[Federal Register Volume 77, Number 20 (Tuesday, January 31, 2012)]
[Notices]
[Pages 4848-4850]
[FR Doc No: 2012-2036]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66237; File No. SR-NYSEAmex-2012-02]

Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending NYSE Amex
Options Rule 902NY To Create a Reserve Floor Market Maker Amex Trading
Permit

January 25, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 24, 2012, NYSE Amex LLC (the ``Exchange'' or ``NYSE Amex'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the self-regulatory organization. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE Amex Options Rule 902NY to
create a Reserve Floor Market Maker Amex Trading Permit (``Reserve
ATP''). The text of the proposed rule change is available at the
Exchange, the Commission's Public Reference Room, and 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend NYSE Amex Options Rule 902NY to
create a Reserve ATP.
    Under the current Fee Schedule, an ATP Holder \3\ acting as a
Market Maker must pay $5,000 per month per Amex Trading Permit
(``ATP'').\4\ In order to act as a Floor Market Maker, an individual
must be specifically named on the relevant Market Maker's ATP. On some
occasions, a Floor Market Maker may be absent from the floor due to
illness or other unexpected absence, in which case the ATP Holder may
wish to have a Market Maker Authorized Trader \5\ (``MMAT'') employee
engage in open outcry trading to cover for the absent Floor Market
Maker. However, at present the ATP Holder cannot do so unless the MMAT
employee is specifically named on the relevant ATP, and it may not be
economical for the ATP Holder to maintain an additional ATP to address
such unexpected or limited situations or to complete the approval
process for an additional ATP in a timely way when a short-term need
arises. In such cases, the ATP Holder must carry out its
responsibilities with fewer than the optimal number of Floor Market
Makers on the trading floor. For example, currently under NYSE Amex
Rule 923NY, a total of four ATPs are required to stream quotes
electronically into all option issues traded on the Exchange.
Additionally, each ATP can have an individual named to act as a Floor
Market Maker in open outcry trading on the Floor of the Exchange. Thus,
an ATP Holder with four ATPs may stream quotes in every option issue on
the Exchange and have four

individuals conduct trading in open outcry on the trading Floor as
Floor Market Makers. If one of those four individuals is unavailable
due to sickness, vacation or other reason, the ATP Holder is required
to pay for an additional ATP (presently $5,000) in order to have
another individual trade in open outcry as a Floor Market Maker. If the
ATP Holder activates an individual on an ATP for any portion of a
month, even as little as one day, the ATP Holder is charged the full
$5,000 monthly ATP fee.
---------------------------------------------------------------------------

    \3\ An ``ATP Holder'' is a natural person, sole proprietorship,
partnership, corporation, limited liability company or other
organization, in good standing, that has been issued an Amex Trading
Permit. See NYSE Amex Rule 900.2NY(5).
    \4\ The fee is calculated based on the maximum number of ATPs
held by the ATP Holder during the calendar month.
    \5\ A ``Market Maker Authorized Trader'' is an authorized trader
who performs market making activities pursuant to Rule 920NY on
behalf of an ATP Holder registered as a Market Maker. See NYSE Amex
Rule 900.2NY(37). A Market Maker Authorized Trader must meet the
same registration requirements as a Floor Market Maker before they
can be designated as a Market Maker Authorized Trader. See NYSE Amex
Rule 921.1NY.
---------------------------------------------------------------------------

    The Exchange believes that an option should be available to Market
Maker firms to address the short-term absence of an employee in a more
economical way, which also would assist the Exchange in maintaining
fair and orderly markets. In addition, certain Market Maker firms have
requested that the Exchange amend the present system to address the
issue of an absent Floor Market Maker. Accordingly, the Exchange
proposes to create a Reserve ATP under which an ATP Holder would be
permitted to have a qualified MMAT employee cover for the absent Floor
Market Maker under the firm's ATP, effectively empowering the
individual acting as a qualified MMAT to act as a Floor Market Maker in
lieu of the absent individual until such time as the absent Floor
Market Maker returns. When a Floor Market Maker is or will be absent,
an ATP Holder that maintains a Reserve ATP would be required to provide
written notice to the Exchange that it will utilize such Reserve ATP,
at least a day in advance of the utilization. The notice will identify
both the Floor Market Maker who will not be utilizing the ATP Holder's
ATP and the MMAT who will be acting as the substitute Floor Market
Maker. While the notice is in effect, only the specifically named MMAT
acting as a substitute Floor Market Maker will be authorized to utilize
the ATP. When the original Floor Market Maker returns, the ATP Holder
will provide written notice to the Exchange, and, as of the date
specified in the notice, the original Floor Market Maker may resume
reliance on the ATP and the MMAT will no longer be able to utilize the
ATP. In this manner, an ATP Holder that has purchased the four ATPs
required to quote every issue on the Exchange would have the ability to
ensure it has sufficient Floor Market Maker coverage in the event of an
absence, without having to incur the full $5,000 ATP fee, by instead
paying a Reserve ATP fee of $175 per month, which would be established
by a separate fee filing with the Commission. The proposed fee would be
assessed to an ATP Holder for each MMAT in its employ whom the ATP
Holder wishes to be eligible to be named to the ATP to act as a Floor
Market Maker to cover for another Floor Market Maker who is otherwise
unable to be at work that day.
    Any natural person to whom a Reserve ATP is issued would be
required, as of the date of notice, to (a) be fully qualified and
approved by the Exchange to be an ATP Holder authorized as an MMAT; and
(b) meet all of the requirements of an ATP Holder under the Exchange's
rules.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\6\ in general, and furthers the objectives of Section 6(b)(5),\7\
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, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system. Specifically, the Exchange
believes that the proposed rule change would provide a method for ATP
Holders to have fully qualified personnel step in to handle other
employees' absences without requiring the ATP Holders to pay the full
fee every month for the ATPs used by such substitute persons, thereby
contributing to the efficient use of ATP Holder personnel and
resources, and fair and orderly markets. Additionally, the Exchange
notes that it is filing this rule change to respond to the Market Maker
firms that have requested a solution to the issues they face when they
have an absent Floor Market Maker.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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 \8\ and Rule 19b-4(f)(6) thereunder.\9\
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.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \10\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\11\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    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 email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2012-02 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-NYSEAmex-2012-02. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NW.,
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-NYSEAmex-2012-02 and should
be submitted on or before February 21, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-2036 Filed 1-30-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 21, 2008 (Volume 73, Number 226)]
[Notices]
[Page 70633-70635]
[DOCID:fr21no08-50]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-10-000]

Dominion Transmission, Inc.; Notice of Intent To Prepare an
Environmental Assessment for the Proposed Rural Valley Project, Request
for Comments on Environmental Issues

November 17, 2008.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Rural Valley Project involving
construction and operation of facilities by Dominion Transmission, Inc.
(DTI) in Armstrong, Westmoreland, Elk and McKean Counties, PA.\1\ These
facilities would consist of about 1.40 miles of various diameter
pipeline, 57,500 horsepower (hp) of compression and four new Metering
and Regulation (M&R) stations. This EA will be used by the Commission
in its decision-making process to determine whether the project is in
the public convenience and necessity.
---------------------------------------------------------------------------

    \1\ On October 15, 2008, DTI filed its application with the
Commission under section 7 of the Natural Gas Act and Part 157 of
the Commission's regulations. The Commission issued its Notice of
Application on October 27, 2008.
---------------------------------------------------------------------------

    If you are a landowner receiving this notice, you may be contacted
by a DTI company representative about survey permission and/or the
acquisition of an easement to construct, operate, and maintain the
proposed facilities. The company would seek to negotiate a mutually
acceptable agreement. However, if the project is approved by the
Commission, that approval conveys with it the right of eminent domain.
Therefore, if easement negotiations fail to produce an agreement, the
natural gas company could initiate condemnation proceedings in
accordance with state law.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility On My Land? What Do I Need To Know?'' was attached to the
project notice DTI provided to landowners. This fact sheet addresses a
number of typically asked questions, including the use of eminent
domain and how to participate in the Commission's proceedings. It is
available for viewing on the FERC Internet Web site (http://
www.ferc.gov).

Summary of the Proposed Project

    DTI proposes to create a firm transportation outlet for natural gas

supplies in western Pennsylvania by providing 57,500 dekatherms per day
from multiple locations along lines LN-19 and LN-20 to an existing
interconnect with Texas Eastern Transmission. DTI seeks authority to:
     Install a compressor station, consisting of two high speed
reciprocating gas compressor units, one 1,775 unit hp and one 3,550 hp
unit, totaling 5,325 hp, known as the Rural Valley Compressor Station,
located approximately three miles west of Rural Valley, PA;
     Install 1.08 miles of 10-inch-diameter pipeline
interconnecting Dominion People's Line TP-7625 with DTI's new Rural
Valley Compressor Station;
     Install 0.02 mile of 10-inch-diameter pipeline
interconnecting DTI's LN-19 with the new compressor station;
     Install 0.30 mile of 8-inch-diameter discharge pipeline
connecting the compressor station to DTI's LN-50X3;
     Install a new M&R station (Rural Valley) adjacent to the
Rural Valley Compressor Station in Armstrong County, PA;
     Install a pig launcher and receiver adjacent to the Rural
Valley M&R station;
     Install a new M&R station (Oakford) within the existing
Oakford Compressor Station boundary in Westmoreland County, PA;
     Install a new M&R station (National Forest) located on a
former M&R site adjacent to the LN-20 right-of-way (ROW) in Elk County,
PA; and
     Install a new M&R station (Big Springs), located at an
existing pig launcher location adjacent to the LN-20 ROW in McKean
County, PA.
    The general location of the project facilities is shown in Appendix
1.\2\
---------------------------------------------------------------------------

    \2\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies of all appendices, other
than Appendix 1 (maps), are available on the Commission's Web site
at the ``eLibrary'' link or from the Commission's Public Reference
Room, 888 First Street, NE., Washington, DC 20426, or call (202)
502-8371. For instructions on connecting to eLibrary, refer to the
last page of this notice. Copies of the appendices were sent to all
those receiving this notice in the mail.
---------------------------------------------------------------------------

Land Requirements for Construction

    Project activities will occur on property that will be purchased by
DTI from private landowners who adjoin the property of the proposed
compressor and M&R station sites in Armstrong County, property already
owned by DTI, and land to be leased from the Alleghany National Forest
and the Commonwealth of PA, Bureau of Forestry. Construction of the
proposed aboveground facilities would impact about 7.0 acres of land.
Following construction, approximately 6.4 acres would be maintained for
operation. The remaining 0.6 acres of land would be restored and
allowed to revert to its former use. Construction of the proposed
pipelines would impact about 15.3 acres of land. Following
construction, approximately 8.35 acres of land would be maintained for
operation. The remaining 6.95 acres of land would be restored and
allowed to revert to its former use.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
to discover and address concerns the public may have about proposals.
This process is referred to as ``scoping''. The main goal of the
scoping process is to focus the analysis in the EA on the important
environmental issues. By this Notice of Intent, the Commission staff
requests public comments on the scope of the issues to address in the
EA. All comments received are considered during the preparation of the
EA. State and local government representatives are encouraged to notify
their constituents of this proposed action and encourage them to
comment on their areas of concern.
    In the EA we \3\ will discuss impacts that could occur as a result
of the construction and operation of the proposed project under these
general headings:
---------------------------------------------------------------------------

    \3\ ``We'', ``us'', and ``our'' refer to the environmental staff
of the Office of Energy Projects (OEP).
---------------------------------------------------------------------------

     Geology and soils
     Land use
     Water resources, fisheries, and wetlands
     Cultural resources
     Vegetation and wildlife
     Air quality and noise
     Endangered and threatened species
     Hazardous waste
     Public safety
    We will also evaluate reasonable alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    Our independent analysis of the issues will be in the EA. Depending
on the comments received during the scoping process, the EA may be
published and mailed to Federal, state, and local agencies, public
interest groups, interested individuals, affected landowners,
newspapers, libraries, and the Commission's official service list for
this proceeding. A comment period will be allotted for review if the EA
is published. We will consider all comments on the EA before we make
our recommendations to the Commission.
    To ensure your comments are considered, please carefully follow the
instructions in the public participation section below.

Currently Identified Environmental Issues

    We have already identified several issues that we think deserve
attention based on a preliminary review of the proposed facilities and
the environmental information provided by DTI. This preliminary list of
issues may be changed based on your comments and our analysis.
     Proposed right-of-way width and configuration.
     Impacts on 8.6 acres of agricultural land, including a
total of 3.2 acres of prime farmland soils.
     Impacts of air and noise emissions.

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the Rural Valley Project. Your comments
should focus on the potential environmental effects of the proposal,
reasonable alternatives, and measures to avoid or lessen the
environmental impacts. The more specific your comments, the more useful
they will be. To ensure that your comments are timely and properly
recorded, please send in your comments so that they will be received in
Washington, DC on or before December 18, 2008.
    For your convenience, there are three methods which you can use to
submit your comments to the Commission. In all instances please
reference the project docket number with your submission. The docket
number can be found on the front of this notice. The Commission
encourages electronic filing of comments and has dedicated eFiling
expert staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You may file your comments electronically by using the Quick
Comment feature, which is located on the Commission's internet Web site
at http://www.ferc.gov under the link to Documents and Filings. A Quick
Comment is an easy method for interested persons to submit text-only
comments on a project.
    (2) You may file your comments electronically by using the eFiling
feature, which is located on the

Commission's internet Web site at http://www.ferc.gov under the link to
Documents and Filings. eFiling involves preparing your submission in
the same manner as you would if filing on paper, and then saving the
file on your computer's hard drive. You will attach that file as your
submission. New eFiling users must first create an account by clicking
on ``Sign up'' or ``eRegister''. You will be asked to select the type
of filing you are making. A comment on a particular project is
considered a ``Comment on a Filing.''
    (3) You may file your comments via mail to the Commission by
sending an original and two copies of your letter to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Room 1A, Washington, DC 20426.
    Label one copy of the comments for the attention of Gas Branch 3,
PJ11.3.

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an official party to the proceeding, or ``intervenor''. To
become an intervenor you must file a motion to intervene according to
Rule 214 of the Commission's Rules of Practice and Procedure (18 CFR
385.214). Intervenors have the right to seek rehearing of the
Commission's decision. Motions to Intervene should be electronically
submitted using the Commission's eFiling system at http://www.ferc.gov.
Persons without Internet access should send an original and 14 copies
of their motion to the Secretary of the Commission at the address
indicated previously. Persons filing Motions to Intervene on or before
the comment deadline indicated above must send a copy of the motion to
the Applicant. All filings, including late interventions, submitted
after the comment deadline must be served on the Applicant and all
other intervenors identified on the Commission's service list for this
proceeding. Persons on the service list with e-mail addresses may be
served electronically; others must be served a hard copy of the filing.
    Affected landowners and parties with environmental concerns may be
granted intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which would not be
adequately represented by any other parties. You do not need intervenor
status to have your environmental comments considered.

Environmental Mailing List

    As described above, we may publish and distribute the EA for
comment. If you are interested in receiving an EA for review and/or
comment, please return the Environmental Mailing List Form (Appendix
3). If you do not return the Environmental Mailing List Form, you will
be taken off the mailing list. All individuals who provide written
comments will remain on our environmental mailing list for this
project.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC or on the
FERC Internet Web site (http://www.ferc.gov) using the eLibrary link.
Click on the eLibrary link, click on ``General Search'' and enter the
docket number, (CP09-10-000), excluding the last three digits in the
Docket Number field. Be sure you have selected an appropriate date
range. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at http://www.ferc.gov/EventCalendar/
EventsList.aspx along with other related information.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-27691 Filed 11-20-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 37 (Friday, February 26, 2021)]
[Proposed Rules]
[Pages 11678-11680]
[FR Doc No: 2021-03277]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2020-0541; FRL-10019-42-Region 8]

Approval and Promulgation of Implementation Plans; Utah; R307-204
Emission Standards: Smoke Management

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision package submitted by the State of Utah on November 5, 2019.
The November 5, 2019 revision amends R307-204 to meet the requirements
set forth in Utah's 2019 House Bill (H.B.) 155. This action is being
taken under section 110 of the Clean Air Act (CAA).

DATES: Written comments must be received on or before March 29, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2020-0541, to the Federal Rulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
www.regulations.gov. The EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., 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 in
www.regulations.gov. To reduce the risk of COVID-19 transmission, for
this action we do not plan to offer hard copy review of the docket.
Please email or call the person listed in the FOR FURTHER INFORMATION
CONTACT section if you need to make alternative arrangements for access
to the docket.

FOR FURTHER INFORMATION CONTACT: Amrita Singh, Air and Radiation
Division, EPA, Region 8, Mailcode 8ARD-IO, 1595 Wynkoop Street, Denver,
Colorado 80202-1129,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Specifically, EPA is proposing to approve
revisions to sections: R307-204-1. Purpose and Goals; R307-204-2.
Applicability; R307-204-3. Definitions; R307-204-4. General
Requirements; R307-204-5. Burn Schedule; R307-204-6. Small Prescribed
Fires (de minimis); R307-204-7. Small Prescribed Fires (de minimis);
R307-204-8. Large Prescribed Fires; R307-204-9. Large Prescribed Pile
Fires; and R307-204-10. Requirements for Wildland Fire Use Events.
    Throughout this document wherever ``we,'' ``us,'' or ``our'' is
used, we mean the EPA.

I. Background

    The EPA's Interim Air Quality Policy on Wildland and Prescribed
Fires \1\ was designed to integrate two public policy goals, (1) to
allow fire to function as nearly as possible, in its natural role in
maintaining healthy wildland ecosystems, and (2) to protect public
health and welfare by mitigating the impacts of air pollutant emissions
on air quality and visibility. The document expands on the
responsibilities of wildland owners/managers and state/tribal air
quality managers to coordinate fire activities, minimize air pollutant
emissions, manage smoke from prescribed fires as well as wildland fires
used for resource benefits, and establish emergency action programs to
mitigate the unavoidable impacts on the public.
---------------------------------------------------------------------------

    \1\ See EPA's ``Interim Air Quality Policy on Wildland and
Prescribed Fires'' May 15, 1998.
---------------------------------------------------------------------------

    EPA does not directly regulate the use of fire within a state or in
Indian country. The agency's authority is to enforce the requirements
of the CAA, which requires states to attain and maintain the National
Ambient Air Quality Standards (NAAQS) adopted to protect public health
and welfare. The Air Quality Policy on Wildland and Prescribed Fires
recommends that states/tribes implement Smoke Management Plans (SMPs)
to mitigate the public health and welfare impacts of fires managed for
resource benefits. The SMPs establish a basic framework of procedures
and requirements for managing smoke from fires managed for resource
benefits and are typically developed by states/tribes with cooperation
and participation by wildland owners/managers. The goal of SMPs is to
prevent deterioration of air quality and NAAQS violations; to address
visibility impacts in mandatory Class 1 Federal areas; and to reduce
the nuisance and public safety hazards posed by smoke intrusions into
populated areas.
    The SMP serves as the operational plan for the state administrative
rule, R307-204, by providing the direction and operating procedures for
all organizations involved in the use of prescribed fire, wildfire, and
wildland fire use. The procedures that land managers are required to
follow to mitigate the impact of smoke on public health and visibility
in the State is established by the rule, R307-204. The

Utah Enhanced Smoke Management Plan (ESMP)),\2\ (Appendix B of the
SMP), provides details on the visibility requirements of the Regional
Haze Rule, 40 CFR 51.309(d)(6), and operating procedures to reduce
visibility impacts from smoke in Class 1 Federal areas.\3\ The SMP was
approved by the EPA on Nov. 8, 1999,\4\ under the Interim Air Quality
Policy on Wildland and Prescribed Fires. The requirements established
in the SMP provide the framework for R307-204 Emission Standards: Smoke
Management. Previously, EPA approved the September 29, 2011 R307-204
submittal which superseded and replaced the R307-204 portion of the
December 12, 2003 submittal and all of the May 8, 2006 submittal.
---------------------------------------------------------------------------

    \2\ See docket for Utah's Enhanced Smoke Management Plan August
1, 2003.
    \3\ Areas designated as mandatory Class I Federal areas consist
of national parks exceeding 6,000 acres, wilderness areas and
national memorial parks exceeding 5,000 acre, and all international
parks that were in existence on August 7, 1977. 42 U.S.C. 7472(a).
In accordance with section 169A of the CAA, EPA, in consultation
with the Department of the Interior, promulgated a list of 156 areas
where visibility is identified as an important value. 44 FR 69122
(November 30, 1979). The extent of a Mandatory Class I area includes
subsequent changes in boundaries, such as park expansions. 42 U.S.C.
7472(a). Although states and tribes may designate as Class I
additional areas which they consider having visibility as an
important value, the requirements of the visibility program set
forth in section 169A of the CAA apply only to ``mandatory Class I
Federal areas. Each mandatory Class I Federal area is the
responsibility of a `Federal Land Manager.''
    \4\ See docket for Utah's Smoke Management Plan approved in 1992
and last revised on January 16, 2006.
---------------------------------------------------------------------------

II. The EPA's Evaluation

    Section 110(k) of the CAA addresses the EPA's rulemaking action on
SIP submissions by states. The CAA requires states to observe certain
procedural requirements in developing SIP revisions for submittal to
the EPA. Section 110((a)(2) of the CAA requires that each SIP revision
be adopted after reasonable notice and public hearing. This must occur
prior to the revision being submitted by a state to EPA.
    Pursuant to 40 CFR 51.309(d)(6), a state must show that its smoke
management program and all federal or private programs for prescribed
fire in the state have a mechanism in place for evaluating and
addressing the degree of visibility impairment from smoke in their
planning and application of burning. A state must also ensure that its
prescribed fire smoke management programs have at least the following
seven elements: Action to minimize emissions; evaluation of smoke
dispersion; alternatives to fire; public notification; air quality
monitoring; surveillance and enforcement; and program evaluation.
    On June 5, 2019 the State of Utah's Department of Environmental
Quality, Air Quality Board approved proposed amendments to R307-204 to
include requirements established by the Utah State Legislature set
forth in 2019 H.B. 155.\5\ A public comment period was held from July 1
to July 31, 2019. One non-substantive comment was received, and no
public hearing was requested. The main purpose for amending R307-204
was to meet the requirements set forth in 2019 H.B. 155 which states:
---------------------------------------------------------------------------

    \5\ See docket for Utah's State Legislature's H.B. 155 from the
2019 General Session.

    ``In the rules made by the board . . . . . the board shall
require the land manager to:
    (i) describe the use of state, county, or municipal resource in
the large prescribed fire or large prescribed pile fire;
    (ii) provide the division the burn plan for a large prescribed
fire or large prescribed pile fire by no later than one week before
the day of the burn window; and
    (iii) notify the division of nonfull suppression event once a
fire becomes a nonfull suppression event.''

    The rule revisions include removing outdated terminology, such as,
``wildland fire use,'' ``plan stage'' and language regarding adjusting
fire emission factors. Also, in EPA's 1998 ``Interim Air Quality Policy
on Wildland and Prescribed Fires,'' it is stated that federally
prescribed fire projects would be considered to conform with the
implementation plan if they are managed under a certified basic SMP.
Since, Utah's SMP meets that criteria, the State will be removing
conformity from R307-204. Finally, Section R307-204-6. Small Prescribed
Fires (de minimis), R307-204-7. Small Prescribed Pile Fires (de
minimis), Section R307-204-8. Large Prescribed Fires and R302-20-9.
Large Prescribed Pile Fires will be combined to reduce redundancies.

III. Proposed Action

    EPA is proposing to approve a SIP revision submitted by the State
of Utah on November 5, 2019. The revisions meet the requirements set
forth in Utah's State Legislature's H.B. 155 and reduce redundancies
and outdated portions of the rule, while also streamlining it. EPA is
proposing to approve revisions to sections: R307-204-1. Purpose and
Goals; R307-204-2. Applicability; R307-204-3. Definitions; R307-204-4.
General Requirements; R307-204-5. Burn Schedule; R307-204-6. Small
Prescribed Fires (de minimis); R307-204-7. Small Prescribed Fires (de
minimis); R307-204-8. Large Prescribed Fires; R307-204-9. Large
Prescribed Pile Fires; and R307-204-10. Requirements for Wildland Fire
Use Events. The revision for R307-204 meets the applicable CAA
requirements and contains smoke management requirements for land
managers within the State of Utah as required by 40 CFR 51.309(d)(6).

IV. Incorporation by Reference

    In this document, the EPA, is proposing to include regulatory text
in an EPA final rule that includes incorporation by reference. In
accordance with the requirements of 1 CFR 51.5, the EPA is proposing to
incorporate by reference the Utah rules promulgated in the Division of
Administrative Rule (DAR), R307-204-1, R307-204-2, R307-204-3, R307-
204-4, R307-204-5, R307-204-6, R307-204-7, R307-204-8, R307-204-9 and
R307-204-10, as discussed in section III of the preamble. The EPA has
made, and will continue to make, these materials generally available
through www.regulations.gov and at the EPA Region 8 Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);

     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Greenhouse gases, Incorporation by reference, Intergovernmental
relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting
and recordkeeping requirements, Sulfur oxides, Volatile organic
compounds.

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

    Dated: February 11, 2021.
Debra Thomas,
Acting Regional Administrator, EPA Region 8.
[FR Doc. 2021-03277 Filed 2-25-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)]
[Notices]
[Pages 51282-51283]
[FR Doc No: 2017-23952]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-2044]

Determination That REVEX (Nalmefene Hydrochloride Injection), 0.1
Milligram Base/Milliliter and 1.0 Milligram Base/Milliliter, Was Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that REVEX (nalmefene hydrochloride injection), 0.1
milligram (mg) base/milliliter (mL) and 1.0 mg base/mL, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for REVEX (nalmefene hydrochloride injection), 0.1
mg base/mL and 1.0 mg base/mL, if all other legal and regulatory
requirements are met.

FOR FURTHER INFORMATION CONTACT: Kelley Nduom, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993-0002, 301-
796-8597.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0
mg base/mL, is the subject of NDA 20-459, currently held by West-Ward
Pharmaceuticals International Limited, and initially approved on April
17, 1995. REVEX is indicated for the complete or partial reversal of
opioid drug effects, including respiratory depression, induced by
either natural or synthetic opioids. REVEX is also indicated in the
management of known or suspected opioid overdose.
    In a letter dated June 5, 2009, Baxter Healthcare Corporation, the
NDA holder at the time, notified FDA that the manufacturing and
distribution of REVEX (nalmefene hydrochloride injection), 0.1 mg base/
mL and 1.0 mg base/mL, had been discontinued on May 21, 2008, for
business reasons. REVEX (nalmefene hydrochloride injection), 0.1 mg
base/mL and 1.0 mg base/mL, is currently listed in the ``Discontinued
Drug Product List'' section of the Orange Book.
    Nirsum Pharmaceuticals, LLC, submitted a citizen petition dated
March 31, 2017 (Docket No. FDA-2017-

P-2044), under 21 CFR 10.30, requesting that the Agency determine
whether REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and
1.0 mg base/mL, was withdrawn from sale for reasons of safety or
effectiveness.
    After considering the citizen petition (and comments submitted to
the docket) and reviewing Agency records, and based on the information
we have at this time, FDA has determined under Sec.  314.161 that REVEX
(nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg
base/mL, was withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg
base/mL, from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
found no information that would indicate that this drug product was
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list REVEX (nalmefene
hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to this drug product may
be approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: October 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23952 Filed 11-2-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)]
[Notices]
[Pages 478-481]
[FR Doc No: 2015-33298]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0794; FRL-9940-41]

Registration Review; Draft Human Health and Ecological Risk
Assessments; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's draft human
health and ecological risk assessments for the registration review of a
group of pesticides identified individually in this document in the
table in Unit III, and opens a public comment period. Registration
review is EPA's periodic review of pesticide registrations to ensure
that each pesticide continues to satisfy the statutory standard for
registration, that is, the pesticide can perform its intended function
without unreasonable adverse effects on human health or the
environment. As part of the registration review process, the Agency has
completed a comprehensive draft human health and ecological risk
assessment for the identified pesticides. After reviewing comments
received during the public comment period on each assessment, EPA may
issue revised risk assessments and explain any changes to the draft
risk assessments, and respond to substantive comments on the risk
assessments. EPA may also request public input on risk mitigation
before completing a proposed registration review decision for the
identified pesticides. Through this program, EPA is ensuring that each
pesticide's registration is based on current scientific and other
knowledge, including its effects on human health and the environment.

DATES: Comments must be received on or before March 7, 2016.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2015-0794, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online

instructions for submitting comments. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information
contact: The Chemical Review Manager (CRM) identified in the table in
Unit III.
    For general questions on the registration review program contact:
Richard Dumas, Pesticide Re-Evaluation Division (7508P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others may also be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager listed in the table in Unit III.

 B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/commenting-epa-dockets#tips.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document compared to the general population.

II. Authority

    EPA is conducting its registration review of these pesticides
pursuant to section 3(g) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and the Procedural Regulations for Registration
Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides,
among other things, that the registrations of pesticides are to be
reviewed every 15 years. Under FIFRA, a pesticide product may be
registered or remain registered only if it meets the statutory standard
for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)).
When used in accordance with widespread and commonly recognized
practice, the pesticide product must perform its intended function
without unreasonable adverse effects on the environment; that is,
without any unreasonable risk to man or the environment, or a human
dietary risk from residues that result from the use of a pesticide in
or on food.

III. Registration Reviews

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations for the pesticides listed in the table to ensure that
they continue to satisfy the FIFRA standard for registration--that is,
that these pesticides can still be used without unreasonable adverse
effects on human health or the environment.

  Table--Draft Risk Assessments Being Made Available for Public Comment
------------------------------------------------------------------------
                                                       Chemical review
 Registration review case name      Docket ID No.    manager and contact
            and No.                                      information
------------------------------------------------------------------------
Azoxystrobin, 7020.............  EPA-HQ-OPP-2009-08  Veronica Dutch,
                                  35<EMAIL_ADDRESS>(703) 308-
                                                      8585.
Bensulfuron-methyl, 7216.......  EPA-HQ-OPP-2011-06  Moana Appleyard,
                                  63<EMAIL_ADDRESS>(703) 308-
                                                      8175.
Bifenazate, 7609...............  EPA-HQ-OPP-2012-06  Garland Waleko,
                                  33<EMAIL_ADDRESS>(703) 308-
                                                      8049.
Boric Acid and Sodium Borate     EPA-HQ-OPP-2009-03  Moana Appleyard,
 Salts, 0024.                     06<EMAIL_ADDRESS>(703) 308-
                                                      8175.
Ethephon, 0382.................  EPA-HQ-OPP-2010-00  Marquea D. King,
                                  98<EMAIL_ADDRESS>(703) 305-
                                                      7432.
Hymexazol, 7016................  EPA-HQ-OPP-2010-01  Caitlin Newcamp,
                                  27<EMAIL_ADDRESS>(703) 347-
                                                      0325.
Lithium hypochlorite, 3084.....  EPA-HQ-OPP-2013-06  Donna Kamarei,
                                  06<EMAIL_ADDRESS>(703) 347-
                                                      0443.
Pronamide, 0082................  EPA-HQ-OPP-2009-03  Wilhelmena
                                  26.                 Livingston,
<EMAIL_ADDRESS>(703)
                                                      308-8025.
------------------------------------------------------------------------

    Azoxystrobin. Draft Human Health and Ecological Risk Assessments
(EPA-HQ-OPP-2009-0835). Azoxystrobin is a systemic fungicide and
antimicrobial registered for use on a variety of terrestrial food and
feed crops, including vegetables, fruits and nuts; terrestrial non-food
crops, including turf and ornamentals; and non-crop sites including
additives for the manufacture of paint, rubber, paper products,
textiles, and adhesives. The Agency has conducted draft human health
and ecological risk assessments for the conventional and antimicrobial
uses of azoxystrobin. A full endangered species assessment has not been
completed for azoxystrobin at this time. For foliar

applications, the ecological risk assessment identifies risks of
concern for aquatic plants, freshwater fish, aquatic invertebrates, and
mammals. For seed treatments, risks of concern are identified for birds
and mammals. The conventional uses of azoxystrobin are associated with
inhalation risks of concern for residential handlers and some
occupational post-application scenarios even with maximum personal
protective equipment (PPE). The antimicrobial uses of azoxystrobin are
not associated with ecological risks of concern, but the human health
risk assessment identifies potential risks of concern for residential
and occupational handlers. Azoxystrobin has not been assessed under the
endocrine disruptor screening program (EDSP) or for risks to
pollinators.
    Bensulfuron-methyl. Draft Human Health Risk Assessment (EPA-HQ-OPP-
2011-0663). Bensulfuron-methyl is a sulfonylurea herbicide that acts by
inhibiting acetolactate synthase. Bensulfuron-methyl is registered for
use to control broadleaf weeds and sedges in aquatic rice production.
Tolerances have been established for crayfish, rice, and rice straw.
There are no registered residential uses of bensulfuron-methyl.
Bensulfuron- methyl was first registered in 1989, and a Final Work Plan
was published in February 2012. The ecological risks of bensulfuron-
methyl were assessed together with all other sulfonylureas in the
Preliminary Ecological Risk Assessment for Registration Review of 22
Sulfonylurea Herbicides, published in September 2015. EPA conducted a
human health risk assessment and did not identify any risks of concern
for dietary, residential, occupational, or aggregate exposure.
Bensulfuron-methyl was not on either initial list of chemicals to be
screened under the EDSP, nor has an endangered species or pollinator
assessment been conducted at this time.
    Bifenazate. Draft Human Health and Ecological Risk Assessments
(EPA-HQ-OPP-2012-0633). Bifenazate is a selective carbazate miticide/
insecticide that is registered for use to control the motile stage of
mites in agricultural and non-agricultural sites including on bearing
and non-bearing fruit and vegetable crops, cotton, conifer plantations,
ornamentals, and in greenhouses, as well as indoor and outdoor
residential, commercial, institutional, and recreational areas. The
human health non-occupational drift assessment was updated in
registration review for bifenazate and found no risks of concern. In
the recent June 2014, new use assessment, all dietary, residential,
occupational, and aggregate risks were not of concern. In the
ecological assessment, chronic risks of concern were identified for
mammals and birds. There are acute risks identified for listed birds,
freshwater fish, freshwater invertebrates, and estuarine and marine
invertebrates. There is also potential acute and chronic risk to
terrestrial invertebrates. Bifenazate was not on either initial list of
chemicals to be screened under the EDSP, nor has an endangered species
or pollinator assessment been conducted at this time.
    Boric Acid and Sodium Borate Salts. Draft Human Health and
Ecological Risk Assessments (EPA-HQ-OPP-2009-0306). Boric acid and its
sodium salts are inorganic compounds with registrations for use as
active ingredients in insecticides, acaricides, herbicides, algaecides,
fungicides, and wood and material preservatives. In small quantities,
boron is an essential nutrient for aquatic vertebrates and
invertebrates and plants. There is also evidence that boron is
essential or, if not essential, beneficial in birds and mammals, in
small quantities. Boric acid and its sodium salts are also present as
inert ingredients in pesticide products and as ingredients in non-
pesticide consumer products. The Agency issued a Final Work Plan for
boric acid in October 2009. The ecological risk assessment identifies
potential risks to terrestrial invertebrates, birds, mammals, reptiles,
terrestrial-phase amphibians, aquatic organisms, and terrestrial
plants. For birds and mammals, risk is primarily associated with the
granular formulations and bait uses. For aquatic organisms, risk is
primarily associated with discharge of swimming pool, hot tub, and spa
effluent directly to surface waters, to storm drains, roadways, and
potentially from storage of treated wood. For terrestrial plants, risk
is primarily associated with discharge of effluent from swimming pools,
hot tubs, and spas. The human health risk assessment did not identify
risks of concern. Boric acid was not on either initial list of
chemicals to be screened under the EDSP, nor has an endangered species
or pollinator assessment been conducted at this time.
    Ethephon. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2010-0098). Ethephon, 2-chloroethylphosphonic acid, is an
organophosphonate plant growth regulator intended to promote fruit
ripening, abscission, flower induction, breaking of apical dominance
(inhibition of the growth of lateral buds by the terminal bud of a
shoot), and other plant responses through the release of ethylene gas,
a natural plant hormone. EPA conducted a human health risk assessment
and identified aggregate risks of concern for children ages 1-2 years
old. EPA also conducted an ecological risk assessment and identified
potential risks to birds, mammals, and non-target plants. A full
endangered species assessment has not been completed for ethephon at
this time. At this time, ethephon has not been evaluated for its
potential to affect endocrine systems in mammals and wildlife, nor has
an assessment of risks to pollinators been conducted.
    Hymexazol. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2010-0127). Hymexazol is a systemic fungicide for control of
foliar and soil-borne plant diseases. There is only one existing
registration as a commercial seed treatment for sugar beets. Hymexazol
may be applied only using commercial seed treatment equipment. A Final
Work Plan for hymexazol was published by the Agency in September 2010,
and data were then required in a generic data call-in, dated October
2011. The reviews of the required data have been incorporated into the
draft risk assessments. The Draft Human Health Risk Assessment
identified no dietary risks of concern but identified potential risk to
occupational workers (individuals treating/mixing seed and individuals
doing multiple activities). The Draft Ecological Risk Assessment
identified potential risks to mammals and birds. Hymexazol was not on
either initial list of chemicals to be screened under the EDSP, and a
complete endangered species assessment has not been conducted at this
time.
    Lithium hypochlorite. Draft Ecological Risk Assessment (EPA-HQ-OPP-
2013-0606). Lithium hypochlorite is an algicide, disinfectant, and
fungicide. Its primary pesticidal use is to control algae, bacteria,
and mildew in swimming pool water systems, hot tubs, and spas. EPA
conducted a qualitative ecological risk assessment on the swimming pool
uses of lithium hypochlorite as part of registration review. EPA
previously conducted human health and ecological risk assessments at
the time of the Reregistration Eligibility Decision (RED) for lithium
hypochlorite in 1993. Lithium hypochlorite was not on either initial
list of chemicals to be screened under the EDSP, and an endangered
species assessment has not been conducted at this time.
    Pronamide. Draft Human Health and Ecological Risk Assessments (EPA-
HQ-OPP-2009-0326). Pronamide, also called propyzamide, 3,5-dichloro-N-
(1,1-dimethyl-2-propynyl)benzamide, is

a selective, systemic, pre-and post-emergence herbicide registered for
the control of grasses and broadleaf weeds in several food and feed
crops as well as woody ornamentals, Christmas trees, grasses grown for
seed or turf (sod), golf course turf, recreational area turf, and
fallow land. EPA conducted a human health risk assessment and did not
identify any risks of concern for dietary, residential, occupational,
or aggregate exposure. EPA also conducted an ecological risk assessment
and identified potential risks to birds, mammals, and plants. An
endangered species and pollinator assessment has not been completed for
pronamide at this time. Pronamide was evaluated for its potential to
affect endocrine systems in mammals and wildlife and the results of the
Agency's review are found in the weight of evidence review in this
registration review docket.
    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity,
through this notice of availability, for interested parties to provide
comments and input concerning the Agency's draft human health and
ecological risk assessments for the pesticides identified in this
document. Such comments and input could address, among other things,
the Agency's risk assessment methodologies and assumptions, as applied
to this draft risk assessment. The Agency will consider all comments
received during the public comment period and make changes, as
appropriate, to the draft human health and ecological risk assessments.
EPA may then issue a revised risk assessment, explain any changes to
the draft risk assessment, and respond to comments. In the Federal
Register notice announcing the availability of the revised risk
assessment, if the revised risk assessment indicates risks of concern,
the Agency may provide a comment period for the public to submit
suggestions for mitigating the risk identified in the revised risk
assessment before developing a proposed registration review decision on
the pesticides identified in this document.
    1. Other related information. Additional information on pesticides
identified in this document is available on the Pesticide Registration
Review Status Web page. Information on the Agency's registration review
program and its implementing regulation is available at http://www.epa.gov/pesticide-reevaluation/registration-review-process.
    2. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
    As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.

    Authority: 7 U.S.C. 136 et seq.

    Dated: December 24, 2015.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2015-33298 Filed 1-5-16; 8:45 am]
BILLING CODE 6560-50-P