[Federal Register Volume 77, Number 76 (Thursday, April 19, 2012)]
[Notices]
[Pages 23485-23486]
[FR Doc No: 2012-9418]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2012-N-0001]

Food and Drug Administration Patient Network Annual Meeting;
Input Into Food and Drug Administration Benefit-Risk Decisionmaking:
Opportunities and Challenges; Hosted by the Food and Drug
Administration Office of Special Health Issues; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing a meeting for
patients, caregivers, independent patient advocates and patient
advocate groups, and health professional groups to explore ways to more
effectively include patient input in regulatory decisionmaking on drug,
device, and biological products. The meeting will serve as a forum for
FDA's patient stakeholders and the general public, including health
professionals, academia, and industry to learn about the regulatory
process related to the medical product life cycle, analyze where in the
process patient input may be most practical and most valuable, and
explore practicable approaches to collecting and incorporating
meaningful input that well represents broad patient perspectives into
regulatory decisions.

DATES: Date and Time: The meeting will be held on May 18, 2012, from 9
a.m. to 4:30 p.m. Register at http://fda.contractmeetings.com/home on
or before May 4, 2012. Please include the name and title of the person
attending, the name of the organization, the role within the
organization, email address, and telephone number. There is no
registration fee for this conference. Early registration is suggested
because space is limited. We request that organizations limit the
number of representatives to two. For further registration information
or problems with the Web site, call Cindy de Sales, 1-240-316-3200,
ext. 207.
    If you need special accommodations due to a disability, please
contact Steve Morin at least 7 days in advance.
    Location: The meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503) Silver Spring, MD 20993.
    Contact Person: Steve Morin, Office of Special Health Issues, 10903
New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>, FAX: 301-
847-8623<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. FDA Patient Network

    This is the inaugural FDA Patient Network Annual Meeting hosted by
the FDA Office of Special Health Issues, the Agency's liaison to the
patient and health professional communities. This annual meeting is
being hosted in conjunction with the launch of the overarching FDA
Patient Network program. The FDA Patient Network is a new resource for
patients, caregivers, independent patient advocates, and patient
advocate groups that seek to:
     Educate and inform patient stakeholders about FDA, its
regulatory

authorities and processes, its initiatives and programs, etc.; and,
     Provide a venue for advocacy for patient stakeholders
within FDA and be transparent to patients about Agency actions.
    In addition to an annual meeting, the FDA Patient Network consists
of other activities, including the:
     FDA Patient Network Web site--A new, patient-centered Web
site that contains educational modules, centralized Agency information,
and multidirectional communication tools;
     Biweekly FDA Patient Network News email newsletter; and
hosting of periodic meetings, briefings, and listening session between
patient advocates and FDA staff.

II. Patient Perspectives in Regulatory Decisionmaking

    Establishing a means for obtaining input from patients and patient
advocate groups will allow FDA to further enhance its benefit-risk
assessment in regulatory decisionmaking. Patients who live with a
disease have a direct stake in the outcomes of the review process and
are in a unique position to contribute to the weighing of benefit-risk
considerations that can occur throughout the medical product
development process. Though several programs exist that facilitate
patient representation on Advisory Committees or participation in
selected review meetings, there are currently few venues in which the
patient perspective is discussed outside of a specific product's
marketing application review. The medical product review process could
benefit from a more scientific, systematic, and expansive approach to
obtaining input from patients who are experiencing a particular disease
condition.
    As part of the proposed agreements for Prescription Drug User Fee
Act (PDUFA) V, FDA plans to conduct meetings with patients and patient
advocacy groups to gather broader patient input. This meeting kicks off
these efforts and provides an opportunity to gain feedback on how FDA
can best structure these upcoming meetings.
    FDA seeks public discussion based on the following questions. These
questions are intended to frame patient input at the May 18, 2012,
meeting and there will be time at the meeting to discuss the following
issues.
    (1) How can FDA ensure gathering a broad range of representative
patient input that is relevant to a specific disease area during its
meetings with patients? For example, who should serve as
representatives of patients?
    (2) What methodological and practical issues should FDA consider as
it develops its strategy for eliciting the patient perspective? For
instance, FDA is interested in addressing topics including, but not
limited to, the following:
    (a) Are there particular advantages or disadvantages to utilizing
face-to-face meetings versus web-based or other methods in obtaining
the patient perspective on a particular disease condition and its
treatment?
    (b) How can FDA ensure that certain subpopulations, such as
patients with the most severe form of the disease, are represented?

III. Center for Drug Evaluation and Research and Center for Biologics
Evaluation and Research Efforts

    Center for Drug Evaluation and Research and Center for Biologics
Evaluation and Research plan to conduct a series of patient-focused
drug development meetings to gather patient input on the clinical
context of a disease and its impact on a patient's daily life. These
considerations, which would include an analysis of the severity of the
disease condition and the current state of the available treatment
options, can be critical in regulatory decisionmaking. FDA is
interested in obtaining patient input on the context of specific
disease areas through the patient-focused drug development meetings.
The following questions are examples of topics for which FDA believes
the patient perspective could add valuable insight. They are presented
in this document for general discussion at the Patient Network
Conference.

A. Understanding the Disease Condition

    (1) What are the clinical manifestations of the disease that have
the greatest impact on patients?
    (2) Are there other aspects of the disease that have a significant
impact on a patient's daily life? (e.g., impaired mobility, sleep
problems, etc.)
    (3) How do the clinical manifestations change with disease
progression?
    (4) How do the other aspects of the disease change with disease
progression?

B. Assessment of Treatment Options

    (1) How effective are approved therapies at treating the clinical
manifestations of the disease?
    (2) How well do approved therapies mitigate the other aspects of
the disease?
    (3) How does the effectiveness of approved therapies change with
progression of the disease?
    (4) Does therapy effectiveness vary by patient subpopulation?
    FDA is continuing to make plans for its efforts and will be able to
provide more detail on the patient-focused drug development meetings at
the Patient Network Conference.
IV. Center for Devices and Radiologic Health Efforts
    Center for Devices and Radiologic Health is interested in a public
discussion on issues related to risk associated with medical products,
and on avenues for patients to provide input into regulatory
decisionmaking related to the amount of risk patients may be willing to
accept in exchange for a potential treatment benefit. The following
questions are presented in this document for general discussion at the
Patient Network Conference.
    (1) How do patients perceive and weigh risks associated with
medical treatment in light of the risk associated with the underlying
condition being treated and the potential benefit from the treatment?
    (2) Under what circumstances and in which populations would various
levels of risk be appropriate/acceptable?
    (3) How can medical device companies, government, academia,
community physicians and patients collaborate to account for the level
of risk acceptable to patients affected by serious or life threatening
illnesses?
    (4) What mechanisms would be appropriate for patients to provide
input into regulatory decisionmaking for new therapeutic and diagnostic
products--e.g., web-based survey instruments? Patient representation at
advisory committee meetings? Patient input to medical device companies
during clinical trial design? Who (FDA, patient advocate groups,
medical device companies, etc.) could sponsor such surveys?
    (5) Are patients willing to accept responsibility for the level of
risk to which they may be exposed if patient input increases risk
tolerance?

    Dated: April 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9418 Filed 4-18-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: February 6, 2007 (Volume 72, Number 24)]
[Notices]
[Page 5483-5485]
[DOCID:fr06fe07-70]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55186; File No. SR-NYSEArca-2007-08]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to Further
Extending the Time Period by Which the Exchange Will Enter Into the
NASD/NYSE Arca Options Agreement Pursuant to Rule 17d-2

January 29, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 23, 2007, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Exchange filed the proposal as
a ``non-controversial'' rule change pursuant to Section 19(b)(3)(A) of
the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\ which renders the
proposal effective upon filing with the Commission.\5\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
    \5\ The Exchange has asked the Commission to waive the 5-day
pre-filing notice requirement and the 30-day operative delay. See 15
U.S.C. 78s(b)(3)(A), 17 CFR 240.19b-4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is proposing to amend its undertaking \6\ to extend
for 90 days from the date of this filing the time period by which the
Exchange will enter into an agreement with the National Association of
Securities Dealers, Inc. (``NASD'') pursuant to Rule 17d-2 under the
Act \7\ (the ``NASD/NYSE Arca Options Agreement'' or ``Agreement'').
The Agreement would expand the allocation to NASD of regulatory
responsibility to encompass all the regulatory oversight and
enforcement responsibilities with respect to the options activities of
Archipelago Securities, L.L.C. (``Archipelago Securities''),\8\ except
for ``real-time market surveillance.''
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    \6\ See Securities Exchange Act Release No. 54238 (July 28,
2006), 71 FR 44758 (August 7, 2006) (SR-NYSEArca-2006-13) (OX
Approval Order). See Securities Exchange Act Release No. 54690
(November 2, 2006), 71 FR 66211 (November 13, 2006) (SR-NYSEArca-
2006-79) (90-Day Extension).
    \7\ 17 CFR 240.17d-2.
    \8\ Archipelago Securities, a wholly-owned subsidiary of
Archipelago Holdings, Inc. and a registered broker-dealer, acts as
the outbound order router for the NYSE Arca Marketplace (formerly
known as the Archipelago Exchange) and, as such, is regulated as an
exchange ``facility'' of NYSE Arca and NYSE Arca Equities, Inc. See
15 U.S.C. 78c(a)(2). As such, any proposed rule change relating to
Archipelago Securities' order-routing function must be filed with
the Commission, and must operate in a manner that is consistent with
the provisions of the Act applicable to exchanges and with NYSE Arca
rules.
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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 Exchange 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 Exchange 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
    In connection with the Commission's approval of the Exchange's new
electronic options trading platform, OX, Archipelago Securities became
a routing broker for OX options orders on the Exchange.\9\ In Amendment
No. 3 to its filing seeking approval of the OX platform,\10\ the
Exchange proposed to

clarify that NASD, a self-regulatory organization unaffiliated with the
Exchange or any of its affiliates, would continue to carry out
oversight and enforcement responsibilities as the Designated Examining
Authority designated by the Commission pursuant to Rule 17d-1 under the
Act \11\ with the responsibility for examining Archipelago Securities
for compliance with the applicable financial responsibility rules.
Furthermore, the Exchange represented that it would enter into the
NASD/NYSE Arca Options Agreement pursuant to Rule 17d-2 under the
Act,\12\ to expand the allocation to NASD of regulatory responsibility
to encompass all the regulatory oversight and enforcement
responsibilities with respect to the options activities of Archipelago
Securities, except for ``real-time market surveillance.'' \13\ The
Exchange agreed to submit the NASD/NYSE Arca Options Agreement to the
Commission under Rule 17d-2 within 90 days of the date of the
Commission's approval of the OX trading platform (July 28, 2006), which
was October 26, 2006.\14\
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    \9\ See OX Approval Order, supra note 6. Pursuant to NYSE Arca
Rule 6.1A(a)(15), which was adopted in connection with the
establishment of the new OX trading platform, the term ``OX Routing
Broker'' refers to the broker-dealer affiliate of the Exchange that
acts as agent for routing orders entered into OX of OTP Holders, OTP
Firms and OTP Firms' Sponsored Participants to other Market Centers
for execution whenever such routing is permitted by Exchange Rules.
Archipelago Securities is the Exchange's only OX Routing Broker.
    \10\ See OX Approval Order, supra note 6.
    \11\ 17 CFR 240.17d-1.
    \12\ 17 CFR 240.17d-2.
    \13\ See OX Approval Order, supra note 6.
    \14\ Id.
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    On October 20, 2006, the Exchange submitted to the Commission a
draft NASD/NYSE Arca Options Agreement and requested a ninety day
extension \15\ of the October 26, 2006 deadline to January 24, 2007, in
order for the Commission to review the proposed NASD/NYSE Arca Options
Agreement. Based on the recommendation of the staff, the Exchange
hereby seeks a further extension of time, permitting an additional 90
days from the date of this filing to enter into the NASD/NYSE Arca
Options Agreement. NYSE Arca believes this will afford the Commission
staff sufficient time to review, publish, and take action on the
proposal.
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    \15\ See 90-Day Extension, supra note 6.
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    The Exchange believes that the requested extension of time is
consistent with the Act and the rules and regulations thereunder, will
not significantly affect the protection of investors or the public
interest, and does not impose any significant burden on competition.
The Exchange notes that NASD already carries out oversight and
enforcement responsibilities as the Designated Examining Authority
designated by the Commission pursuant to Rule 17d-1 with the
responsibility for examining Archipelago Securities for compliance with
the applicable financial responsibility rules.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\16\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\17\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating
clearing, settling, processing information with respect to, and
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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    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    Written comments on the proposed rule change were neither solicited
nor received.

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

    Because the foregoing rule: (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 from the date on which it was filed, or
such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest,\18\ the proposed
rule change has become effective pursuant to Section 19(b)(3)(A) of the
Act \19\ and Rule 19b-4(f)(6) thereunder.\20\
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    \18\ Pursuant to Rule 19b-4(f)(6)(iii) under the Act, the
Exchange is required to give the Commission written notice of its
intent to file the proposed rule change, along with a brief
description and text of the proposed rule change, at least five
business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has requested that the Commission waive the 5-day pre-
filing notice requirement. The Commission has determined to waive
this requirement for this filing.
    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(6).
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    The Exchange has requested that the Commission waive the 30-day
operative delay, which would make the rule change effective and
operative upon filing. The Commission believes that waiving the 30-day
operative delay is consistent with the protection of investors and the
public interest. Such waiver will allow the Exchange to comply with its
undertaking made in connection with the OX Approval Order to submit the
NASD/NYSE Arca Options Agreement to the Commission. The Exchange
requests a waiver of the 30-day period on the basis that the current
deadline for entering into the NASD/NYSE Arca Options Agreement was
January 24, 2007 and a delay of 30 days would place the Exchange out of
compliance with its undertaking. Extending the compliance date for the
Exchange's undertaking by an additional 90 days will provide time for
the Exchange to finalize and file the Agreement. For these reasons, the
Commission designates the proposal to be effective and operative upon
filing with the Commission.\21\
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    \21\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSEArca-2007-08 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2007-08. This
file number should be included on the subject line if e-mail is used.
To help the

Commission process and review your comments more efficiently, please
use only one method. The Commission will post all comments on the
Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).

Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for inspection and copying in the
Commission's Public Reference Room. 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; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.
    All submissions should refer to File Number SR-NYSEArca-2007-08 and
should be submitted on or before February 27, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\22\
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    \22\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-1861 Filed 2-5-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Notices]
[Pages 85684-85685]
[FR Doc No: 2016-28425]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2016-0128]

Pipeline Safety: Meeting of the Voluntary Information-Sharing
System Working Group

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of Voluntary Information-Sharing System Working Group
Meeting.

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SUMMARY: This notice announces a public meeting of the newly created
Voluntary Information-Sharing System (VIS) Working Group. The VIS
Working Group will convene to discuss administrative procedures and
consider the development of a voluntary information-sharing system.

DATES: The VIS Working Group will meet on Monday, December 19, 2016,
from 8:30 a.m. to 5:00 p.m., EST.
    The meeting will not be web cast; however, any documents presented
will be available on the meeting Web site and posted on the E-Gov Web
site: http://www.regulations.gov under docket number PHMSA-2016-0128
within 30 days following the meeting.

ADDRESSES: The meeting will be held at a location yet to be determined
in the Washington, DC Metropolitan area. The meeting location, agenda
and any additional information will be published on the following VIS
Working Group and registration page at: https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=122.

Public Participation

    This meeting will be open to the public. Members of the public who
wish to attend in person are asked to register at: https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=122 no later than
December 16, 2016, in order to facilitate entry and guarantee seating.
Members of the public who attend in person will also be provided an
opportunity to make a statement during the meeting.
    Written comments: Persons who wish to submit written comments on
the meeting may be submitted to the docket in the following ways:

    E-Gov Web site: http://www.regulations.gov. This site allows the
public to enter comments on any Federal Register notice issued by any
agency.
    Fax: 1-202-493-2251.
    Mail: Docket Management Facility; U.S. Department of Transportation
(DOT), 1200 New Jersey Avenue SE., West Building, Room W12-140,
Washington, DC 20590-0001.
    Hand Delivery: Room W12-140 on the ground level of the DOT West
Building, 1200 New Jersey Avenue SE., Washington, DC, between 9:00 a.m.
and 5:00 p.m., Monday through Friday, except on Federal holidays.
    Instructions: Identify the docket number PHMSA-2016-0128 at the
beginning of your comments. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. You should know that anyone is able to
search the electronic form of all comments received into any of our
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). Therefore, you may want to review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000, (65 FR 19477) or view the Privacy Notice at http://www.regulations.gov before submitting any such comments.
    Docket: For access to the docket or to read background documents or
comments, go to http://www.regulations.gov at any time or to Room W12-
140 on the ground level of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC, between 9:00 a.m. and 5:00 p.m., Monday
through Friday, except Federal holidays.
    If you wish to receive confirmation of receipt of your written
comments, please include a self-addressed, stamped postcard with the
following statement: ``Comments on PHMSA-2016-0128.'' The Docket Clerk
will date stamp the postcard prior to returning it to you via the U.S.
mail.

Privacy Act Statement

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL- 14 FDMS), which can be reviewed at
www.dot.gov/privacy.

Services for Individuals With Disabilities

    The public meeting will be physically accessible to people with
disabilities. Individuals requiring accommodations, such as sign
language interpretation or other ancillary aids, are asked to notify
Cheryl Whetsel at<EMAIL_ADDRESS>by December 12, 2016.

FOR FURTHER INFORMATION CONTACT: For information about the meeting,
contact Cheryl Whetsel by phone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The VIS Working Group is a newly created advisory committee
established in accordance with Section 10 of the Protecting our
Infrastructure of Pipelines and Enhancing Safety (PIPES) Act of 2016
(Pub. L. 114-183), the Federal Advisory Committee Act (FACA) of 1972 (5
U.S.C., App. 2, as amended), and 41 CFR 102-3.50(a).

II. Meeting Details and Agenda

    The VIS Working Group will consider and provide recommendations to
the Secretary as specifically outlined in section 10 of Public Law 114-
183:
    (a) The need for, and the identification of, a system to ensure
that dig verification data are shared with in-line inspection operators
to the extent consistent with the need to maintain proprietary and
security-sensitive data in a confidential manner to improve pipeline
safety and inspection technology;
    (b) Ways to encourage the exchange of pipeline inspection
information and the development of advanced pipeline inspection
technologies and enhanced risk analysis;
    (c) Opportunities to share data, including dig verification data
between operators of pipeline facilities and in-line inspector vendors
to expand knowledge of the advantages and disadvantages of the
different types of in-line inspection technology and methodologies;
    (d) Options to create a secure system that protects proprietary
data while encouraging the exchange of pipeline inspection information
and the development of advanced pipeline inspection technologies and
enhanced risk analysis;
    (e) Means and best practices for the protection of safety- and
security-sensitive information and proprietary information; and
    (f) Regulatory, funding, and legal barriers to sharing the
information described in paragraphs (a) through (d).
    The Secretary will publish the VIS Working Group's recommendations
on a publicly available DOT Web site. The VIS Working Group will
fulfill its purpose once its recommendations are published online.
    The agenda will be published on the PHMSA Web site.

    Issued in Washington, DC, on November 21, 2016, under authority
delegated in 49 CFR 1.97.
Linda Daugherty,
Deputy Associate Administrator for Field Operations.
[FR Doc. 2016-28425 Filed 11-25-16; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Pages 7455-7463]
[FR Doc No: 2016-02952]

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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2013-0399; FRL-9941-56]
RIN 2070-AB27

Significant New Use Rule on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for three chemical substances that
were the subject of premanufacture notices (PMNs). This action requires
persons who intend to manufacture (including import) or process any of
the chemical substances for an activity that is designated as a
significant new use by this rule to notify EPA at least 90 days before
commencing that activity. The required notification would provide EPA
with the opportunity to evaluate the intended use and, if necessary, to
prohibit or limit the activity before it occurs.

DATES: This final rule is effective April 12, 2016.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2013-0399, is available at
http://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. 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 (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Manufacturers (including importers) or processors of one
or more subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance to a proposed or final rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
Sec.  721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.

II. Background

A. What action is the Agency taking?

    EPA is finalizing SNURs, under TSCA section 5(a)(2), for three very
long chain chlorinated paraffin (vLCCPs--alkyl chain length of
C21 and above) chemical substances that were the subject of
PMNs P-12-539, P-13-107, and P-13-109. This final rule requires persons
who intend to manufacture or process any of these chemical substances
for an activity that is designated as a significant new use to notify
EPA at least 90 days before commencing that activity.
    In the Federal Register of August 7, 2013 (78 FR 48051) (FRL-9393-
4), EPA issued direct final SNURs on these three chemical substances in
accordance with the procedures at Sec.  721.160(c)(3)(i). EPA received
notices of intent to submit adverse comments on these SNURs. Therefore,
as required by Sec.  721.160(c)(3)(ii), EPA removed the direct final
SNURs in a separate final rule published in the Federal Register of
November 5, 2013 (78 FR 66279) (FRL-9902-16), and issued a proposed
rule in the Federal Register of February 10, 2014 (79 FR 7621) (FRL-
9903-43). The record for the direct final SNURs on these chemical
substances was established as docket EPA-HQ-OPPT-2013-0399. That docket
includes information considered by the Agency in developing the
proposed and final rules, including comments on the proposed rule.
    EPA received several comments on the proposed rules for these three
chemical substances, from a single commenter representing chlorinated
paraffin (CP) manufacturers (including the submitter of the PMNs that
are the subject of these SNURs). A full discussion of EPA's response to
these comments is included in Unit V. of this document. After
consideration of these comments, because the potential remains for
increased exposure that formed the basis for the proposed SNURs, EPA is
issuing the final rules as they were proposed for the chemical
substances.

B. What is the Agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors, listed in Unit IV. of this rule. Once EPA determines that a
use of a chemical substance is a significant new use, TSCA section
5(a)(1)(B) requires persons to submit a significant new use notice
(SNUN) to EPA at least 90 days before they manufacture or process the
chemical substance for that use. Persons who must report are described
in Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the final rule to uses occurring before the effective date of the
final rule. Provisions relating to user fees appear at 40 CFR part 700.
According to Sec.  721.1(c), persons subject to these SNURs must comply
with the same SNUN requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these
requirements include the information submission requirements of TSCA
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it
has received the SNUN. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.

III. Rationale and Objectives of the Final Rule

A. Rationale

    During review of the PMNs submitted for the three chemical
substances that are subject to these final SNURs, EPA concluded that
regulation was warranted under TSCA section 5(e), pending the
development of information sufficient to make reasoned evaluations of
the health and environmental effects of the chemical substances. The
basis for these findings is outlined in Unit IV of the proposed rule.
Based on these findings, a TSCA section 5(e) consent order was
negotiated with the PMN submitter that required manufacture of the
substances at certain cumulative,

aggregate volumes unless the company has submitted the results of
certain environmental effects studies; no manufacture of the substances
with the amount of chlorinated paraffins, with an alkyl chain less than
or equal to 20, to exceed more than 1 percent of that PMN substance by
weight; and risk notification. The SNUR provisions for these chemical
substances are consistent with the provisions of the TSCA section 5(e)
consent order. These final SNURs are issued pursuant to Sec.  721.160.
See the docket under docket ID number EPA-HQ-OPPT-2013-0399 for the
corresponding consent order. For additional discussion of the rationale
for the SNURs on these chemicals, see Units II., IV, and V. of the
proposed rule.

B. Objectives

    EPA is issuing final SNURs for three chemical substances described
above to achieve the following objectives with regard to the
significant new uses designated in this final rule:
     EPA will receive notice of any person's intent to
manufacture or process a listed chemical substance for the described
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
     EPA will be able to regulate prospective manufacturers or
processors of a listed chemical substance before the described
significant new use of that chemical substance occurs, provided that
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
    Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the Internet at
http://www.epa.gov/tsca-inventory/about-tsca-chemical-substance-inventory.

IV. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the
chemical substances listed in this final rule, EPA considered relevant
information about the toxicity of the chemical substances, likely human
exposures and environmental releases associated with possible uses, and
the four bulleted TSCA section 5(a)(2) factors listed in this unit.

V. Response to Comments on Proposed SNUR

    EPA received comments from the Chlorinated Paraffins Industry
Association (CPIA), which represents the CP industry, including the
submitter of the PMN substances that are the subject of these SNURs and
other chlorinated paraffin manufacturers. CPIA's comments, and
associated attachments, can be found in the public docket under ID EPA-
HQ-OPPT-2013-0399-0198.
    Comment 1: Based on existing data and recent reviews, CPIA believes
long chain chlorinated paraffin (LCCP--alkyl chain length of
C18 to C20) production and use in the U.S.
present an extremely low risk to human health and the environment.
Given this, CPIA questions the need for EPA to take specific action
under TSCA Section 5(a)(2) for any substances that could be considered
LCCP. CPIA then provides information on why they believe LCCPs and
vLCCPs do not present a risk.
    Response: The comments primarily addressed the underlying risk
assessments associated with the PMNs. EPA defers a discussion of the
commenter's specific concerns as they are not relevant to the basis for
determining that the uses specified in these SNURs constitute
significant new uses. EPA is neither required to determine that a
particular new use of any chemical substance presents, nor even that it
may present, an unreasonable risk to human health or the environment.
Rather, EPA issues a SNUR for a use of a substance if it is a
significant new use (e.g., EPA has reason to anticipate that the use
would raise significant questions related to potential exposure, so
that the Agency should have an opportunity to review the use before
such use should occur). EPA bases this judgment on a consideration of
all relevant factors, including the specific factors identified at
section 5(a)(2). Pursuant to TSCA section 5(a)(2), the PMN risk
assessment does not serve as the basis for regulation of these SNURs,
but as a valuable source of a breadth of information related to each
substance's potential to threaten human health or the environment.
    Nonetheless, EPA does have concern for these chemical substances
because when released to the environment, vLCCPs are expected to
rapidly partition to particulates and sediments where they are
anticipated to persist in the environment with half-lives of months or
greater. If they do degrade over time, these substances are expected to
form shorter chain chlorinated chemicals. Based on the complex starting
mixtures, lack of data on biological and abiotic reactions, and
potential degradation products, there is high uncertainty regarding the
fate and transport of these substances. Nevertheless, by analogy to
medium chain chlorinated paraffins (MCCPs--alkyl chain length of
C14 to C17) and LCCPs, EPA expects vLCCPs and
possible degradation products to be potentially highly persistent,
potentially highly bioaccumulative, and potentially toxic to aquatic
and sediment-dwelling organisms. Further, within the category of
vLCCPs, EPA expects the shorter carbon chain range of these substances
(C21 to C24) and lower chlorinated substances
(degree of chlorination less than 50%) to present the greatest
potential for risk, as they are expected to be the most
bioaccumulative, mobile in the environment, and toxic. Transport and
magnification across trophic levels may also result in toxicity to
higher organisms, including fish, higher predators, and potentially
humans. EPA has concerns about the potential for the vLCCPs to degrade
to shorter chain chlorinated compounds, as well as concerns about
potential impurities or small fractions of MCCPs and/or LCCPs.
    MCCPs and LCCPs are expected to be PBT chemicals based on the
following lines of evidence: (a) The available data on MCCPs, sediment
core studies, environmental fate studies, and associated calculations,
indicate transformation half-lives of months to years, depending on the
environmental media. Even though there are limited data on the LCCPs,
biodegradation data indicated increasing stability with increasing
chain length. LCCPs are also expected to have transformation half-lives
comparable to, or greater than MCCPs. Therefore, MCCPs and LCCPs are
expected to be very persistent; (b)

The available data on MCCPs and LCCPs indicate that these substances
have bioconcentration factors (BCFs) and bioaccumulation factors (BAFs)
that exceed 1,000 or 5,000 liters per kilogram wet weight of tissue (L/
kg ww). Therefore, MCCPs and LCCPs are expected to be very
bioaccumulative; (c) The available data on MCCPs and LCCPs indicated
acute and chronic toxicity to aquatic organism with effects levels
below 10 milligrams per liter (mg/L) or 0.1 mg/L, depending on the
species and MCCP and LCCP congener evaluated. Therefore, MCCPs and
LCCPs are expected to be toxic to aquatic organisms; (d) EPA is
concerned about PBT chemicals because even small releases may persist
in environmental media, build up in the environment and concentrate/
accumulate in organisms over time. These properties increase the
potential for continual exposure, and thus risk; and (e) EPA expects
there to be releases of the PMN substances to the environment resulting
from distribution in commerce and during processing and all the
substances' intended uses.
    EPA notes that its risk assessments for certain MCCP and LCCP PMNs
have recently been made available for public comment in the Federal
Register of December 23, 2015 (80 FR 79886) (FRL-9940-13).
    Comment 2: CPIA questioned the appropriateness of treating certain
of the substances in the proposed SNUR as chemical analogs to LCCPs or
vLCCPs, because two of the three substances covered by this SNUR are
described as being ``branched and linear'' chloroalkanes: Alkanes,
C21 to C34-branched and linear, chloro, CAS
Registry Number (CASRN) 1417900-96-9 (P-12-0539), and Alkanes,
C22 to C30-branched and linear, chloro, CASRN
1401974-24-0 (P-13-0107). CPIA could not find detailed compositional
information about these substances in the rulemaking docket.
Regardless, CPIA does not expect that anyone intending to make
chlorinated paraffins would intentionally seek to make branched
chloroalkanes. CP manufacturers have always used either n-paraffin or
alpha-olefin feedstocks, both of which should be almost exclusively
linear if they are to be used in CP manufacturing operations. To the
extent that these hydrocarbon feedstocks contain branched or
isoparaffin content, they are considered an impurity and something to
be minimized and closely controlled. The Organisation for Economic
Cooperation and Development (OECD) Screening Information Dataset (SIDS)
dossier and SIDS Initial Assessment Report (SIAR) for LCCP discuss LCCP
isoparaffin content in its section on impurities and states that the
amount should not be more than 1-2%. This is consistent with CPIA's
understanding of the feedstocks used in LCCP manufacture. Only linear
chloroalkanes are desired in commercial CP products and any branched
chloroalkane (i.e. chlorinated isoparaffin) content is considered an
impurity and should be kept to a minimum.
    Response: EPA understands that some CPs may contain only linear
chloroalkanes, but for these two ``branched and linear'' PMN
submissions that EPA has received, the percent branching is greater
than the 1-2% figure mentioned in the CPIA comments and the branching
is thus part of the specific chemical name for TSCA Chemical Inventory
purposes.
    Comment 3: EPA has designated the PMN/SNUR substances as very long
chain chlorinated paraffin (vLCCP), with a nominal carbon chain length
of C21 to C30. EPA has designated LCCP as
C18 to C20 chloroalkanes, although in all other
venues, including EPA's previous CP testing program, the OECD SIDS
assessment, the European Union (EU) Regulation on Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH) dossier,
and other recent assessments, LCCP has been considered as
C18 to C30. Most of the recent LCCP assessments
have evaluated LCCP as a category comprised of three main
subcategories: C18 to C20 Liquid LCCP,
C20 to C30 Liquid LCCP, and C20 to
C30 Solid LCCP.
    Response: EPA recognizes that CPIA does not agree with the EPA
designations for LCCP vs. vLCCP. The designation/cut-off for LCCPs and
vLCCPs represents the chain lengths potentially contained in the liquid
chlorinated paraffins and waxy/solid chlorinated paraffins. These
designations (i.e., the differentiation between C18-20 and
C20 CPs) are consistent with those in other jurisdictions,
e.g., Environment Canada (see Ref. 1). There are a series of
interactions that the CP industry has had with EPA over the years,
including TSCA section 4 test rules on specific TSCA chemicals and the
Toxics Release Inventory (TRI). In previous actions under TSCA and TRI,
the Agency has used a different naming convention, often based on
public comment from industry. However, in each action the chemical
substance that was the subject of the action has been clear because
information such as chemical formula has been part of the
identification. Previous attempts to divide chlorinated paraffins into
various categories were based primarily on industrial usage patterns
and industry comment, not on toxicological information.
    Regardless of the naming conventions raised by the commenter, in
reviewing the studies submitted with the PMNs in this SNUR and other
PMNs, and the scientific literature more broadly, EPA has concluded
that that there is a continuum of effects linked to chain length and
degree of chlorination. On the one end of the spectrum are SCCPs and
MCCPs; more data are available on these chain lengths, and EPA has
concluded that sufficient data exists to conclude that they may be
PBTs. There are also some, albeit significantly less, data on the
vLCCPs, most of which appear to point to a lack of effects, but the
chemical composition of the test substances was poorly characterized.
Ultimately, EPA is interested in specific fate and toxicity tests on
vLCCPs that elucidate the relationship between degree of chlorination
and alkyl chain length. The testing schema is designed to minimize the
burden of testing of complex mixtures with numerous congeners.
    Comment 4: According to the commenter, in the United States,
commercial LCCP products have generally been in either the
C20 to C30 liquid or C20 to
C30 solid subcategories, with C18 to
C20 liquid LCCP products found mostly in the European
market. Given the lack of C18 to C20 liquid LCCP
products in the U.S. market, CPIA does not necessarily object to EPA's
division of the existing category into LCCP and vLCCP. However, CPIA,
believes that drawing a ``bright line'' at a carbon length of
C20 is questionable based on the toxicology and
environmental fate data available. CPIA cites as support the conclusion
of the OECD SIDS Initial Assessment Profile (SIAP) of LCCP, that ``C20-
30 liquid and solid LCCPs are of low concern for the environment based
on their low hazard profiles. . . . Adequate screening-level data are
available to characterize the environmental hazard for the purposes of
the OECD HPV (High Production Volume) Chemicals Programme.''
    Response: EPA recognizes that CPIA does not agree with the EPA
designations for LCCP vs. vLCCP. EPA disagrees with CPIA that linear
C18 to C20 CPs are not available within the
United States, as EPA has received one or more PMN submissions for
these types of CPs and therefore they may be commercially available.
Further, these designations are consistent with those in other
jurisdictions, e.g., Environment Canada (Ref. 1). Please refer to the
response to Comment 1 for the issue of hazard and PBT discussions
pertaining to chain length.

    Comment 5: Limited information on EPA's assessment of vLCCP is
provided in the proposed SNUR, associated Consent Order, and the
rulemaking docket. Perhaps this limited information is due to the
nature of this SNUR and the PMN review process.
    Response: EPA reviewed the PMNs based on the contents of the PMN
and information available on analogs and in the literature. As with all
PMN submissions, EPA has followed the processes, procedures and
statutory provisions of TSCA section 5 for the chlorinated paraffin
PMNs, including EPA's Policy Statement on PBT New Chemical Substances
(64 FR 60194; November 4, 1999; FRL-6097-7). EPA's assessment of
exposures and risks for these three PMN substances is provided in Unit
IV of the Preamble to the section 5(e) Consent Order (available in the
public docket to the proposed rule) and is also presented in the
response to Comment 1. Note that EPA has recently made available
assessments for certain MCCP and LCCP PMNs, in the Federal Register of
December 23, 2015 (80 FR 79886) (FRL-9940-13).
    Comment 6: EPA indicates that it was unable to locate any chronic
aquatic toxicity data on LCCP and as a consequence has relied solely on
MCCP data. Further, EPA claims that based on these MCCP data there may
be concerns regarding vLCCP's aquatic toxicity. EPA should be aware
that there are both chronic fish and invertebrate toxicity data on
various carbon chain length and chlorination level LCCP test materials.
These were included in all of the recent reviews of LCCP, including the
OECD SIDS assessment, the REACH registration dossier, and the U.K. LCCP
Environmental Risk Assessment report.
    Response: As noted in the TSCA section 5(e) Consent Order signed
with the PMN submitter and available in the public docket, there were
no valid chronic aquatic toxicity data available for LCCPs or vLCCPs.
EPA did consider the LCCP REACH Consortium aquatic toxicity database
(see Attachment B in the CPIA comments), but the data were inadequate
to allow EPA to identify a Concentration of Concern (COC). The studies
tested concentrations in excess of the water solubility and did not
analytically measure the concentrations that were in solution, which
led to results orders of magnitude above the water solubility. Given
the lack of reliable test data for the PMN substances listed in the
SNUR, EPA used a read-across approach using MCCPs. The chronic aquatic
toxicity test results and resulting COCs for MCCP data are within the
estimated water solubilities and therefore these data are deemed
reliable. The most reliable and acceptable studies indicate that, for
vLCCPs, the predicted toxicity to aquatic organisms for acute endpoints
are no effects at saturation. For the chronic toxicity endpoint, EPA
used the aquatic invertebrate chronic value of 0.013 mg/L from the
Thompson et al. 1997 study (Ref. 2) based on a MCCP material. This
value was divided by an assessment factor of 10 to yield 0.0013 mg/L or
1.3 micrograms ([mu]g)/L or 1.3 parts per billion (ppb).
    Comment 7: CPIA readily acknowledges that, as EPA notes, toxicity
to aquatic plant life and toxicity to sediment organisms are data gaps
for LCCP. There have been several different approaches used to fill
these data gaps. In the case of aquatic plant life, some testing has
been done on LCCP toxicity to aquatic plant life though the reliability
of these data has been called into question by reviewers and the data
were not deemed sufficiently valid to address the endpoint. Most
assessments of LCCP have thus considered read-across data from MCCP as
being adequate to fill this data gap. The data from MCCP indicate that
neither MCCP, nor LCCP by analogy, are toxic to aquatic plant life.
Given this, CPIA supports the use of MCCP data in the assessment of
LCCP/vLCCP.
    Response: EPA agrees that toxicity to aquatic plant life is a data
gap for LCCP/vLCCP and that MCCP serves as an appropriate analog in a
read-across approach.
    Comment 8: For LCCP sediment toxicity and risk, previous
assessments by the U.K. Environment Agency and the REACH registration
dossier have extrapolated from LCCP aquatic toxicity data to sediment
toxicity using the equilibrium partitioning method. This approach is
detailed in Attachment C of CPIA's comments, which is a direct excerpt
from the U.K. Environment Agency's (EA) LCCP assessment. Given the very
low water solubility of LCCP and the very high predicted Kow, this
method estimates rather high predicted no effect concentrations (PNECs)
for LCCP. A PNEC is functionally similar to EPA's concentration of
concern (CoC) in that both are points of departure for environmental
risk assessment. The comparison between the sediment PNECs derived by
the EA using the equilibrium partitioning method and the sediment CoC
derived by EPA using an MCCP sediment toxicity study are orders of
magnitude apart. Given this large difference and the fact that both
methods have limitations, CPIA thinks that this may be a data gap to
consider for additional testing of vLCCP assuming chemical analysis
concerns can be addressed and only if exposure/release information
actually dictate a need for this testing.
    Response: EPA agrees that sediment toxicity is a data gap for
vLCCPs. The most reliable and acceptable value for the toxicity to
sediment invertebrate organisms is based on the MCCP material from the
Thompson et al. 2002 study (Ref. 3). For vLCCPs, EPA used the 28-day
sediment invertebrate Geometric Mean Acceptable Toxicant Concentration
(GMATC) value of 187 mg/kg dry weight sediment as an analog approach to
assess hazard. To calculate an acute concern concentration, this value
is first multiplied by an acute to chronic ratio for invertebrates of
10 to yield 1,870 mg/kg dry weight sediment, and then this value is
divided by an assessment factor of 5 to yield 374 mg/kg dry weight
sediment. For the chronic toxicity endpoint, EPA used the 28-day
sediment invertebrate GMATC of 187 mg/kg dry weight sediment also from
the Thompson et al. 2002 study. This value is divided by an assessment
factor of 10 to yield 18.7 mg/kg dry weight sediment.
    Comment 9: EPA states that vLCCP by analogy to MCCP may be
``potentially highly persistent, potentially bioaccumulative and
potentially toxic.'' EPA further indicates that, ``[t]ransport and
magnification across trophic levels may also result in toxicity to
higher organisms, including fish, higher predators, and potentially
humans,'' though it is not clear whether this statement is directed at
vLCCP or MCCP as an analog. Regardless, EPA should be aware there has
been considerable research done in recent years on the environmental
fate of MCCP, including new research on biodegradation and the
potential for bioaccumulation, including trophic magnification
potential.
    Response: EPA has reviewed all the information cited by CPIA,
including the specific biodegradation studies described in the comments
and biodegradation studies on LCCPs. No persistence or bioaccumulation
data were available or submitted to EPA for the commercial Unknown or
Variable composition, Complex reaction products and Biological
materials (UVCB) multicomponent substances described in the PMNs. In
the absence of data on the commercial UVCB substances, EPA used data on
their components, analogs and used a read-across approach. EPA notes
that close analogs of MCCPs are the short chain chlorinated paraffins
(SCCPs) which have been proposed for addition to the Stockholm
Convention on Persistent Organic Pollutants.

    Comment 10: Given the available data, CPIA believes that any
analogy to MCCP for vLCCP must consider that while lower chlorinated CP
substances may have somewhat greater capacity to bioaccumulate--though
bioaccumulation will also decrease significantly with increasing carbon
chain length--these same lower chlorinated CPs show a greater potential
to biodegrade. In fact, MCCP constituents up to 50% chlorination have
been found to be readily biodegradable and therefore are not
persistent, bioaccumulative, and toxic chemicals (PBTs). Higher
chlorinated MCCP constituents also showed significant potential to
biodegrade though the results did not reach the ``ready'' criteria.
Perhaps even more telling is the fact that field studies have not shown
MCCP to biomagnify across trophic levels (Ref. 4). CPIA believes that
vLCCP, which is less soluble in water and less bioavailable than MCCP,
will have even less potential to move up through the troposphere and
biomagnify. This conclusion was similarly reached by the U.K.
Environment Agency (Ref. 5), the OECD (Ref. 6), and the European
Chemical Bureau (ECB) PBT Working Group (Ref. 7).
    Response: EPA has reviewed all the information cited by CPIA
including the specific bioaccumulation/biomagnification studies
described in the comments. No persistence or bioaccumulation data were
submitted for the commercial UVCB multicomponent substances described
in the PMNs. In the absence of data on the commercial UVCB
multicomponent substance, EPA used data on components of that
substance, structural analogs and a read-across approach. Although
bioaccumulation data are lacking with vLCCPs, there is still concern
for the presence of lower chain length and moderately chlorinated
components in the vLCCP commercial UVCB multicomponent substance that
have the potential to be both persistent and bioaccumulative. EPA
considered more recent reviews of the bioaccumulation potential of
MCCPs by Thompson and Vaughn (Ref. 4) and Arnot (Ref. 8) in making the
determination that MCCPs may be very bioaccumulative. The framework for
assessing bioaccumulation outlined by Gobas et al. (Ref. 9) describes a
preferred data hierarchy that places field Trophic Magnification Factor
(TMF) studies at the top. EPA recognizes that there are significant
uncertainties associated with the available TMF data for MCCPs. In the
absence of such data, the framework outlines the use of
bioconcentration factors (BCFs), bioaccumulation factors (BAFs), and
biomagnification factors (BMFs) to be considered with caution. EPA
believes that its review of available data on the bioaccumulation
potential of MCCPs is consistent with the approach described by Gobas
et al. (Ref. 9) and that the data support its finding that MCCPs may be
very bioaccumulative and by analogy so may vLCCPs.
    Comment 11: CPIA is concerned that EPA's proposed testing approach
for vLCCP in the proposed SNUR (Attachment A of CPIA's comments) fails
to consider the highly complex nature of the LCCP/vLCCP UVCB substances
and the analytical limitations inherent to this complex composition.
For example, even a single carbon-chain length straight-chain
chloroalkane, will have tens of thousands or more possible isomers.
Tomy et al. (Ref. 10) calculated that for a C13 chloroalkane
at 60% chlorination by weight, the total number of possible isomers is
3,549, even assuming no more than one chlorine atom bound to an
individual carbon atom. This number of theoretical isomers more than
doubles with each added carbon number, suggesting that by
C21, the lowest carbon chain length that EPA has proposed
testing, this test material could have hundreds of thousands of
possible isomers.
    Response: EPA understands the complexity of vLCCPs and therefore
stipulates under the consent order for the PMN substances the testing
of three specific chain lengths and chlorination levels. EPA expects
that a single chain length at a specific chlorination level can be
produced. The purpose of the sequence of testing, i.e., biodegradation
testing and identification of degradation products followed by
bioaccumulation testing and benthic toxicity testing, is to use the
results of the biodegradation tests to identify biodegradation
products. The selection of three less complex congener PMN surrogates
for testing reduces the analytical complexities associated with
characterization of the test substance and identification of products
formed during biodegradation testing.
    Comment 12. Current guidance from manufacturers indicates that
vLCCP substances should not be released to surface water and/or poured
down the drain. When this guidance is applied to exposure models, the
predicted releases levels to surface water and corresponding
concentrations in sediment are below the levels of concern.
    Response: While the SNUR is not based on EPA's risk assessment, EPA
notes that information regarding releases of vLCCPs was submitted to
EPA by the PMN submitter of these three SNUR substances and is used in
the risk assessment. EPA's risk assessment for the PMN substances
indicated that releases of the substances may occur and that without
the less than 1 weight percent of chlorinated paraffins with an alkyl
chain <= 20 manufacturing restriction, those releases may pose an
unreasonable risk to the environment. Further, apart from any risk
resulting from releases assessed for the PMN chemical substance,
chlorinated paraffins with alkyl chain lengths <= 20 are very
persistent and very bioaccumulative toxic chemical substances. Thus a
SNUR is important because it gives EPA an opportunity to review and
evaluate data on the significant new use before it commences. These
significant new use may have release and exposure profiles that are
different from that considered in the PMN.
    To the extent that the commenter is suggesting that the predicted
releases to surface water do not present a risk and thus do not support
a significant new determination, EPA notes that a significant new use
determination is not based on risk.

VI. Applicability of the Significant New Use Designation

    If uses begun after the proposed rule was published were considered
ongoing rather than new, any person could defeat the SNUR by initiating
the significant new use before the final rule was issued. Therefore EPA
has designated the date of publication of the proposed rule as the
cutoff date for determining whether the new use is ongoing. Consult the
Federal Register notice of April 24, 1990 (55 FR 17376, FRL 3658-5) for
a more detailed discussion of the cutoff date for ongoing uses.
    Any person who began commercial manufacture or processing of the
chemical substances identified in this rule for any of the significant
new uses designated in the proposed SNUR after the date of publication
of the proposed SNUR, must stop that activity before the effective date
of the final rule. Persons who ceased those activities will have to
first comply with all applicable SNUR notification requirements and
wait until the notice review period, including any extensions, expires,
before engaging in any activities designated as significant new uses.
If a person were to meet the conditions of advance compliance under 40
CFR 721.45(h), the person would be considered to have met the

requirements of the final SNUR for those activities.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require the development
of any particular test data before submission of a SNUN. The two
exceptions are:
    1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
    Recommended testing that would address the criteria of concern of
Sec.  721.170 can be found in Unit IV. of the proposed rule.
Descriptions of tests are provided only for informational purposes. EPA
strongly encourages persons, before performing any testing, to consult
with the Agency pertaining to protocol selection.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notice requirements and EPA regulatory procedures as
persons submitting a PMN, including submission of test data on health
and environmental effects as described in Sec.  720.50. SNUNs must be
on EPA Form No. 7710-25, generated using e-PMN software, and submitted
to the Agency in accordance with the procedures set forth in Sec. Sec.
721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn.

IX. Economic Analysis

    EPA evaluated the potential costs of SNUN requirements for
potential manufacturers and processors of the chemical substances in
the rule. The Agency's complete Economic Analysis is available in the
docket under docket ID number EPA-HQ-OPPT-2014-0390

X. References

    The following is a listing of those documents used to prepare the
preamble to this final rule. Additional information for this final rule
can be located under docket ID number EPA-HQ-OPPT-2013-0399, which is
available for inspection as specified under ADDRESSES.

1. Environment Canada, August 2008. Canadian Environmental
Protection Act, 1999 Follow-up Report on a PSL1 Assessment for Which
Data Were Insufficient to Conclude Whether the Substances Were
``Toxic'' to the Environment and to the Human Health: Chlorinated
Paraffins.
2. Thompson, R.S., N.J. Williams, and E. Gillings. 1997. Chlorinated
Paraffin (52% Chlorinated, C14-C17): Chronic Toxicity to Daphnia
Magna. AstraZeneca Confidential Report, BL 5791/B.
3. Thompson, R.S., D.V. Smyth, and E. Gillings. 2002. Medium-Chain
Chlorinated Paraffin (52% Chlorinated, C14	17): Effects in Sediment
on the Survival, Growth and Sexual Development of the Freshwater
Amphipod, Hyalella Azteca. AstraZeneca Confidential Report BL7469/B.
4. Thompson, Roy and Martin Vaughn. 2014. Medium-chain chlorinated
paraffins (MCCPs): A review of bioaccumulation potential in the
aquatic environment. Integrated Environmental Assessment and
Management. Volume 10, Issue 1, pages 78-86, January 2014.
5. U.K. Environment Agency (EA). 2009. Environmental Risk Evaluation
Report: Long-Chain Chlorinated Paraffins. January 2009.
6. Organisation for Economic Cooperation and Development (OECD).
2009. SIDS Initial Assessment Report (SIAR) and SIDS Initial
Assessment Profile (SIAP) for Long Chain Chlorinated Paraffins
(LCCPs). Reviewed and approved at SIAM-29, October 20-23, 2009.
7. European Chemicals Bureau (ECB) PBT Working Group. 2007. Results
of the Evaluation of the PBT/vPvB Properties of Paraffin waxes and
Hydrocarbon waxes, chlor; EC number 264-150-0; CAS number 63449-39-
8. PBT List No. 110. September 11, 2007.
8. Arnot, Jon. 2013. Comments on Preliminary Bioaccumulation
Assessment of Medium Chain Chlorinated Paraffins (MCCPs): Prepared
for the MCCP REACH Consortium. April 30, 2013.
9. Gobas, Frank APC; Watze de Wolf; Lawrence P. Burkhard; Eric
Verbruggen; Kathleen Plotzke. 2009. Revisiting Bioaccumulation
Criteria for POPs and PBT Assessments. Integrated Environmental
Assessment and Mangement 5(4): 624-637.
10. Tomy, Gregg T.; Gary A. Stern, Derek C.G. Muir, Aaron T. Fisk,
Chris D. Cymbalisty, and John B. Westmore. 1997. Quantifying C10-C13
Polychloroalkanes in Environmental Samples by High-Resolution Gas
Chromatography/Electron Capture Negative Ion High-Resolution Mass
Spectrometry. Analytical Chemistry 69: 2762-2771.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    This final rule establishes SNURs for chemical substances that were
the subject of PMNs. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this final rule. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
    The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the

Agency, the annual burden is estimated to average between 30 and 170
hours per response. This burden estimate includes the time needed to
review instructions, search existing data sources, gather and maintain
the data needed, and complete, review, and submit the required SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
    1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
    A copy of that certification is available in the docket for this
final rule.
    This final rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit VIII.
and EPA's experience promulgating SNURs (discussed in the
certification), EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity
significantly more than $8,300.
    Therefore, the promulgation of the SNUR would not have a
significant economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this final rule.
As such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

    This action will not have a substantial direct effect on 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, entitled
``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
final rule does not significantly nor uniquely affect the communities
of Indian Tribal governments, nor does it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not
apply to this final rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because
this action is not expected to affect energy supply, distribution, or
use and because this action is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to
this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).

XII. Congressional Review Act (CRA)

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: February 5, 2016.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.

0
Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority:  7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C.
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326,
1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f,
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q,
7542, 9601-9657, 11023, 11048.

0
2. In Sec.  9.1, add the following sections in numerical order under
the undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:

Sec.  9.1  OMB Approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB Control
                     40 CFR citation                            No.
------------------------------------------------------------------------

                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------

                                * * * * *
721.10673...............................................       2070-0012
721.10674...............................................       2070-0012
721.10675...............................................       2070-0012

                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
4. Add Sec.  721.10673 to subpart E to read as follows:

Sec.  721.10673  Alkanes, C21-34-branched and linear, chloro.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes, C21-34-
branched and linear, chloro (PMN P-12-539; CAS No. 1417900-96-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (j)(manufacture of the PMN substance with
less than 1 weight percent of chlorinated paraffins with an alkyl chain
<= 20) and (p) (1,200,000 kg, 14,100,000 kg, 59,100,000 kg, 78,400,000
kg, and 86,100,000 kg of the aggregate of the PMN substances P-12-539,
P-13-107, and P-13-109, from the March 19, 2013 effective date of the
TSCA section 5(e) consent order for P-12-539, P-13-107, and P-13-
109).).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
5. Add Sec.  721.10674 to subpart E to read as follows:

Sec.  721.10674  Alkanes, C22-30-branched and linear, chloro.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes, C22-30-
branched and linear, chloro (PMN P-13-107; CAS No. 1401947-24-0) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (j)(manufacture of the PMN substance with
less than 1 weight percent of chlorinated paraffins with an alkyl chain
<= 20) and (p) (1,200,000 kg, 14,100,000 kg, 59,100,000 kg, 78,400,000
kg, and 86,100,000 kg of the aggregate of the PMN substances P-12-539,
P-13-107, and P-13-109, from the March 19, 2013 effective date of the
TSCA section 5(e) consent order for P-12-539, P-13-107, and P-13-109).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
6. Add Sec.  721.10675 to subpart E to read as follows:

Sec.  721.10675  Alkanes, C24-28, chloro.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes, C24-28,
chloro (PMN P-13-109; CAS No. 1402738-52-6) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (j) (manufacture of the PMN substance with
less than 1 weight percent of chlorinated paraffins with an alkyl chain
<= 20) and (p) (1,200,000 kg, 14,100,000 kg, 59,100,000 kg, 78,400,000
kg, and 86,100,000 kg of the aggregate of the PMN substances P-12-539,
P-13-107, and P-13-109, from the March 19, 2013 effective date of the
TSCA section 5(e) consent order for P-12-539, P-13-107, and P-13-109).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2016-02952 Filed 2-11-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 244 (Thursday, December 21, 2023)]
[Notices]
[Pages 88387-88388]
[FR Doc No: 2023-28131]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-492-000]

Florida Gas Transmission Company, LLC; Notice of Availability of
the Environmental Assessment for the Proposed South Louisiana Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the South
Louisiana Project, proposed by Florida Gas Transmission Company, LLC
(FGT) in the above-referenced docket. FGT requests to increase its
certificated capacity and throughput by 100,000 million British thermal
units per day to its shipper, Florida Power & Light Company, to
diversify its supply sources of natural gas for downstream customers.
FGT would accomplish this by modifying certain compressor stations in
St. Landry, East Baton Rouge, and Washington Parishes, Louisiana, and
Perry County, Mississippi.
    The EA assesses the potential environmental effects of the
construction and operation of the South Louisiana Project in accordance
with the requirements of the National Environmental Policy Act. The
FERC

staff concludes that approval of the proposed project, with appropriate
mitigating measures, would not constitute a major federal action
significantly affecting the quality of the human environment.
    The proposed South Louisiana Project includes the following
facilities:
     uprating two existing natural gas-fired compressor turbine
units at FGT's existing Compressor Station 7.5 in St. Landry Parish,
Louisiana from 6,500 horsepower (hp) to 7,700 hp, each;
     adding process cooling units to support the existing gas
compressor units at FGT's existing Compressor Station 8 in East Baton
Rouge Parish, Louisiana;
     installing one new 7,700 hp natural gas-fired turbine
compressor unit at FGT's existing Compressor Station 9 in Washington
Parish, Louisiana;
     installing one new 15,900 hp natural gas-fired compressor
turbine unit at FGT's existing Compressor Station 10 in Perry County,
Mississippi; and
     installing and modifying auxiliary facilities as needed at
each location.
    The Commission mailed a copy of the Notice of Availability to
federal, state, and local government representatives and agencies;
elected officials; environmental and public interest groups; Native
American tribes; potentially affected landowners and other interested
individuals and groups; and newspapers and libraries in the project
area. The EA is only available in electronic format. It may be viewed
and downloaded from the FERC's website (www.ferc.gov), on the natural
gas environmental documents page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). In addition, the EA
may be accessed by using the eLibrary link on the FERC's website. Click
on the eLibrary link (https://elibrary.ferc.gov/eLibrary/search),
select ``General Search'' and enter the docket number in the ``Docket
Number'' field (i.e., CP23-492). Be sure you have selected an
appropriate date range. For assistance, please contact FERC Online
Support at [email protected] or toll free at<PHONE_NUMBER>,
or for TTY, contact<PHONE_NUMBER>.
    The EA is not a decision document. It presents Commission staff's
independent analysis of the environmental issues for the Commission to
consider when addressing the merits of all issues in this proceeding.
Any person wishing to comment on the EA may do so. Your comments should
focus on the EA's disclosure and discussion of potential environmental
effects, reasonable alternatives, and measures to avoid or lessen
environmental impacts. The more specific your comments, the more useful
they will be. To ensure that the Commission has the opportunity to
consider your comments prior to making its decision on this project, it
is important that we receive your comments in Washington, DC on or
before 5:00 p.m. Eastern Time on January 16, 2024.
    For your convenience, there are three methods you can use to file
your comments to the Commission. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or [email protected]. Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
FERC Online. This is an easy method for submitting brief, text-only
comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's website (www.ferc.gov) under the
link to FERC Online. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP23-
492-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Filing environmental comments will not give you intervenor status,
but you do not need intervenor status to have your comments considered.
Only intervenors have the right to seek rehearing or judicial review of
the Commission's decision. At this point in this proceeding, the
timeframe for filing timely intervention requests has expired. Any
person seeking to become a party to the proceeding must file a motion
to intervene out-of-time pursuant to Rule 214(b)(3) and (d) of the
Commission's Rules of Practice and Procedures (18 CFR 385.214(b)(3) and
(d)) and show good cause why the time limitation should be waived.
Motions to intervene are more fully described at https://www.ferc.gov/how-intervene.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to https://www.ferc.gov/ferc-online/overview to
register for eSubscription.

    Dated: December 15, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-28131 Filed 12-20-23; 8:45 am]
BILLING CODE 6717-01-P