[Federal Register: January 13, 2010 (Volume 75, Number 8)]
[Notices]
[Page 1790-1791]
[DOCID:fr13ja10-70]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0605]

Draft Guidance for Institutional Review Boards, Clinical
Investigators, and Sponsors: IRB Continuing Review After Clinical
Investigation Approval; 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availability of a draft guidance entitled, ``Guidance for IRBs,
Clinical Investigators, and Sponsors: IRB Continuing Review After
Clinical Investigation Approval.'' The draft guidance announced in this
notice is intended to assist institutional review boards (IRBs) in
carrying out their continuing review responsibility by providing
recommendations regarding the criteria, process, and frequency of
continuing review to assure the protection of the rights and welfare of
subjects in clinical investigations. The draft guidance should also
help clinical investigators and sponsors better understand their
responsibilities related to continuing review.

DATES: Although comments on any guidance can be submitted at any time
(see 21 CFR 10.115(g)(5)), to ensure that the agency considers a
comment on this draft guidance before it begins work on the final
version of the guidance, written or electronic comments on the draft
guidance should be submitted by March 15, 2010. Submit written comments
on the draft guidance to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://www.regulations.gov. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

ADDRESSES:  Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10903 New
Hampshire Ave., White Oak (WO) Bldg. 51, rm. 2201, Silver Spring, MD
20993-0002 (1-888-463-6332 or<PHONE_NUMBER>); or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448 (1-800-835-4709 or
301-827-1800); or the Division of Small Manufacturers, International,
and Consumer Assistance, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave. (WO
Bldg. 66, rm. 4622), Silver Spring, MD 20993 (1-800-638-2041 or 301-
796-7100). Send one self-addressed adhesive label to assist the office
in processing your requests.

FOR FURTHER INFORMATION CONTACT:  Sara Goldkind, Office of Good
Clinical Practice (HF-34), Food and Drug Administration, 5600 Fishers
Lane, rm. 16-85, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled,
``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB
Continuing Review After Clinical Investigation Approval.'' This
guidance is intended to assist IRBs in carrying out their continuing
review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing
recommendations regarding the criteria, process, and frequency of
continuing review to assure the protection of the rights and welfare of
subjects in clinical investigations. The draft guidance should also
help clinical investigators and sponsors better understand their
responsibilities related to continuing review. When finalized, this
guidance will supersede the Information Sheet, ``Continuing Review
After Study Approval'' (September 1998, Office of Health Affairs, Food
and Drug Administration).
    To enhance human subject protection and reduce regulatory burden,
the Department of Health and Human Services, Office for Human Research
Protections (OHRP) and FDA have been actively working to harmonize the
agencies' regulatory requirements and guidance for human subject
research. This draft guidance document was developed as part of these
efforts.
    FDA is issuing this as a draft guidance because it has been
substantially revised in response to numerous questions about the
continuing review process from the IRB and research communities.
Changes include more detailed discussion about what should be submitted
to assist the IRB in conducting continuing review, discussion of the
circumstances in which expedited review procedures may be used for
continuing review, and guidance about how continuing review dates
should be determined.
    This draft guidance is part of the Information Sheet Guidance
Initiative, announced in the Federal Register of February 3, 2006 (71
FR 5861), which describes FDA's intention to update the process for
developing, issuing, and making available guidances intended for IRBs,
clinical investigators, and sponsors. Known as ``Information Sheets,''
these guidances have provided recommendations to IRBs, clinical
investigators, and sponsors to help them fulfill their responsibilities
to protect human subjects who participate in research regulated by the
FDA. The Information Sheet Guidance Initiative is intended to ensure
that the Information Sheets are updated, consistent with the FDA's good
guidance practices (GGPs). As part of the initiative, which will be
ongoing, the agency plans to rescind Information Sheets that are
obsolete, revise and reissue guidances that address current issues, and
develop new guidance documents as needed.
    The draft guidance is being issued consistent with FDA's GGPs
regulation (21 CFR 10.115). The draft guidance, when finalized, will
represent FDA's current thinking on this topic. 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 statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance includes information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520)
(PRA). The collections of information referenced in this guidance that
are related to IRB recordkeeping requirements under 21 CFR 56.115,
which include the requirements for records of continuing review, have
been approved under OMB Control No. 0910-0130; the collections of
information in part 312 (21 CFR part 312) have been approved under OMB
control number 0910-0014; and the collections of information in part
812 (21 CFR part 812) have been approved under OMB control number 0910-
0078. In accordance with the PRA, prior to publication of any final
guidance document, FDA intends to solicit public comment, and obtain
OMB approval for any information collections recommended in this
guidance that are new or that would represent material modifications to
these previously approved collections of information found in FDA
regulations.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this draft
guidance. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, or http://www.fda.gov/ScienceResearch/
SpecialTopics/RunningClinicalTrials/
ProposedRegulationsandDraftGuidances/default.htm

    Dated: January 7, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-426 Filed 1-12-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Notices]
[Page 53137]
[FR Doc No: 2016-19077]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-484-000]

El Paso Natural Gas Company, L.L.C.; Notice of Request Under
Blanket Authorization

    Take notice that on July 21, 2016, El Paso Natural Gas Company,
L.L.C. (EPNG), Post Office Box 1087, Colorado Springs, Colorado 80944
filed a prior notice request pursuant to sections 157.205 and
157.208(f) of the Commission's regulations under the Natural Gas Act
for authorization to decrease the Maximum Allowable Operating Pressure
(MAOP) of a segment of its 6-inch O.D. Hayden Line (Line No. 2023)
located in Gila County, Arizona. EPNG proposes to decrease the MAOP of
this section of Line No. 2023 from 474 pounds per square inch gauge
(psig) down to 85 psig to align the MAOP with the existing operations
of Line No. 2023. The proposed MAOP reduction will not alter the
capacity of EPNG's system, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. The filing may also be viewed on the web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this Application should be directed to
Francisco Tarin, Director Regulatory Department, El Paso Natural Gas
Company, L.L.C., Post Office Box 1087, Colorado Springs, Colorado
80944, or by calling<PHONE_NUMBER>.
    Any person or the Commission's staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention. Any person filing to intervene or
the Commission's staff may, pursuant to section 157.205 of the
Commission's Regulations under the NGA (18 CFR 157.205) file a protest
to the request. If no protest is filed within the time allowed
therefore, the proposed activity shall be deemed to be authorized
effective the day after the time allowed for protest. If a protest is
filed and not withdrawn within 30 days after the time allowed for
filing a protest, the instant request shall be treated as an
application for authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with he Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.

    Dated: August 1, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-19077 Filed 8-10-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Pages 8138-8141]
[FR Doc No: 2019-03982]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85220; File No. SR-NYSEArca-2019-06]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change To Amend Commentary .01 to NYSE Arca Rule
8.600-E Relating to Generic Listing Standards for Managed Fund Shares
Applicable To Holdings in Fixed Income Securities

February 28, 2019.
    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, on February 14, 2019, 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 and II
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 amend Commentary .01(b)(5) to NYSE Arca
Rule 8.600-E relating to a generic listing standards for Managed Fund
Shares applicable to holdings in fixed income securities. The proposed
change is available on the Exchange's website at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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
    Commentary .01 to NYSE Arca Rule 8.600-E sets forth generic listing
standards for listing and trading of Managed Fund Shares on the
Exchange.\4\ The Exchange proposes to amend Commentary .01(b)(5) to
Rule 8.600-E, as described below.\5\
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    \4\ A Managed Fund Share is a security that represents an
interest in an investment company registered under the Investment
Company Act of 1940 (15 U.S.C. 80a-1) (the ``1940 Act'') organized
as an open-end investment company or similar entity that invests in
a portfolio of securities selected by its investment adviser
consistent with its investment objectives and policies. In contrast,
an open-end investment company that issues Investment Company Units,
listed and traded on the Exchange under NYSE Arca Rule 5.2-E(j)(3),
seeks to provide investment results that correspond generally to the
price and yield performance of a specific foreign or domestic stock
index, fixed income securities index or combination thereof.
    \5\ The Commission approved the generic listing standards in
Commentary .01 to NYSE Arca Rule 8.600-E in Securities Exchange Act
Release No. 78397 (July 22, 2016), 81 FR 49320 (July 27, 2016) (SR-
NYSEArca-2015-110) (Order Granting Approval of Proposed Rule Change,
as Modified by Amendment No. 7 Thereto, Amending NYSE Arca Equities
Rule 8.600 to Adopt Generic Listing Standards for Managed Fund
Shares).
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Proposed Amendment to Commentary .01(b)(5) to Rule 8.600-E
    Commentary .01(b) to NYSE Arca Rule 8.600-E sets forth generic
listing standards applicable to fixed income securities included in the
portfolio of a series of Managed Fund Shares.\6\ Commentary .01(b)(5)
provides that non-agency, non- GSE and privately-issued mortgage-
related and other asset-backed securities (``ABS'' and, collectively,
``non-agency ABS'') components of a portfolio shall not account, in the
aggregate, for more than 20% of the weight of the fixed income portion
of the portfolio. The Exchange proposes to amend Commentary .01(b)(5)
by deleting the words ``fixed income portion'' to provide that such 20%
limitation would apply to the entire portfolio rather than to only the
fixed income portion of the portfolio. Thus, Commentary .01(b)(5) would
provide that non-agency, non-GSE and privately-issued mortgage-related
and other ABS components of a portfolio shall not account, in the
aggregate, for more than 20% of the weight of the portfolio.
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    \6\ Commentary .01(b) provides that fixed income securities are
debt securities that are notes, bonds, debentures or evidence of
indebtedness that include, but are not limited to, U.S. Department
of Treasury securities (``Treasury Securities''), government-
sponsored entity securities (``GSE Securities''), municipal
securities, trust preferred securities, supranational debt and debt
of a foreign country or a subdivision thereof, investment grade and
high yield corporate debt, bank loans, mortgage and asset backed
securities, and commercial paper.
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    The Exchange believes this amendment is appropriate because a
fund's investment in non-agency, non-GSE and privately-issued mortgage-
related and other ABS may provide a fund with benefits associated with
increased diversification, as such investments may be less correlated
to interest rates than many other fixed income securities. The Exchange
notes that application of the 20% limitation only to the fixed income
portion of a fund's portfolio may impose a much more restrictive
percentage limit on permitted holdings of non-agency ABS for funds that
have a more diversified investment portfolio than for funds that hold
principally or exclusively fixed income securities. For example, a fund
holding 100% of its assets in fixed income securities can hold 20% of
its entire portfolio's weight in non-agency ABS. In contrast, a fund
holding 25% of its assets in fixed income securities, 25% in U.S
Component Stocks, and 50% in cash and cash equivalents is limited to a
5% (25%*20%=5%) allocation to non-agency ABS. The Exchange, therefore,
believes application of the 20% limitation to a fund's entire portfolio
would be more equitable for Managed Fund Shares issuers with different
investment objectives and holdings.
    In addition, a fund's investment in non-agency, non-GSE and
privately-issued mortgage-related and other ABS will be subject to a
fund's liquidity risk management program as approved by a fund's board
of directors.\7\ The liquidity procedures generally include public
disclosure by funds of their liquidity and redemption practices. A
fund's holdings in non-agency ABS would be encompassed within a fund's
liquidity risk management program. To the extent a fund's procedures
facilitate its ability to meet its redemption obligations, they may
reduce potential manipulation of a fund's shares by promoting an
efficient redemption mechanism for exchange-traded funds, including
funds that hold non-agency ABS.
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    \7\ Rule 22e-4(b) under the 1940 Act requires, among other
things, that a fund ``adopt and implement a written liquidity risk
management program that is reasonably designed to assess and manage
its liquidity risk.'' The rule is ``designed to promote effective
liquidity risk management throughout the open-end investment company
industry, thereby reducing the risk that funds will be unable to
meet their redemption obligations and mitigating dilution of the
interests of fund shareholders.'' See Release Nos. 33-10233; IC-
32315; File No. S7-16-15 (October 13, 2016).
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    The Exchange notes that the Commission has previously approved the
listing of actively managed exchange-traded funds that can invest 20%
of their total assets in non-U.S. Government, non-agency, non-GSE and
other privately issued ABS and mortgage-backed securities (``MBS'').\8\
In addition, the Commission has previously approved listing and trading
of shares of an issue of Managed Fund Shares where such fund's
investments in non-U.S. Government, non-agency, non-GSE and other
privately issued ABS will, in the aggregate, not exceed 20% of the
total assets of the fund, rather than the weight of the fixed income
portion of the fund's portfolio.\9\ Therefore, the Exchange believes it
is appropriate to apply the 20% limitation to a fund's investment in
non-agency, non-GSE and privately-issued mortgage-related and other ABS
components of a portfolio in Commentary .01(b)(5) to a fund's total
assets.
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    \8\ See, e.g., Securities Exchange Act Release Nos. 80946 (June
15, 2017) 82 FR 28126 (June 20, 2017) (SR-NASDAQ-2017-039)
(permitting the Guggenheim Limited Duration ETF to invest up to 20%
of its total assets in privately-issued, non-agency and non-GSE ABS
and MBS); 76412 (November 10, 2015), 80 FR 71880 (November 17, 2015)
(SR-NYSEArca-2015-111) (permitting the RiverFront Strategic Income
Fund to invest up to 20% of its assets in privately-issued, non-
agency and non-GSE ABS and MBS); 74814 (April 27, 2015), 80 FR 24986
(May 1, 2015) (SR-NYSEArca-2014-107) (permitting the Guggenheim
Enhanced Short Duration ETF to invest up to 20% of its assets in
privately-issued, non-agency and non-GSE ABS and MBS); 74109
(January 21, 2015), 80 FR 4327 (January 27, 2015) (SR-NYSEArca-2014-
134) (permitting the IQ Wilshire Alternative Strategies ETF to
invest up to 20% of its total assets in MBS and other ABS, without
any limit on the type of such MBS and ABS).
    \9\ See Securities Exchange Act Release No. 83319 (May 24,
2018), 83 FR 25097 (May 31, 2018) (SR-NYSEArca-2018-15) (Order
Approving a Proposed Rule Change, as Modified by Amendment No. 1
Thereto, to Continue Listing and Trading Shares of the PGIM Ultra
Short Bond ETF Under NYSE Arca Rule 8.600-E).
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    The Exchange believes the proposed amendments would provide issuers
of Managed Fund Shares with additional investment choices for fund
portfolios for issues permitted to list and trade on the Exchange
pursuant to the Rule 19b-4(e), which would enhance competition among
market participants, to the benefit of investors and the marketplace.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\10\ in general, and furthers the
objectives of Sections 6(b)(5) of the Act,\11\ in particular,

because 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 regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to, and
perfect the mechanisms of, a free and open market and a national market
system and, in general, to protect investors and the public interest
and because it is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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    The Exchange has in place surveillance procedures that are adequate
to properly monitor trading in series of Managed Fund Shares in all
trading sessions and to deter and detect violations of Exchange rules
and applicable federal securities laws. The Exchange notes that the
Exchange or Financial Industry Regulatory Authority (``FINRA''), on
behalf of the Exchange, or both, would communicate as needed regarding
trading in Managed Fund Shares with other markets and other entities
that are members of the Intermarket Surveillance Group, and the
Exchange or FINRA, on behalf of the Exchange, or both, could obtain
trading information regarding trading in Managed Fund Shares from such
markets and other entities. In addition, the Exchange could obtain
information regarding trading in Managed Fund Shares from markets and
other entities that are members of ISG or with which the Exchange has
in place a comprehensive surveillance sharing agreement.
    With respect to the proposed amendment to Commentary .01(b)(5), the
Exchange believes this amendment is appropriate because a fund's
investment in non-agency, non-GSE and privately-issued mortgage-related
and other ABS may provide a fund with benefits associated with
increased diversification, as such investments may be less correlated
to interest rates than many other fixed income securities. As noted
above, application of the 20% limitation to only the fixed income
portion of a fund's portfolio may impose a much lower percentage limit
on permitted holdings of non-agency ABS for funds that have a more
diversified investment portfolio than for funds that hold principally
or exclusively fixed income securities. The Exchange, therefore,
believes application of the 20% limitation to a fund's entire portfolio
would be more equitable for Managed Fund Shares issuers with different
investment objectives and holdings.
    In addition, a fund's investment in non-agency, non-GSE and
privately-issued mortgage-related and other ABS will be subject to a
fund's risk management program as approved by a fund's board of
directors, as required by Rule 22e-4 under the 1940 Act, which requires
investment companies, including in-kind exchange-traded funds, to adopt
a liquidity risk management program.\12\ The liquidity procedures
generally include public disclosure by funds of their liquidity and
redemption practices. A fund's holdings in non-GSE and privately-issued
mortgage-related and other ABS would be encompassed within a fund's
liquidity risk management program. To the extent a fund's procedures
facilitate its ability to meet its redemption obligations, they may
reduce potential manipulation of a fund's shares by promoting an
efficient redemption mechanism for exchange-traded funds, including
those that hold non-agency ABS.
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    \12\ See note 7, supra.
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    The Exchange notes that the Commission has previously approved the
listing of actively managed exchange-traded funds that can invest 20%
of their total assets in non-U.S. Government, non-agency, non-GSE and
other privately issued ABS and MBS.\13\ In addition, the Commission has
previously approved listing and trading of shares of an issue of
Managed Fund Shares where such fund's investments in non-U.S.
Government, non-agency, non-GSE and other privately issued ABS will, in
the aggregate, not exceed more than 20% of the total assets of the
fund, rather than the weight of the fixed income portion of the fund's
portfolio.\14\ Therefore, the Exchange believes it is appropriate to
apply the 20% limitation to a fund's investment in non-agency, non-GSE
and privately-issued mortgage-related and other ABS components of a
portfolio in Commentary .01(b)(5) to a fund's total assets.
---------------------------------------------------------------------------

    \13\ See note 8, supra.
    \14\ See note 9, supra.
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    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest in that it will facilitate the listing and trading of
additional types of Managed Fund Shares that will enhance competition
among market participants, to the benefit of investors and the
marketplace.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\15\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The proposed rule change would permit Exchange
listing and trading under Rule 19b-4(e) of additional types of Managed
Fund Shares, which would enhance competition among market participants,
to the benefit of investors and the marketplace.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2019-06 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2019-06. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/

rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for website
viewing and printing in the Commission's Public Reference Room, 100 F
Street NE, Washington, DC 20549 on official business days between the
hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2019-06 and should
be submitted on or before March 27, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-03982 Filed 3-5-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 73 (Monday, April 19, 2021)]
[Notices]
[Pages 20385-20386]
[FR Doc No: 2021-07925]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4517-DR; Docket ID FEMA-2021-0001]

West Virginia; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of West Virginia (FEMA-4517-DR), dated April 3, 2020, and
related determinations.

DATES:  This amendment was issued February 2, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, pursuant to the
President's Memorandum to Extend Federal Support to Governors' Use of
the National Guard to Respond to COVID-19 and to Increase Reimbursement
and Other Assistance Provided to States, dated January 21, 2021 and the
President's Memorandum on Maximizing Assistance from the Federal
Emergency Management Agency, dated February 2, 2021 FEMA is amending
the cost-sharing arrangements regarding Federal funds provided under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the ``Stafford Act'') for all of
the COVID-19 emergency and major disaster declarations. FEMA is
amending this declaration as follows:

    Federal funds for emergency protective measures (Category B),
including direct Federal assistance, under the Public Assistance
program (Section 403) are authorized at 100 percent of total
eligible costs for work performed from January 20, 2020 through
September 30, 2021.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals

and Households--Other Needs; 97.036, Disaster Grants--Public
Assistance (Presidentially Declared Disasters); 97.039, Hazard
Mitigation Grant).

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-07925 Filed 4-16-21; 8:45 am]
BILLING CODE 9111-23-P


Warbler, Golden-cheeked	Dendroica chrysoparia	R1	R1	R1	R1	R1

Warbler, Kirtland’s	Dendroica kirtlandii	R1	R1, R2	R1

R1, R2

Woodpecker, Red-cockaded	Picoides borealis	R1	R1, R2	R1, R2	R1	R1, R2

Woodpecker, Ivory-billed	Campephilus principalis

R2

	R2

Table   SEQ Table \* ARABIC  32 .  Listed reptiles and amphibians potentially at risk from fomesafen

Common Name	Scientific Name	Pine	Soybean	Cotton	Dry Beans	Snap Beans

Frog, Dusky Gopher	Rana capito sevosa	R1

R1

Salamander, Cheat Mountain	Plethodon nettingi

R2

	R2

Salamander, Flatwoods	Ambystoma cingulatum	R1	R1	R1

R1

Salamander, Red Hills	Phaeognathus hubrichti	R1	R1	R1

R1

Salamander, Shenandoah	Plethodon shenandoah

R2

	R2

Toad, Houston	Bufo houstonensis	R1	R1	R1	R1	R1

Tortoise, Gopher	Gopherus polyphemus	R1	R1	R1	R1	R1

Turtle, Alabama Red-bellied	Pseudemys alabamensis	R1	R2	R1

R1

Turtle, Northern Bog	Clemmys muhlenbergii

R1

R2	R2

Turtle Flattened Musk	Sternotherus depressus	R1	R3	R1	R1	R1

Turtle Plymouth Red-bellied	Pseudemys rebriventris bangsi

	R3

Turtle, Ringed Sawback	Graptemys oculifera	R1	R1	R1	R1	R1

Turtle, Yellow-blotched Map	Graptemys flavimaculata	R1	R2	R1	R1	R1

Table   SEQ Table \* ARABIC  33   Summary of Risk to Listed Plants

Assessment Endpoint	Type	Application Rate

lb ai/A	LOC Exceedence2	Clearance estimate1

Distance from site (ft)	Rate

(lb ai/A)

Acute Risk to Monocots	Aerial Application

	Upland	0.5	Yes	100	0.03

0.375	Yes

0.312	Yes

0.25	No	Clears at current rate

0.17	No

Wetland	0.5	Yes	100	0.03

0.375	Yes

0.312	Yes

0.25	Yes

0.17	No	Clears at current rate

	Ground Application

	Upland	0.5	Yes	20	0.03

0.375	No	Clears at current rate

0.312	No

	0.25	No

	0.17	No

Wetland	0.5	Yes	20	0.03

0.375	Yes	10

	0.312	Yes

0.25	Yes

0.17	Yes

Acute Risk to Dicots	Aerial Application

	Upland	0.5	Yes	>900	<0.002

0.375	Yes

0.312	Yes

0.25	Yes

0.17	Yes

	Wetland	0.5	Yes

0.375	Yes

0.312	Yes

0.25	Yes

0.17	Yes

	Ground Application

	Upland	0.5	Yes	300	<0.002

0.375	Yes	200

	0.312	Yes	200

	0.25	Yes	150

	0.17	Yes	80

Wetland	0.5	Yes	300

	0.375	Yes	200

	0.312	Yes	200

	0.25	Yes	150

	0.17	Yes	80

	6.3.3	Plants

Using LOCATES, a list of plants co-occurring with labeled crops was generated.  For crops listed only on Syngenta labels, which contain wording such that application outside the designated regions would be considered misuse, search parameters were constrained to only states listed on the label.  BASF labels (soybeans only) contained less specific language, thus the search was nationwide, resulting in the inclusion of Florida and Hawaii.  Table 30 shows the number of species potentially affected by crop and state.  Numbers of monocots and dicots are shown separately.  Ferns, cycads, and lichens, for which no data were available, are listed with dicots, which are more sensitive to fomesafen.

Direct Effects

Exceedences of endangered species LOC (based on NOAECs) for the most sensitive plants tested constitute a “may affect” determination.  Based on this definition, use of fomesafen may affect listed plants of all varieties located near the application site.  Spray drift analysis using AgDrift (Tier I, Terrestrial Assessment, Point Deposition, ASAE fine to medium spray) resulted in clearance distances of approximately 1,000 ft for dicots, and 200 ft for monocots for aerial applications at a maximum rate of 0.375 lb ai/A.  For ground applications, clearance distances were estimated at 850 ft for dicots and 20 ft for monocots.  As no data are available to evaluate the sensitivity of endangered plants to fomesafen, all are conservatively assumed to be as sensitive as the most sensitive species tested.

While plants are not subject to the same “take” definitions as animals, the dicot listed species clearance distances for fomesafen are approximately the same as the dicot clearance distances for non-listed species, which are based on a 25% reduction in the most sensitive endpoint for the most sensitive plant.  For fomesafen, the most sensitive endpoints are typically biomass and percent survival.  While it is difficult to predict community-level effects on the plant community supporting the listed plants, a 25% reduction in these endpoints is likely to reduce the viability of any affected population.

Thus, fomesafen is likely to adversely affect dicots up to 1,000 ft away from the application point, and likely to adversely affect monocots up to 100 ft away from the application point for aerial applications, based on the maximum application rate of 0.375 lb ai/A.  For ground applications, the respective distances would be 850 ft for dicots, and 10 ft for monocots.

Note that spray drift estimates do not take into the account the effects of runoff from the treated site.  Because runoff conditions and the quality of vegetated buffers vary widely from site to site, these effects are difficult to estimate in a general sense.  However, except in cases of extreme channelization or nearly bare ground, runoff across a 1,000 ft buffer is likely to be low.  Because fomesafen is less toxic to monocots, a grassy buffer would likely be more effective.

Potential mitigation measures include but are not limited to: 1) restricting applications of fomesafen within 1,000 ft of populations of endangered plants, and 2) restricting applications of fomesafen at sites where runoff to wetland areas is likely.  Removal of aerial application methods from the label is another possibility.  However, in light of the fact that anticipated effects zones are almost as wide for ground applications, this may not be the most beneficial mitigation.

Indirect Effects

Pesticide-mediated indirect effects to plants are usually the loss of an important pollinator or dispersal species.  Given the relatively low toxicity of fomesafen to animals in general, the likelihood of these types of effects appears to be extremely low.  Some endangered plant species may require the presence of other non-endangered plant species to create a suitable habitat.  Fomesafen effects on the habitat plants could constitute an indirect effect, but without detailed information on the plant’s life history and distribution, EFED is unable to even qualitatively evaluate this type of effect.

6.3.4	Action Area

The action area is determined based on the furthest range of anticipated effects. Based on the work of Russo et al (2007) and Russo and Madec (2007), it appears that fomesafen induces an immune response in freshwater snails and no definitive NOEC for this effect has been experimentally determined. Therefore for purposes of the ESA, the action area is considered to be the entire U.S.

Other than this sub-lethal snail immune response, the most sensitive organisms evaluated are terrestrial dicots.  Based on an analysis with AgDrift, deposition from aerial applications at the highest Section 3 rate (0.375 lb ai/A) at 950 ft away from the point of application will be 0.004 lb ai/A.  The most sensitive endpoint is the dicot NOAEC of 0.002 lb ai/A.  At approximately 1,000 ft, the decline curve in AgDrift based empirical measurements is asymptotic.  For a fine-to-medium droplet size spray, only 1.2% of applied will be deposited on the downwind side of the field, presuming no interception.

Thus, for practical reasons, the extent of these dicot effects is estimated at 1,000 ft from point of application.  This applies to all agricultural land in the regions where fomesafen is registered for use under the existing Syngenta labels.

Table   SEQ Table \* ARABIC  34   Endangered Plants by Crop and State

State	Pine	Soybeans	Cotton	Dry Beans	Snap Beans

	Monocot	Dicot1	Monocot	Dicot1	Monocot	Dicot1	Monocot	Dicot1	Monocot Dicot1

AL	3	13	3	11	3	13	1	1	3	12

AR

	0	3	0	2

	0	3

CT

	1	0

	0	2	1	1

DC

	2	0

DE

	2	0	2	0

GA	6	12	6	12	4	12

	6	11

IA

	2	4

	2	3	2	4

IL

	2	7

	1	7

IN

	1	4

	0	1	1	4

KS

	1	1	1	1

	1	1

KY

	0	10

	0	9

LA

	0	2

	0	2

MA

	1	0

	1	0	2	1

ME

	2	1

	2	1	2	1

MD

	2	4

	1	2	2	4

MI

	3	3

	3	2	3	5

MN

	2	1

	1	2	2	2

MO

	1	7	0	3	0	1	2	2

MS	0	3	0	3	0	3	0	1	0	3

NC	5	21	5	21	3	16	1	5	5	22

ND

	1	0

	1	0	1	0

NE

	1	1

	1	2	1	0

NH

	1	0	1	1

NJ

	3	2

	3	0	3	2

NY

	1	5

	1	5	1	5

OH

	2	4

	1	1	2	4

OK

	2	0

	2	0

PA

	2	0

	2	0	2	0

RI

	0	1

	1	1

SC	6	14	6	14	3	11	1	5	6	14

SD

	1	0

	1	0	1	0

TN

	2	18	0	5

	1	3

TX	2	5	2	14	2	24	2	11	2	13

VA

	1	3	2	7	0	1	4	13

VT

	0	1

	0	1

WI

	2	4

	2	4

WV

	0	1	1	4

BASF Labels only (soybeans nationwide)

FL

	1	25

HI

	11	74

Dicot1  This category also includes fern, lichens, and cycads, which are reported separately in LOCATES.

Blank rows or section of rows indicate that crop does not co-occur with any endangered plants in that state.

6.3.5	Probability of Individual Effects

Generally, available toxicity data provides an LC50 or an EC50, (the concentration at which 50% of the test population exhibits the designated endpoint, usually mortality).  Because the Endangered Species Act (ESA) requires determination of potential effects at an individual level, this information must be extrapolated from existing data. The Agency uses the probit dose response relationship as a tool for deriving the probability of effects on a single individual (U.S. EPA, 2004).  The individual effects probability associated with the acute RQ is based on the mean estimate of the probit dose response slope and an assumption that that probit model is appropriate for the data set.  In some cases, probit is not the appropriate model for the data, and EFED has low confidence in extrapolations from these types of data sets.  In addition to a single effects probability estimate based on the mean, upper, and lower estimates of the effects probability are also provided to account for variance in the slope, if available.  The upper and lower bounds of the effects probability are based on available information on the 95% confidence interval of the slope.  Individual effect probabilities are calculated based on an Excel spreadsheet tool IECV1.1 (Individual Effect Chance Model Version 1.1) developed by the U.S. EPA, OPP, Environmental Fate and Effects Division (June 22, 2004).

Probability of individual effects for the various assessment endpoints, if the acute RQ equals the endangered species LOC, is provided below in   REF _Ref160961235 \h  \* MERGEFORMAT  Table 35 .  Probablity of individual effects is only evaluated for animals on an acute basis.  For plant endangered species risk quotients and animal chronic risk quotients, the endpoint used is a no effect level, thus an evaluation of the probability of individual effects is not applicable.

Table   SEQ Table \* ARABIC  35   Probability of Individual Effects

Assessment Endpoint	Surrogate Species	LC50 and Slope	Fits Probit	Chance of Individual Effect

Acute Toxicity to FW Fish	Rainbow trout	126 mg/L and 9.7 (lower bound)

126 mg/L and 14.6

126 mg/L and 19.5 (upper bound)

At LOC of 0.05	Yes	<1 in 1016

<1 in 1016

<1 in 1016

1 in 4.2×108

Acute Toxicity to FW Aquatic Invertebrates	Water flea	376 mg/L and 3.9 (lower bound)

376 mg/L and 5.6

376 mg/L and 7.3 (upper bound)

At LOC of 0.05	Yes	1 in 5.1x106

1 in 6.3x1012

<1 in 1016

1 in 4.2×108

Acute Toxicity to SW Fish	Sheepshead minnow	>163 mg/L and 4.5 (default slope)

At LOC of 0.05	No	1 in 2.9x105

NA

Acute Toxicity to SW Aquatic Invertebrates	Mysid shrimp	>163 mg/L and 4.5 (default slope)

At LOC of 0.05	No	1 in 2.9x105

NA

Acute Toxicity to Mammals	Guinea pig	607 mg/kg and 4.5 (default slope)

At LOC of 0.1	No	1 in 2.9x105

1 in 2.9×105

Acute Toxicity to Birds, Terrestrial phase Amphibians and Reptiles Mallard duck	Dose

>5,000 mg/kg and 4.5(default slope)

At LOC of 0.1

Diet

>20,000 mg/kg and 4.5(default slope)

At LOC of 0.1	No

1 in 2.9x105

NA

1 in 2.9x105

NA

N.A. – Non-definitive endpoint.

6.4	Risk Conclusions

Fomesafen is persistent in surface and ground water, and has high potential to leach to ground water, given its mobility in soil.  Ecologically, the organisms most at risk from fomesafen are terrestrial plants, especially dicots.  Because terrestrial plants are important both ecologically (they provide a critical part of both the structure and function that defines “habitat”) and economically (nearby non-target, non-treated crop plants may be affected), these potential impacts are an important consideration.  No LOCs were exceeded for aquatic endpoints except the listed species LOC for freshwater non-vascular plants.  At the time of this assessment, there were no listed non-vascular freshwater plants, and no listed species had been identified as having an obligate relationship with freshwater non-vascular plants.  For terrestrial organisms, chronic LOCs were exceeded for birds (and by extension, reptiles, and amphibians) at all but the lowest application rate.  Chronic LOCs were exceeded for mammals only for small herbivorous mammals at the highest application rate.  These LOC exceedences apply to both listed and non-listed species.  Based on spray drift estimations, clearance distances for chronic exceedences are well within the clearance distances for terrestrial plants, thus if terrestrial plants are protected, then by virtue of sensitivity, other vulnerable organisms should be protected as well.  Clearance distances for chronic effects on birds, reptiles, amphibians, and mammals are 10 ft from the application source for ground applications (based on low boom estimates) and 100 ft for aerial applications (based on application parameters used in AgDrift Tier I estimates).  For terrestrial plants, using drift estimates based on the more sensitive dicots, effects should be anticipated as far as 850 ft for ground applications, and 1,000 ft for aerial applications.

Table   SEQ Table \* ARABIC  36   Summary of Direct and Indirect Effects

Evaluation Organism	LOCATES Category	Direct Effects	Indirect Effects Critical Habitat

Effects

Monocots	Monocots	Yes

Ground ≤100 ft

Aerial ≤ 100ft

from point of application	Yes

Potential for effects on other plants in the community.  Alteration of habitat may create environment unsuitable to the listed species.

Effects may occur up to

Ground ≤300 ft

Aerial ≤ 900ft

from point of application	No?

(only listed monocot affected is aquatic)

Dicots	Other1	Yes

Ground ≤300 ft

Aerial ≤ 900ft

from point of application

No

(No potentially affected species have designated critical habitat

	Dicots

	Yes

(6 potentially affected species have designated critical habitat

Birds	Birds	Yes

Chronic Exceedences

Ground ≤10 ft

Aerial ≤ 100ft

from point of application	Yes

Potential for effects on other plants in the community.  Alteration of habitat may create environment unsuitable to the listed species.

Effects may occur up to

Ground ≤300 ft

Aerial ≤ 900ft

from point of application	Yes

Potential for effects on other plants in the community.  Alteration of habitat may create environment unsuitable to the listed species.

Effects may occur up to

Ground ≤300 ft

Aerial ≤ 900ft

from point of application

	Reptiles

Terrestrial Phase Amphibians

	Mammals	Mammals

	FW Aquatic Plants2	FW Aquatic Plants	No

No LOC exceedences

SW Aquatic Plants	SW Aquatic Plants

	FW Aquatic Invertebrates	FW Crustacea

FW Bivalves

FW Gastropods

	FW Fish	FW Fish

Aquatic Phase Amphibians

	SW Aquatic Invertebrates	SW Crustacea

SW Bivalves

SW Gastropods

	SW Fish	SW Fish

	1 Cycads, Conifers, Fern Allies. These genera have no direct corollary test organism, and have been evaluated based on the most sensitive plant endpoint.

2 Evaluated based on both non-vascular plants (algae) and vascular plants (duckweed)

7.0	Uncertainties

Risk assessment, by its very nature, is not exact, and requires the risk assessor to make assumptions regarding a number of parameters, to use data which may or may not accurately reflect the species of concern, and to use models which are a simplified representation of complex ecological processes.  In this risk assessment, EFED has attempted to locate the best available data regarding use and toxicity of fomesafen.  Frequently, such information are better expressed as ranges rather then points, and when this is the case, EFED has opted to make use of the end of range which would result in a conservative estimate of risk.  These uncertainties, and the directions in which they may bias the risk estimate, are described below.

7.1	Exposure Assessment Uncertainties

7.1.1	Aquatic Exposure

Overall, the uncertainties inherent in the aquatic exposure assessment tend to result in over-estimation of exposures.  This is apparent when comparing modeling results with monitoring data.  Estimated peak exposures are generally 1-2 orders of magnitude above the highest detections in the monitoring data.  In general, the monitoring data should be considered a lower bound on exposure, while modeling represents an upper bound.  The modeling conservatively assumes that the receiving water body and the application site are adjacent.

<IP_ADDRESS>	Modeling Assumptions

The uncertainties incorporated in the exposure assessment cannot be quantitatively characterized.  However, given the available data and EFED’s policy to rely on conservative modeling assumptions, it is expected that the modeling results in an over-prediction in exposure.  Qualitatively, conservative assumptions which may affect exposure include the following:

The assessment assumes all applications within the modeled watersheds occur concurrently (same time and same day) at the maximum application rate.

The assessment assumes all applications are at maximum label rate.

<IP_ADDRESS>	Monitoring Data

No surface water monitoring data was identified for fomesafen.. Groundwater data was only available from the registrant submitted prospective groundwater study.

<IP_ADDRESS>	Impact of Vegetative Setbacks on Runoff

EFED does not currently have an effective tool to evaluate the impact of vegetative setbacks on runoff and pesticide loadings.  The effectiveness of such setbacks is highly dependent on the condition of the vegetative strip.  A well-established, healthy vegetative setback can be a very effective means of reducing runoff and erosion from agricultural fields and may substantially reduce loading to aquatic ecosystems.  However, a setback that is narrow, of poor vegetative quality, or channelized is likely to be ineffective at reducing loadings.  The presence and quality of setbacks are site-specific, and may vary widely, even within a small geographic area.  EFED does not currently incorporate any “buffer reduction” in its runoff exposure estimates.  Until such time as quantitative methods to estimate the effect of vegetative setbacks of various conditions on pesticide loadings become available, EFED’s aquatic exposure predictions are likely to overestimate exposure where healthy vegetative setbacks exist and may underestimate exposure where poorly developed, channelized or no setbacks exist.

<IP_ADDRESS>	PRZM Modeling Inputs and Predicted Aquatic Concentrations

EFED used the linked PRZM/EXAMS model in this assessment, which produces estimated aquatic concentrations based on site conditions and historical meteorological files (generally 30-year).  The “peak” pesticide concentration used in the assessment is probability-based, and is expected to be exceeded once within a ten-year period.  PRZM is a process-based "simulation" model, which calculates what happens to a pesticide in a farmer's field on a day-to-day basis.  It considers factors such as rainfall and plant transpiration of water, as well as how and when the pesticide is applied.  The two major components are hydrology and chemical transport.  Water movement in and off the field is simulated by the use of generalized soil parameters, including field capacity, wilting point, and saturation water content.  Soils in each scenario are selected to represent high availability conditions for the pesticide.  The chemical transport component simulates the method of pesticide application on the soil or on the plant foliage and the environmental processes acting on the pesticide.  Dissolved, adsorbed, and vapor-phase concentrations in the soil are estimated by simultaneously considering the processes of pesticide uptake by plants, surface runoff, erosion, decay, volatilization, foliar wash-off, advection, dispersion, and retardation.

Uncertainty associated with each of these individual components adds to the overall uncertainty of the modeled concentrations.  Equations in the model have not been shown to exert any directional bias.  Model inputs from the required environmental degradation studies are chosen to represent the upper confidence bound of the mean, and are not expected to be exceeded in the environment 90% of the time.  Mobility input values are selected to be representative of conditions in the open environment.  Natural variation in soils adds to the uncertainty of modeled values.  Factors such as application date, crop emergence date, and canopy cover can affect estimated concentrations.  Ambient environmental factors, such as soil temperatures, sunlight intensity, antecedent soil moisture, and surface water temperatures may cause actual aquatic concentrations to differ from the modeled values.

Terrestrial Exposure Uncertainties

For terrestrial exposure estimates, the T-REX model is used to estimate exposure and calculate RQs.

<IP_ADDRESS>	Residue Levels Selection

The Agency relies on the work of Fletcher et al (1994) for setting the assumed pesticide residues in wildlife dietary items.  These residue assumptions are believed to reflect a realistic upper-bound residue estimate, although the degree to which this assumption reflects a specific percentile estimate is difficult to quantify.  It is important to note that the field measurement efforts used to develop the Fletcher estimates of exposure involve highly varied sampling techniques.  It is possible that much of these data reflect residues averaged over entire above ground plants in the case of grass and forage sampling.

<IP_ADDRESS>	Dietary Intake

It was assumed that ingestion of food items in the field occurs at rates commensurate with those in the laboratory. Although the screening assessment process adjusts dry-weight estimates of food intake to reflect the increased mass in fresh-weight wildlife food intake estimates, it does not allow for gross energy differences.  Direct comparison of a laboratory dietary concentration- based effects threshold to a fresh-weight pesticide residue estimate would result in an underestimation of field exposure by food consumption by a factor of 1.25–2.5 for most food items.

Differences in assimilative efficiency between laboratory and wild diets suggest that current screening assessment methods do not account for a potentially important aspect of food requirements.  Depending upon species and dietary matrix, bird assimilation of wild diet energy ranges from 23 – 80%, and mammal’s assimilation ranges from 41 – 85% (U.S. Environmental Protection Agency, 1993).  If it is assumed that laboratory chow is formulated to maximize assimilative efficiency (e.g., a value of 85%), a potential for underestimation of exposure may exist by assuming that consumption of food in the wild is comparable with consumption during laboratory testing.  In the screening process, exposure may be underestimated because metabolic rates are not related to food consumption.

7.2	Effects Assessment Uncertainties

7.2.1	Age Class and Sensitivity of Effects Thresholds

It is generally recognized that test organism age may have a significant impact on the observed sensitivity to a toxicant.  For guideline tests, young (and theoretically more sensitive) organisms are used.  Testing of juveniles may overestimate toxicity at older age classes for active ingredients of pesticides which act directly (without metabolic transformation) on the organism, because younger age classes often have not developed enzymatic systems associated with the detoxification of xenobiotics.  When the available toxicity data provides a range of sensitivity information with respect to age class, the risk assessors use the most sensitive life-stage information as measures of effect.

7.2.2	Use of Surrogate Species Data

Currently, there are no FIFRA guideline toxicity tests for amphibians or reptiles.  Therefore, in accordance with EFED policy, data for the most sensitive freshwater fish are used as a surrogate for aquatic-phase amphibians, and data for the most sensitive bird are used as a surrogate for terrestrial-phase amphibians and reptiles.  Use of data from the most sensitive organism is assumed to be protective of the majority of other organisms which may encounter the pesticide.

7.2.3	Extrapolation of Effects

Length of exposure and concurrent environmental stressors will likely affect the response of the organism to fomesafen.  Because of the complexity of an organism’s response to multiple stressors, the overall direction of the response is unknown.  Additional environmental stressors may decrease or increase the sensitivity to the herbicide.  Timing, peak concentration, and duration of exposure are critical in terms of evaluating effects, and these factors will vary both temporally and spatially.  Overall, the effect of this variability may result in either an overestimation or underestimation of risk

7.2.4	Acute LOC Assumptions

The risk characterization section of this assessment includes an evaluation of the potential for individual effects.  The individual effects probability associated with the acute RQ is based on the assumption that the dose-response curve fits a probit model.  It uses the mean estimate of the slope and the LC50 to estimate the probability of individual effects.

References

Barron, MG, Little EE, Calfee R, and S. Diamond. 2000. Quantifying solar spectral irradiance in aquatic habitats for the assessment of photoenhanced toxicity.  Environmental Toxicology and Chemistry 19:920-925.

Diamond, SA, Trenham, PC, Adams MJ, Hossack, BR, Knapp, RA, Stark, SL, Bradford, D, Corn PS, Czarnowski, K, Brooks, PD Fagre, D, Breen , B, Detenbeck NE, and K Tonessen. 2005.  Estimated Ultraviolte radiation doeses in wetlands in six national parks.  Ecosystems. 8:462-477.

EFED. 2007.  Memo on: Environmental Fate and Effects Division recommendation regarding the light dependent peroxidizing herbicides (LDPHs), DP Barcode D333803, dated 4/16/2007.

Fletcher, J.S., J.E. Nellesson and T. G. Pfleeger. 1994.  Literature review and evaluation of the EPA food-chain (Kenaga) nomogram, an instrument for estimating pesticide residues on plants.  Environ. Tox. And Chem. 13(9):1383-1391.

HED 2006.  Fomesafen sodium human health risk assessment for a proposal to amend se on soybeans and proposals to add uses on cotton, dry beans, and snap beans.  DP Barcode D325797, dated 2/28/06.

Matringe, M, Camadro, J-M, Labbe, D, and R. Scalla. 1989.  Protophorphyrinogen oxidase as a molecular target for diphenyl ether herbiciceds.  Biochem J. 260:231-235.

Roberts, T. (Ed.). 1998. Metabolic Pathways of Agrochemicals, Part One: Herbicides and Plant Growth Regulators. Royal Society of Chemistry, Cambridge. 849pp.

Smith, L.L. and Elcombe, C.R., 1989. Mechanistic studies: their role in the toxicological evaluation of pesticides. Food Addit. Contam. 6 Suppl. 1, pp. S57–S65.

U.S. EPA.  2004.  Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs.  Office of Prevention, Pesticides, and Toxic Substances.  Office of Pesticide Programs.  Washington, D.C.  January 23, 2004.

U.S. EPA. 2006.  Fomesafen Sodium.  Human Health Risk Assessment for a Proposal To Amend Use on Soybeans, and Proposals to Add Uses on Cotton, Dry Bean and Snap Bean.  DP Barcode D325797.  Health Effects Division, Office of Pesticide Programs, Washington D.C. February 28, 2006.

Guideline Study References

Avian Single Dose Oral Toxicity

163168  Roberts, N.; Fairley, C. (1981) The Acute Oral Toxicity (LD50) of PP021 to the Mallard Duck: ICI/370/WL/80792. Unpublished study prepared by Huntingdon Research Centre. 16 p

Avian Dietary Toxicity

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摧䇮~ᔀ; Fairley, C.; Woodhouse, R. (1981) The Subacute Dietary Toxicity (LC50) of PP021 to the Bobwhite Quail: ICI 335/80798. (Unpublished study received May 28, 1982 under 10182-EX-30; pre- pared by Huntington Research Centre, England, submitted by ICI Americas, Inc., Wilmington, DE; CDL:247592-D)

163384  Roberts, N.; Fairley, C.; Woodhouse, R. (1981) The Subacute Dietary Toxicity LC50 of PP021 to the Mallard Duck: HRC Report No. ICI 336/80816. Unpublished study prepared by Huntingdon Research Centre. 29 p.

Avian Reproduction

135639  Roberts, N.; Fairley, C.; Chanter, D.; et al. (1982) The Effect of the Dietary Inclusion of Fomesafen on Reproduction in the Mal- lard Duck: HRC Report No. ICI 338/82134. (Unpublished study re- ceived Nov 22, 1983 under 10182-83; prepared by Huntingdon Re- search Centre, Eng., submitted by ICI Americas, Inc., Wilming- ton, DE; CDL:072156-B)

135640  Roberts, N.; Fairley, C.; Hakin, B.; et al. (1982) The Effect of Dietary Inclusion of Fomesafen on Reproduction in the Bobwhite Quail: HRC Report No. ICI 337/82259. (Unpublished study re- ceived Nov 22, 1983 under 10182-83; prepared by Huntingdon Re- search Centre, Eng., submitted by ICI Americas, Inc., Wilming- ton, DE; CDL:072156-C)

Acute Toxicity to Freshwater Fish

103023  Hill, R.; Harland, B.; Maddock, B. (1981) PP021: Determination of the Acute Toxicity of JF7383 a 25% w/v Formulation to Rainbow Trout (Salmo gairdneri): BL/B/2026. (Unpublished study received May 28, 1982 under 10182-EX-30; prepared by Imperial Chemical Industries PLC, Eng., submitted by ICI Americas, Inc., Wilming- ton, DE; CDL:247592-E)

163169  Hill, R.; Maddock, B.; Harland, B. (1981) PP021: Determination of the Acute Toxicity of JF 7383, a 25% w/v Formulation to Bluegill Sunfish (Lepomis macrochirus): Brixham Report No. BL/B/2014; Brixham Study No. F697/B. Unpublished study prepared by Imperial Chemical Industries PLC. 20 p.

Acute Toxicity to Freshwater Invertebrates

103024  Edwards, P.; Brown, S.; Francis, P.; et al. (1980) PP021: Toxicity of Technical Material and Formulation, JF7383, to First Instar Daphnia magna: Report Series RJ 0111 B. (Unpublished study re- ceived May 28, 1982 under 10182-EX-30; submitted by ICI Ameri- cas, Inc., Wilmington, DE; CDL:247592-G)

Acute Toxicity to Estuarine/Marine Organisms

135643  Jaber, M.; Hawk, R. (1982) The Acute Toxicity of PP021 as the Aque- ous Sodium Salt (GFU060) to the Sheepshead Minnow: Report No. TMUE0019/B. (Unpublished study received Nov 22, 1983 under 10182-83; submitted by ICI Americas, Inc., Wilmington, DE; CDL: 072156-F)

135645  Jaber, M.; Hawk, R. (1982) The Acute Toxicity of PP021 as the Aque- ous Sodium Salt (GFU 060) to the Fiddler Crab: Report No. TMUE0020/B. (Unpublished study received Nov 22, 1983 under 10182-83; submitted by ICI Americas, Inc., Wilmington, DE: CDL: 072156-H)

135646  Jaber, M.; Hawk, R. (1982) The Acute Toxicity of PP021 as the Aque- ous Sodium Salt (GFU 060) to the Pink Shrimp: Report No. TMUE0021/B. (Unpublished study received Nov 22, 1983 under 10182-83; submitted by ICI Americas, Inc., Wilmington, DE; CDL: 072156-I)

135647  Jaber, M.; Hawk, R. (1982) The Acute Toxicity of Technical Grade PP021 to Mysid Shrimp: Report No. TMUE0024/B. (Unpublished study received Nov 22, 1983 under 10182-83; submitted by ICI Americas, Inc., Wilmington, DE; CDL:072156-J)

135649  Thompson, R.; Comber, M.; Hill, R. (1982) Fomesafen: Acute Toxici- ty of JF 7383 to Larvae of the Pacific Oyster: Study No. G018/C; Report No. BL/B/2219. (Unpublished study received Nov 22, 1983 under 10182-83; prepared by Imperial Chemical Industries PLC, Eng., submitted by ICI Americas, Inc., Wilmington, DE; CDL: 072156-L)

Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study

135644  Hill, R.; Caunter, J.; Cornish, S. (1983) Fomesafen: The Toxicity of an Aqueous Solution of Its Sodium Salt (JF7383) to Sheepshead Minnow ... Embryos and Larvae: Study No. J530/C; Report No. BL/ B/2293. (Unpublished study received Nov 22, 1983 under 10182- 83; prepared by Imperial Chemical Industries PLC, Eng., submit- ted by ICI Americas, Inc., Wilmington, DE; CDL:072156-G)

Acute oral toxicity in rats

15523  Bathe, R. (1973) Acute Oral LDI50^ of Technical CGA-24705 in the Rat: Project No. Siss 2979. (Unpublished study received Mar 1, 1974 under 5G1553; prepared by Ciba-Geigy, Ltd., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:094220-B)

158241  Kieczka, H. (1985) Report on the Study of Acute Oral Toxicity on the Rat ...: [BAS 530 04 H]: Project No. 10A123/85; Report No. 85/260. Unpublished study prepared by BASF Aktiengesellschaft. 10 p.

64314  Hofmann, H.T.; Freisberg, K.O. (1974) Acute Oral Toxicity of the Sodium Salt of 3-Isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-one- 2,2-dioxide to the Rat. (Translation from German; unpublished study received Jul 12, 1974 under 3G1309; prepared by BASF, W. Germany, submitted by BASF Wyandotte Corp., Parsippany, N.J.; CDL:092065-R)

92065  Mobil Chemical Company (1971) ?Nematocides for the Control of Nematodes in Sugarcane|. (Compilation; unpublished study, in- cluding published data, received Jun 25, 1972 under 2F1204; CDL: 091025-A)

164900  Henderson, C. (1981) PP021: Acute Oral Toxicity, Skin Irritation and Eye Irritation: CTL Report No. CTL/P/562. Unpublished study prepared by Imperial Chemical Industries Ltd., Central Toxicolo- gy Laboratory. 25 p.

164901  Henderson, C. (1980) PP021: Acute Toxicity and Local Irritation: CTL Report No. CTL/P/506. Unpublished study prepared by Imperial Chemical Industries Ltd., Central Toxicology Labora- tory. 43 p.

40340802  Kieczka, H. (1985) Report on the Study of Acute Oral Toxicity on the Rat Based on OECD of BAS 530 03H: Reg. Doc. #BASF 85/0258. Unpublished study prepared by BASF Aktiengesellschaft. 14 p.

40439201  Barber, J. (1987) Fluazifop-P-Butyl/Fomesafen: Acute Oral Toxicity to the Rat of a 0.75/1.0 lb/US gal Formulation: Rept. No. CTL/P/ 1971. Unpublished study prepared by Imperial Chemical Industries, Ltd. 27 p.

43236202  Duerden, L. (1994) Fomesafen: Acute Oral Toxicity to the Rat of a 120g/l ME Formulation: Lab Project Number: CTL/P/4371: AR5709. Unpublished study prepared by Zeneca Central Toxicology Lab. 49 p.

43949801  Lees, D.; Connolly, H. (1996) Fomesafen: Acute Oral Toxicity to the Rat of a 240 g/l SL Formulation: Lab Project Number: AR6152: CTL/P/4912. Unpublished study prepared by Zeneca Central Toxicology Lab. 59 p.

44030101  Robinson, P. (1996) Flexstar HL (Fomesafen): Acute Toxicity Study in Rats of a 225.57 g/l ME Formulation: Lab Project Number: AR6173: CTL/P/4949. Unpublished study prepared by Zeneca Central Toxicology Laboratory. 62 p.

44032401  Robinson, P. (1996) Fomesafen Sodium Salt Aqueous Concentrate: Acute Oral Toxicity Study in Rats of a 316.1 g/L MUP Formulation: Lab Project Number: AR6155: CTL/P/4979. Unpublished study prepared by Zeneca Central Toxicology Lab. 62 p.

44036702  Robinson, P. (1996) Twister: Fomesafen/Fenoxaprop/Fluazifop-p-Butyl: Acute (Oral) Toxicity Study in Rats of a 130.78/19.22/68.42 g/L ME Formulation: Lab Project Number: AR6174: CTL/P/4931. Unpublished study prepared by Zeneca Central Toxicology Lab. 73 p.

2-generation repro.-rat

144862  Tinston, D.; Bishop, L.; Hollis, K.; et al. (1984) Fomesafen: Two Generation Reproduction Study in the Rat: Report Nos. CTL/P/869 and CTL/P/869S. Unpublished study prepared by Imperial Chemical Industries PLC. 1052 p.

Registrant Submitted Non-guideline

135635 ICI Americas, Inc. (1983) Flex 2LC Herbicide (Containing Fomesafen). (Compilation; unpublished study, Nov 22, 1983 under 10182-83; CDL:072153-A)

46585104  Palmer, S.; Kendall, T.; Krueger, H. (2005) Oxyfluorfen: An Early Life-Stage Toxicity Test with the Fathead Minnow (Pimephales promelas) Under Ultraviolet Light Conditions. Project Number: 379A/114, 040442. Unpublished study prepared by Wildlife International, Ltd. 127 p.

47587101  Overmeyer, JP, Wall, SB, Chen, W, Henry, KS. (2008)  Supporting Data and Information for EPA’s Endangered Species Assessments. Syngenta Crop Protection, Inc. Greensboro, NC.

ECOTOX References

Caquet, T. ( 2006). Use of Carbon and Nitrogen Stable Isotope Ratios to Assess the Effects of Environmental Contaminants on Aquatic Food Webs.  Environ.Pollut. 141: 54-59.

	EcoReference No.: 95935

	Caquet, T., Deydier-Stephan, L., Lacroix, G., Le Rouzic, B., and Lescher-Moutoue, F. (2005). Effects of Fomesafen, Alone and in Combination with an Adjuvant, on Plankton Communities in Freshwater Outdoor Pond Mesocosms.  Environ.Toxicol.Chem. 24: 1116-1124.

	EcoReference No.: 87334

Krijt, J., Psenak, O., Vokurka, M., Chlumska, A., and Fakan, F. (2003). Experimental Hepatic Uroporphyria Induced by the Diphenyl-Ether Herbicide Fomesafen in Male DBA/2 Mice.  Toxicol.Appl.Pharmacol. 189: 28-38.

EcoReference No.: 95588

	Krijt, J., Stranska, P., Sanitrak, J., Chlumska, A., and Fakan, F. (1999). Liver Preneoplastic Changes in Mice Treated with the Herbicide Fomesafen.  Hum.Exp.Toxicol. 18: 338-344.

EcoReference No.: 95400

	Krijt, J., Van Holsteijn, I., Hassing, I., Vokurka, M., and Blaauboer, B. J. (1993). Effect of Diphenyl Ether Herbicides and Oxadiazon on Porphyrin Biosynthesis in Mouse Liver, Rat Primary Hepatocyte Culture and HepG2 Cells.  Arch.Toxicol. 67: 255-261.

EcoReference No.: 95026

Krijt, J., Vokurka, M., Sanitrak, J., and Janousek, V. (1994). Effect of Protoporphyrinogen Oxidase Inhibitors on Mammalian Porphyrin Metabolism.  ACS Symp.Ser. 559: 247-254.

EcoReference No.: 95589

	Krijt, J., Vokurka, M., Sanitrak, J., Janousek, V., Van Holsteijn, I., and Blaauboer, B. J. (1994). Effect of the Protoporphyrinogen Oxidase-Inhibiting Herbicide Fomesafen on Liver Uroporphyrin and Heptacarboxylic Porphyrin in Two Mouse Strains.  Food Chem.Toxicol. 32: 641-650.

EcoReference No.: 95399

Nemoto, M. C. M., Nahas, E., Pitelli, R. A., and Coelho, L. (2002). Germination and Mycelial Growth of Bipolaris euphorbiae Muchovej & Carvalho as Influenced by Herbicides and Surfactants.  Braz.J.Microbiol. 33: 352-357.

EcoReference No.: 95538

	Perschbacher, P. W., Stone, N., Ludwig, G. M., and Guy, C. B. Jr. (1997 ). Evaluation of Effects of Common Aerially-Applied Soybean Herbicides and Propanil on the Plankton Communities of Aquaculture Ponds.  Aquaculture 157: 117-122.

EcoReference No.: 53095

	Russo, J., Lefeuvre-Orfila, L., and Lagadic, L. (2007). Hemocyte-Specific Responses to the Peroxidizing Herbicide Fomesafen in the Pond Snail Lymnaea stagnalis (Gastropoda, Pulmonata).  Environ.Pollut. 146: 420-427.

EcoReference No.: 95100

	Russo, J. and Madec, L. (2007). Haemocyte Apoptosis as a General Cellular Immune Response of the Snail, Lymnaea stagnalis, to a Toxicant.  Cell Tissue Res. 328: 431-441.

EcoReference No.: 95590

 The classification is currently undergoing the QA/QC process within EFED.

1 Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides. Version II, 2/28/02.

  Clarification of label language provided in email from James Stone, Registration Division, OPP on May 1, 2008.  BASF labels (7969-82, 7969-83) contain the phrase “intended for use” in certain geographic areas, which is too vague for use outside the listed areas to be construed as misuse.

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Soil

invertebrates

Soil accumulation, leaching and runoff

Terrestrial

plants

Aquatic

plants

invertebrates

vertebrates

Attribute

Change

Habitat integrity

Reduced cover

Community change

Food chain

Reduction in primary productivity

Reduction in prey

Shift in community composition

Individual organisms

Reduced survival

Reduced growth

Reduced reproduction

Terrestrial

insects

Birds and Mammals

Receptors

b

a

Spray drift

Direct application

Runoff

Source

Stressor

Fomesafen applied to crop


[Federal Register Volume 87, Number 70 (Tuesday, April 12, 2022)]
[Notices]
[Pages 21657-21658]
[FR Doc No: 2022-07805]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-142-000]

Florida Gas Transmission Company, LLC; Notice of Request Under
Blanket Authorization and Establishing Intervention and Protest
Deadline

    Take notice that on March 30, 2022, Florida Gas Transmission
Company, LLC (FGT), 1300 Main St., Houston, Texas 77002, filed in the
above referenced docket a prior notice pursuant to sections 157.205,
157.208, 157.210, and 157.211 of the Commission's regulations under the
Natural Gas Act (NGA) and its blanket certificate issued in Docket No.
CP82-553-000 requesting authorization to: (1) Construct the
approximately 2.0-mile, 12-inch-diameter Brazoria County Lateral in
Brazoria County, Texas; (2) the new Rosharon--Brotman meter and
regulation station in Brazoria County, Texas; (3) various appurtenances
in Brazoria County, Texas; and (4) modify and uprate an existing
reciprocating compressor unit from 2,000 horsepower (hp) to 2,700 hp at
its Compressor Station 4 in Matagorda County, Texas (Brazoria County
Project). FGT states the project will enable it to deliver up to 68,000
million British thermal units per day of new firm transportation
service to Brotman Generating, LLC. FGT estimates the cost of the
Brazoria County Project to be approximately $11 million, all as more
fully set forth in the request which is on file with the Commission and
open to public inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this request should be directed to Blair
Lichtenwalter, Senior Director of Certificates, Florida Gas
Transmission Company, LLC, 1300 Main St., Houston, Texas 77002, by
telephone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, or by email at
[email protected].

Public Participation

    There are three ways to become involved in the Commission's review
of this project: You can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on June 6, 2022. How
to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\1\ any person \2\ or the Commission's staff may file a protest
to the request. If

no protest is filed within the time allowed or if a protest is filed
and then withdrawn within 30 days after the allowed time for filing a
protest, the proposed activity shall be deemed to be authorized
effective the day after the time allowed for protest. If a protest is
filed and not withdrawn within 30 days after the time allowed for
filing a protest, the instant request for authorization will be
considered by the Commission.
---------------------------------------------------------------------------

    \1\ 18 CFR 157.205.
    \2\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\3\ and must be submitted by
the protest deadline, which is June 6, 2022. A protest may also serve
as a motion to intervene so long as the protestor states it also seeks
to be an intervenor.
---------------------------------------------------------------------------

    \3\ 18 CFR 157.205(e).
---------------------------------------------------------------------------

Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is June 6, 2022. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \4\ 18 CFR 385.214.
    \5\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before June 6, 2022. The filing of a comment alone will not serve
to make the filer a party to the proceeding. To become a party, you
must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP22-142-000 in your submission. The Commission encourages electronic
filing of submissions.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select ``General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing.''
    The Commission's eFiling staff are available to assist you at (202)
502-8258 or [email protected]
    (2) You can file a paper copy of your submission. Your submission
must reference the Project docket number CP22-142-000.
    To mail via USPS, use the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    To mail via any other courier, use the following address: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at:
[email protected], 1300 Main St., Houston, Texas
77002. Any subsequent submissions by an intervenor must be served on
the applicant and all other parties to the proceeding. Contact
information for parties can be downloaded from the service list at the
eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission 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. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: April 6, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-07805 Filed 4-11-22; 8:45 am]
BILLING CODE 6717-01-P


From:
Self, Traci I<EMAIL_ADDRESS>Sent:
Thursday, September 15, 2016 3:17 PM
To:
Jones, DonnaLee<EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Cc:
Zavoda, Rich<EMAIL_ADDRESS>Shelton, Randy E<EMAIL_ADDRESS>Subject:
ICR proposed testing schedule- ArcelorMittal Monessen LLC.

Dr. Jones,
Attached is the proposed testing schedule for the Monessen facility.  I apologize for the delay in responding.
As you know, we had several technical issues with the testing and engaged in a dialogue with EPA to resolve these issues.    We have worked diligently to solicit and review proposals to conduct the Coke ICR testing.  However, the open technical issues resulted in the delay as summarized below.
Please note that on 6/9/16 we sent the attached request for the use of Prior Site Testing. You responded to our request on 6/24/16.
 On 6/10/16, we sent the attached correspondence with Quench Tower Testing Concerns that included challenges to the proposed quench tower testing based on the use of non-promulgated Test Methods. Please note that we are the only byproduct coke plant being requested to test a quench tower who has not previously tested a quench tower. You responded on 6/24/16. We shared your feedback with stack testing consultants and requested that their proposals be updated based on the latest information.
 We also shared your attached Frequently Asked Questions revision dated 8/30/16 with our contractors since new guidance was specifically provided for non-isokinetic testing of one-half of a quench tower using 12 traverse points from only one side of the tower that is specifically pertinent to the non-standard testing planned for Monessen's quench tower.  Please note that because of the location of the baffles and water sprays in the quench tower, it is not physically possible for the new ports that are to be located near the top of the tower to also meet the EPA Method 1 upstream and requirements criteria. There are still unresolved ongoing safety concerns with testing of the quench tower.  The temperature in the body of the steam cloud that can and does drift and bend over the top edge of the tower is 200 [o]F-210 [o]F and would scald workers on the test platform near the top of the quench tower which confirms that the testing crew cannot be on the testing platform during the quenching of hot coke.  This issue may not be resolved until testing is attempted and may impact the ability to complete the requested test.
We hope this helps explain why additional time was necessary to submit the testing schedule.  Please be advised that we will notify you of any significant changes in the schedule dates.
Traci I. Self | Environmental Manager
ArcelorMittal Monessen LLC

Monessen Coke Plant | 345 Donner Ave
Monessen, PA 15062

T +1<PHONE_NUMBER> | F +1<PHONE_NUMBER> |<EMAIL_ADDRESS>
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From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Wednesday, July 27, 2016 2:36 PM
To: Zavoda, Rich<EMAIL_ADDRESS>Self, Traci I<EMAIL_ADDRESS>Shelton, Randy E<EMAIL_ADDRESS>Cc: GABRIELLE RAYMOND<EMAIL_ADDRESS>Subject: testing schedule-Monessen

Hello All  -  We were looking through our records and we do not see any email or other correspondence relating to the ICR test schedule for your Monessen coke facility. Have you settled on a date yet? All other coke facilities replied by the deadline of 27-Jun-16. If you have already sent something by email, please resend. I apologize if I am the reason for the missing information.
_____________________________________________________________
Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D 243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
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"Reasonableness never fails to be appreciated."  - anon.