[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Rules and Regulations]
[Pages 70044-70046]
[FR Doc No: 2011-28752]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0721; Directorate Identifier 2010-NM-217-AD;
Amendment 39-16861; AD 2011-23-10]
RIN 2120-AA64

Airworthiness Directives; ATR-GIE Avions de Transport
R[eacute]gional Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Model ATR42 and ATR72 airplanes. This AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    One ATR operator has experienced in-flight elevator travel
limitations with unusual effort being necessary on pitch axis to
control the aeroplane, while the ``pitch mistrim'' message appeared
on the ADU [advisory display unit] display. The elevators seemed to
be jammed.
    During the post-flight inspection, it was discovered that the LH
[left-hand] elevator lower stop assembly was broken at the level of
the angles, which may have prevented the elevator to respond
normally to the flight control input.
    This condition, if not detected and corrected, could lead to
reduced control of the aeroplane.
* * * * *

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective December 15, 2011.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of December 15,
2011.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on August 5, 2011 (76
FR 47520). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    One ATR operator has experienced in-flight elevator travel
limitations with unusual effort being necessary on pitch axis to
control the aeroplane, while the ``pitch mistrim'' message appeared
on the ADU display. The elevators seemed to be jammed.
    During the post-flight inspection, it was discovered that the LH
elevator lower stop assembly was broken at the level of the angles,
which may have prevented the elevator to respond normally to the
flight control input.
    This condition, if not detected and corrected, could lead to
reduced control of the aeroplane.
    For the reasons described above, and as a precautionary measure,
this [EASA] AD requires a one-time [general visual and detailed]
inspection [for damaged angles] of the elevator hinge fittings and
the reporting of all findings. Depending on the results, further
action may be considered.

Corrective actions also include replacement of damaged angles with
serviceable parts; and a detailed inspection of adjacent areas for
damage, and repair if necessary. You may obtain further information by
examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (76 FR 47520), August 5,
2011) or on the determination of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.

    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 86 products of U.S. registry.
We also estimate that it will take about 4 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $29,240, or $340 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 60 work-hours and require parts costing $960, for a cost of
$6,060 per product. We have no way of determining the number of
products that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (76 FR 47520, August 5,
2011), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2011-23-10 ATR-GIE Avions de Transport R[eacute]gional: Amendment
39-16861. Docket No. FAA-2011-0721; Directorate Identifier 2010-NM-
217-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective December
15, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to ATR-GIE Avions de Transport
R[eacute]gional Model ATR42-200, -300, -320, and -500 airplanes, all
manufacturer serial numbers (MSN) up to MSN 643 inclusive; and Model
ATR72-101, -102, -201, -202, -211, -212, and -212A airplanes, all
MSNs up to MSN 728 inclusive; certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 55:
Stabilizers.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    One ATR operator has experienced in-flight elevator travel
limitations with unusual effort being necessary on pitch axis to
control the aeroplane, while the ``pitch mistrim'' message appeared
on the ADU [advisory display unit] display. The elevators seemed to
be jammed.
    During the post-flight inspection, it was discovered that the LH
[left-hand] elevator lower stop assembly was broken at the level of
the angles, which may have prevented the elevator to respond
normally to the flight control input.
    This condition, if not detected and corrected, could lead to
reduced control of the aeroplane.
* * * * *

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 6 months after the effective date of this AD, perform
a general visual inspection of the inboard hinge fitting area and a
detailed inspection of lower stop angles of the inboard hinge
fittings on both LH and right-hand (RH) elevators, in accordance
with the Accomplishment Instructions of Avions de Transport
R[eacute]gional Service Bulletin ATR42-55-0014, dated May 11, 2010;
or Avions de Transport R[eacute]gional Service Bulletin ATR72-55-
1006, dated May 11, 2010; as applicable.
    (1) If any damaged angle is found during the inspection required
by paragraph (g) of this AD, before further flight, replace the
damaged angles with serviceable parts and accomplish a detailed
inspection of the adjacent areas to detect any damage, in accordance
with the Accomplishment Instructions of Avions de Transport
R[eacute]gional Service Bulletin ATR42-55-0014, dated May 11, 2010;
or Avions de Transport R[eacute]gional Service Bulletin ATR72-55-
1006, dated May 11, 2010; as applicable.
    (2) If any damage is detected in adjacent areas during the
inspection required by paragraph (g)(1) of this AD, before further
flight, repair the damage using a method approved by either the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; or European Aviation Safety Agency (EASA) (or its
delegated agent).
    (h) Submit a report of the findings (damaged angles found on the
LH and RH side elevator) of the inspection required by paragraph (g)
of this AD to ATR Engineering, Service Bulletin Group, 1 Allee
Pierre Nadot, 31712 Blagnac Cedex, France, at the applicable time
specified in paragraph (h)(1) or (h)(2) of this AD. The report must
include the MSN, accomplishment date, registration number, number of
flights, flight hours, inspection results, and performed actions. In
addition, return any damaged lower stop angles to ATR Engineering,
Service Bulletin Group, 1 Allee Pierre Nadot, 31712 Blagnac Cedex,
France.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.

    (2) If the inspection was done before the effective date of this
AD: Submit the report within 30 days after the effective date of
this AD.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (i) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, has the authority to approve AMOCs
for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch, send it to ATTN: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the local flight standards district
office/certificate holding district office. The AMOC approval letter
must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

Related Information

    (j) Refer to MCAI EASA Airworthiness Directive 2010-0138, dated
July 1, 2010; Avions de Transport R[eacute]gional Service Bulletin
ATR42-55-0014, dated May 11, 2010; and Avions de Transport
R[eacute]gional Service Bulletin ATR72-55-1006, dated May 11, 2010;
for related information.

Material Incorporated by Reference

    (k) You must use Avions de Transport R[eacute]gional Service
Bulletin ATR42-55-0014, dated May 11, 2010; or Avions de Transport
R[eacute]gional Service Bulletin ATR72-55-1006, dated May 11, 2010;
as applicable; to do the actions required by this AD, unless the AD
specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact ATR--
GIE Avions de Transport R[eacute]gional, 1, All[eacute]e Pierre
Nadot, 31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62 21;
fax +33 (0) 5 62 21 67 18; email<EMAIL_ADDRESS>
Internet http://www.aerochain.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on October 27, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-28752 Filed 11-9-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 75 (Tuesday, April 19, 2022)]
[Notices]
[Pages 23283-23287]
[FR Doc No: 2022-08282]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94709; File No. SR-LTSE-2022-03]

Self-Regulatory Organizations; Long-Term Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Adopt on a Permanent Basis the Pilot Rules for Market-Wide Circuit
Breakers in Rule 11.280

April 13, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 12, 2022, Long-Term Stock Exchange, Inc. (``LTSE'' or the
``Exchange'') 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\ 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

    LTSE proposes a rule change to adopt on a permanent basis the Pilot
Rules for Market-Wide Circuit Breakers in Rule 11.280.
    The text of the proposed rule change is available at the Exchange's
website at https://longtermstockexchange.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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in Sections A, B, and C below, of the
most significant aspects of such statements.

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

1. Purpose
    On March 16, 2022, the Commission approved the proposal of the New
York Stock Exchange LLC (``NYSE'') to adopt on a permanent basis the
pilot program for Market-Wide Circuit Breakers (``MWCB'') in NYSE Rule
7.12.\3\ The Exchange proposes to adopt on a permanent basis the Pilot
Rules for Market-Wide Circuit Breakers in Rule 11.280.
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    \3\ See Securities Exchange Act Release No. 94441 (March 16,
2022) (SR-NYSE-2021-40).
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Background
    The Market-Wide Circuit Breaker (``MWCB'') rules, including the
Exchange's Rule 11.280, provide an important, automatic mechanism that
is invoked to promote stability and investor confidence during periods
of significant stress when cash equities securities experience extreme
market-wide declines. The MWCB rules are designed to slow the effects
of extreme price declines through coordinated trading halts across both
cash equity and equity options securities markets.
    The cash equities rules governing MWCBs were first adopted in 1988
and, in 2012, all U.S. cash equity exchanges and FINRA amended their
cash equities uniform rules on a pilot basis (the ``Pilot Rules'').\4\
The Pilot Rules currently provide for trading halts in all cash equity
securities during a severe market decline as measured by a single-day
decline in theS&P 500 Index (``SPX'').\5\ Under the Pilot Rules, a
market-wide trading halt will be triggered if SPX declines in price by
specified percentages from the prior day's closing price of that index.
The triggers are set at three circuit breaker thresholds: 7%

(Level 1), 13% (Level 2), and 20% (Level 3). A market decline that
triggers a Level 1 or Level 2 halt after 9:30 a.m. and before 3:25 p.m.
would halt market-wide trading for 15 minutes, while a similar market
decline at or after 3:25 p.m. would not halt market-wide trading.
(Level 1 and Level 2 halts may occur only once a day.) A market decline
that triggers a Level 3 halt at any time during the trading day would
halt market-wide trading for the remainder of the trading day.
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    \4\ See Securities Exchange Act Release No. 67090 (May 31,
2012), 77 FR 33531 (June 6, 2012) (SR-BATS-2011-038; SR-BYX-2011-
025; SR-BX-2011-068; SR-CBOE-2011-087; SR-C2-2011-024; SR-CHX-2011-
30; SR-EDGA-2011-31; SR-EDGX-2011-30; SR-FINRA-2011-054; SR-ISE-
2011-61; SR-NASDAQ-2011-131; SR-NSX-2011-11; SR-NYSE-2011-48; SR-
NYSEAmex-2011-73; SR-NYSEArca-2011-68; SR-Phlx-2011-129) (``Pilot
Rules Approval Order''). LTSE adopted Pilot Rules as part of its
approval as a national securities exchange. See generally Securities
Exchange Act Release No. 85828 (May 10, 2019), 84 FR 21841 (May 15,
2019).
    \5\ The rules of the equity options exchanges similarly provide
for a halt in trading if the cash equity exchanges invoke a MWCB
Halt. See, e.g., NYSE Arca Rule 6.65-O(d)(4).
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    The Commission approved the Pilot Rules, the term of which was to
coincide with the pilot period for the Plan to Address Extraordinary
Market Volatility Pursuant to Rule 608 of Regulation NMS (the ``LULD
Plan''),\6\ including any extensions to the pilot period for the LULD
Plan.\7\ In April 2019, the Commission approved an amendment to the
LULD Plan for it to operate on a permanent, rather than pilot,
basis.\8\ In conjunction with the proposal to make the LULD Plan
permanent, the Exchange amended Rule 11.280 to untie the Pilot Rules'
effectiveness from that of the LULD Plan and to extend the Pilot Rules'
effectiveness to the close of business on October 18, 2020.\9\ The
Exchange subsequently amended Rule 11.280, to extend the Pilot Rules'
effectiveness for an additional year to the close of business on
October 18, 2021.\10\ The Exchange then further amended Rule 11.280, to
extend the Pilot Rules' effectiveness for another five months to the
close of business on March 18, 2022,\11\ and for another month to the
close of business on April 18, 2022.\12\
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    \6\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012). The LULD Plan provides a
mechanism to address extraordinary market volatility in individual
securities.
    \7\ See e.g. Securities Exchange Act Release Nos. 67090 (May 31,
2012), 77 FR 33531 (June 6, 2012) (SR-NYSE-2011-48) (Approval
Order); and 68784 (January 31, 2013), 78 FR 8662 (February 6, 2013)
(SR-NYSE-2013-10).
    \8\ See Securities Exchange Act Release No. 85623 (April 11,
2019), 84 FR 16086 (April 17, 2019).
    \9\ See Securities Exchange Act Release 87357 (October 18, 2019)
84 FR 57070 (October 24, 2019) (SR-LTSE-2019-03).
    \10\ See Securities Exchange Act Release No. 90125 (October 8,
2020), 85 FR 65114 (October 14, 2020) (SR-LTSE-2020-18).
    \11\ See Securities Exchange Act Release No. 93376 (October 18,
2021), 86 FR 58713 (October 22, 2021) (SR-LTSE-2021-06).
    \12\ See Securities Exchange Act Release No. 34-94403 (March 11,
2022), 87 FR 15279 (March 17, 2022) (SR-LTSE-2022-01)
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The MWCB Working Group's Study
    Beginning in February 2020, at the outset of the COVID-19 pandemic,
the markets experienced increased volatility, culminating in four MWCB
Level 1 halts on March 9, 12, 16, and 18, 2020. In each instance,
pursuant to the Pilot Rules, the markets halted as intended upon a 7%
drop in SPX and did not start the process to resume trading until the
prescribed 15-minute halt period ended.
    On September 17, 2020, the Director of the Commission's Division of
Trading and Markets asked the SROs to conduct a study of the design and
operation of the Pilot Rules and the LULD Plan during the period of
volatility in March 2020. In response to the request, the SROs created
a MWCB ``Working Group'' composed of SRO representatives and industry
advisers that included members of the advisory committees to both the
LULD Plan and the NMS Plans governing the collection, consolidation,
and dissemination of last-sale transaction reports and quotations in
NMS Stocks. The Working Group met regularly from September 2020 through
March 2021 to consider the Commission's request, review data, and
compile its study.
    On March 31, 2021, the MWCB Working Group submitted its study (the
``Study'') to the Commission.\13\ The Study included an evaluation of
the operation of the Pilot Rules during the March 2020 events and an
evaluation of the design of the current MWCB system. In the Study, the
Working Group concluded: (1) The MWCB mechanism set out in the Pilot
Rules worked as intended during the March 2020 events; (2) the MWCB
halts triggered in March 2020 appear to have had the intended effect of
calming volatility in the market, without causing harm; (3) the design
of the MWCB mechanism with respect to reference value (SPX), trigger
levels (7%/13%/20%), and halt times (15 minutes) is appropriate; (4)
the change implemented in Amendment 10 to the LULD Plan did not likely
have any negative impact on MWCB functionality; and (5) no changes
should be made to the mechanism to prevent the market from halting
shortly after the opening of regular trading hours at 9:30 a.m.
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    \13\ See Report of the Market-Wide Circuit Breaker (``MWCB'')
Working Group Regarding the March 2020 MWCB Events, submitted March
31, 2021 (the ``Study''), available at https://www.nyse.com/publicdocs/nyse/markets/nyse/Report_of_the_Market-Wide_Circuit_Breaker_Working_Group.pdf.
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    In light of those conclusions, the MWCB Working Group also made
several recommendations, including that (1) the Pilot Rules should be
made permanent without any changes, and (2) SROs should adopt a rule
requiring all designated Regulation SCI firms to participate in at
least one Level 1/Level 2 MWCB test each year and to verify their
participation via attestation.\14\
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    \14\ See id. at 46.
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Proposal To Make the Pilot Rules Permanent
    On July 16, 2021, NYSE proposed a rule change to make the Pilot
Rules permanent, consistent with the Working Group's
recommendations.\15\ On March 16, 2022, the Commission approved NYSE's
proposal.\16\
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    \15\ See Securities Exchange Act Release No. 92428 (July 16,
2021), 86 FR 38776 (July 22, 2021) (SR-NYSE-2021-40).
    \16\ See supra note 3.
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    Consistent with the Commission's approval of NYSE's proposal, the
Exchange now proposes that its MWCB Pilot Rules (i.e., paragraphs (a)-
(e) of Rule 11.280) be made permanent. To accomplish this, the Exchange
proposes to remove language in paragraph (a) describing the MWCB as
part of a pilot. The Exchange does not propose any changes to
paragraphs (b)-(e) of the Rule.
    Consistent with the Commission's approval of NYSE's proposal, the
Exchange proposes to add new paragraphs (f), (g), and (h) to Rule
11.280, as follows:

    (f) Market-Wide Circuit Breaker (``MWCB'') Testing
    (1) The Exchange will participate in all industry-wide tests of
the MWCB mechanism. Members designated pursuant to Rule 2.250 to
participate in mandatory testing of backup systems are required to
participate in at least one industry-wide MWCB test each year and to
verify their participation in that test by attesting that they are
able to or have attempted to:
    (A) Receive and process MWCB halt messages from the securities
information processors (``SIPs'');
    (B) receive and process resume messages from the SIPs following
a MWCB halt;
    (C) receive and process market data from the SIPs relevant to
MWCB halts; and
    (D) send orders following a Level 1 or Level 2 MWCB halt in a
manner consistent with their usual trading behavior.
    (2) To the extent that a Member participating in a MWCB test is
unable to receive and process any of the messages identified in
paragraph (f)(1)(A)-(D) of this Rule, its attestation should notify
the Exchange which messages it was unable to process and, if known,
why.
    (3) Members not designated pursuant to standards established in
Rule 2.250 are permitted to participate in any MWCB test.
    (g) In the event that a halt is triggered under this Rule
following a Level 1, Level 2, or Level 3 Market Decline, the
Exchange, together with other SROs and industry representatives (the
``MWCB Working Group''), will review such event. The MWCB Working
Group will prepare a report that documents its analysis and
recommendations and will provide that report to the Commission
within 6 months of the event.

    (h) In the event that there is (1) a Market Decline of more than
5%, or (2) an SRO implements a rule that changes its reopening
process following a MWCB Halt, the Exchange, together with the MWCB
Working Group, will review such event and consider whether any
modifications should be made to this Rule. If the MWCB Working Group
recommends that a modification should be made to this Rule, the MWCB
Working Group will prepare a report that documents its analysis and
recommendations and provide that report to the Commission.
2. Statutory Basis
    The Exchange believes that the proposal to make the Pilot Rules
permanent is consistent with Section 6(b) of the Act,\17\ in general,
and furthers the objectives of Section 6(b)(5) of the Act,\18\ in
particular, in that it is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in general
to protect investors and the public interest.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Pilot Rules set out in Rule 11.280(a)-(e) are an important,
automatic mechanism that is invoked to promote stability and investor
confidence during periods of significant market stress when securities
markets experience broad-based declines. The four MWCB halts that
occurred in March 2020 provided the exchanges, other SROs, and market
participants with real-world experience as to how the Pilot Rules
actually function in practice. Based on the Working Group's Study and
the Exchange's own analysis of those events, the Exchange believes that
making the Pilot Rules permanent would benefit market participants,
promote just and equitable principles of trade, remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and protect investors and the public interest.
    Specifically, the Exchange believes that making the Pilot Rules
permanent would benefit market participants, promote just and equitable
principles of trade, remove impediments to and perfect the mechanism of
a free and open market and a national market system, and protect
investors and the public interest, because the Pilot Rules worked as
intended during the March 2020 events. As detailed above, the markets
were in communication before, during, and after each of the MWCB Halts
that occurred in March 2020. All 9,000+ equity symbols were
successfully halted in a timely manner when SPX declined 7% from the
previous day's closing value, as designed. The Exchange believes that
market participants would benefit from having the Pilot Rules made
permanent because such market participants are familiar with the design
and operation of the MWCB mechanism set out in the Pilot Rules, and
know from experience that it has functioned as intended on multiple
occasions under real-life stress conditions. Accordingly, the Exchange
believes that making the Pilot Rules permanent would enhance investor
confidence in the ability of the markets to successfully halt as
intended when under extreme stress.
    The Exchange further believes that making the Pilot Rules permanent
would benefit market participants, promote just and equitable
principles of trade, remove impediments to and perfect the mechanism of
a free and open market and a national market system, and protect
investors and the public interest, because the halts that were
triggered pursuant to the Pilot Rules in March 2020 appear to have had
the intended effect of calming volatility in the market without causing
harm. As detailed above, after studying a variety of metrics concerning
opening and reopening auctions, quote volatility, and other factors,
the Exchange concluded that there was no significant difference in the
percentage of securities that opened on a trade versus on a quote for
the four days in March 2020 with MWCB Halts, versus the other periods
studied. In addition, while the post-MWCB Halt reopening auctions were
smaller than typical opening auctions, the size of those post-MWCB Halt
reopening auctions plus the earlier initial opening auctions in those
symbols was on average equal to opening auctions in January 2020. The
Exchange believes this indicates that the MWCB Halts on the four March
2020 days did not cause liquidity to evaporate. Finally, the Exchange
observes that while quote volatility was generally higher on the four
days in March 2020 with MWCB Halts as compared to the other periods
studied, quote volatility stabilized following the MWCB Halts at levels
similar to the January 2020 levels, and LULD Trading Pauses worked as
designed to address any additional volatility later in the day. From
this evidence, the Exchange concludes that the Pilot Rules actually
calmed volatility on the four MWCB Halt days in March 2020, without
causing liquidity to evaporate or otherwise harming the market. As
such, the Exchange believes that making the Pilot Rules permanent would
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and protect investors and the
public interest.
    The Exchange believes that that making the Pilot Rules permanent
without any changes would benefit market participants, promote just and
equitable principles of trade, remove impediments to and perfect the
mechanism of a free and open market and a national market system, and
protect investors and the public interest, because the current design
of the MWCB mechanism as set out in the Pilot Rules remains
appropriate. As detailed above, the Exchange considered whether SPX
should be replaced as the reference value, whether the current trigger
levels (7%/13%/20%) and halt times (15 minutes for Level 1 and 2 halts)
should be modified, and whether changes should be made to prevent the
market from halting shortly after the opening of regular trading hours
at 9:30 a.m., and concluded that the MWCB mechanism set out in the
Pilot Rules remains appropriate, for the reasons cited above. The
Exchange believes that public confidence in the MWCB mechanism would be
enhanced by the Pilot Rules being made permanent without any changes,
given investors' familiarity with the Pilot Rules and their successful
functioning in March 2020.
    The Exchange believes that proposed paragraph (f) regarding MWCB
testing is designed to promote just and equitable principles of trade,
to remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general to protect
investors and the public interest. The Working Group recommended that
all cash equities exchanges adopt a rule requiring all designated
Regulation SCI firms to participate in MWCB testing and to attest to
their participation. The Exchange believes that these requirements
would promote the stability of the markets and enhance investor
confidence in the MWCB mechanism and the protections that it provides
to the markets and to investors. The Exchange further believes that
requiring firms participating in a MWCB test to identify any inability
to process messages pertaining to such MWCB test would contribute to a
fair and orderly market by flagging potential issues that should be
corrected. The Exchange would preserve such attestations pursuant to
its obligations to retain books and records of the Exchange.\19\
---------------------------------------------------------------------------

    \19\ See 17 CFR 240.17a-1.
---------------------------------------------------------------------------

    The Exchange believes that proposed paragraph (g) would benefit
market participants, promote just and equitable

principles of trade, remove impediments to and perfect the mechanism of
a free and open market and a national market system, and protect
investors and the public interest. Having the MWCB Working Group review
any halt triggered under Rule 11.280 and prepare a report of its
analysis and recommendations would permit the Exchange, along with
other market participants and the Commission, to evaluate such event
and determine whether any modifications should be made to Rule 11.280
in the public interest. Preparation of such a report within 6 months of
the event would permit the Exchange, along with the MWCB Working Group,
sufficient time to analyze such halt and prepare their recommendations.
    The Exchange believes that proposed paragraph (h) would benefit
market participants, promote just and equitable principles of trade,
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and protect investors and the
public interest. Having the MWCB Working Group review instances of a
Market Decline of more than 5% or an SRO implementing a rule that
changes its reopening process following a MWCB Halt would allow the
MWCB Working Group to identify situations where it recommends that Rule
11.280 be modified in the public interest. In such situations where the
MWCB Working Group recommends that a modification should be made to
Rule 11.280, the MWCB Working Group would prepare a report that
documents its analysis and recommendations and provide that report to
the Commission, thereby removing impediments to and perfecting the
mechanism of a free and open market and a national market system while
protecting investors and the public interest.
    For the foregoing reasons, the Exchange believes that the proposed
change is consistent with the Act.

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 not necessary or appropriate in
furtherance of the purposes of the Act. The proposed change is not
intended to address competition, but rather, makes permanent the
current MWCB Pilot Rules for the protection of the markets. The
Exchange believes that making the current MWCB Pilot Rules permanent
would have no discernable burden on competition at all, since the Pilot
Rules have already been in effect since 2012 and would be made
permanent without any changes. Moreover, because the MWCB mechanism
contained in the Pilot Rules requires all exchanges and all market
participants to cease trading at the same time, making the Pilot Rules
permanent would not provide a competitive advantage to any exchange or
any class of market participants.
    Further, the Exchange understands that the other SROs will submit
substantively identical proposals to the Commission. Thus, the proposed
rule change will help to ensure consistency across SROs without
implicating any competitive issues.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(iii) \20\ of the Act and Rule 19b-4(f)(6) thereunder \21\
in that it effects a change that: (i) Does not significantly affect the
protection of investors or the public interest; (ii) does not impose
any significant burden on competition; and (iii) by its terms, does not
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate if consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \21\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \22\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\23\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange asked
that the Commission waive the 30 day operative delay so that the
proposal may become operative immediately upon filing. Waiver of the
30-day operative delay would allow the Exchange to immediately provide
the protections included in this proposal in the event of a MWCB halt,
which is consistent with the protection of investors and the public
interest. Therefore, the Commission hereby waives the 30-day operative
delay and designates the proposed rule change as operative upon
filing.\24\
---------------------------------------------------------------------------

    \22\ 17 CFR 240.19b-4(f)(6).
    \23\ 17 CFR 240.19b-4(f)(6)(iii).
    \24\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \25\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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 protected]. Please include
File Number SR-LTSE-2022-03 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-LTSE-2022-03. 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-LTSE-2022-03
and should be submitted on or before May 10, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
---------------------------------------------------------------------------

    \26\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-08282 Filed 4-18-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 20, 2005 (Volume 70, Number 202)]
[Notices]
[Page 61123-61124]
[DOCID:fr20oc05-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2738-054-NY]

New York State Electric & Gas Corporation; Notice of Availability
of Environmental Assessment

October 6, 2005.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, 18 CFR part
380 (Order No. 486, 52 FR 47879), the Office of Energy Projects has
reviewed the application for a new license for the Saranac River
Hydroelectric Project, located on the Saranac River, in Clinton County,
New York, and has prepared an Environmental Assessment (EA). In the EA,
Commission staff analyze the potential environmental effects of
relicensing the project and conclude that issuing a new license for the
project, with appropriate environmental measures, would not constitute
a major Federal action that would significantly affect the quality of
the human environment.
    A copy of the EA is on file with the Commission and is available
for public inspection. The EA may also be viewed on the Commission's
Web site at http://www.ferc.gov using the ``eLibrary'' link. Enter the

docket number excluding the last three digits in the docket number
field to access documents. For assistance, contact FERC Online Support
at

<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,

(202) 502-8659.
    Any comments should be filed within 30 days from the issuance date
of this notice, and should be addressed to the Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Room 1-A,
Washington, DC 20426. Please affix ``Saranac River Project No. 2738''
to all comments. Comments may be filed electronically via Internet in
lieu of paper. The Commission strongly encourages electronic filings.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site under the ``eFiling'' link. For further information, contact
Tom Dean at<PHONE_NUMBER>.

 Magalie R. Salas,
Secretary.
 [FR Doc. E5-5788 Filed 10-19-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 169 (Tuesday, September 1, 2015)]
[Notices]
[Page 52775]
[FR Doc No: 2015-21656]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4235-DR; Docket ID FEMA-2015-0002]

Commonwealth of the Northern Mariana Islands; Amendment No. 2 to
Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster for the
Commonwealth of the Northern Mariana Islands (FEMA-4235-DR), dated
August 5, 2015, and related determinations.

DATES: Effective Date: August 24, 2015.

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, in a letter
dated August 24, 2015, the President amended 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 et seq. (the ``Stafford Act''), in a letter to W. Craig
Fugate, Administrator, Federal Emergency Management Agency, Department
of Homeland Security, under Executive Order 12148, as follows:

    I have determined that the damage in certain areas of the
Commonwealth of the Northern Mariana Islands resulting from Typhoon
Soudelor during the period of August 1-3, 2015, is of sufficient
severity and magnitude that special cost sharing arrangements are
warranted regarding Federal funds provided under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act'').
    Therefore, I amend my declaration of August 5, 2015, to
authorize Federal funds for all categories of Public Assistance,
Hazard Mitigation, and Other Needs Assistance under Section 408 of
the Stafford Act at 90 percent of total eligible costs.
(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.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2015-21656 Filed 8-31-15; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57902-57903]
[FR Doc No: 2016-20305]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0427; FRL-9950-47]

Public Meeting; Data That Support the Registration of Plant-
Incorporated Protectants (PIPs)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) will hold a one-day
public symposium on the types of data that support the registration of
plant-incorporated protectants (PIPs). The symposium is open to the
public and can be attended in person and online.

DATES: The meeting will be held on September 29, 2016, from
approximately 9:00 a.m. to 5:00 p.m. Sign-in begins at 8:30 a.m.
    If you wish to participate in person, we encourage registration on
or before September 26, 2016.
    If you wish to attend in person and would like to request
accommodation for a disability, please follow the registration link
under III. How Can I Request to Participate in this Meeting? and follow
the prompts for in-person attendance. In order to give EPA as much time
as possible to process your request, we encourage participants to
request accommodations at least 10 days prior to the meeting.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center Room S1204/06, Lobby Level, One Potomac Yard
(South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: Wiebke Tapken, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; main 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. This action may,
however, be of interest to persons who are or may be required to
conduct testing of pesticidal

substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) and/
or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2016-0427, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. Background

    The purpose of the symposium is to provide a forum for
biotechnology developers, the agricultural sector, researchers, and the
public, to receive first-hand information on the scope of the
scientific pesticide application review process that determines the
safety of PIPs, including the type of data EPA typically needs to make
a regulatory decision. We anticipate that this symposium and the
information being presented will promote transparency, clarity, and
consistency for EPA's regulation of PIPs. The symposium will provide
opportunities for the audience to ask questions on each of the topics
covered. EPA is not requesting public comment or advice on the
materials being presented during the symposium. Following the meeting,
the materials that will be presented will be made available in docket
ID No. EPA-HQ-OPP-2016-0427.

III. How can I request to participate in this meeting?

    No fees are associated with the attendance of the symposium. You
may request to participate online and in-person by referring to this
link and following the prompts: https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/plant-incorporated-protectants-data-requirements.

    Authority: 7 U.S.C. 136.

    Dated: August 16, 2016.
Mark A. Hartman,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. 2016-20305 Filed 8-23-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 49 (Thursday, March 12, 2020)]
[Proposed Rules]
[Pages 14449-14451]
[FR Doc No: 2020-05177]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 299

[Docket No. FRA-2019-0068, Notice No. 2]
RIN 2130-AC84

Texas Central Railroad High-Speed Rail Safety Standards

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Proposed rule; announcement of public hearings.

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

SUMMARY: On March 10, 2020, FRA published a notice of proposed
rulemaking (NPRM) that would establish safety standards for the Texas
Central Railroad (TCRR) high speed rail system. FRA is announcing three
public hearings to provide members of the public an opportunity to
provide oral comments on the proposed safety requirements.

DATES: The public hearings will be conducted on the following dates at
the following times (members of the public will be able to access the
hearing location 30 minutes prior to the start of each hearing):
     Dallas, TX: March 31, 2020, from 4 p.m. (CDT) to 9 p.m.
(CDT).
     Navasota, TX: April 1, 2020, from 5 p.m. (CDT) to 9 p.m.
(CDT).
     Houston, TX: April 2, 2020, from 5 p.m. (CDT) to 9 p.m.
(CDT).

    The comment period for the proposed rule published on March 10,
2020 (85 FR 14036), closes on May 11, 2020. Written comments in
response to views or information provided at the public hearings must
be received by that date.

ADDRESSES: The public hearings will be at the following locations:
     Dallas, TX: Waxahachie Civic Center, 2000 Civic Center Ln,
Waxahachie, TX 75165.
     Navasota, TX: Grimes County Fairgrounds and Expo Center,
5220 FM 3455, Navasota, Texas 77868.
     Houston, TX: Waller High School Auditorium, 20950 Field
Store Rd, Waller, TX 77484.
    Written comments in response to views or information provided at
the public hearings may be submitted by any of the methods listed in
the NPRM. See 85 FR 14036.

FOR FURTHER INFORMATION CONTACT: Mr. Kenton Kilgore, Program Analyst,
U.S. Department of Transportation, Federal Railroad Administration,
Office of Railroad Safety, 1200 New Jersey Avenue SE, Washington, DC
20590 (telephone:<PHONE_NUMBER>; email: Kenton.Kilgore@dot.gov).

SUPPLEMENTARY INFORMATION:

Prior Public Engagement as Part of the Environmental Review Process

    During the environmental review process, FRA provided many
opportunities for public involvement and engagement, beginning with 12
public scoping meetings held in various locations in Texas in October
and December of 2014. On December 22, 2017, FRA published the draft
environmental impact statement (EIS) for this project. FRA then
conducted 11 public hearings regarding the draft EIS along the proposed
alignment. In addition to providing a forum to present oral comments
and submit written comments, the public hearings for the draft EIS
included an information session where the public had an opportunity to
review project exhibits (such as maps of the proposed alignments) and
engage with FRA and TCRR regarding the environmental review. During the
77-day comment period on the draft EIS, which closed on March 9, 2018,
FRA received a total of 21,173 submissions from approximately 6,000
individuals, agencies, elected officials, businesses and
organizations.\1\
---------------------------------------------------------------------------

    \1\ FRA is considering all comments received and will provide
responses to the comments submitted during the public comment period
for the draft EIS in the final EIS. FRA anticipates releasing the
final EIS in late spring of this year.
---------------------------------------------------------------------------

Public Hearings To Receive Oral Comment on the NPRM--Purpose and Scope

    As stated above, FRA published the NPRM proposing safety
requirements specific to the TCRR high-speed rail system, and opened
the public comment period on March 10, 2020. See 85 FR 14036. The
public comment period for the NPRM is scheduled to close on May 11,
2020. FRA is holding three public hearings to receive oral comment on
the provisions proposed in the NPRM; however, no information session
will be conducted. During the hearing conducted in Dallas, TX, FRA will
also conduct proceedings under 49 U.S.C. 20306, which are discussed
further below.
    Members of the public are invited to present oral statements, and
to offer information and views about the technical safety requirements
proposed in the NPRM at the upcoming hearings. Unlike the public
hearings conducted for the environmental review, the purpose and scope
of these hearings is to receive oral comments on the technical safety
requirements proposed in the NPRM, along with the associated economic
analysis. The NPRM public hearings are not a forum for debate on the
project as a whole or to provide comment on proceedings outside of the
NPRM, such as the environmental review process. Rather, the NPRM
hearings are meant to help inform FRA's decisions regarding the
technical safety requirements proposed in the NPRM, and associated
economic analysis. The hearings on the NPRM will be conducted by
representatives of FRA designated under FRA's Rules of Practice (49 CFR
211.25). The rules of evidence will not apply. The hearings will be
informal, which means that they are non-adversarial proceedings and
there will be no cross examination of persons presenting statements or
offering evidence. These hearings are an opportunity to provide
relevant technical information to FRA regarding the proposed
requirements, and associated economic analysis, and a mechanism to
place that information on the record for review and consideration by
FRA.

Exemption for Technological Improvements--Proceedings Under 49 U.S.C.
20306

    As noted above, as part of the hearing conducted in Dallas, TX, FRA
will conduct proceedings under 49 U.S.C. 20306 to determine whether to
invoke its discretionary authority to provide relief to TCRR from
certain requirements of 49 U.S.C. ch. 203 for its planned operation of
new high-speed trainsets built to the proposed requirements contained
in the NPRM. FRA will conduct these proceedings during the first hour
of the hearing.
    Under 49 U.S.C. 20306, FRA may exempt TCRR from the above-
identified statutory requirements based on evidence received and
findings developed at a hearing demonstrating that the statutory
requirements ``preclude the development or implementation of more
efficient railroad transportation equipment or other transportation
innovations under existing law.'' Accordingly, to receive such evidence
and develop findings to determine whether FRA should invoke its
discretionary authority under 49 U.S.C. 20306 in this instance,
proceedings will be conducted as part of the public hearing scheduled
for Tuesday, March 31, 2020, at 4:00 p.m. (CDT) at the Waxahachie Civic
Center. Interested parties are invited to present oral statements at
the hearing regarding the technical information presented in the NPRM
addressing the application of 49 U.S.C. ch. 203. Again, as mentioned
above, this part of the proceedings will be an informal hearing limited
in scope to the technical information presented regarding the proposed
requirements concerning safety appliances, and is not a forum to
generally debate the project or other proceedings outside of the
rulemaking.
    In its rulemaking petition, submitted April 16, 2016, TCRR
requested FRA exercise its authority under 49 U.S.C. 20306 to exempt
its high-speed passenger rail trainsets from the requirements of 49
U.S.C. 20302, mandating that railroad vehicles be equipped with (1)
secure sill steps and efficient hand brakes; (2) secure grab irons or
handholds on vehicle ends and sides for greater security to individuals
coupling and uncoupling vehicles; and (3) the standard height of
drawbars. See 49 U.S.C. 20302(a)(1)(B), (a)(2), and (a)(3).
    In support of its request for an exemption, TCRR noted in its
petition that safety appliances such as sill steps or end or side
handholds are typically used in conventional North American practice by
maintenance personnel who ride the side of trainsets in yards or
maintenance facilities for marshalling operations. The N700 series
trainset, as proposed in the NPRM, is a fixed-consist trainset where
trainset make-up only occurs in defined locations where maintenance
personnel can safely climb on, under, or between the equipment,
consistent with the protections afforded under 49 CFR part 218.
Additionally, the leading and trailing ends of the

N700 series trainset are equipped with an automatic coupler located
behind a removable shroud. These couplers, as proposed by TCRR, will
only be used for rescue operations in accordance with TCRR's operating
rules, and provide for the safe coupling of one trainset to another
(i.e., each end will have automatic self-centering couplers that couple
to other trainsets on impact and uncouple by mechanisms that do not
require a person to go between trainsets or the activation of a
traditional uncoupling lever). Further, as proposed, level boarding
will be provided at all locations in trainset maintenance facilities
where crew and maintenance personnel are normally required to access or
disembark trainsets. Moreover, because the equipment is a fixed-consist
trainset in which individual vehicles are semi-permanently coupled and,
as noted above, individual vehicles can only be disconnected in repair
facilities where personnel can work on, under, or between units under
protections consistent with 49 CFR part 218, having drawbars at the
statutorily prescribed height is unnecessary.
    As such, there is not a functional need to equip the ends of the
trainsets with sill steps, end or side handholds, or uncoupling levers.
As this technology is intended to operate at high-speeds, the inclusion
of these appurtenances would have a significant and detrimental impact
on the aerodynamics of the trainset. This increase in the aerodynamic
footprint would negatively impact both efficiency and aerodynamic noise
emissions.
    TCRR also noted that trainset securement will be provided by the
use of wheel chocks in addition to stringent operating rules and
procedures, which will be consistent with the service-proven procedures
utilized on the Tokaido Shinkansen. Additionally, as proposed in the
NPRM, TCRR will be required to demonstrate, as part of its vehicle
qualification procedures, that the procedures effectively secure the
trainset (see proposed Sec.  299.607).
    In sum, TCRR asserted that requiring compliance with the identified
statutory requirements would serve to preclude the development or
implementation of more efficient railroad transportation equipment or
other transportation innovations under existing law.

Procedures for Public Participation in the Hearings on the NPRM

    At each NPRM hearing, FRA representatives will make opening
statements reiterating the scope of the hearing as described above, and
any relevant procedures to be followed at the hearing. Following FRA's
opening statements, there will be an opportunity for members of the
public to present a brief oral comment on the record. Time permitting,
FRA will allow everyone who desires to provide an oral comment at a
hearing the opportunity to do so. Those members of the public wishing
to make a statement at the hearing will be required to sign up to do so
at the hearing location prior to the commencement of the proceeding.
    FRA will generally limit the duration of individual presentations,
as necessary, to afford all persons who wish to speak the opportunity
to do so. However, during the proceedings under 49 U.S.C. 20306, in
Dallas, TX, TCRR may be afforded additional time to present information
to support its request for FRA to invoke its discretionary authority
under 49 U.S.C. 20306.
    FRA will announce additional procedures that may be necessary for
the conduct of each hearing, at each hearing, to include the specific
time limit for individual presentations, which will be based on the
number of people who sign up to provide comment at each hearing. FRA
reserves the right to limit participation in the hearing of persons who
exceed their allotted time, or who discuss topics or issues outside the
scope of the proposed rulemaking.
    There will be a court reporter present to record and transcribe
oral comments presented at each hearing verbatim. FRA will add the
transcripts of the hearings to the public docket in this rulemaking
proceeding.
    For information on facilities or services for persons with
disabilities, or to request special assistance at the hearing, contact
FRA Program Analyst, Mr. Kenton Kilgore, by telephone, email, or in
writing, at least 5 working days before the date of the hearing by one
of the means listed in the FOR FURTHER INFORMATION CONTACT section.

John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2020-05177 Filed 3-10-20; 4:15 pm]
 BILLING CODE 4910-06-P


[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)]
[Notices]
[Pages 56033-56035]
[FR Doc No: 2017-25457]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6526]

Grandfathering Policy for Packages and Homogenous Cases of
Product Without a Product Identifier; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Grandfathering Policy for Packages and Homogenous Cases of Product
Without a Product Identifier.'' This draft guidance specifies whether
and under what circumstances packages and homogenous cases of product
not labeled with a product identifier shall be exempted, as
grandfathered, from certain requirements of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments on the draft
guidance by January 26, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
concerning the collection of information proposed in the draft guidance
by January 26, 2018.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the

manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6526 for ``Grandfathering Policy for Packages and Homogenous
Cases of Product Without a Product Identifier; Draft Guidance for
Industry.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Abha Kundi, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Grandfathering Policy for Packages and Homogenous Cases of
Product Without a Product Identifier.'' On November 27, 2013, the Drug
Supply Chain Security Act (DSCSA) (Title II of Pub. L. 113-54) was
signed into law. Section 202 of the DSCSA added section 582 to the FD&C
Act, which established product tracing requirements for manufacturers,
repackagers, wholesale distributors, and dispensers. The DSCSA phases
in its requirements over a period of 10 years.
    A critical set of phased product tracing requirements outlined in
section 582 of the FD&C Act (21 U.S.C. 360eee-1) relate to the product
identifier. Among its provisions, section 582 requires that each
package and homogenous case of product in the pharmaceutical
distribution supply chain bear a product identifier that is encoded
with the product's standardized numerical identifier, lot number, and
expiration date by specific dates. Under the statute, manufacturers
must begin affixing or imprinting a product identifier to each package
and homogenous case of a product intended to be introduced into
commerce no later than November 27, 2017. Repackagers are required to
do the same no later than November 27, 2018.
    Sections 582(c)(2), (d)(2), and (e)(2)(A)(iii) of the FD&C Act
restrict trading partners' ability to engage in transactions involving
packages and homogenous cases of product that are not labeled with a
product identifier after specific dates. Beginning November 27, 2018,
repackagers may not engage in a transaction involving a package or
homogenous case of a product that is not encoded with a product
identifier. Similar restrictions go into effect for wholesale
distributors and dispensers on November 27, 2019, and November 27,
2020, respectively.
    Section 582(a)(5)(A) of the FD&C Act gives FDA authority to exempt
packages and homogenous cases of product without a product identifier
from the product tracing requirements discussed above. We are required
to issue guidance that specifies whether and under what circumstances
we will exercise this authority. The draft guidance addresses this
requirement. As explained in the draft guidance, only packages and
homogenous cases of product that are in the pharmaceutical distribution
supply chain at the time of the effective date of the requirements of
section 582 are eligible for an exemption under section 582(a)(5)(A).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the
grandfathering policy for packages and homogenous cases of product
without a product identifier. Guidance documents generally do not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. For this
particular document, section 582 of the FD&C Act gives FDA authority to
issue binding guidance specifying the circumstances under which
packages and homogenous cases of product that are not labeled with a
product identifier shall be exempted from the requirements of section
582 of the FD&C Act. Thus, insofar as section IV of this

guidance specifies the circumstances under which packages and
homogenous cases of product that are not labeled with a product
identifier and that are in the pharmaceutical distribution supply chain
at the time of the effective date of the requirements of section 582 of
the FD&C Act shall be exempted from certain requirements of section
582, it will have binding effect upon finalization.

II. Electronic Access

    Persons with access to the internet may obtain the guidance
document at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25457 Filed 11-24-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22620-22621]
[FR Doc No: 2016-08900]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1109]

Tobacco Farm Site Tours Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco
Products (CTP), is announcing an invitation for participation in its
voluntary Tobacco Farm Site Tours Program. This program is intended to
give CTP staff an opportunity to visit farms that grow tobacco for sale
to tobacco product manufacturers in order to gain a better
understanding of tobacco farming and the processes involved in curing
and preparing tobacco intended for sale to tobacco product
manufacturers. This program is not an FDA regulatory inspection, and
tobacco farms are not regulated entities unless they are also a tobacco
product manufacturer or controlled by a tobacco product manufacturer.
The purpose of this notice is to invite parties interested in
participating in the Tobacco Farm Site Tours Program to submit requests
to CTP.

DATES: Submit either an electronic or written request for participation
in this program by June 17, 2016. See section IV of this document for
information on requests for participation.

ADDRESSES: If your farm is interested in offering a site visit, please
submit a request either electronically to http://www.regulations.gov or
in writing to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Office of Science,
Center for Tobacco Products, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 5426, Silver Spring, MD 20993-0002, 1-
877-287-1373, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Pub. L. 111-31) into law, amending
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA
authority to regulate tobacco product manufacturing, distribution, and
marketing.
    CTP's Office of Science is conducting the Tobacco Farm Site Tours
Program to provide its staff an opportunity to visit farms that grow
tobacco for sale to tobacco product manufacturers (a ``tobacco product
manufacturer'' is defined as any person, including any repacker or
relabeler, who manufactures, fabricates, assembles, processes, or
labels a tobacco product, or imports a finished tobacco product for
sale or distribution in the United States (section 900(20) of the FD&C
Act (21 U.S.C. 387(20))). Although farms that grow tobacco are not FDA-
regulated entities unless they are also a tobacco product manufacturer
or controlled by a tobacco product manufacturer (see section 901(c)(2)
of the FD&C Act (21 U.S.C. 387a(c)(2))), tobacco farm site visits will
aid the Agency in gaining a better understanding of tobacco farming and
the processes involved in curing and preparing tobacco leaf intended
for sale to tobacco product manufacturers. The goal for the Tobacco
Farm Site Tours Program is for CTP staff to gain firsthand exposure to
tobacco farming practices, including cultivation, harvesting, curing,
and preparation for sale of tobacco leaf to tobacco product
manufacturers.

II. Description of Tobacco Farm Site Tours Program

    In the Tobacco Farm Site Tours Program, small groups of CTP staff
plan to observe the operations of farms that grow tobacco for sale to
tobacco product manufacturers. Please note that FDA does not regulate
these farms and the Tobacco Farm Site Tours Program is not an
inspection of facilities to determine compliance with the FD&C Act;
rather, this program is meant to educate CTP staff and improve their
understanding of tobacco farming. It is anticipated that the tobacco
farm site tours will take place in the fall of 2016.

III. Site Selection

    CTP hopes to be able to tour small, medium, and large farms, and
farms that grow tobacco for different kinds of tobacco products. Final
site selections will be based on the availability of funds and
resources for the relevant fiscal year as well as the desire to visit a
wide variety of types of tobacco farms. FDA plans on visiting nine or
fewer farms. All FDA travel expenses associated with the farm site
tours will be the responsibility of FDA.

IV. Requests for Participation

    To aid in site selection, your request for participation should
include the following information:
     A description of your farm, including the size of the
farm;
     A list of the type(s) of tobacco grown and the kinds of
tobacco product manufacturers to whom you sell tobacco;
     The physical address(es) of the site(s) for which you are
submitting a request; and
     A proposed 1-day tour agenda.
    Identify requests for participation with the docket number found in
brackets in the heading of this document. Received requests are
available for public examination in the Division of Dockets Management
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08900 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P


                      Emerald-Kalama Bio solids Delisting
                    Preliminary Information Needs Analysis

Basic Study Questions
 Define Constituents of Concern for delisting risk assessment analysis and for verification parameter identification
 Need to evaluate both constituents already known and identified and the potential for other constituents, considering both historical practices (e.g. GW remediation that may capture spills/releases from past production processes).
 Should consider both input to the anaerobic and aerobic WWTP, as well as the capabilities and destruction/removal efficiency of each WWTP.  Note:  Data pertaining to the aerobic WWTP will be needed for purposes of defining inputs to the aerobic WWTP.
 Delisting decision may be a consideration of production processes (past, current and future), WWTP performance and capabilities, and direct analytical verification.  Direct analytical verification will be necessary, but the particular scope and frequency will likely depend on the analysis of production processes and WWTP performance measures.
 Identification of constituents of concern will likely be an iterative process, starting from an initial suite of constituents of concern for input to the DRAS risk analysis software followed by revisions base on initial modelling results.
 While the delisting is specific to the bio solids waste stream, Emerald-Kalama (EK) will need to present data that gives EPA and Ecology and understanding of both the generating and waste treatment processes sufficient to account for all dangerous waste, dangerous constituents and "other factors" associated with these processes as they relate to characterization of the bio solids waste stream.
 The delisting application will need to provide a written record for the decisions EPA and Ecology will make regarding the following:
 What dangerous waste, dangerous constituents and "other factors" were considered in the delisting analysis;
 What specific decision criteria will apply to whether or not bio solids are exempt from dangerous waste/hazardous waste regulation;
 What verification process will be applied to demonstrating bio solids meet the delisting criteria;
Specific Information Needs
 Comprehensive process flow diagram, indicating all inputs to both the aerobic and anaerobic WWTPs.   The process flow diagram will need to identify all contributions to the aerobic and anaerobic WWTPs.  Inputs may be aggregated by production or remediation processes for purposes of defining constituents of concern and documenting waste stream characterization.
 Paired influent/effluent data for both the anaerobic and aerobic WWTP for purposes of defining or estimating constituent specific and constituent class destruction removal efficiencies.
 EK will need to describe in engineering terms how best to evaluate how input waste streams relate to performance of the two WWTPs and the eventual production of bio solids (e.g., whether inputs to the WWTP are best described by the weighted average properties of the various input waste streams, or if inputs are variable over time.
 EPA's and Ecology's intent is not to regulate how either WWTP system is designed or operated through the delisting process, but rather to evaluate how inputs and the design and operation relate to identification of and compliance with delisting verification parameters.
 While the EPA and Ecology delisting decisions will need to comprehensively consider all dangerous waste, dangerous constituents and "other factors" that apply or may apply to the candidate bio solids, particular verification parameters for direct analytical verification testing may be a smaller set of constituents that provide an effective measure of meeting delisting performance criteria.   In other words, delisting performance criteria may be a combination of meeting influent criteria, WWTP operating parameters (those that demonstrate that it is operated effectively in a matter representative of performance associated with DRE data upon which the delisting analysis is based) as well as direct analytical verification data.