous day will be available via the Consolidated Tape.\23\ The
Trust's Web site will include, on a per Share basis, for the Trust: (1)
The midpoint of the bid-ask price at the close of trading in relation
to NAV as of the time the NAV is calculated (``Bid/Ask Price''), and a
calculation of the premium or discount of such price against such NAV;
(2) data displaying the frequency of distribution of discounts and
premiums of the Bid/Ask Price against the NAV, within appropriate
ranges, for each of the four previous calendar quarters; and (3) the
Trust's prospectus, as well as the two most recent reports to
stockholders.\24\ The Trust's Web site also will provide the last sale
price of the Shares as traded in the U.S. market.\25\
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    \22\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
    \23\ See Notice, supra note 4, at 76373, 76374.
    \24\ See Notice, supra note 4, at 76372.
    \25\ See Notice, supra note 4, at 76372.
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    The Commission believes that the proposal to list and trade the
Shares is reasonably designed to promote disclosure of information that
may be necessary to price Shares appropriately and to help prevent
trading when a reasonable degree of transparency cannot be assured. The
Trust's Web site will provide daily a breakdown of the holdings of the
Trust by the form in which gold is held.\26\ The value of the Trust's
holdings also will be reported on the Trust's Web site daily.\27\ Prior
to the commencement of trading in the Shares on the Exchange, the
Exchange will obtain a representation from the Sponsor that the NAV
will be calculated daily and will be made available to all market
participants at the same time.\28\ Moreover, there is a considerable
amount of gold price and gold market information available on public
Web sites and through professional and subscription services.\29\ For
example, Reuters and Bloomberg provide at no charge on their Web sites
delayed information regarding the spot price of gold and last sale
prices of gold futures, as well as information about news and
developments in the gold market.\30\ Reuters and Bloomberg also offer a
professional service to subscribers for a fee that provides information
on gold prices directly from market participants.\31\
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    \26\ See Notice, supra note 4, at 76372.
    \27\ See Notice, supra note 4, at 76372.
    \28\ See Notice, supra note 4, at 76372. Under NYSE Arca
Equities Rule 7.34(a)(5), if the Exchange becomes aware that the NAV
is not being disseminated to all market participants at the same
time, it must halt trading on the NYSE Marketplace until such time
as the NAV is available to all market participants.
    \29\ See Notice, supra note 4, at 76373.
    \30\ See Notice, supra note 4, at 76373.
    \31\ See Notice, supra note 4, at 76373.
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    The Exchange will consider suspending trading in the Shares
pursuant to NYSE Arca Rule 8.201(e)(2) if, after the initial 12-month
period following commencement of trading: (1) The value of gold is no
longer calculated or available on at least a 15-second delayed basis
from a source unaffiliated with the Sponsor, Trust, Custodian, or the
Exchange, or the Exchange stops providing a hyperlink on its Web site
to the value of gold; or (2) if the intraday trust value (``IIV'') is
no longer made available on at least a 15-second delayed basis.\32\ If
the IIV is not being disseminated as required, the Exchange may halt
trading during the day in which the disruption occurs; if the
interruption persists past the day in which it occurred, the Exchange
will halt trading no later than the beginning of the trading day
following the interruption.\33\ The Exchange will halt trading in the
Shares if the NAV of the Trust is not calculated or disseminated
daily.\34\
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    \32\ See NYSE Arca Equities Rules 8.201(e)(2)(iv) and (v). More
generally, NYSE Arca may halt trading in the Shares on the Exchange
because of market conditions or for reasons that, in the Exchange's
view, make trading in the Shares inadvisable, including: (1) The
extent to which conditions in the underlying gold market have caused
disruptions and/or lack of trading; and (2) whether other unusual
conditions or circumstances detrimental to the maintenance of a fair
and orderly market are present. See Notice, supra note 4, at 76373.
Additionally, trading in the Shares will be subject to trading halts
caused by extraordinary market volatility pursuant to NYSE Arca's
``circuit breaker'' rule. See Notice, supra note 4, at 76373; NYSE
Arca Equities Rule 7.12.
    \33\ See Notice, supra note 4, at 76373.
    \34\ See Notice, supra note 4, at 76373.
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    In support of its proposal, the Exchange has made representations,
including:
    (1) The Shares will be listed and traded on the Exchange pursuant
to the initial and continued listing criteria in NYSE Arca Equities
Rule 8.201.\35\
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    \35\ See Notice, supra note 4, at 76374.
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    (2) The Exchange has appropriate rules to facilitate transactions
in the Shares during all trading sessions.\36\
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    \36\ See Notice, supra note 4, at 76373.
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    (3) The Exchange's existing surveillance procedures applicable to
derivative products (including Commodity-Based Trust Shares) are
adequate to properly monitor Exchange trading of the Shares in all
trading sessions and to deter and detect violations of Exchange rules
and applicable federal securities laws.\37\
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    \37\ See Notice, supra note 4, at 76373.
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    (4) Prior to the commencement of trading, the Exchange will inform
its ETP Holders in an Information Bulletin of the special
characteristics and risks associated with trading the Shares.
Specifically, the Information Bulletin will discuss the following: (1)
The procedures for purchases and redemptions of Shares; (2) NYSE Arca
Equities Rule 9.2(a), which imposes a duty of due diligence on its ETP
Holders to learn the essential facts relating to every customer prior
to trading the Shares; (3) the requirement that ETP Holders deliver a
prospectus to investors purchasing newly issued Shares prior to or
concurrently with the confirmation of a transaction; (4) the
possibility that trading spreads and the resulting premium or discount
on the Shares may widen as a result of reduced liquidity of gold
trading during the Core and Late Trading Sessions after the close of
the major world gold markets; and (5) trading information.\38\
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    \38\ See Notice, supra note 4, at 76374.
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    (5) A minimum of 100,000 Shares will be outstanding at the
commencement of trading on the Exchange.\39\
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    \39\ See Notice, supra note 4, at 76373.
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    This approval order is based on all of the Exchange's
representations and

description of the Trust, including those set forth above and in the
Notice, as modified by Amendment No. 1.
    For the foregoing reasons, the Commission believes the proposal to
list and trade the Shares is consistent with the Exchange Act.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Exchange Act,\40\ that the proposed rule change (SR-NYSEArca-2013-137),
as modified by Amendment No. 1, be, and it hereby is, approved.
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    \40\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\41\
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    \41\ 17 CFR 200.30-3(a)(12).

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2014-01662 Filed 1-28-14; 8:45 am]
BILLING CODE 8011-01-P


Meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to Consider and Review Scientific Issues Associated with Weight-of-Evidence:  Evaluating Results of EDSP Tier 1 Screening

                           July 30 - August 2, 2013

Docket Number: EPA-HQ-OPP-2013-0230				OPP Docket Tel:<PHONE_NUMBER>

Please note that all times are approximate (see note at the end of the agenda)

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Tuesday, July 30, 2013

8:30 A.M.	Opening of Meeting and Administrative Procedures  -  Joseph Bailey, Designated Federal Official, Office of Science Coordination and Policy, EPA

8:35 A.M. 	Introduction and Identification of Panel Members  -  Daniel Schlenk, Ph.D., Chair, FIFRA Scientific Advisory Panel

8:45 A.M.	Opening Remarks  -  David Dix, Ph.D., Acting Director, Office of Science Coordination and Policy (OSCP); Steven Bradbury, Ph.D.,  Director, Office of Pesticide Programs (OPP), EPA

9:00 A.M. 	Overview of the Endocrine Disruptor Screening Program (EDSP) - Mary Manibusan, Director, Exposure Assessment Coordination and Policy Division (EACPD), OSCP, EPA

9:30 A.M.	EDSP Weight-of-Evidence (WoE) Process- Thomas M. Steeger, Ph.D., Environmental Fate and 	Effects Division (EFED), OPP, EPA

10:00 A.M.	Case Study Chemicals:  Chemical A - Gregory Akerman, Ph.D.,  Health Effects Division (HED), OPP, EPA

10:30 A.M.	Break

10:45 A.M.	Case Study Chemicals:  Chemical S - John Liccione, Ph.D., HED, OPP, EPA

11:15 A.M.	Case Study Chemicals:  Chemical J - Amy Blankinship, M.S., EFED, OPP, EPA

11:45 A.M.	Case Study Chemicals:  Chemical N - Catherine Aubee, M.P.A., EFED, OPP, EPA

12:15 P.M.	Lunch

1:15 P.M.	Case Study Chemicals:  Chemical X - Patience Browne, Ph.D., EACPD, OSCP, EPA

1:45 P.M.	Concluding Remarks - Thomas M. Steeger, Ph.D., EFED, OPP, EPA

2:15 P.M.	Break

2:30 P.M.	Public Comments

5:00 P.M.	Adjournment

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Wednesday, July 31, 2013
8:30 A.M.	Opening of Meeting and Administrative Procedures  -  Joseph Bailey, Designated Federal Official, Office of Science Coordination and Policy, EPA

8:35 A.M. 	Introduction and Identification of Panel Members  -  Daniel Schlenk, Ph.D., Chair, FIFRA Scientific Advisory Panel

8:45 A.M.	Follow-up from Previous Day's Meeting

9:00 A.M.	Panel Discussion of Charge

Charge 1.1. Please comment on whether the agency has transparently described the conduct and results of the individual Tier 1 studies and the OSRI for each of the case studies (Sections 6-9 of the white paper), and specifically whether the level of detail is sufficient to ensure that a study is reliable for determining the potential to interact with E, A, or T signaling pathways and the rationale for the preliminary study conclusion.

10:15 A.M.	Break

10:30 A.M.	Panel Discussion of Charge

Charge 1.2. For each of the case studies, please comment on whether the performance criteria are clearly stated for the Tier 1 assays and, when results were not within the boundaries of the performance criteria, whether EPA has clearly expressed why the data are still considered reliable.

11:30 A.M.	Panel Discussion of Charge

Charge 1.3. The test guidelines for Tier 1 assays recommend that the organism is challenged by attaining sufficiently high treatment doses/concentrations.  Difficult to test substances may be encountered in Tier 1 screening. Chemical S is an illustration of this situation.  In the case of Chemical S, consistent exposure was not achieved in the Amphibian Metamorphosis assay (AMA) due to the physical-chemical characteristics of the test substance. The compound has low solubility and is highly lipophilic (high Kow) and prone to sorbing to surfaces (high Koc). Due largely to these properties, the contributing laboratory performing the AMA with Chemical S did not achieve a concentration level high enough to produce a response indicative of a maximum tolerated dose.  Nonetheless, the agency concluded that the data were still useful in the WoE analysis. This determination was based on the agency's understanding that while measured exposure concentrations were lower than the targeted nominal concentrations, exposure was reasonably quantified and that it is not likely that the
chemical would be any less problematic to test if the study were repeated. Further, while higher exposure concentrations could have been achieved in the AMA, the FSTRA indicates that these higher concentrations likely would have resulted in overt toxicity.

Please comment on the agency's conclusion regarding the utility of the AMA data for Chemical S to still reliably evaluate its potential endocrine interaction in a WoE analysis.

12:15 P.M.	Lunch

1:15 P.M.	Panel Discussion of Charge

Charge 2.1.a.  Chemical A can result in cholinergic toxicity given that its pesticidal mode of action is cholinesterase inhibition.  In particular, overt toxicity was observed at high concentrations in the FSTRA.  Although a number of endocrine responses were observed (e.g., decrease in female VTG, fecundity/fertility, GSI, male tubercles) at the highest concentration in the FSTRA, there was also pronounced overt toxicity that included abnormal behavior and significant body weight reductions consistent with cholinergic intoxication.   Given the directionality of the FSTRA responses (i.e., decreases in the measured endpoints), EPA concluded that the effects found at the high concentration in the FSTRA may not necessarily be reflective of an endocrine-mediated response, but rather a reflection of a compromised organism with limited ability to maintain reproductive function and homeostasis.  Although in male fish, overt toxicity was not observed at the intermediate concentration, possible endocrine responses were limited to two effects that lacked diagnostic specificity (i.e., altered GSI and histology).

Please comment on how the agency has applied its decision logic to integrate an understanding of overt toxicity in the context of observed Tier 1 in vivo responses , and in particular, the agency's determination not to place weight  on the FSTRA high concentration responses coincident with overt toxicity.

2:15 P.M.	Panel Discussion of Charge

Charge 2.1.b.  The pesticidal mode of action of Chemical S involves the uncoupling of mitochondrial oxidative phosphorylation and resulting in the depletion of ATP.  Another plausible mode of toxic action is related to its irritation properties including irritation that compromises the integrity of the gastro-intestinal tract in mammals leading to restricted caloric intake due to reduced food consumption.  Reflective of these toxic modes of action, observations in the Tier 1 studies and OSRI included body weight reductions, behavioral effects, and decreased survival.  The majority of potential androgen and estrogen-related responses (decreases in testosterone, decreases in male and female gonadal weights, delays in VO and PPS, decreases in male fertility, an increase in male GSI and VTG) were coincident with this overt toxicity.  At concentrations where no apparent overt toxicity occurred, there were no endocrine related responses in the FSTRA, and responses in female rats were limited to a 2 day delay in VO, and for male rats, a decrease in the weights of  two androgen-dependent tissues.  The majority of Tier 1 responses were decreases in the measured endpoints, which were largely expressed in the presence of overt toxicity, are consistent with a depletion of ATP and restricted caloric intake. Although male VTG was increased in fish this is likely an artifact of a single elevated response.

Please comment on how the agency has applied its decision logic to integrate an understanding of overt toxicity in the context of observed Tier 1 in vivo responses, and in particular, on the agency's determination to place less weight on the Tier 1 in vivo responses in the presence of overt toxicity.

3:15 P.M. 	Break

3:30 P.M.	Panel Discussion of Charge

Charge 2.1.c.  Chemical N is a cyclic unsaturated ketone whose acute mode of toxic action is nonpolar narcosis (toxicologically induced and reversible stages of neural disruption, i.e. general anesthesia). Unlike the other case study chemicals, there is no pesticidal mode of toxic action for N given that it is an inert ingredient. Testing required reaching limit doses/concentrations in order to sufficiently challenge the animal. Potential androgen responses only occurred in the FSTRA (decrease female VTG, decrease fecundity/fertility, altered histology) and in the male pubertal assay (decreases in testosterone, decreases in androgen sensitive tissue weights, delays in PPS) near limit doses/concentrations (as described in the white paper and test guidelines). However, a significant decrease in female VTG was observed at the intermediate dose.
Observations of overt toxicity (decreased body weights and feeding) were reported in the highest treatment group (i.e., near limit concentrations) in the FSTRA, but no overt toxicity was reported in the male pubertal assay.  Unlike Chemicals A and S, the overt toxicity is not as pronounced for Chemical N. The responses in fish and rats at the high dose could be due to a compromised metabolic ability and inability to reduce chemical load.

Please comment on the agency's analysis in characterizing Tier 1 responses that are expressed at or near limit doses where some degree of overt toxicity occurs, and the extent to which such responses are considered in the WoE analysis.

4:15 P.M.	Panel Discussion of Charge

Charge 2.1.d.  The case study analyses described above all involve situations in which overt toxicity was observed coincident with Tier 1 responses.

Please comment on the agency's overall approach to characterizing Tier 1 responses coincident with overt toxicity and determining the weight to be given to such responses.

5:00 P.M.  	Adjournment

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Thursday, August 1, 2013
8:30 A.M.	Opening of Meeting and Administrative Procedures  -  Joseph Bailey, Designated Federal Official, Office of Science Coordination and Policy, EPA

8:35 A.M. 	Introduction and Identification of Panel Members  -  Daniel Schlenk, Ph.D., Chair, FIFRA Scientific Advisory Panel

8:45 A.M.	Follow-up from Previous Day's Meeting

9:00 A.M.	Panel Discussion of Charge

Charge 2.2. In certain case studies, there was a lack of anticipated complementary and redundant responses (within an in vivo assay or across assays) at different levels of biological organization (molecular, cellular, tissue/organ, and organism) indicative of a chemical interaction with an endocrine signaling pathway. The estrogen signaling pathway will be used as an illustration. In the case of Chemical N, the mammalian assays were negative and responses within the FSTRA did not progress to higher level responses (e.g., an effect on VTG did not translate to an effect on gonadal-tissue or on fecundity). In the case of Chemical A, the rat uterotrophic and female pubertal assays (i.e., an organism with an intact hypothalamic-pituitary-gonadal axis) were negative for estrogen-related responses, and although there were some responses in the FSTRA in the absence of overt toxicity, they lacked diagnostic specificity (e.g., effects on male gonadal tissue or GSI).  Given the lack of complementarity and redundancy in responses within and across assays, the agency considered these situations as insufficient to support a robust conclusion of an interaction with endocrine signaling pathways.

Please comment on the decision logic the agency has used to characterize these types of situations where there is a lack of robustness in terms of complementarity and redundancy, and the transparency and reasonableness of the approach.

10:00 A.M.	Break

10:15 A.M.	Panel Discussion of Charge

Charge 2.3.  In contrast to the situation described in question 2.2., Chemical J appears to interact with the estrogen signaling pathway in terms of complementarity and redundancy across multiple levels of biological organization as evidenced through altered steroidogenesis, resulting in decreased VTG in female fish which in turn translates to a higher-level response (e.g., reduced fecundity) in fish.  However, this biological continuum was not observed in the Tier 1 rat female pubertal assays and the Part 158 mammalian data.

Please comment on the how the agency has characterized this endocrine interaction at different levels of biological organization across taxa, and the transparency and reasonableness of the conclusions drawn.  Please include in your response, comments regarding the agency's conclusion about differences in sensitivities between taxa (i.e., fish and rats), regarding chemicals that appear to alter steroidogenesis.

11:15 A.M.	Panel Discussion of Charge

Charge 2.4. Chemical A illustrates a situation where a molecular event has been initiated along a pathway via binding to the androgen receptor and by altered steroidogenesis, with corroborative evidence from the Hershberger assay. However, at a higher level of biological organization, an anti-androgenic response is not expressed within the context of the mammalian intact hypothalamic-pituitary-gonadal axis (based on the Tier 1 mammalian assays and the mammalian in vivo OSRI).  In the absence of overt toxicity, there were some possible endocrine-related responses in the FSTRA, but they lacked diagnostic specificity (e.g., reduced GSI and altered histology).  The agency concluded that although there is evidence of an endocrine interaction (i.e., the androgen signaling pathway) at lower levels of biological organization, clear endocrine-driven responses are not expressed at higher levels of biological organization in organisms with an intact HPG-axis, presumably due to compensatory processes.

Please comment on how the agency has integrated different sources of data along a biological continuum to characterize endocrine interactions of Chemical A and the transparency and reasonableness of the decision logic.

12:00 P.M.	Lunch

1:00 P.M.	Panel Discussion of Charge

Charge 2.5. In some chemical situations, the in vitro Tier 1 data are negative.  Nonetheless, this does not necessarily detract from a conclusion of a potential endocrine interaction in vivo either because a different molecular initiating event (MIE) may be occurring than what the in vitro assay evaluates or because an activated metabolite may be responsible for the in vivo effects. Chemicals N and S provide an illustration of this situation in that the MIE is uncertain due to the negative Tier 1 in vitro assays. But, there were Tier 1 in vivo responses that are consistent with potential interactions with the androgen or estrogen signaling pathways.

For Chemical N, anti-androgen related responses were observed in the male pubertal assay that were complementary within the assay (i.e., decreased in testosterone levels that progressed to effects at the organ (tissue weight decreases in androgen sensitive tissues) and organism level (delay in PPS).  In the FSTRA, more limited responses were observed in the absence of overt toxicity, i.e., a decrease in female VTG that did not manifest into higher level effects.  In this case, there is in vivo evidence of an endocrine interaction but compared to other case studies (e.g., as Chemical J), the complementarity and redundancy in responses are not as robust.

In the case of Chemical S for the A pathway, in the Hershberger there was a decrease in androgen-sensitive tissue weights. In the case of the male pubertal assay, there were complementary responses in that a cellular response (i.e., decreases in testosterone levels) progressed to effects at the organ (tissue weight decreases in androgen sensitive tissues) and organism level (delay in PPS).  In the FSTRA, there were altered male gonadal weights and reduced tubercles. Although these effects in the fish lack specificity, they are supported by the mammalian responses. Tier 1 in vivo responses are not observed at the lower concentrations in organisms with an intact HPG-axis, presumably due to compensatory processes.

Please comment on the how the agency has integrated different sources of data along a biological continuum to characterize this endocrine interaction and the transparency and reasonableness of the conclusion drawn.

2:00 P.M.	Panel Discussion of Charge

Charge 2.6. In each of the cases studies, there was a lack of anticipated complementary and redundant responses indicative of a chemical's interaction with the thyroid signaling pathway. In the rat, there were T4 changes that were either marginal or equivocal (Chemical A), or isolated organ weight changes (Chemicals J and S) or histopathological changes of the thyroid gland (Chemical J) that were not coincident with hormone changes.  In the AMA, there were some isolated responses not necessarily indicative in terms of the endpoint specificity of a hypothalamic-pituitary-thyroid axis perturbation (Chemicals A and N). The agency considered the lack of complementarity and redundancy in responses to support a conclusion of no interaction with the HPT axis, and viewed these isolated responses insufficient to support a conclusion of an interaction with the thyroid signaling pathway.

Please comment on the how the agency has characterized this endocrine interaction at different levels of biological organization, and the transparency and reasonableness of the conclusion drawn.

3:00 P.M. 	Break

3:15 P.M.	Panel Discussion of Charge

Charge 2.7.  In the absence of Tier 1 data, OSRI was available for Chemical X that indicated effects on thyroid endpoints in the rat but the results were inconsistent within and among studies and there was no OSRI presented from amphibian studies. Because of studies that were not specifically validated to detect an interaction with the thyroid hormonal pathway, limited data, and ambiguous results, the potential for Chemical X to interact with the thyroid pathway cannot be excluded.

Please comment on the how the agency has characterized this endocrine interaction at different levels of biological organization, and the transparency and reasonableness of the conclusion drawn.

4:15 P.M.	Panel Discussion of Charge

Charge 3.  Based on all of the case study analyses, please provide overall comments on how the agency has employed its WoE guidance and characterized the evidence and conclusions and include in your response the following points:

a.   How consistent and transparent the cases studies are in terms of documentation.

b.   How adequately the agency has described the extent of complementarity and redundancy of responses and has integrated and interpreted diverse lines of evidence across different biological levels of organization and taxa to reach preliminary conclusions regarding endocrine interactions.

c.   How the agency has used OSRI data to further characterize the observations from EDSP Tier 1 assays in determining potential chemical interactions with the E, A, and T signaling pathways.

d.  How the agency has considered the understanding of a chemical's mode of action and how that informs the weight that is placed on Tier 1 responses in the presence of uncertainties introduced by dose setting, overt toxicity, and portal of entry issues.

5:00 P.M.  	Adjournment

--------------------------------------------------------------------------------
Friday, August 2, 2013

8:30 A.M.	Opening of Meeting and Administrative Procedures  -  Joseph Bailey, Designated Federal Official, Office of Science Coordination and Policy, EPA

8:35 A.M. 	Introduction and Identification of Panel Members  -  Daniel Schlenk, Ph.D., Chair, FIFRA Scientific Advisory Panel

8:45 A.M.	Follow-up from Previous Day's Meeting

9:00 A.M.	Panel Discussion of Charge

10:00 A.M.	Break

10:15 A.M.	Panel Discussion of Charge

11:00 A.M.	Panel Discussion of Charge

12:00 P.M.	Lunch

1:00 P.M.	Panel Discussion of Charge

3:00 P.M. 	Break

3:15 P.M.	Panel Discussion of Charge

5:00 P.M.  	Adjournment

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


[Federal Register: July 17, 2006 (Volume 71, Number 136)]
[Notices]
[Page 40493]
[DOCID:fr17jy06-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12582-001]

Clover Creek Hydro, LLC; Notice of Surrender of Preliminary
Permit

July 10, 2006.
    Take notice that Clover Creek Hydro, LLC, permittee for the
proposed Byram Hydroelectric Project, has requested that its
preliminary permit be terminated. The permit was issued on December 29,
2005, and would have expired on November 30, 2008.\1\ The project would
have been located on the Clover Creek portion of the Main Canal of the
North Side Canal Company and Little Wood River, near Gooding, in
Gooding County, Idaho.
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    \1\ 113 FERC ] 62,257.
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    The permittee filed the request on June 26, 2006, and the
preliminary permit for Project No. 12582 shall remain in effect through
the thirtieth day after issuance of this notice unless that day is a
Saturday, Sunday, part-day holiday that affects the Commission, or
legal holiday as described in section 18 CFR 385.2007, in which case
the effective date is the first business day following that day. New
applications involving this project site, to the extent provided for
under 18 CFR part 4, may be filed on the next business day.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-11191 Filed 7-14-06; 8:45 am]

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[Federal Register Volume 77, Number 32 (Thursday, February 16, 2012)]
[Notices]
[Page 9227]
[FR Doc No: 2012-3601]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-1002-000]

AP Gas & Electric (NJ), LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
AP Gas & Electric (NJ), LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is February 29, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 9, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-3601 Filed 2-15-12; 8:45 am]
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[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Page 67047]
[FR Doc No: 2021-25682]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 553-238]

City of Seattle, Washington; Notice of Availability of Final
Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office
of Energy Projects has reviewed an application submitted by the City of
Seattle, Washington to construct a replacement fuel dock and associated
infrastructure at Diablo Lake at the Skagit River Project No. 553. The
Skagit River Project is located on the Skagit River in Snohomish,
Skagit, and Whatcom counties, Washington. The project occupies a
portion of the Ross Lake National Recreation Area administered by the
U.S. National Park Service and the Mount Baker National Forest
administered by the U.S. Forest Service.
    A Final Environmental Assessment (FEA) has been prepared as part of
staff's review of the proposal.\1\ The FEA contains the Commission
staff's analysis of the probable environmental effects of the proposed
action and concludes that approval of the proposal, with Commission
staff's recommended measures, would not constitute a major federal
action that would significantly affect the quality of the human
environment.
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    \1\ On July 16, 2020, the Council on Environmental Quality (CEQ)
issued a final rule, Update to the Regulations Implementing the
Procedural Provisions of the National Environmental Policy Act
(Final Rule, 85 FR 43,304), which was effective as of September 14,
2020; however, the NEPA review of this project was in process at
that time and was prepared pursuant to CEQ's 1978 NEPA regulations.
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    The FEA may be viewed on the Commission's website at http://www.ferc.gov using the ``elibrary'' link. Enter the docket number (P-
553) in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC Online
Support at [email protected] or toll-free at 1-866-208-3372,
or for TTY,<PHONE_NUMBER>.

    Dated: November 18, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-25682 Filed 11-23-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81753-81754]
[FR Doc No: 2016-27805]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 271-146]

Entergy Arkansas, Inc.; Notice of Application Accepted for
Filing, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Federal Energy Regulatory Commission and is available
for public inspection:
    a. Type of Application: Non-project use of project lands and water.
    b. Project No: 271-146.
    c. Date Filed: October 11, 2016.
    d. Applicant: Entergy Arkansas Inc. (licensee).
    e. Name of Project: Carpenter-Remmel Hydroelectric Project.
    f. Location: Lake Catherine in Garland County, Arkansas.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Eugene Knighten, Manager, Entergy Arkansas,
Inc., 141 West County Line Road, Malvern, Arkansas 72104; phone (501)
844-2168.
    i. FERC Contact: Ms. Joy Kurtz at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and protests
is 30 days from the issuance of this notice by the Commission. The
Commission strongly encourages electronic filing. Please file motions
to intervene, protests, and comments using the Commission's eFiling
system at 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>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-271-146.
    k. Description of Request: The licensee requests Commission
approval to grant the City of Hot Springs, Arkansas permission to use
project lands and water within the project boundary to increase its
discharge of treated sewage effluent from the Hot Springs Wastewater
Treatment Plant into Lake Catherine from the currently-approved 12
million gallons per day (mgd) to 16 mgd. There are no physical
improvements or additions to the treatment plant proposed within the
project boundary, hence no ground-disturbing work is necessary within
the project boundary to facilitate the discharge increase. All
discharge would be subject to meeting the Arkansas Department of
Environmental Quality's discharge permit requirements. The increase in
discharge is necessary to support the growth of the City of Hot Springs
and its service area.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's Web site at 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. You may also register
online at http://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, call<PHONE_NUMBER> or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is also
available for inspection and reproduction at the address in item (h)
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments 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 comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS''; ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (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. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to the non-project use application. 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. If an intervener
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. A copy of all other filings in reference to this
application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: November 10, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-27805 Filed 11-17-16; 8:45 am]
BILLING CODE 6717-01-P