[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36512-36514]
[FR Doc No: 2022-13086]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0545]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Biological Products: Reporting of Biological Product
Deviations and Human Cells, Tissues, and Cellular and Tissue-Based
Product Deviations in Manufacturing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements relating to the reporting of biological product deviations
and human cells, tissues, and cellular and tissue-based product (HCT/P)
deviations in manufacturing, and Forms FDA 3486 and 3486A.

DATES: Submit either electronic or written comments on the collection
of information by August 16, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 16, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2009-N-0545 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Biological Products: Reporting of
Biological Product Deviations and Human Cells, Tissues, and Cellular
and Tissue-Based Deviations in Manufacturing; Forms FDA 3486 and
3486A.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Biological Products: Reporting of Biological Product Deviations and
Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations
in Manufacturing; Forms FDA 3486 and 3486A

OMB Control Number 0910-0458--Extension

    Under section 351 of the Public Health Service Act (PHS Act) (42
U.S.C. 262), all biological products, including human blood and blood
components, offered for sale in interstate commerce must be licensed
and meet standards, including those prescribed in the FDA regulations,
designed to ensure the continued safety, purity, and potency of such
products. In addition, under section 361 of the PHS Act (42 U.S.C.
264), FDA may issue and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases between
the States or possessions or from foreign countries into the States or
possessions. Further, the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351) provides that drugs and devices (including human
blood and blood components) are adulterated if they do not conform with
current good manufacturing practice (CGMP) assuring that they meet the
requirements of the FD&C Act. Establishments manufacturing biological
products, including human blood and blood components, must comply with
the applicable CGMP regulations (parts 211, 606, and 820 (21 CFR parts
211, 606, and 820)) and current good tissue practice (CGTP) regulations
(part 1271 (21 CFR part 1271)) as appropriate. FDA regards biological
product deviation (BPD) reporting and HCT/P deviation reporting to be
an essential tool in its directive to protect public health by
establishing and maintaining surveillance programs that provide timely
and useful information.
    Section 600.14 (21 CFR 600.14), in brief, requires the manufacturer
who holds the biological product license, for other than human blood
and blood components, and who had control over a distributed product
when the deviation occurred, to report to the Center for Biologics
Evaluation and Research (CBER) or to the Center for Drug Evaluation and
Research (CDER) as soon as possible but at a date not to exceed 45
calendar days after acquiring information reasonably suggesting that a
reportable event has occurred. Section 606.171 (21 CFR 606.171), in
brief, requires licensed manufacturers of human blood and blood
components, including Source Plasma, unlicensed registered blood
establishments, and transfusion services, who had control over a
distributed product when the deviation occurred, to report to CBER as
soon as possible but at a date not to exceed 45 calendar days after
acquiring information reasonably suggesting that a reportable event has
occurred. Similarly, Sec.  1271.350(b) (21 CFR 1271.350(b)), in brief,
requires HCT/P establishments that manufacture non-reproductive HCT/Ps
described in Sec.  1271.10 (21 CFR 1271.10) to investigate and report
to CBER all HCT/P deviations relating to a distributed HCT/P that
relates to the core CGTP requirements, if the deviation occurred in the
establishment's facility or in a facility that performed a
manufacturing step for the establishment under contract, agreement or
other arrangement. Form FDA 3486 is used to submit BPD reports and HCT/
P deviation reports.
    Respondents to this collection of information are: (1) licensed
manufacturers of biological products other than human blood and blood
components, (2) licensed manufacturers of blood and blood components
including Source Plasma, (3) unlicensed registered blood
establishments, (4) transfusion services, and (5) establishments that
manufacture non-reproductive HCT/Ps regulated solely under section 361
of the PHS Act as described in Sec.  1271.10. The number of respondents
and total annual responses are based on the BPD reports and HCT/P
deviation reports FDA received in fiscal year (FY) 2021. The number of
licensed manufacturers and total annual responses under Sec.  600.14
include the estimates for BPD reports submitted to both CBER and CDER.
Based on the information from industry, the estimated average time to
complete a deviation report is 2 hours, which includes a minimal one-
time burden to create a user account for those reports submitted
electronically. The availability of the standardized report form, Form
FDA 3486, and the ability to submit this report electronically to CBER
(CDER does not currently accept electronic filings) further streamlines
the report submission process.
    CBER has developed a web-based addendum to Form FDA 3486 (Form FDA
3486A) to provide additional information when a BPD report has been
reviewed by FDA and evaluated as a possible recall. The additional
information requested includes information not contained in the Form
FDA 3486 such as: (1) distribution pattern; (2) method of consignee

notification; (3) consignee(s) of products for further manufacture; (4)
additional product information; (5) updated product disposition; and
(6) industry recall contacts. This information is requested by CBER
through email notification to the submitter of the BPD report. This
information is used by CBER for recall classification purposes. CBER
estimates that 3 percent of the total BPD reports submitted to CBER
would need additional information submitted in the addendum. CBER
further estimates that it would take between 10 and 20 minutes to
complete the addendum. For calculation purposes, CBER is using 15
minutes.
    Activities such as investigating, changing standard operating
procedures or processes, and follow up are currently required under
parts 211 (approved under OMB control number 0910-0139), 606 (approved
under OMB control number 0910-0116), 820 (approved under OMB control
number 0910-0073), and 1271 (approved under OMB control number 0910-
0543) and, therefore, are not included in the burden calculation for
the separate requirement of submitting a deviation report to FDA.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of                        Average
                21 CFR section; activity                   FDA form No.      Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
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600.14; Reporting of product deviations by licensed                 3486             103           6.864             707               2           1,414
 manufacturers..........................................
606.171; Reporting of product deviations by licensed                3486           2,008           6.883          13,821               2          27,642
 manufacturers, unlicensed registered blood
 establishments, and transfusion services...............
1271.350(b); HCT/P deviations...........................            3486              80           2.575             206               2             412
Web-based Addendum......................................       \2\ 3486A              66            6.69             442            0.25           110.5
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............          15,176  ..............        29,578.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Three percent of the number of respondents ((2,008 + 103 + 80) x 0.03 = 66) and total annual responses to CBER ((13,821 + 707 + 206) x 0.03 = 442).

    Our estimated burden for the information collection reflects an
overall decrease of approximately 65,014 hours and a corresponding
decrease of 34,152 responses. We attribute this adjustment to a
decrease in the number of deviation reports we received in FY 2021 from
licensed manufacturers and unlicensed registered blood establishments
under Sec.  606.171. This is likely due to our issuance of the revised
guidance document entitled ``Biological Product Deviation Reporting for
Blood and Plasma Establishments'' (85 FR 14682, March 13, 2020), which
provided blood and plasma establishments with revised recommendations
related to BPD reporting. The revised guidance provided a less
burdensome policy for reporting BPDs that is consistent with public
health and eliminated the reporting of post donation information (PDI)
events as BPD reports because these reports were no longer unexpected
or unforeseeable. Given the substantial number of PDI reports FDA has
received, the Agency is aware that these events occur, and the
submission of additional PDI reports to FDA is unlikely to facilitate
the identification of manufacturing or safety issues.

    Dated: June 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13086 Filed 6-16-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Page 57079]
[FR Doc No: 2014-22735]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9917-11-Region 5]

Final Decision To Grant Warner-Lambert Company a Modification of
Its Land-Ban Exemption

AGENCY: Environmental Protection Agency.

ACTION: Notice of final decision.

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SUMMARY: Notice is hereby given by the U.S. Environmental Protection
Agency (EPA or Agency) that modification of an exemption to the land
disposal restrictions under the 1984 Hazardous and Solid Waste
Amendments to the Resource Conservation and Recovery Act (RCRA) has
been granted to Warner-Lambert Company (Warner-Lambert), a wholly-owned
subsidiary of Pfizer, Inc., of Holland, Michigan.

DATES: This action is effective as of September 24, 2014.

FOR FURTHER INFORMATION CONTACT: Stephen Roy, Lead Petition Reviewer,
EPA, Region 5, Water Division, Underground Injection Control Branch,
WU-16J, Environmental Protection Agency, 77 W. Jackson Blvd., Chicago,
Illinois 60604-3590; telephone number:<PHONE_NUMBER>; fax number (312)
692-2951; email address<EMAIL_ADDRESS>Copies of the petition
and all pertinent information are on file and are part of the
Administrative Record. It is recommended that you contact the lead
reviewer prior to reviewing the Administrative Record.

SUPPLEMENTARY INFORMATION: On April 30, 1998, EPA granted Warner-
Lambert (owned by Parke-Davis Division of Warner-Lambert Company at the
time) an exemption from the land disposal restrictions of the 1984
Hazardous and Solid Waste Amendments (63 FR 23786, April 30, 1998). In
August 2008, Warner-Lambert submitted a request to modify the exemption
to include wastes bearing four additional wastes codes. EPA received
additional information on this topic in 2014.
    After careful review of the material submitted, EPA has determined,
as required by 40 CFR 148.20(f), that there is a reasonable degree of
certainty that waste streams containing constituents designated by
these codes will behave hydraulically and chemically similarly to
wastes for which Warner-Lambert was granted an exemption, and will not
migrate from the injection zone within 10,000 years.
    A public notice of the proposed decision was issued on June 30,
2014. The public comment period expired on July 31, 2014. No comments
were received. Therefore, EPA is issuing the final exemption
modification as proposed.
    As a result of this action and the April 30, 1998 exemption,
Warner-Lambert may inject wastes bearing the RCRA waste codes D023,
D024, D025 and D037 into its three injection wells in Holland,
Michigan. This decision constitutes a final Agency action for which
there is no administrative appeal. General conditions of this exemption
are found at 40 CFR Part 148. The exemption granted to Warner-Lambert
on April 30, 1998 included three conditions, all of which remain
unchanged and in force.
    Electronic Access. You may access this Federal Register document
electronically from the Government Printing Office under the ``Federal
Register'' listings at FDSys (http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR).

    Dated: September 4, 2014.
Tinka G. Hyde,
Director, Water Division.
[FR Doc. 2014-22735 Filed 9-23-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13156-13158]
[FR Doc No: 2018-06101]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82922; File No. SR-NYSE-2018-09]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Change To
Amend the Eleventh Amended and Restated Operating Agreement

March 22, 2018.
    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 March 12, 2018, New York Stock Exchange

LLC (``NYSE'' or the ``Exchange'') filed with the Securities and
Exchange Commission (the ``Commission'') the proposed rule change as
described in Items I, II, and III below, which Items have been prepared
by the self-regulatory organization. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Eleventh Amended and Restated
Operating Agreement of New York Stock Exchange LLC (the ``Operating
Agreement'') to make a technical change updating the registered office
and registered agent in the state of New York. A conforming change
would be made to update the date of the Operating Agreement. 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
    The Exchange proposes to amend the Operating Agreement to make a
technical change updating the registered office and registered agent in
the state of New York. A conforming change would be made to update the
date of the Operating Agreement.
    The Exchange is a limited liability company organized under the
laws of the State of New York. As such, it has and maintains a
registered office and registered agent in New York.\4\
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    \4\ See N.Y. Ltd. Liab. Co. Law Sec.  302.
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    Article I, Section 1.05 of the Operating Agreement provides that
the address of the registered office of the Exchange in the State of
New York is c/o National Registered Agents, Inc., 875 Avenue of the
Americas, Suite 501, New York, NY 10001. The Exchange proposes to amend
such provision to provide that the address is c/o United Agent Group
Inc., 15 North Mill Street, Nyack, Rockland County, New York 10960.
    Article I, Section 1.06 of the Operating Agreement provides that
the name and address of the registered agent of the Exchange for
service of process on the Exchange in the State of New York is National
Registered Agents, Inc., 875 Avenue of the Americas, Suite 501, New
York, NY 10001. The Exchange proposes to amend such provision to
provide that the name and address is United Agent Group Inc., 15 North
Mill Street, Nyack, Rockland County, New York 10960.
    The changes are non-substantive technical administrative changes.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Exchange Act \5\ in general, and with Section
6(b)(1) \6\ in particular, in that it enables the Exchange to be so
organized as to have the capacity to be able to carry out the purposes
of the Exchange Act and to comply, and to enforce compliance by its
exchange members and persons associated with its exchange members, with
the provisions of the Exchange Act, the rules and regulations
thereunder, and the rules of the Exchange.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(1).
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    The proposed rule change is a non-substantive administrative change
that does not impact the governance or ownership of the Exchange. The
Exchange believes that the proposed rule change would enable the
Exchange to continue to be so organized as to have the capacity to
carry out the purposes of the Exchange Act and comply and enforce
compliance with the provisions of the Exchange Act by its members and
persons associated with its members, because ensuring that the
Operating Agreement identifies the registered agent and registered
office in New York and making a conforming change to the date of the
Operating Agreement would contribute to the orderly operation of the
Exchange by adding clarity and transparency to its rules.
    For similar reasons, the Exchange also believes that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\7\ in that
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system and,
in general, to protect investors and the public interest.
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    \7\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change would remove
impediments to and perfect the mechanism of a free and open market and
a national market system by ensuring that market participants can more
easily navigate, understand and comply with its rules. The Exchange
believes that, by ensuring that such rules accurately identify the
registered agent and registered office in New York, and by making a
conforming change to the date of the Operating Agreement, the proposed
rule change would reduce potential investor or market participant
confusion.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Exchange Act. The proposed rule
change is not designed to address any competitive issue but rather is
concerned solely with making a technical change updating the registered
office and registered agent of the Exchange.

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

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

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

    The proposed rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(3) \9\ thereunder in that
the proposed rule change is concerned solely with the administration of
the Exchange.
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may 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) \10\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \10\ 15 U.S.C. 78s(b)(2)(B).
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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-NYSE-2018-09 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-NYSE-2018-09. 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-NYSE-2018-09, and should be submitted on
or before April 17, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Eduardo A. Aleman,
Assistant Secretary.
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    \11\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2018-06101 Filed 3-26-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 124 (Thursday, June 27, 2013)]
[Proposed Rules]
[Pages 38672-38679]
[FR Doc No: 2013-14911]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 228

[EPA-R06-OW-2011-0712; FRL-9826-5]

Ocean Dumping; Sabine-Neches Waterway (SNWW) Ocean Dredged
Material Disposal Site Designation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The EPA is proposing to designate four new Ocean Dredged
Material Disposal Site(s) (ODMDS) located offshore of Texas for the
disposal of dredged material from the Sabine-Neches Waterway (SNWW),
pursuant to the Marine Protection, Research and Sanctuaries Act, as
amended (MPRSA). The new sites are needed for the disposal of
additional dredged material associated with the SNWW Channel
Improvement Project, which includes an extension of the Entrance
Channel into the Gulf of Mexico. Final action by EPA on this proposal
would authorize the disposal of the additional dredged materials at the
additional ocean disposal sites.

DATES: Comments on this proposed rule must be received on or before
August 12, 2013.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OW-
2011-0712, by one of the following methods:
     Federal e-Rulemaking Portal: http://www.regulations.gov;
follow the online instruction for submitting comments.
     Email: Dr. Jessica Franks at<EMAIL_ADDRESS>     Fax: Dr. Jessica Franks, Marine and Coastal Section (6WQ-
EC) at fax number<PHONE_NUMBER>.
     Mail: Dr. Jessica Franks, Marine and Coastal Section (6WQ-
EC), Environmental Protection Agency, Mailcode: (6WQ-EC), 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733.
    Instructions: Direct your comments to Docket No. EPA-R06-OW-2011-
0712. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
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SUPPLEMENTARY INFORMATION:

Table of Contents

A. Potentially Affected Entities
B. Background
C. Disposal Volume Limit
D. Site Management and Monitoring Plan
E. Ocean Dumping Site Designation Criteria
    General Selection Criteria
    Specific Selection Criteria
F. Regulatory Requirements
    1. National Environmental Policy Act (NEPA)
    2. Endangered Species Act Consultation
    3. Magnuson-Stevens Fishery Conservation and Management Act of
1996
    4. Coastal Zone Management Act
    5. Coastal Barrier Improvement Act of 1990
G. Administrative Review
    1. Executive Order 12886
    2. Paperwork Reduction Act
    3. Regulatory Flexibility Act, as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996
    4. Unfunded Mandates
    5. Executive Order 13132: Federalism
    6. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    7. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks

    8. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use Compliance With Administrative
Procedure Act
    9. National Technology Transfer Advancement Act
    10. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low Income
Populations
List of subjects in 40 CFR Part 228
Part 228--[Amended]

    The supporting document for these site designations is the Final
Environmental Impact Statement (EIS) for the Sabine-Neches Waterway
Channel Improvement Project: Southeast Texas and Southwest Louisiana
(SNWW CIP) dated March 2011 prepared by the U.S. Army Corps of
Engineers (also Corps or USACE). Appendix B of Volume III contains the
Ocean Dredged Material Disposal Sites Final Environmental Impact
Statement. Comments will only be considered on the proposed site
designations. The U.S. Army Corps of Engineers Final EIS for the SNWW
CIP was published in the Federal Register (FR) March 4, 2011 (76 FR
12108). This document is available for public inspection at the
following locations:
    1. Environmental Protection Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202-2733
    2. Federal e-Rulemaking Portal: http://www.regulations.gov; follow
the online instruction for submitting comments.

A. Potentially Affected Entities

    Persons potentially affected by this final action include those who
seek or might seek permits or approval by EPA to dispose of dredged
material into ocean waters pursuant to the Marine Protection, Research,
and Sanctuaries Act, 33 U.S.C. 1401 et seq. The EPA's action is
relevant to persons, including organizations and government bodies,
seeking to dispose of dredged material in ocean waters offshore of
Texas for the disposal of dredged material from the Sabine-Neches
Waterway. Currently, the US Army Corps of Engineers will be most
impacted by this final action. Potentially affected categories and
persons include:

----------------------------------------------------------------------------------------------------------------
                                                                             Examples of potentially regulated
                                Category                                                  persons
----------------------------------------------------------------------------------------------------------------
Federal government......................................................   U.S. Army Corps of Engineers Civil
                                                                           Works projects, and other Federal
                                                                           agencies.
Industry and general public.............................................   Port authorities, marinas and
                                                                           harbors, shipyards and marine repair
                                                                           facilities, berth owners.
State, local and tribal governments.....................................  Governments owning and/or responsible
                                                                           for ports, harbors, and/or berths,
                                                                           Government agencies requiring
                                                                           disposal of dredged material
                                                                           associated with public works
                                                                           projects.
----------------------------------------------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding persons likely to be affected by this
action. For any questions regarding the applicability of this action to
a particular person, please refer to the contact person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.

B. Background

    Ocean disposal of dredged materials is regulated under Title I of
the Marine Protection, Research and Sanctuaries Act, 33 U.S.C. 1401 et
seq. (MPRSA). The EPA and the USACE share responsibility for the
management of ocean disposal of dredged material. Under Section 102 of
MPRSA, EPA is responsible for designating an acceptable location for
the ocean dredged material disposal sites (ODMDS). With concurrence
from EPA, the USACE issues permits under MPRSA Section 103 for ocean
disposal of dredged material deemed suitable according to EPA criteria
in MPRSA Section 102 and EPA regulations in 40 CFR part 227. In lieu of
the permit procedure for a federal project involving dredged material,
the USACE may issue and abide by regulations using the same criteria,
other factors to be evaluated, same procedures and same requirements
that apply to the issuance of permits.

    Pursuant to its voluntary NEPA policy, published on October 29,
1998 (63 FR 58045), EPA typically relies on the EIS process to
enhance public participation on the proposed designation of an
ODMDS. A site designation EIS evaluates alternative sites and
examines the potential environmental impacts associated with
disposal of dredged material at various locations. Such an EIS first
demonstrates the need for the ODMDS designation action (40 CFR
6.203(a) and 40 CFR 1502.13) by describing available or potential
aquatic and non-aquatic (i.e., land-based) alternatives and the
consequences of not designating a site--the No Action Alternative.
Once the need for an ocean disposal site is established, potential
sites are screened for feasibility through a Zone of Siting
Feasibility (ZSF) process. Potential alternative sites are then
evaluated using EPA's ocean disposal criteria at 40 CFR part 228 and
compared in the EIS. Of the sites that satisfy these criteria, the
site that best complies is selected as the preferred alternative for
designation through a rulemaking proposal published in the Federal
Register, as here.

    Formal designation of an ODMDS in the Federal Register and
codification in the Code of Federal Regulations does not constitute
approval of dredged material for ocean disposal. Site designation
merely identifies a suitable ocean location in the event that dredged
material is later approved for ocean disposal. Designation of an ODMDS
provides an ocean disposal alternative for consideration in the review
of each proposed dredging project. Before any ocean disposal may take
place, the dredging project proponent must demonstrate a need for ocean
disposal, including consideration of alternatives. Alternatives to
ocean disposal, including the option for beneficial re-use of dredged
material, are evaluated for each dredging project that may result in
the ocean disposal of dredged materials from such project. Ocean
disposal of dredged material is only allowed after both EPA and USACE
determine that the proposed activity is environmentally acceptable
under criteria codified in 40 CFR part 227 and 33 CFR part 336,
respectively. In addition, ongoing management of these ODMDS would be
subject to Site Management and Monitoring Plan(s) (SMMP) required by
MPRSA section 102(c)(3)(F) and (c)(4), which are discussed more fully
below.
    Decisions to allow ocean disposal are made on a case-by-case basis
through the MPRSA Section 103 permitting process, resulting in a USACE
permit or its equivalent process for USACE's Civil Works projects.
Material proposed for disposal at a designated ODMDS must conform to
EPA's permitting criteria for acceptable quality (40 CFR parts 225 and
227), as determined from physical, chemical, and bioassay/
bioaccumulation tests prescribed by national sediment testing protocols
(EPA and USACE 1991). Only clean non-toxic dredged material is
acceptable for ocean disposal. The newly designated sites will be
subject to ongoing monitoring and management to ensure continued
protection of the marine environment.
    Evaluation of the proposed ODMDS under EPA's general and specific
criteria is described in the March 2011 ``Final Environmental Impact
Statement for Sabine-Neches Waterway Channel Improvement Project
Southeast Texas and Southwest Louisiana, Appendix B.'' As identified in
that appendix, the

environmentally preferred sites that EPA now proposes to designate are
SNWW-A, which is located 21 miles from shore, SNWW-B, which is located
24 miles from shore, SNWW-C, which is located 27 miles from shore, and
SNWW-D, which is located 30 miles from shore. Each of the ODMDS
occupies an area of 5.3 square statute miles, with depths ranging from
44 to 46 feet. The bottom topography is flat. The proposed action, once
final, would provide adequate, environmentally-acceptable ocean
disposal site capacity for suitable dredged material generated from new
work (construction) and future maintenance dredging along the SNWW
Entrance Channel 13.2 mile extension by formally designating the SNWW
A-D sites as acceptable ocean disposal locations for dredged material
meeting applicable requirements.

C. Disposal Volume Limit

    The action would formally designate the SNWW A-D for a one-time
placement of approximately 18,737,000 cubic yards (cy) of new work
(construction) material plus approximately 37,725,000 cubic yards of
maintenance material over a 50-year period. The need for ongoing ocean
disposal capacity would be based on modeling in the USACE SNWW CIP
Engineering Appendix.

D. Site Management and Monitoring Plan

    Continuing use of the sites requires verification that significant
impacts do not occur outside of the disposal site boundaries through
implementation of the SMMP developed as part of the Final EIS developed
for the Sabine-Neches Waterway Project. The main purpose of the SMMP is
to provide a structured framework to ensure that dredged material
disposal activities will not unreasonably degrade or endanger human
health, welfare, the marine environment, or economic potentialities
(Section 103(a) of the MPRSA). Two main objectives for management of
SNWW A-D are: (1) To ensure that only dredged material that satisfies
the criteria set forth in 40 CFR part 227 subparts B, C, D, E, and G
and part 228.4(e) and is suitable for unrestricted placement at the
ODMDS is, in fact, disposed at the sites, and; (2) to avoid excessive
mounding, either within the site boundaries or in areas adjacent to the
sites, as a direct result of placement operations.
    The EPA and USACE Galveston District personnel would achieve these
SMMP objectives by jointly administering the following activities in
accordance with MPRSA section 102(c)(3): (1) A baseline assessment of
conditions at the sites; (2) a program for monitoring the sites; (3)
special management conditions or practices to be implemented at the
sites that are necessary for protection of the environment; (4)
consideration of the quantity of dredged material to be discharged at
the sites, and the presence, nature, and bioavailability of the
contaminants in the material; (5) consideration of the anticipated use
of the sites over the long term, including the anticipated closure date
for the sites, if applicable, and any need for management of the sites
after the closure; and (6) a schedule for review and revision of the
SMMP.
    The SMMP prepared for the sites requires periodic physical
monitoring to confirm that disposal material is deposited within the
seafloor disposal boundary, as well as bathymetric surveys to confirm
that there is no excessive mounding or short-term transport of material
beyond the limits of the ODMDS. Physical and chemical sediment and
biological monitoring requirements are described in the SMMP and are
required to be conducted based on the Evaluation of Dredged Material
Proposed for Ocean Disposal Testing Manual, EPA 503/8-91/001 and the
Joint EPA-USACE Regional Implementation Agreement (RIA) procedures.
Results will be used to confirm that dredged material actually disposed
at the site satisfies the criteria set forth in 40 CFR part 227
subparts B, C, D, E, and G and part 228.4(e) and is suitable for
unrestricted ocean disposal. Other activities implemented through the
SMMP to achieve these objectives include: (1) Regulating quantities and
types of material to be disposed, including the time, rates, and
methods of disposal; and (2) recommending changes to site use
requirements, including disposal amounts or timing, based on periodic
evaluation of site monitoring results.

E. Ocean Dumping Site Designation Criteria

    In proposing to designate these Sites, the EPA assessed the
proposed Sites according to the criteria of the MPRSA, with particular
emphasis on the general and specific regulatory criteria of 40 CFR
228.5 and 228.6(a), to determine whether the proposed site designations
satisfy those criteria.

General Selection Criteria

    1. The dumping of materials into the ocean will be permitted only
at sites or in areas selected to minimize the interference of disposal
activities with other activities in the marine environment,
particularly avoiding areas of existing fisheries or shellfisheries,
and regions of heavy commercial or recreational navigation.
    The EPA selected SNWW A-D, including appropriate buffer zones, to
avoid sport and commercial fishing activities, as well as other areas
of biological sensitivity. The preferred ODMDS are outside the channel,
including the navigation channel buffer zone, and safety fairways, and
avoid known navigational obstructions, although they do infringe on two
Fairway Anchorage areas.
    2. Locations and boundaries of disposal sites will be so chosen
that temporary perturbations in water quality or other environmental
conditions during initial mixing caused by disposal operations anywhere
within the site can be expected to be reduced to normal ambient
seawater levels or to undetectable contaminant concentrations or
effects before reaching any beach, shoreline, marine sanctuary, or
known geographically limited fishery or shellfishery.
    The proposed sizes for the buffer zones and for the SNWW A-D sites
are based on sediment transport modeling and the physical oceanographic
characterization of the Sabine Pass area. Modeling and
characterization, combined with the information on the expected quality
of the material to be dredged, ensures that perturbations caused by
placement are reduced to ambient conditions at the boundaries of the
site. Reports of the modeling and characterization are included in the
administrative record for this action.
    3. If at any time during or after disposal site evaluation studies,
it is determined that existing disposal sites presently approved on an
interim basis for ocean dumping do not meet the criteria for site
selection set forth in Sections 228.5 through 228.6, the use of such
sites will be terminated as soon as suitable alternate disposal sites
can be designated.
    This criterion would not apply to the proposed site designations
because they are not existing sites that had previously been approved
on an interim basis.
    4. The sizes of the ocean disposal sites will be limited in order
to localize for identification and control any immediate adverse
impacts and permit the implementation of effective monitoring and
surveillance programs to prevent adverse long-range impacts. The size,
configuration, and location of any disposal site will be determined as
a part of the disposal site evaluation or designation study.
    The sizes of the proposed sites are as small as possible to
reasonably meet the

criteria stated in 40 CFR 228.5 and 40 CFR 228.6(a). The size for each
proposed ODMDS is 5.32 square statute miles (4.02 square nautical
miles). The SMMPs have been designed to provide adequate surveillance
to prevent adverse long-range impacts.
    5. The EPA will, wherever feasible, designate ocean dumping sites
beyond the edge of the continental shelf and other such sites that have
been historically used.
    Cost, safety, and time factors plus difficulties with monitoring
and surveillance preclude the designation of any ODMDS beyond the edge
of the Continental Shelf off Sabine Pass (and the Gulf of Mexico
generally). Additionally, uncertainty about the resilience of the deep-
ocean benthic community indicates that an off-shelf disposal site could
threaten severe adverse impacts to that off-shelf benthic community.
The EPA did not identify an environmental advantage to an off-shelf
site designation, whereas possible adverse impacts to the human
environment could be more easily monitored at a nearshore site. The
existing ODMDS that have been used historically, while large enough to
accommodate future maintenance material, are cost prohibitive with
regard to disposal of dredged material from the channel extension.
Without designation of the four new ODMDS, this material would need to
be transported to the existing maintenance ODMDS. The end of the
existing channel is roughly 13 miles from the end of the proposed
extension, resulting in an increased travel distance of 26 miles for
each load of dredged material from the extension work. Construction
costs are expected to double under this scenario, making it impossible
to economically justify the SNWW CIP.

Specific Selection Criteria

    1. Geographical position, depth of water, bottom topography, and
distance from the coast.
    The proposed sites are bounded by the following coordinates
(Location North American Datum from 1983):

A ODMDS......................  29[deg]24'47'' N, 93[deg]43'29'' W;
                                29[deg]24'47'' N, 93[deg]41'08'' W
                               29[deg]22'48'' N, 93[deg]41'09'' W;
                                29[deg]22'49'' N, 93[deg]43'29'' W
B ODMDS......................  29[deg]21'59'' N, 93[deg]43'29'' W;
                                29[deg]21'59'' N, 93[deg]41'08'' W
                               29[deg]20'00'' N, 93[deg]41'09'' W;
                                29[deg]20'00'' N, 93[deg]43'29'' W
C ODMDS......................  29[deg]19'11'' N, 93[deg]43'29'' W;
                                29[deg]19'11'' N, 93[deg]41'09'' W
                               29[deg]17'12'' N, 93[deg]41'09'' W;
                                29[deg]17'12'' N, 93[deg]43'29'' W
D ODMDS......................  29[deg]16'22'' N, 93[deg]43'29'' W;
                                29[deg]16'22'' N, 93[deg]41'10'' W
                               29[deg]14'24'' N, 93[deg]44'10'' W;
                                29[deg]14'24'' N, 93[deg]43'29'' W

    The water depth at the proposed SNWW A-D sites ranges from 44 to 46
feet and the bottom topography is flat. SNWW-A would be located 21
miles from shore, SNWW-B would be located 24 miles from shore, SNWW-C
would be located 27 miles from shore and SNWW-D would be located 30
miles from shore.
    2. Location in relation to breeding, spawning, nursery, feeding, or
passage areas of living resources in adult or juvenile phases.
    Due to the marine open water locale of these sites, the presence of
aerial, pelagic, or benthic living resources is likely within the area
of the proposed sites. The location of the proposed ODMDS can be
described as being between the principal spawning areas and the
estuarine nursery areas. The water column and benthic effects
associated with ocean disposal of dredged material at the proposed
ODMDS would not adversely affect the passage of organisms to and from
the spawning-nursery areas through the waters above the disposal sites.
Localized and intermittent dredged material disposal operations are
unlikely to adversely affect migration, feeding, or nesting of marine
mammals and sea turtles.
    3. Location in relation to beaches and other amenity areas.
    The preferred sites are over 21 miles from any beach and Sabine
Bank is at least 1.7 miles from the nearest of the proposed ODMDS.
According to the dredged material transport model (available in the
administrative record), the maximum distance for the mounded dredged
material to reach ambient depth was 1,081 feet. Doubling this distance
would provide a buffer of 0.4 mile, only a fraction of the 1.7 miles to
Sabine Bank.
    4. Types and quantities of wastes proposed to be disposed of, and
proposed methods of release, including methods of packaging the waste,
if any.
    Only suitable dredged material from the SNWW Entrance Channel 13.2
mile extension may be disposed at the sites. Dredged material proposed
for ocean disposal is subject to strict testing requirements
established by the EPA and USACE, and only clean (non-toxic) dredged
materials from the SNWW Entrance Channel 13.2 mile extension would be
allowed to be disposed of at the SNWW A-D sites. Approximately 18.7 mcy
of new work material will be dredged during the construction of 13.2-
mile extension of the Entrance Channel. Maintenance material per
dredging cycle is estimated at three mcy for a total of 37.7 mcy over a
period of 50 years. Dredged material is expected to be released from
hopper dredges.
    5. Feasibility of surveillance and monitoring.
    The proposed sites are amenable to surveillance and monitoring. The
SMMP prepared for the sites consists of (1) A method for recording the
location of each discharge; (2) bathymetric surveys; and, (3) grain-
size analysis, sediment chemistry characterization, and benthic
infaunal analysis at selected stations.
    6. Dispersal, horizontal transport, and vertical mixing
characteristics of the area, including prevailing current direction and
velocity, if any.
    These three physical oceanographic parameters were used by the U.S.
Army Corps of Engineers to develop the necessary buffer zones for the
exclusion analysis and to determine the adequacy of size of the
proposed sites. Predominant long shore currents, and thus predominant
long shore transport, are to the west. Long-term mounding has not
historically occurred in the existing nearby ODMDS. Therefore, steady
longshore transport and occasional storms, including hurricanes, are
expected to remove the disposed material from the sites through
dispersal, horizontal transport, and vertical mixing.
    7. Existence and effects of current and previous discharges and
dumping in the area (including cumulative effects).
    The Final Environmental Impact Statement discusses the results of
chemical and bioassay testing of samples collected to support the
proposed Waterway Extension and surrounds, and concluded that there
were no indications of water or sediment quality problems in the ZSF,
including the proposed disposal sites. Testing of dredged material
collected and tested from past maintenance dredging indicates that the
material dredged from the channel was acceptable for ocean disposal
according

to the evaluation criteria published at 40 CFR part 227. Based on
current direction and modeling of the new work and maintenance
material, the proposed disposal sites would be situated to prevent
discharged material from reentering the channel and to ensure that any
mounding poses no obstruction to navigation. No cumulative mounding has
been detected at the existing ODMDS and there is no reason to expect
any at the proposed ODMDS.
    8. Interference with shipping, fishing, recreation, mineral
extraction, desalination, fish and shellfish culture, areas of special
scientific importance, and other legitimate uses of the ocean.
    The interference considerations that are pertinent to the present
situation are shipping, mineral extraction, commercial and recreational
fishing, and recreational areas. The preferred sites would not
interfere with these or other legitimate uses of the ocean because the
exclusion processes used to identify the proposed sites was designed to
prevent the selection of sites that would cause any such interference.
Ocean disposal of dredged material in the past has not interfered with
other uses.
    9. Existing water quality and ecology of the site as determined by
available data or by trend assessment or baseline surveys.
    The FEIS to support the proposed Waterway Extension project cited a
baseline study, which used sediment samples from the area of the
proposed Extension and the ZSF. No adverse water or sediment quality
concerns were indicated. Benthos of the area was sampled and
characterized, is dominated by polychaetes (57.7%) and included
abundant populations of malacostracans (18.3%) and bivalves (7.7%).
Density ranged from 4,055 organisms/square foot at Station 3 (north of
ODMDS A) up to 30,265 organisms/square foot at Station 26 (center of
ODMDS B). Areas of moderately high sand content (68 to 91%) supported
the highest densities, located near ODMDS B and ODMDS C, near the
center of the ZSF. In general, the water and sediment quality is good
throughout the ZSF and in the existing (historically used) ODMDS. There
have been no long-term adverse impacts on water and sediment quality or
benthos at the existing ODMDS, and none are expected with use of the
proposed sites.
    10. Potentiality for the development or recruitment of nuisance
species in the disposal site.
    With disturbances to any benthic community, opportunistic species
would initially recolonize the area. At this location, however, these
species would not be nuisance species, i.e., they would not interfere
with other legitimate uses of the ocean, that they would not be human
pathogens, and would not be non-indigenous species. The placement of
dredged material in the past has not attracted nor promoted development
or recruitment of nuisance species, and the placement of the dredged
material from new work and future maintenance dredged material should
not attract or promote the development or recruitment of nuisance
species.
    11. Existence at or in close proximity to the site of any
significant natural or cultural features of historical importance.
    Historic records generated by the former Minerals Management
Service (MMS) indicate that no historic shipwrecks are mapped within
the limits of the proposed ODMDS, but remote-sensing surveys have not
been conducted. Ocean disposal of dredged material is not expected to
adversely affect any unrecorded wrecks given the depth of water through
which the material would settle and the expected depth of burial at the
time of disposal, particularly given the dispersive nature of the
seabed environment in this portion of the Gulf. The distribution,
depth, and dispersion of dredged material within these ODMDS have been
evaluated by numerical modeling (PBS&J, 2006). Hopper dredges would
drop dredged material onto the proposed ODMDS, forming mound fields
with individual mounds totaling no more than five feet in height. The
effects of the deposition of material on any undiscovered resource
would be cushioned by settling through water depths ranging from 30 to
45 feet. Previous monitoring of existing placement areas and studies of
bottom ocean currents has shown that the material would disperse
between channel maintenance cycles and not accumulate. The proposed
ODMDS would be located in Federal waters (i.e., outside of adjacent
State jurisdiction).

F. Regulatory Requirements

1. National Environmental Policy Act (NEPA)

    Pursuant to section 102(2)(C) of the National Environmental Policy
Act of 1969 (NEPA), federal agencies are generally required to prepare
an environmental impact statement (EIS) on major federal actions
significantly affecting the quality of the human environment. Under the
doctrine of functional equivalency, EPA designations of ODMDS under
MPRSA are not subject to NEPA requirements. The EPA believes the NEPA
process enhances public participation on such designations and the
potential effects of these proposed designations were fully analyzed in
an EIS on the Sabine-Neches Waterway Channel Improvement Project:
Southeast Texas and Southwest Louisiana (SNWW CIP). The Corps of
Engineers was the lead agency on that EIS and EPA a cooperating agency.
    Notice of the draft EIS was published in the Federal Register on
December 24, 2009, and the document was available for review and
comment through March 10, 2010. In addition, public meetings on the EIS
were held in Beaumont, Texas and Lake Charles, Louisiana. Comments
included concerns on pipeline relocation, marsh ecology, beneficial use
of dredged material, and increased danger from storms. Few comments
were received on designation of the ODMDS. Detailed responses to
comments were published in Appendix A of the final EIS, notice of which
was published in the Federal Register on March 4, 2012. The EPA has
relied on information from the EIS and its technical appendices in its
consideration and application of ocean dumping criteria to the four
ODMDS it proposes to designate today.

2. Endangered Species Act Consultation

    During development of the SNWW CIP project EIS referenced above,
USACE and EPA consulted with the U.S. Fish and Wildlife Service (USFWS)
and the National Marine Fisheries Service (NMFS) pursuant to the
provisions of the Endangered Species Act (ESA), regarding the potential
for designation and use of the ocean disposal sites to jeopardize the
continued existence of any Federally-listed species. The consultation
process is documented in that EIS.
    Of the Threatened or Endangered Species noted in the biological
assessment for the SNWW CIP, only sea turtles and whales are found as
far offshore as the proposed ODMDS. The NMFS issued a biological
opinion on August 13, 2007, that the proposed action (including
proposed site designations) is not likely to jeopardize the continued
existence of any Federally-listed species.

3. Magnuson-Stevens Fishery Conservation and Management Act of 1996

    The designation of the proposed ODMDS will not adversely affect
essential fish habitat. By letter dated March 8, 2010, the National
Marine Fisheries Service concurred with the USACE findings that
beneficial features

associated with the project would offset any adverse impacts of the
Waterway Expansion project.

4. Coastal Zone Management Act

    Pursuant to section 307(c)(1) of the Coastal Zone Management Act,
federal activities that affect a state's coastal zone must be
consistent to the maximum extent practicable with the enforceable
policies of the state's approved Coastal Zone Management (CZM) program.
To implement that requirement, federal agencies prepare coastal
consistency determinations and submit them to the appropriate state
agencies, which may concur in or object to a consistency determination.
    In connection with its preparation of the EIS on the Sabine-Neches
Waterway Channel Improvement Project, the Corps prepared a coastal
consistency determination on its proposed navigation projects and the
ODMDS designation, which it submitted to the Louisiana Department of
Natural Resources (LDNR) and the Texas General Land Office (TGLO), the
agencies implementing approved coastal zone management plans for their
respective states. On March 30, 2010, TGLO concurred in the Corps
consistency determination. By letter of March 31, 2010, LDNR concurred
on condition that the Corps submit a supplemental consistency
determination to LDNR after the project planning and design process,
resulting in a more detailed description of project features. LDNR's
letter also generally opposed EPA's ODMDS designation, claiming it
would provide the Corps an option other than beneficial use for
disposal of dredged material.
    More detailed plans and descriptions of the proposed navigation
projects may be needed for LDNR and the Corps to resolve potential
issues on the practicability of beneficial use of dredged materials in
Louisiana's coastal zone. Such issues are independent of EPA's proposed
ODMDS designations, however, which only make an offshore disposal
option available when the Corps deems beneficial use that might
otherwise be required by a state CZM program impracticable. EPA
supports beneficial use of dredged material, but ODMDS designations do
not in any way require that the Corps forego beneficial use in favor of
ocean disposal.
    Moreover, the closest of any of the four proposed ODMDS is
approximately 20 miles off the Texas coast at its nearest point.
Predominant longshore currents in the proposed ODMDS locations flow
from east to west and dredged material transport modeling shows that
any dredged materials discharged to them will not thus enter or
otherwise affect Louisiana's coastal zone. Because the proposed ODMDS
designations will not affect any land or water use or natural resource
of Louisiana's coastal zone, no coastal consistency determination need
be prepared for today's proposal.

5. Coastal Barrier Improvement Act of 1990

    The disposal of dredged materials related to maintenance and
construction is an exception to Federal expenditure restrictions
related to Coastal Barrier Resources Act of 1982; therefore, project
activities related to disposal are exempt from the prohibitions set
forth in this act.

G. Administrative Review

    This rulemaking proposes the designation of ocean dredged material
disposal sites pursuant to Section 102 of the MPRSA. This proposed
action complies with applicable executive orders and statutory
provisions as follows:

1. Executive Order 12866

    Under Executive order 12866 (58 FR 51735, October 4, 1993) EPA must
determine whether the regulatory action is ``significant'', and
therefore subject to office of Management and Budget (OMB) review and
other requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to lead to a
rule that may:
    (a) Have an annual effect on the economy of $100 million or more,
or adversely affect in a material way, the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local or Tribal governments or communities;
    (b) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    (c) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs, or the rights and obligations of
recipients thereof: or
    (d) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    This Proposed Rule should have minimal impact on State, local or
Tribal governments or communities. Therefore, EPA has determined that
this Proposed Rule is not a ``significant regulatory action'' under the
terms of Executive Order 12866.

2. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., is intended to
minimize the reporting and recordkeeping burden on the regulated
community, as well as to minimize the cost of Federal information
collection and dissemination. In general, the Act requires that
information requests and record-keeping requirements affecting ten or
more non-Federal respondents be approved by OMB. The EPA anticipates
that few, if any, non-federal entities will use the sites as none have
in the past.

3. Regulatory Flexibility Act, as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996

    The Regulatory Flexibility Act (RFA) provides that whenever an
agency promulgates a final rule under 5 U.S.C. 553, the agency must
prepare a regulatory flexibility analysis unless the head of the agency
certifies that the final rule will not have a significant economic
impact on a substantial number of small entities (5 U.S.C. 604 and
605). The site designation and management actions would only have the
effect of setting maximum annual disposal volume and providing a
continuing disposal option for dredged material. Consequently, EPA's
action will not impose any additional economic burden on small
entities. For this reason, the Regional Administrator certifies,
pursuant to section 605(b) of the RFA, that the Proposed Rule will not
have a significant economic impact on a substantial number of small
entities.

4. Unfunded Mandates

    Title II of the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub.
L. 104-4) establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and Tribal
governments and the private sector. This Proposed Rule contains no
Federal mandates (under the regulatory provisions of Title II of the
UMRA) for State, local or Tribal governments or the private sector that
may result in estimated costs of $100 million or more in any year. It
imposes no new enforceable duty on any State, local or Tribal
governments or the private sector nor does it contain any regulatory
requirements that might significantly or uniquely affect small
government entities. Thus, the requirements of section 203 of the UMRA
do not apply to this Proposed Rule.

5. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
meaningful and timely input by State and local officials in the
development of

regulatory policies that have federalism implications. ``Policies that
have federalism implications'' are defined in the Executive Order to
include regulations that have ``substantial direct effects 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.''
    This Proposed Rule does not have federalism implications. It will
not have substantial direct effects 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,
as specified in Executive Order 13132.

6. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by Tribal officials in the development of regulatory
policies that have Tribal implications.'' This Proposed Rule does not
have Tribal implications, as defined in Executive Order 13175.

7. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This Executive Order (62 FR 19885, April 23, 1997) applies to any
rule that: (1) Is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health or safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, EPA must evaluate the environmental health or safety
effects of the planned rule on children, and explain why the planned
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by EPA. This Proposed Rule is not
subject to the Executive Order because it is not economically
significant as defined in Executive Order 12866, and because EPA does
not have reason to believe the environmental health or safety risks
addressed by this action present a disproportionate risk to children.

8. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use Compliance With Administrative Procedure
Act

    This proposed rule is not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it
is not a significant regulatory action under Executive Order 12866. The
Proposed Rule would only have the effect of setting maximum annual
disposal volumes and providing a continuing disposal option for dredged
material. Thus, EPA concluded that this proposed rule is not likely to
have any adverse energy effects.

9. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. This proposed rule does not involve technical
standards. Therefore, EPA is not considering the use of any voluntary
consensus standards.

10. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low Income Populations

    Executive Order 12898 (59 FR 7629) directs Federal agencies to
determine whether the proposed rule would have a disproportionate
adverse impact on minority or low-income population groups within the
project area. The proposed rule would not significantly affect any low-
income or minority population.

List of Subjects in 40 CFR Part 228

    Environmental protection, Water pollution control.

    Dated: June 12, 2013.
Ron Curry,
Regional Administrator, Region 6.

    In consideration of the foregoing, EPA is proposing to amend part
228, chapter I of title 40 of the Code of Federal Regulations as
follows:

PART 228--CRITERIA FOR THE MANAGEMENT OF DISPOSAL SITES FOR OCEAN
DUMPING

0
1. The authority citation for part 228 continues to read as follows:

    Authority:  33 U.S.C. 1412 and 1418.

0
2. Section 228.15 is amended by adding paragraphs (j) (23 through 26)
to read as follows:

Sec.  228.15  Dumping sites designated on a final basis.

* * * * *
    (j) * * *
    (23) Sabine-Neches, TX Dredged Material Site A.
    (i) Location: 29[deg]24'47'' N., 93[deg]43'29'' W.; 29[deg]24'47''
N., 93[deg]41'08'' W.; 29[deg]22'48'' N., 93[deg]41'09'' W.;
29[deg]22'49'' N., 93[deg]43'29'' W.; thence to point of beginning.
    (ii) Size: approximately 5.3 square miles.
    (iii) Depth: Ranges from 44 to 46 feet.
    (iv) Primary Use: Dredged material.
    (v) Period of Use: Continuing use.
    (vi) Restrictions: Disposal shall be limited to dredged material
from the Sabine-Neches 13.2 mile Extension Channel that complies with
EPA's Ocean Dumping Regulations. Dredged material that does not meet
the criteria set forth in 40 CFR part 227 shall not be placed at the
site. Disposal operations shall be conducted in accordance with
requirements specified in a Site Management and Monitoring Plan
developed by EPA and USACE, to be reviewed periodically, at least every
10 years.
    (24) Sabine-Neches, TX Dredged Material Site B.
    (i) Location: 29[deg]21'59'' N., 93[deg]43'29'' W.; 29[deg]21'59''
N., 93[deg]41'08'' W.; 29[deg]20'00'' N., 93[deg]41'09'' W.;
29[deg]20'00'' N., 93[deg]43'29'' W.; thence to point of beginning.
    (ii) Size: approximately 5.3 square miles.
    (iii) Depth: Ranges from 44 to 46 feet.
    (iv) Primary Use: Dredged material.
    (v) Period of Use: Continuing use.
    (vi) Restrictions: Disposal shall be limited to dredged material
from the Sabine-Neches 13.2 mile Extension Channel that complies with
EPA's Ocean Dumping Regulations. Dredged material that does not meet
the criteria set forth in 40 CFR part 227 shall not be placed at the
site. Disposal operations shall be conducted in accordance with
requirements specified in a Site Management and Monitoring Plan
developed by EPA and USACE, to be reviewed periodically, at least every
10 years.
    (25) Sabine-Neches, TX Dredged Material Site C.
    (i) Location: 29[deg]19'11'' N., 93[deg]43'29'' W.; 29[deg]19'11''
N, 93[deg]41'09'' W.; 29[deg]17'12'' N., 93[deg]41'09'' W.;
29[deg]17'12'' N., 93[deg]43'29'' W.; thence to point of beginning.
    (ii) Size: approximately 5.3 square miles.
    (iii) Depth: Ranges from 44 to 46 feet.
    (iv) Primary Use: Dredged material.
    (v) Period of Use: Continuing use.
    (vi) Restrictions: Disposal shall be limited to dredged material
from the Sabine-Neches 13.2 mile Extension Channel that complies with
EPA's Ocean Dumping Regulations. Dredged

material that does not meet the criteria set forth in 40 CFR part 227
shall not be placed at the site. Disposal operations shall be conducted
in accordance with requirements specified in a Site Management and
Monitoring Plan developed by EPA and USACE, to be reviewed
periodically, at least every 10 years.
    (26) Sabine-Neches, TX Dredged Material Site D.
    (i) Location: 29[deg]16'22'' N., 93[deg]43'29'' W.; 29[deg]16'22''
N., 93[deg]41'10'' W.; 29[deg]14'24'' N., 93[deg]44'10'' W.;
29[deg]14'24'' N., 93[deg]43'29'' W.; thence to point of beginning.
    (ii) Size: approximately 5.3 square miles.
    (iii) Depth: Ranges from 44 to 46 feet.
    (iv) Primary Use: Dredged material.
    (v) Period of Use: Continuing use.
    (vi) Restrictions: Disposal shall be limited to dredged material
from the Sabine-Neches 13.2 mile Extension Channel that complies with
EPA's Ocean Dumping Regulations. Dredged material that does not meet
the criteria set forth in 40 CFR part 227 shall not be placed at the
site. Disposal operations shall be conducted in accordance with
requirements specified in a Site Management and Monitoring Plan
developed by EPA and USACE, to be reviewed periodically, at least every
10 years.
* * * * *
[FR Doc. 2013-14911 Filed 6-26-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 68 (Thursday, April 9, 2015)]
[Notices]
[Page 19108]
[FR Doc No: 2015-08106]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Research, Engineering and Development Advisory Committee; Meeting

    Pursuant to section 10(A) (2) of the Federal Advisory Committee
Act (Pub. L. 92-463; 5 U.S.C. App. 2), notice is hereby given of a
meeting of the FAA Research, Engineering and Development (R,E&D)
Advisory Committee.

AGENCY: Federal Aviation Administration.

ACTION: Notice of Meeting.

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NAME:  Research, Engineering & Development Advisory Committee

TIME AND DATE:  April 22, 2015--9:30 a.m. to 4:00 p.m.
    Place: Federal Aviation Administration, 800 Independence Avenue
SW.,--Round Room (10th Floor), Washington, DC 20591
    Purpose: The meeting agenda will include receiving from the
Committee guidance for FAA's research and development investments in
the areas of air traffic services, airports, aircraft safety, human
factors and environment and energy. Attendance is open to the
interested public but seating is limited. Persons wishing to attend the
meeting or obtain information should contact Chinita A. Roundtree-
Coleman at<PHONE_NUMBER> or<EMAIL_ADDRESS>Members
of the public may present a written statement to the Committee at any
time.
    Issued in Washington, DC on March 25, 2015.

Chinita A. Roundtree-Coleman,
Computer Specialist.
[FR Doc. 2015-08106 Filed 4-8-15; 8:45 am]
 BILLING CODE 4910-13-P