[Federal Register Volume 76, Number 164 (Wednesday, August 24, 2011)]
[Notices]
[Pages 53012-53015]
[FR Doc No: 2011-21661]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65166; File No. SR-NYSEArca-2011-57]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Deleting the Text
of NYSE Arca Equities Rules 6.16 and 6.16A, and Adopting New NYSE Arca
Equities Rule 5320 That Is Substantially the Same as Financial Industry
Regulatory Authority Rule 5320 To Prohibit Trading Ahead of Customer
Orders With Certain Exceptions (Commonly Known as the Manning Rule)

August 18, 2011.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that August 11, 2011, NYSE Arca, Inc. (the ``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit

comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to delete the text of NYSE Arca Equities
Rules 6.16 and 6.16A, which limit trading ahead of customer limit and
market orders, and adopt new NYSE Arca Equities Rule 5320 that is
substantially the same as Financial Industry Regulatory Authority
(``FINRA'') Rule 5320. The text of the proposed rule change is
available at the Exchange, the Commission's Public Reference Room, and
http://www.nyse.com.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose

    The Exchange proposes to delete the text of NYSE Arca Equities
Rules 6.16 and 6.16A, which limit trading ahead of customer limit and
market orders, and adopt new NYSE Arca Equities Rule 5320 that is
substantially the same as FINRA Rule 5320.\4\ As with FINRA Rule 5320,
proposed NYSE Arca Equities Rule 5320 would prohibit trading ahead of
customer orders with certain exceptions, including large order and
institutional account exceptions, a no-knowledge exception, a riskless
principal exception, an intermarket sweep order (``ISO'') exception,
and odd lot and bona fide error transaction exceptions, discussed in
detail below. Proposed NYSE Arca Equities Rule 5320 also provides the
same guidance as FINRA Rule 5320 on minimum price improvement
standards, order handling procedures, and trading outside normal market
hours.
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    \4\ See Securities Exchange Act Release No. 63895 (February 11,
2011), 76 FR 9386 (February 17, 2011) (SR-FINRA-2009-090). The
Exchange's affiliates, New York Stock Exchange LLC and NYSE Amex
LLC, also have filed substantially similar rule filings. See SR-
NYSE-2011-43 and SR-NYSEAmex-2011-59.
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Background

    NYSE Arca Equities Rule 6.16 generally prohibits an ETP Holder from
trading on a proprietary basis ahead of an unexecuted customer order.
However, NYSE Arca Equities Rule 6.16 allows an ETP Holder to negotiate
specific terms and conditions applicable to the acceptance of limit
orders pursuant to certain conditions of the rule, and NYSE Arca
Equities Rule 6.16A allows an ETP Holder to negotiate specific terms
and conditions applicable to the acceptance of market orders pursuant
to certain conditions of the rule. NYSE Arca Equities Rule 6.16 is
based on NASD Interpretive Material 2110-2 and NYSE Arca Equities Rule
6.16A is based on NASD Rule 2111.\5\
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    \5\ See Securities Exchange Act Release No. 64780 (June 30,
2011), 76 FR 39960 (July 7, 2011) (SR-NYSEArca-2011-40).
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Proposal To Adopt Text of FINRA Rule 5320
    In conjunction with its rules harmonization with FINRA, the
Exchange proposes to delete the text of NYSE Arca Equities Rules 6.16
and 6.16A and adopt the text of FINRA Rule 5320, with certain technical
changes, as NYSE Arca Equities Rule 5320. FINRA Rule 5320 generally
provides that a FINRA member that accepts and holds an order in an
equity security from its own customer or a customer of another broker-
dealer without immediately executing the order is prohibited from
trading that security on the same side of the market for its own
account at a price that would satisfy the customer order, unless it
immediately thereafter executes the customer order up to the size and
at the same or better price at which it traded for its own account.
    Proposed NYSE Arca Equities Rule 5320 permits an ETP Holder to
trade a security on the same side of the market for its own account at
a price that would satisfy a customer order in certain circumstances.
Large Orders and Institutional Accounts
    The most notable exception to the customer order protection rule is
to allow ETP Holders to negotiate terms and conditions on the
acceptance of certain large-sized orders (orders of 10,000 shares or
more unless such orders are less than $100,000 in value) or orders from
institutional accounts as defined in NASD Rule 3110. Such terms and
conditions would permit the ETP Holder to continue to trade alongside
or ahead of such customer orders if the customer agrees.
    Specifically, under the proposed rule, an ETP Holder would be
permitted to trade a security on the same side of the market for its
own account at a price that would satisfy a customer order provided
that the ETP Holder provides clear and comprehensive written disclosure
to each customer at account opening and annually thereafter that (a)
Discloses that the ETP Holder may trade proprietarily at prices that
would satisfy the customer order, and (b) provides the customer with a
meaningful opportunity to opt in to the NYSE Arca Equities Rule 5320
protections with respect to all or any portion of its order.
    If a customer does not opt in to the protections with respect to
all or any portion of its order, the ETP Holder may reasonably conclude
that such customer has consented to the ETP Holder trading a security
on the same side of the market for its own account at a price that
would satisfy the customer's order.\6\
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    \6\ As is always the case, customers retain the right to
withdraw consent at any time. Therefore, an ETP Holder's reasonable
conclusion that a customer has consented to the ETP Holder trading
along with such customer's order is subject to further instruction
and modification from the customer.
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    In lieu of providing written disclosure to customers at account
opening and annually thereafter, the proposed rule would permit ETP
Holders to provide clear and comprehensive oral disclosure to, and
obtain consent from, a customer on an order-by-order basis, provided
that the ETP Holder documents who provided such consent and that such
consent evidences the customer's understanding of the terms and
conditions of the order. In addition, where a customer has opted in to
the NYSE Arca Equities Rule 5320 protections, an ETP Holder may still
obtain consent on an order-by-order basis to trade ahead of or along
with an order from that customer, provided that the ETP Holder
documents who provided such consent and that such consent evidences the
customer's understanding of the terms and conditions of the order.
No-Knowledge Exception
    The Exchange is also proposing to include a ``no-knowledge''
exception to its customer order protection rule. The proposed exception
would allow a proprietary trading unit of an ETP Holder to continue
trading in a proprietary capacity and at prices that would satisfy
customer orders that were being held by another, separate trading unit
at the ETP Holder. The no-knowledge exception would be applicable with
respect to NMS stocks, as defined in Rule 600 of SEC Regulation NMS. In
order to avail itself

of the no-knowledge exception, an ETP Holder must first implement and
utilize an effective system of internal controls (such as appropriate
information barriers) that operate to prevent the proprietary trading
unit from obtaining knowledge of the customer orders that are held at a
separate trading unit.
    An ETP Holder that structures its order handling practices in NMS
stocks to permit its proprietary and/or market-making desk to trade at
prices that would satisfy customer orders held by a separate trading
unit must disclose in writing to its customers, at account opening and
annually thereafter, a description of the manner in which customer
orders are handled by the ETP Holder and the circumstances under which
the ETP Holder may trade proprietarily at its market-making desk at
prices that would satisfy the customer order.
Riskless Principal Exception
    The Exchange's proposal also provides that the obligations under
this rule shall not apply to an ETP Holder's proprietary trade if such
proprietary trade is for the purposes of facilitating the execution, on
a riskless principal basis, of another order from a customer (whether
its own customer or the customer of another broker-dealer), provided
that the ETP Holder (a) Submits a report, contemporaneously with the
execution of the facilitated order, identifying the trade as riskless
principal to the Exchange and (b) has written policies and procedures
to ensure that riskless principal transactions relied upon for this
exception comply with applicable Exchange rules. At a minimum these
policies and procedures must require that the customer order was
received prior to the offsetting principal transaction, and that the
offsetting principal transaction is at the same price as the customer
order exclusive of any markup or markdown, commission equivalent or
other fee and is allocated to a riskless principal or customer account
in a consistent manner and within 60 seconds of execution.
    ETP Holders must have supervisory systems in place that produce
records that enable the ETP Holder and the Exchange to reconstruct
accurately, readily, and in a time-sequenced manner all orders on which
an ETP Holder relies in claiming this exception.
ISO Exception
    The proposed rule change also provides that an ETP Holder shall be
exempt from the obligation to execute a customer order in a manner
consistent with NYSE Arca Equities Rule 5320 with regard to trading for
its own account that is the result of an intermarket sweep order routed
in compliance with Rule 600(b)(30)(ii) of SEC Regulation NMS where the
customer order is received after the ETP Holder routed the ISO. Where
an ETP Holder routes an ISO to facilitate a customer order and that
customer has consented to not receiving the better prices obtained by
the ISO, the ETP Holder also shall be exempt with respect to any
trading for its own account that is the result of the ISO with respect
to the consenting customer's order.
Odd Lot and Bona Fide Error Exception
    In addition, the Exchange proposes applying an exception for a
firm's proprietary trade that (1) Offsets a customer odd lot order
(i.e., an order less than one round lot, which is typically 100 shares)
or (2) corrects a bona fide error. With respect to bona fide errors,
ETP Holders would be required to demonstrate and document the basis
upon which a transaction meets the bona fide error exception.
Minimum Price Improvement Standards
    The proposed rule change establishes the minimum amount of price
improvement necessary for an ETP Holder to execute an order on a
proprietary basis when holding an unexecuted limit order in that same
security without being required to execute the held limit order.
Order Handling Procedures
    The proposed rule change provides that an ETP Holder must make
every effort to execute a marketable customer order that it receives
fully and promptly. An ETP Holder that is holding a customer order that
is marketable and has not been immediately executed must make every
effort to cross such order with any other order received by the ETP
Holder on the other side of the market up to the size of such order at
a price that is no less than the best bid and no greater than the best
offer at the time that the subsequent order is received by the ETP
Holder and that is consistent with the terms of the orders. In the
event that an ETP Holder is holding multiple orders on both sides of
the market that have not been executed, the ETP Holder must make every
effort to cross or otherwise execute such orders in a manner that is
reasonable and consistent with the objectives of the proposed rule and
with the terms of the orders. An ETP Holder can satisfy the crossing
requirement by contemporaneously buying from the seller and selling to
the buyer at the same price.
Trading Outside Normal Market Hours
    An ETP Holder generally may limit the life of a customer order to
the period of normal market hours of 6:30 a.m. to 1 p.m. Pacific
Standard Time. However, if the customer and ETP Holder agree to the
processing of the customer's order outside normal market hours, the
protections of proposed NYSE Arca Equities Rule 5320 would apply to
that customer's order(s) at all times the customer order is executable
by the ETP Holder.
Conforming and Other Changes
    For consistency with Exchange rules, NYSE Arca Equities Rule 5320
will have certain differences from FINRA Rule 5320. The Exchange
proposes not to include Supplementary Material .02(b) and portions of
Supplementary Material .06, which relate to OTC equity securities, in
the Commentary of NYSE Arca Equities Rule 5320 and to change all
references from ``members'' to ``ETP Holders.''
Implementation Date
    The Exchange proposes to implement NYSE Arca Equities Rule 5320 on
the same date that FINRA implements FINRA Rule 5320, which FINRA has
announced will be September 12, 2011.\7\ The Exchange will provide
notice of the implementation date to ETP Holders via a Regulatory
Information Bulletin.
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    \7\ See FINRA Regulatory Notice 11-24.
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2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \8\ of the
Act, in general, and furthers the objectives of Section 6(b)(5) \9\ in
particular in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, 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. The Exchange believes that adopting the proposed rule
at the same time that FINRA implements a substantially similar rule
will contribute to investor protection by defining important parameters
by which ETP Holders must abide when trading proprietarily while
holding customer limit and market orders, and foster cooperation by
harmonizing

requirements across self-regulatory organizations.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \10\ and Rule 19b-4(f)(6) thereunder.\11\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \12\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\13\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml ); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2011-57 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2011-57. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml ). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSEArca-2011-57 and should be submitted on or before September 14,
2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy.
Secretary.
[FR Doc. 2011-21661 Filed 8-23-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: September 23, 2010 (Volume 75, Number 184)]
[Notices]
[Page 57963-57964]
[DOCID:fr23se10-67]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0459]

Draft Guidance for Industry and Food and Drug Administration
Staff; Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for the Detection of Helicobacter pylori;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Establishing the
Performance Characteristics of In Vitro Diagnostic Devices for the
Detection of Helicobacter pylori.'' This draft guidance document
provides industry and agency staff with updated recommendations
concerning 510(k) submissions for various types of in vitro diagnostic
devices (IVDs) intended to be used for detecting Helicobacter pylori
(H. pylori). This draft guidance is not final nor is it in effect at
this time.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment of
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 22, 2010.

ADDRESSES:  Submit written requests for single copies of the draft
guidance document entitled ``Establishing the Performance
Characteristics of In Vitro Diagnostic Devices for the Detection of
Helicobacter pylori'' to the Division of

Small Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Freddie M. Poole, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5520, Silver Spring, MD 20993-0002, 301-
796-5457.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document provides recommendations on developing
studies for establishing the performance characteristics of in vitro
diagnostic devices for the direct or indirect detection of H. pylori
bacteria in human blood, serum, urine, stool, or breath specimens. FDA
believes these recommended studies will be relevant for premarket
notification (510(k)) submissions for these device types. Detection
methods listed in this guidance include blood and urine antibody tests,
stool antigen test, carbon-13 (\13\C) urea breath and blood tests, and
the urease test. This draft guidance has been updated since the 1992
guidance document entitled ``Review Criteria for Assessment of
Laboratory Tests for the Detection of Antibodies to Helicobacter
pylori,'' to suggest information that submitters provide that is more
appropriate given changes in understanding of the science of detection
of H. pylori and to include technologies outside the scope of the old
guidance, such as H. pylori urea breath tests and H. pylori antigen
detection tests.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on establishing
the performance characteristics of in vitro diagnostic devices for the
detection of H. pylori. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Establishing the Performance
Characteristics of In Vitro Diagnostic Devices for the Detection of
Helicobacter pylori'' you may either send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 1712 to identify the draft guidance you are
requesting. A search capability for all CDRH guidance documents is
available at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations and guidance documents. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part
812 have been approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 42 CFR 493.17 have been approved under OMB control
number 0910-0607; and the collections of information in 21 CFR 56.115
have been approved under OMB control number 0910-0130.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23644 Filed 9-22-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: September 5, 2007 (Volume 72, Number 171)]
[Notices]
[Page 50954-50960]
[DOCID:fr05se07-42]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-0490; FRL-8146-2]

TSCA Section 21 Petition on Nonylphenol and Nonylphenol
Ethoxylates; Response to Citizens' Petition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: On June 6, 2007, the Sierra Club, the Environmental Law and
Policy Center, the Pacific Coast Federation of Fishermen's
Associations, the Washington Toxics Coalition, Physicians for Social
Responsibility, and UNITE HERE petitioned EPA under section 21 of the
Toxic Substances Control Act (TSCA) to initiate rulemaking proceedings
under sections 4 and 6 of TSCA. Specifically, petitioners requested
that EPA require manufacturers and importers to conduct certain health
and safety studies under TSCA section 4; and also require, under TSCA
section 6(a), labeling on all products containing nonylphenol (NP) and
nonylphenol ethoxylates (NPEs), and limit the use of NP and NPEs where
the use of these substances presents an unreasonable risk to public
health and the environment. For the reasons set forth in this notice,
EPA is granting the petitioners' request to initiate a proceeding for
chronic aquatic toxicity testing under TSCA section 4 and will

also request comment on potential additional testing related to certain
of the petitioners' requests, but is denying the petition in regard to
TSCA section 6 and to the remaining specific TSCA section 4 requests.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
    For technical information contact: Mary Dominiak or John Schaeffer,
Chemical Control Division (7405M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER> or (202)
564-8173; e-mail address:
<EMAIL_ADDRESS>or<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture,
import, or distribute in commerce NP or NPEs. Potentially affected
entities may include, but are not limited to:
     Chemical manufacturers (including importers) (NAICS codes
325, 32411, e.g., chemical manufacturing and petroleum refineries) of
one or more of the subject chemicals.
     Surface active agent manufacturers (NAICS code 325613).
     Industrial launderers (NAICS code 81233).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2007-0490. All documents
in the docket are listed in the docket's index available at http://www.regulations.gov.
 Although listed in the index, some information is

not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly available docket materials are
available electronically at http://www.regulations.gov, or, if only

available in hard copy, at the OPPT Docket. The OPPT Docket is located
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays. The telephone number of the EPA/DC Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>. Docket visitors are required to show
photographic identification, pass through a metal detector, and sign
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. Background

A. What is a TSCA Section 21 Petition?

    Section 21 of TSCA allows citizens to petition EPA to initiate a
rulemaking proceeding for the issuance, amendment, or repeal of a rule
under TSCA section 4, 6, or 8 or an order under TSCA section 5(e) or
6(b)(2). A TSCA section 21 petition must set forth facts that the
petitioner believes establish the need for the action requested. EPA is
required to grant or deny the petition within 90 days of its filing. If
EPA grants the petition, the Agency must promptly commence an
appropriate proceeding. If EPA denies the petition, the Agency must
publish its reasons for the denial in the Federal Register. The
petitioners may commence a civil action in a U.S. district court to
compel initiation of the requested rulemaking proceeding within 60 days
of either a denial or the expiration of the 90-day period.

B. What Criteria Apply to a Decision on a TSCA Section 21 Petition?

    1. TSCA section 21. TSCA section 21, itself, does not expressly
identify the basis under which EPA should decide whether to grant or
deny a citizens' petition. Rather, TSCA section 21(b)(1) requires that
the petition set forth the facts that it is claimed establish it is
``necessary'' to issue a rule or order that is the subject of the
petition. In addition, TSCA section 21 establishes standards the court
must use to decide whether to order EPA to initiate rulemaking in the
event of a lawsuit filed by the petitioner after denial of a TSCA
section 21 petition. (15 U.S.C. 2620(b)(4)(B)). Further, TSCA section
21 implicitly incorporates the statutory standards under TSCA sections
4 and 6 for issuing regulations, requiring petitioners to ``set forth
the facts which it is claimed establish that it is necessary to
issue...a rule under section [4 or 6].'' (15 U.S.C. 2620(b)(1)
(emphasis added)). Accordingly, EPA has relied on the standards in TSCA
section 21 and in TSCA sections 4 and 6 as the basis for evaluating and
deciding on the NP/NPE petition.
    2. Legal standards regarding TSCA section 4 test rules. Under TSCA
section 4, EPA must make a number of findings in order to issue a rule
to require testing. In all cases, EPA must find that data on a chemical
are insufficient to evaluate its effects and that testing of the
chemical is necessary to develop the missing data. (15 U.S.C.
2603(a)(1)(A) and (B)). In addition, EPA must either find that:
     i. The chemical may present an unreasonable risk of injury or
    ii. The chemical is:
    a. Produced in substantial quantities, and
    b. May either:
    A. Result in significant or substantial human exposure, or
    B. Result in substantial environmental release.
    TSCA section 21 allows a court to order EPA to initiate rulemaking
if the court makes essentially the same determination after a de novo
review of the petition. However, TSCA section 21 omits the third
finding required under TSCA section 4 from the findings that a court
must make in order to require EPA to initiate TSCA section 4
rulemaking--i.e., the finding that ``testing is necessary to develop
the data.'' (15 U.S.C. 2620(b)(4)(B)(i)). Nonetheless, EPA believes
TSCA section 21(b)(4) is best interpreted as incorporating all of the
TSCA section 4 findings. The alternative would be to read the statute
as empowering a court

to require EPA to initiate a rule even where the Agency could not make
proposed findings consistent with TSCA section 4 or take final action
on the rule. EPA's interpretation is supported by legislative history.
(House conference report (H. Conf. Rept.) 94-1679 at 97-99 (1976)).
    3. Legal standards regarding TSCA section 6 control rules. In
evaluating the request for rules under TSCA section 6 to control
chemicals, EPA assessed whether such rules are necessary to protect
against unreasonable risk. This is the same test the court would apply
under TSCA section 21.
    The finding of unreasonable risk is a judgment under which the
decisionmaker determines that the risk of health or environmental
injury from a chemical outweighs the burden to society of potential
regulations. An unreasonable risk decision cannot be made considering
risk alone. Rather, the probability of harm must be considered against
the impacts of regulation. In promulgating any rule under TSCA section
6, the statute requires that the Administrator consider:
     The effects of the substance or mixture on health and the
environment and the magnitude of the exposure of human beings and the
environment to the substance or mixture.
     The benefits of the substance or mixture for various uses
and the availability of substitutes for such uses.
     The reasonably ascertainable economic consequences of the
rule, after consideration of the effect on the national economy, small
business, technological innovation, the environment, and public health.
(15 U.S.C. 2605 (c)).

C. What Action is Requested Under this TSCA Section 21 Petition?

    On June 6, 2007, the Sierra Club, the Environmental Law and Policy
Center, the Pacific Coast Federation of Fishermen's Associations, the
Washington Toxics Coalition, Physicians for Social Responsibility, and
UNITE HERE petitioned EPA to take action under TSCA section 4 for seven
categories of tests and under TSCA section 6 for four categories of
restrictions.
The requested actions under TSCA section 4 are:
    1. Require testing to ``fill the gaps'' for chronic toxicity of NPE
oligomers (oligomers are the 1-2 mole ethoxylate of NP, also known as
``short-chain'' NPEs) to aquatic organisms.
    2. Require the testing of mixtures to ``fill the gaps'' regarding
the additive toxicity of NP and NPE oligomers to aquatic organisms.
    3. Require testing on the estrogenic disruption impact, including
multi-generational and population level impact, of NP and NPEs to
aquatic organisms.
    4. Require testing of NP and NPEs for vitellogenin gene expression.
    5. Require testing to ascertain certain aspects of NP and NPE
toxicity to humans, including general population exposure, metabolism,
dermal absorption, and placental development.
    6. Require epidemiology testing for industrial laundry workers
exposed to NPEs.
    7. Require testing to determine exposure to NPEs in residential
indoor air.
The requested actions under TSCA section 6 are:
    1. Require labeling on all products containing NP and NPEs.
    2. Restrict the use of NPEs where the user cannot verify that the
chemicals will receive proper wastewater treatment.
    3. Ban the use of NP and NPEs in industrial and consumer
detergents.
    4. Require pollution prevention planning by facilities that use
2,000 kilograms (kg) or more of NP or NPEs.

III. Disposition of Petition

    Using the criteria in Unit II.B. to assess the NP/NPE petition, EPA
has concluded that, with respect to petitioners' first request for
chronic toxicity testing of ``short-chain'' NPEs, the petitioners have
provided facts demonstrating that existing data may be insufficient to
permit a reasoned evaluation of the effects of the chemicals, and that
the chemicals are produced in substantial quantities and either may
result in significant or substantial human exposure, or may result in
substantial environmental release. Accordingly, EPA grants the
petitioners' request that EPA initiate a proceeding for the issuance of
a rule under TSCA section 4 regarding chronic aquatic toxicity testing
on certain NPEs. However, EPA has determined that petitioners have not
provided facts to support the conclusion that the other tests they
requested are necessary to permit a reasoned evaluation of the
chemicals and EPA is, accordingly, denying the petitioners' remaining
specific TSCA section 4 testing requests. Further, EPA has determined
that petitioners failed to provide sufficient justification for any of
the requested control actions under TSCA section 6 and, therefore, EPA
is denying these requests. Each of the petitioners' requests is
addressed specifically in the following discussion.

A. Grant of Request to Initiate a Section 4 Test Rule

    Petitioners' first request was that EPA initiate testing to
determine the chronic toxicity of NPEs, especially ``short-chain''
NPEs, ``for development of protective water quality criteria and
standards that account for the full range of negative impacts from NP
and NPEs.'' EPA agrees that data concerning the chronic effects of
``short-chain'' NPEs appear to be limited (Refs. 1 and 2) and may be
insufficient to adequately evaluate the risk of chronic exposures to
aquatic organisms from ``short-chain'' NPEs. However, to develop a
properly tailored test requirement that would provide EPA with
sufficient data, EPA believes it would be most productive to examine a
number of additional considerations prior to the issuance of a proposed
rule. These considerations include determining which NPEs might be
studied to adequately characterize the potential risk presented by
chronic exposures to these chemicals, based on such factors as the
potential for aquatic organisms to be exposed to them. For example,
NP1EO and NP2EO have been detected in the environment and may be the
candidates for further testing, but other NPEs, including various
derivatives and degradation products, may not need to be considered.
EPA further notes that, if adequate acute aquatic toxicity testing data
are not already available on specific NPEs in the same species
appropriate for chronic testing, those acute data may need to be
developed in order to set appropriate concentration levels for chronic
testing and for calculating acute-to-chronic ratios. Additional
considerations may include determining how many taxa are needed, and
which species in those taxa would be most appropriate in order to
properly characterize the potential aquatic toxicity of the chemicals
present in freshwater and saltwater systems. EPA may also consider
whether chronic aquatic toxicity testing for NP in saltwater fish
species may be warranted, and whether testing to assess the toxicity
and fate of sediment-bound NP in both freshwater and marine/estuarine
habitats should be considered, since these data are limited (Refs. 2,
3, and 4). Finally, EPA notes that the apparent focus of the petition
is the development of water quality criteria (WQC). Although
petitioners have referenced testing designed to satisfy the
requirements imposed by States and EPA for data sufficient for setting
WQC values, EPA notes that the standards for setting WQC are different
than the standard for requiring testing under TSCA section 4, and a
reasoned

evaluation of the chemicals under TSCA may require different tests than
the full battery of studies necessary to issue such criteria.
Accordingly, rather than initially proposing a rule pursuant to TSCA
section 4, where the Agency would present its preliminary conclusions
on these points, EPA will publish an Advanced Notice of Proposed
Rulemaking (ANPRM) initiating proceedings under TSCA section 4. The
ANPRM will identify these issues for public comment. The information
received from this process would guide EPA in developing a proposed
testing program under TSCA section 4.

B. Denials of Requests to Initiate TSCA Section 4 Test Rules

    Petitioners' second request was that EPA ``fill the data gaps
regarding the additive toxicity of NP and NPE oligomers to species.''
Petitioners requested testing of unspecified mixtures of NP and NPEs in
acute and chronic assays to address this perceived gap. The petitioners
noted that, given their similar structure and mode of action, the
toxicity of NP and NPEs may be additive. EPA currently believes that
the question of additive toxicity of various NPEs would not be
addressed effectively by requiring the testing of unspecified mixtures
of them. Additive toxicity is often more pragmatically addressed by
using methods to combine the results of testing the individual
components of mixtures. Petitioners provided no rationale to explain
why this more pragmatic approach of testing individual chemicals would
be inadequate in this instance. Therefore, EPA does not believe it has
the basis at this time to support the finding required under TSCA
section 4(a)(2) for ordering the testing of mixtures: That the effects
of the mixture ``may not be reasonably and more efficiently
determined...by testing the chemical substances which comprise the
mixture.'' EPA considers that obtaining certain acute and chronic
aquatic toxicity data on the appropriate individual NPE, as described
in this unit in the response to petitioners' first request, could
provide useful information addressing the additive toxicity question
raised by petitioners. EPA thus denies the specific request that EPA
order the testing of mixtures, but EPA may consider multiple approaches
to addressing the questions concerning possible additive toxicity in
the ANPRM.
    Petitioners' third request was that EPA conduct research on
individual endocrine disruption impacts and on the relationship between
individual endocrine disruption impacts and population-level impacts,
including multi-generation effects. In general, EPA questions whether
such mechanism-specific testing is needed to permit a reasoned
evaluation of these chemicals given other data that exist and the
additional data that EPA would consider in the ANPRM. Available studies
already evaluate effects on the test organisms' mortality, growth, and
reproduction, which are apical to any endocrine disruption that may
occur. As summarized in EPA's Office of Water Ambient Water Quality
Criteria (WQC) Document for NP, the ability of nonylphenol to induce
estrogenic effects has seldom been reported at concentrations below the
freshwater final chronic value of 6.6 micrograms/Liter ([micro]g/L)
(Ref. 3). EPA considers at this time that the existing data,
particularly combined with the acute and chronic aquatic toxicity data
that EPA proposes to discuss in its ANPRM, would be sufficient to
evaluate effects on individuals and populations (Refs. 3, 5, and 6). In
addition, test methods to assess multi-generational impacts are not
currently available, and it is not yet certain that such methods would
provide data that would significantly advance understanding beyond
existing chronic study data with regard to NP, given that NP
demonstrates estrogenic effects at concentrations at or above which
chronic effects are also seen. The Office of Prevention, Pesticides,
and Toxic Substances (OPPTS) Endocrine Disruptor Screening Program
(EDSP) is currently developing and validating freshwater and saltwater
fish 2-generation test methods and also a crustacean (mysid) 2-
generation test method. However, those methods are not expected to be
fully validated before 2010, and additional work with the test method
will be required to demonstrate the benefit of performing these
studies. As noted in the WQC document, when the appropriate EDSP
testing protocols have been developed and validated, EPA may consider
whether additional testing of NP and NPE might be warranted (Ref. 3).
For these reasons, EPA cannot conclude that the available information
relevant to this requested testing is insufficient to permit a reasoned
evaluation of the health or environmental effects of these chemicals or
that the requested testing is necessary, and EPA, therefore, denies
this request.
    Petitioners' fourth request was that EPA apply a specific
vitellogenin gene expression assay to NP and each individual NPE. In
general, EPA questions whether such mechanism-specific testing is
needed to permit a reasoned evaluation of these chemicals given other
data that exist. Several different vitellogenin gene expression tests
exist (Refs. 7, 8, and 9), but each serves the same purpose of
demonstrating the potential of a chemical for estrogenic expression.
The Agency considers that available information on NP and various NPEs
is sufficient to adequately demonstrate and evaluate the estrogenic
expression of NP and also to provide enough of a basis on which to
project the lesser contribution of various NPEs, making further
vitellogenin assays unnecessary (Refs. 5, 6, 10, and 11). Accordingly,
EPA cannot conclude that the available information relevant to this
requested testing is insufficient to permit a reasoned evaluation of
the health or environmental effects of these chemicals or that the
requested testing is necessary, and EPA, therefore, denies the request
for a TSCA section 4 test rule requiring the vitellogenin gene
expression assay.
    Petitioners' fifth request encompasses a diverse cluster of
testing, including dermal absorption, oxidative metabolism, the effects
of NP on human placental development, and NP and NPE exposure to the
general population of the United States. Data to evaluate these effects
either already exist or are being generated under other programs and
need not be duplicated. For example, a combination of existing human
and animal studies provides a reasonable understanding of the
metabolism of NP in humans. The data available indicate a metabolic
profile common to phenols (Refs. 12, 13, and 14). In addition, studies
on dermal absorption of NP and NPEs have already been conducted and
have concluded that dermal absorption of NP is negligible, and that
dermal absorption of NPEs through human and animal skin is less than 1%
(Ref. 15). The petitioners cited a study done on human placental tissue
suggesting that NP may have some effect on trophoblastic cells of the
placenta, and specifically requested that a similar study be repeated.
EPA does not believe that repeating this non-standard study or
attempting to design a similar one would add to the understanding of
these chemicals, because existing studies on whole organisms have
already more fully addressed reproductive and other health effects
(Ref. 16). Reproductive studies of NP in mammals have been conducted
(Refs. 17 and 18), as well as other studies which have examined the
estrogenic effects of NP in mammals (e.g., uterotrophic assay) (Refs.
19, 20, and 21), and, on the basis of these data,

EPA believes it has sufficient information to evaluate NP's
reproductive risks to human health without conducting a non-standard
placental study of the type requested by petitioners. With regard to
assessing NP and NPE exposure to the general U.S. population, EPA notes
that the Centers for Disease Control and Prevention (CDC) indicated
through a notice published in 2003 that NP has already been slated for
inclusion in the National Report on Human Exposure to Environmental
Chemicals, and there is thus no need for EPA to duplicate that activity
(Ref. 22). For these reasons, EPA cannot conclude that the available
information relevant to this requested testing is insufficient to
permit a reasoned evaluation of the health or environmental effects of
these chemicals or that the requested testing is necessary, and EPA,
therefore, denies these requests for testing under TSCA section 4.
    Petitioners' sixth request was that EPA conduct an epidemiology
study of industrial laundry workers who may be exposed to NP and NPEs
in detergents. Before an epidemiology study can be effectively designed
or conducted, however, there needs to be evidence that there are
sufficient exposures to a substance to warrant a study of human health
effects potentially attributable to those exposures. As noted in the
comments submitted by the Uniform and Textile Service Association
(UTSA) and the Textile Rental Services Association (TRSA),
approximately 90% of industrial laundries use injected liquid detergent
(Ref. 23). Given the low volatility (Ref. 24) and the negligible dermal
absorption of NP and NPE (Ref. 15), these industrial laundry operations
would not present significant exposure potential. Accordingly, there is
no evidence to support a conclusion that significant exposures exist
that would warrant an epidemiological study in this overall industry.
However, for the approximate 10% of industrial laundry operations and
an unknown number of institutional laundry operations that may use
powdered detergent, EPA considers that there is potential for
inhalation exposure to dust containing NP and NPE by workers and that
the number of potentially exposed workers involved could be substantial
(Ref. 25). As these concerns are based on estimates and not actual
exposure monitoring data, they would not support a conclusion that
there are sufficient exposures to warrant an epidemiology study.
However, EPA considers that obtaining additional exposure information
may be warranted to reasonably assess the potential for risk associated
with this one exposure scenario. Accordingly, EPA denies the
petitioners' specific request for an epidemiology study, but plans to
include in the ANPRM a discussion of the need for data concerning NP
and NPE exposures of laundry workers where powdered detergents are
used, and to solicit comment on the best means to obtain that
information (e.g., whether through requiring an exposure study,
workplace exposure monitoring, the voluntary submission of existing
monitoring data, or other means).
    Finally, the petitioners' seventh request concerned ordering a
nationwide study of residential exposures based on one study which
found levels of NP and NPEs in dust and indoor air in all homes in the
study. However, in both the study cited by petitioners and in a second
study that found NP or NPEs in only 10% of the homes studied (Refs. 26
and 27), the levels of NP found were far below any level of concern
suggested in reviews (e.g., Ref. 16). Neither study could be assumed to
be representative of households across the United States, but both
studies would suggest that residential indoor air and dust do not
contribute significantly to household exposure. Therefore, EPA cannot
conclude that the available information relevant to this requested
testing is insufficient to permit a reasoned evaluation of the health
effects of these chemicals. Similarly, EPA believes there is no
evidence indicating that exposures of the general population to NP and
NPEs are of concern at the present, and notes that the CDC human
biomonitoring work will provide nationally representative data on the
levels of general population exposures to NP irrespective of exposure
source. Accordingly, EPA denies the request for a nationwide
residential exposure study under TSCA section 4.

C. Denial of Requests to Issue TSCA Section 6 Control Rules

    EPA has concluded that the petitioners have not set forth the facts
establishing the need for the control actions requested under TSCA
section 6. Although the petition asserts that an unreasonable risk
exists, the petition does not present a reasonable basis to conclude
both that the chemicals present or will present an unreasonable risk
and that the specific actions requested by petitioners would be
necessary to protect adequately against such risk using the least
burdensome requirements. Accordingly, EPA denies the petitioners'
requests for control actions under TSCA section 6.
    The petitioners requested that EPA issue TSCA section 6 actions to
require labeling, not just Material Safety Data Sheets (MSDSs), on all
products containing NP and NPE; to restrict the use of NP and NPE where
the user (including the 25% of U.S. households that rely on septic
systems) cannot verify that the chemical will receive proper/effective
treatment at a well-managed sewage treatment plant from an activated
sludge treatment process designed to nitrify; to ban the use of the
chemicals in industrial and consumer detergents in favor of existing,
less toxic alternatives; and, similar to Canada, to require facilities
that use 2,000 kg or more of NP or NPEs to develop formal pollution
prevention plans, and to consider safer substitutes consistent with
OPPT's Safer Detergents Stewardship Initiative (SDSI).
    As noted in Unit III.B., in order to issue a rule under TSCA
section 6, EPA must affirmatively find that the risks are unreasonable,
and in making that determination, must consider a number of specified
issues. These relate not merely to the effects of the chemical(s), but
also to:
    1. The benefits of the substance(s) for various uses and the
availability of substitutes for such uses.
    2. The reasonably ascertainable economic consequences of the
control mechanisms proposed to control the risk, including the effect
on the national economy and small business and technical innovation.
These considerations are integral to the determination that a substance
presents an unreasonable risk, and the petitioners have not presented
sufficient facts to allow EPA to evaluate the issues. It is not
sufficient in a petition under TSCA section 21 to assert that an
unreasonable risk exists without providing the facts that would support
that assertion.
    For example, in presenting their argument for actions under TSCA
section 6, the petitioners failed to provide information that would
permit consideration of the effect of their requested controls on the
national economy, small business and technological innovation, the
environment, and public health. Petitioners asserted that the costs of
their requested controls would be small and that the benefits of their
controls would reduce risk, but provided no data to substantiate either
their estimates of cost or of the efficacy of their proposed control
actions.
    In addition, petitioners did not address the extent to which
actions taken under other statutes or voluntary programs may already be
addressing the

risk that may be presented by these chemicals, and whether those other
statutes or voluntary programs may provide more appropriate tools than
TSCA section 6 action to control risk to the extent necessary as
additional data are generated on chemical effects and exposure. EPA has
addressed NP and, to some extent, NPE in recent regulatory actions with
respect to water quality criteria (Refs. 3 and 28) and to the
reassessment of tolerances for pesticide inerts on food (Ref. 29). EPA
also sought public comment in May 2007 on SDSI (Ref. 30). SDSI is
intended to complement the water quality criteria for NP by promoting
the voluntary conversion by the detergent industry to alternative
surfactants that break down quickly to less toxic compounds. EPA must
assess those public comments and the potential of SDSI to impact the
need for any further regulatory controls.
    The data and information supplied in the petition and the
information provided in public comments do not provide a reasonable
basis to conclude that NP or NPE pose an unreasonable risk to health or
the environment. Consequently, EPA has determined that petitioners have
failed to provide sufficient justification for any of their requests
for control actions under TSCA section 6 of TSCA, and EPA is denying
the request that EPA initiate actions under TSCA section 6.

IV. Comments Received

    EPA published a notice in the Federal Register issue of July 10,
2007, announcing receipt of the petition and inviting public comment on
or before July 25, 2007 (Ref. 31). EPA received ten timely comments
from one individual, one petitioner, one State agency, and seven
nonprofit trade or professional associations, and about 1,900 mass-
mailed comments from private citizens through a mass comment campaign
evidently sponsored by one or more of the petitioners. EPA also
received a request for an extension of the comment period on July 25,
2007, submitted by UNITE HERE and the Sierra Club, two of the
petitioners. The request for extension was denied because of the
schedule for response mandated by TSCA section 21, although EPA
indicated that late comments would be considered to the extent
possible. One late comment was submitted on August 1, 2007, by another
trade association. One State agency submitted a late letter addressed
to the Administrator which was received on August 6, 2007, and was
directed to the docket as a late comment.
    The petitioner (the Environmental Law and Policy Center), the
individual, the two State agencies (the New York State Department of
Environmental Conservation and the Illinois Environmental Protection
Agency), and the mass mailing campaign supported the petition, without
presenting additional significant substantive data apart from an
additional reference provided by the petitioner. This reference
concerned data already in EPA's possession.
    All but one of the trade or professional organizations opposed the
petition on the grounds that existing data were already sufficient to
assess the chemicals and that no unreasonable risk was demonstrated in
the petition. Five of the organizations (the UTSA, the TRSA, the Soap
and Detergent Association, the Consumer Specialty Products Association,
and the Alkylphenols and Ethoxylates Research Council) submitted
detailed comments with references to data. These data were already in
EPA's possession. The remaining opposing organization (CropLife
America) and the association submitting late comments (the Chemical
Producers and Distributors Association) supported the position
expressed by the Alkylphenols and Ethoxylates Research Council.
    The National Association of Clean Water Agencies (NAWCA) did not
comment on the substance of the petition, but indicated that any action
taken by EPA in response to the petition should not place the burden
for response on the nation's wastewater treatment utilities.

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nonylphenols, and comparison with a yeast estrogenicity assay.
Regulatory Toxicology and Pharmacology. 25, 176-188.
    20. Lee, P.C. and Lee, W. 1996. In vivo estrogenic action of
nonylphenol in immature female rats. Bulletin of Environmental
Contamination and Toxicology. 57(3): 341-348.
    21. Kim, H.S.; Shin, J-H; Moon, H.J.; Kang, I.H.; Kim, T.S.; Kim,
I.Y.; Seok, J-H; Pyo, M-Y; and Han, S.Y. 2002. Comparative estrogenic
effects of p-nonylphenol by 3-day uterotrophic assay and female
pubertal onset assay. Reproductive Toxicology. 16(3): 259-268.
    22. CDC, HHS. Candidate Chemicals for Possible Inclusion in Future
Releases of the National Report on Human Exposure to Environmental
Chemicals. Federal Register (68 FR 56296, September 30, 2003) (FR Doc.
03-24671; Filed 9-29-03). Available on-line at http://www.cdc.gov/exposurereport/pdf/fr_093003.pdf
 .

    23. UTSA and TRSA. Letter from Tony Wagner, Director, Environmental
and Government Affairs, Uniform and Textile Service Association and
Robert Schaffer, Director, Environmental Affairs, Textile Rental
Services Association to Office of Pollution Prevention and Toxics
(OPPT), Document Control Office. Re: Comments of the Uniform and
Textile Service Association (UTSA) and Textile Rental Services
Association of America (TRSA) on TSCA Section 21 Petition on
Nonylphenol and Nonylphenol Ethoxylates: Docket ID number EPA-HQ-OPPT-
2007-0490-0010. July 25, 2007.
    24. EPA. E-mail communication from Greg Fritz to John Schaeffer and
Mary Dominiak. Subject: Vapor Pressure estimates for NP and NPEs (NP1EO
and NP2EO) (with two attachments: Huntsman Corporation Technical
Bulletin: SURFONIC[reg] N-31.5 Surfactant (2005) and EPIWIN [SRC CORP.]
Program Estimates (EPI--est.doc)). August 14, 2007.
    25. EPA. Draft Engineering Report of Nonylphenol (NP) and
Nonylphenol Ethoxylates (NPEs) In Response to Section 21 Petition. EPA,
OPPT, Economics, Exposure and Technology Division, Chemical Engineering
Branch. July 18, 2007. 15 pp.
    26. Rudel, R.A.; Camann, D.E.; Spengler, J.D.; Korn, L.R.; and
Brody, J.G. 2003. Phthalates, Alkylphenols, Pesticides, Polybrominated
Diphenyl Ethers, and Other Endocrine-Disrupting Compounds in Indoor Air
and Dust. Environmental Science and Technology. 37 (20):4543-4553.
    27. Morgan, M.K.; Sheldon, L.S.; and Croghan, C.W. 2004. A Pilot
Study of Children's Total Exposure to Persistent Pesticides and Other
Persistent Organic Pollutants (CTEPP). Volume I: Final Report to U.S.
Environmental Protection Agency, Contract Number 68-D-99-011, Task
Order 0002.
    28. EPA. Notice of Availability of Final Aquatic Life Ambient Water
Quality Criteria for Nonylphenol. Notice. Federal Register (71 FR 9337,
February 23, 2006) (FRL-OW-8035-8). Available on-line at http://www.epa.gov/fedrgstr
.

    29. EPA. Memorandum from Kerry Leifer, Inert Ingredient Assessment
Branch, Registration Division and Pauline Wagner, Chief, Inert
Ingredient Assessment Branch, Registration Division to Lois Rossi,
Director, Registration Division. Subject: Reassessment of Four
Exemptions from the Requirement of a Tolerance for Nonylphenol
Ethoxylates (with attached Action Memorandum: Inert Reassessments: Four
Exemptions from the Requirement of a Tolerance for Nonylphenol
Ethoxylates, dated July 31, 2006).
    30. EPA. Safer Detergents Stewardship Initiative (SDSI). Available
on-line at http://www.epa.gov/dfe/pubs/projects/formulat/sdsi.htm.

Agency Information Collection Activities; Proposed Collection; Comment
Request; Safer Detergent Stewardship Initiative (SDSI) Program; EPA ICR
No 2261.01, OMB Control No. 2070-new. Notice. Federal Register (72 FR
26357, May 9, 2007) (FRL-8125-4). Available on-line at http://www.epa.gov/fedrgstr
.

     31. EPA. TSCA Section 21 Petition on Nonylphenol and Nonylphenol
Ethoxylates; Notice of Receipt. Notice. Federal Register (72 FR 37530,
July 10, 2007) (FRL-8139-7). Available on-line at http://www.epa.gov/fedrgstr
.

List of Subjects

    Environmental protection, Hazardous substances, Nonylphenol,
Nonylphenol Ethoxylates.

    Dated: August 29, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-17542 Filed 9-4-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: December 14, 2009 (Volume 74, Number 238)]
[Notices]
[Page 66117]
[DOCID:fr14de09-37]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13515-000]

Lock+ Hydro Friends Fund XIV, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

December 7, 2009.
    On June 16, 2009, Lock+ Hydro Friends Fund XIV, LLC filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act, proposing to study the feasibility of the Project
Emerald, which would be located at the U.S. Army Corps of Engineer's
W.D. Mayo Lock and Dam No. 14 located on the Arkansas River near the
town of Spiro, Sequoyah County, OK and in Le Flore County, OK. 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 the following:
    (1) Two lock frame modules consisting of eighteen turbines rated at
36,000 kilowatts. The modules would be placed in a concrete-lined
conduit of unknown dimensions. The modules would be located adjacent to
and northeast of the Corps dam; and (2) a proposed 69 kV transmission
line approximately 1.4 miles long extending from the turbine units to
an existing distribution line located 1.4 miles south of the dam. The
proposed transmission line would cross the Arkansas River. The project
would have an estimated annual generation of 284 gigawatt-hours.
    Applicant Contact: Wayne F. Krouse; Hydro Green Energy, LLC; 5090
Richmond Avenue 390; Houston, TX 77056; phone:<PHONE_NUMBER>
x709.
    FERC Contact: Monte TerHaar at<EMAIL_ADDRESS>or phone 202-
502-6035.
    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.
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/ferconline.asp) under the ``eFiling''
link. For a simpler method of submitting text only comments, click on
``Quick Comment.'' For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>call toll-free at<PHONE_NUMBER>; or,
for TTY, contact<PHONE_NUMBER>. Although the Commission strongly
encourages electronic filing, documents may also be paper-filed. To
paper-file, mail an original and eight 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 the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13515) in the docket number field to access
the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-29623 Filed 12-11-09; 8:45 am]

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[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Page 41636]
[FR Doc No: 2020-15033]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: Notice is hereby given, pursuant to the provisions of
the Government in the Sunshine Act, Public Law 94-409, that the
Securities and Exchange Commission Asset Management Advisory Committee
(``AMAC'') will hold a public meeting on Thursday, July 16, 2020 at
9:00 a.m.

PLACE: The meeting will be conducted by remote means. Members of the
public may watch the webcast of the meeting on the Commission's website
at www.sec.gov.

STATUS: The meeting will begin at 9:00 a.m. and will be open to the
public by webcast on the Commission's website at www.sec.gov.

MATTER TO BE CONSIDERED: On June 18, 2020, the Commission issued notice
of the meeting (Release No. 34-89087), indicating that the meeting is
open to the public and inviting the public to submit written comments
to AMAC. This Sunshine Act notice is being issued because a majority of
the Commission may attend the meeting.
    The meeting will include a discussion of matters in the asset
management industry relating to two topics: (1) Improving diversity and
inclusion and (2) data and technology.

CONTACT PERSON FOR MORE INFORMATION: For further information, please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: July 8, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-15033 Filed 7-8-20; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Rules and Regulations]
[Pages 30905-30907]
[FR Doc No: 2019-13788]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0416]
RIN 1625-AA00

Safety Zone; Upper Mississippi River, Chester, IL, Thebes, IL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the Upper Mississippi River from Chester, IL to
Thebes, IL from mile maker 109.9 to 33.0. The safety zone is needed to
protect personnel, vessels, and the marine environment from potential
hazards created by high water. Entry of vessels or persons into the
zone is prohibited unless specifically authorized by the Captain of the
Port Sector Ohio Valley.

DATES: This rule is effective without actual notice from June 28, 2019
through July 2, 2019. For the purposes of enforcement, actual notice
will be used from June 2, 2019 through June 28, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0416 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
rulemaking, call or email MST2 Dylan Caikowski, MSU Paducah, U.S. Coast
Guard; telephone<PHONE_NUMBER> ext. 2120, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. It is
impracticable because we must establish this safety zone immediately
and lack sufficient time to provide a reasonable comment period and
then consider those comments before issuing this rule. The NPRM process
would delay the establishment of the safety zone and compromise public
safety.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30

days after publication in the Federal Register. Delaying this rule
would be contrary to the public interest because immediate action is
necessary to respond to the safety hazards associated with high water
and flooding on this area of the Mississippi River.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Ohio
Valley (COTP) has determined that potential hazards associated with
high water starting June 2, 2019, will be a safety concern for
personnel, vessels, and the marine environment. This rule is needed to
protect personnel, vessels, and the marine environment in the navigable
waters within the safety zone during high water.

IV. Discussion of the Rule

    This rule establishes a safety zone from June 2, 2019 through July
2, 2019. The rule will be enforced from June 2, 2019 through July 2,
2019 or until the Cape Girardeau river gauge falls below 45 feet,
whichever occurs first. The safety zone will cover all navigable waters
of the Upper Mississippi River from mile marker (MM) 109.9 to MM 33.0.
The duration of the zone is intended to protect personnel, vessels, and
the marine environment in these navigable waters during high water. A
broadcast notice to mariners will be issued to inform the public when
the safety zone is being enforced. No vessel or person will be
permitted to enter the safety zone without obtaining permission from
the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. The safety zone
will only impact a relatively small portion of the waterway for about
30 days, and will only be in effect during the duration of high water.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zones may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone on the Upper Mississippi
River from MM 109.9 to MM 33.0. It is categorically excluded from
further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard
Environmental

Planning Implementing Procedures 5090.1. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0416 to read as follows:

Sec.  165.T08-0416  Safety Zone; Upper Mississippi River, Chester, IL,
Thebes, IL.

    (a) Location. The safety zone will cover all navigable waters of
the Upper Mississippi River from mile marker (MM) 109.9 to MM 33.0.
    (b) Effective period. This section is effective without actual
notice from June 28, 2019 through July 2, 2019. For the purposes of
enforcement, actual notice will be used from June 2, 2019 through June
28, 2019.
    (c) Enforcement period. This section will be enforced from June 2,
2019 through July 2, 2019 or until the Cape Girardeau river gauge falls
below 45 feet, whichever occurs first
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry of vessels or persons into the zone is prohibited
unless specifically authorized by the Captain of the Port Sector Ohio
Valley (COTP) or designated representative. A designated representative
is a commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector Ohio
Valley.
    (2) Vessels requiring entry into the safety zone must request
permission from the COTP or a designated representative. To seek entry
into the safety zone, contact the COTP or the COTP's representative by
telephone at<PHONE_NUMBER> or on VHF-FM channel 16.
    (3) Persons and vessels permitted to enter the safety zone must
transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (e) Information broadcasts. The COTP or a designated representative
will inform the public when the safety zone is being enforced via a
Broadcast Notices to Mariners.

    Dated: May 31, 2019.
M.B. Zamperini,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2019-13788 Filed 6-27-19; 8:45 am]
BILLING CODE 9110-04-P