[Federal Register: October 1, 2010 (Volume 75, Number 190)]
[Notices]
[Page 60761-60762]
[DOCID:fr01oc10-74]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0270]

Medical Device User Fee and Modernization Act; Notice to Public
of Web site Location of Fiscal Year 2011 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the Web
site location where it will post a list of guidance documents the
Center for Devices and Radiological Health (CDRH) is considering for
development. In addition, FDA has established a docket where
stakeholders may provide comments and/or draft language for those
topics as well as suggestions for new or different guidances.

DATES:  Submit either written or electronic comments at any time.

ADDRESSES:  Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. Identify comments with the docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nancy Pirt, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. WO66, rm. 4438, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations over the reauthorization of the Medical Device
User Fee and Modernization Act (MDUFMA), FDA agreed, in return for
additional funding from industry, to meet a variety of quantitative and
qualitative goals intended to help get safe and effective medical
devices to market more quickly. These commitments include annually
posting a list of guidance documents that CDRH is considering for
development and providing stakeholders an opportunity to provide
comments and/or draft language for those topics, or suggestions for new
or different guidances. This notice announces the Web site location of
the list of guidances on which CDRH is intending to work over the next
Fiscal Year (FY). We note that the agency is not required to issue
every guidance on the list, nor is it precluded from issuing guidance
documents that are not on the list. The list includes topics that
currently have no guidance associated with them, topics where updated
guidance may be helpful, and topics for which CDRH has already issued
level 1 drafts that may be finalized following review of public
comments. We will consider stakeholder comments as we prioritize our
guidance efforts.
    FDA and CDRH priorities are subject to change at any time. Topics
on this and past guidance priority lists may be removed or modified
based on current priorities. We also note that CDRH's experience over
the years has shown that there are many reasons CDRH staff does not
complete the entire annual agenda of guidances it undertakes. Staff are
frequently diverted from guidance development to other activities,
including review of premarket submissions or postmarket problems. In
addition, the Center is required each year to issue a number of
guidances that it cannot anticipate at the time the annual list is
generated. These may involve newly identified public health issues as
well as special control guidance documents for de novo classifications
of devices. It will be helpful, therefore, to receive comments that
indicate the relative priority of different guidance topics to
interested stakeholders.
    Through feedback from stakeholders, including draft language for
guidance documents, CDRH expects to be able to better prioritize and
more efficiently draft guidances that will be useful to industry and
other stakeholders. This will be the fourth annual list CDRH has
posted. FDA intends to update the list each year.
    FDA invites interested persons to submit comments on any or all of
the guidance documents on the list. FDA has established a docket where
comments about the FY 2011 list, draft language for guidance documents
on those topics, and suggestions for new or different guidances may be
submitted (see ADDRESSES). FDA believes this docket is an important
tool for receiving information from interested parties and for sharing
this information with the public. Similar information about planned
guidance development is included in the annual agency-wide notice
issued by FDA under its good guidance practices (21 CFR 10.115(f)(5)).
This CDRH list, however, will be focused exclusively on device-related
guidances and will be made available on FDA's Web site prior to the
beginning of each FY from 2008 to 2012.
    To access the list of the guidance documents CDRH is considering
for development in FY 2011, visit the FDA Web site http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 28, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-24669 Filed 9-30-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Page 74213]
[FR Doc No: 2015-29937]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Delayed Applications

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

ACTION: List of application delayed more than 180 days.

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SUMMARY: In accordance with the requirements of 49 U.S.C. 5117(c),
PHMSA is publishing the following list of special permit applications
that have been in process for 180 days or more. The reason(s) for delay
and the expected completion date for action on each application is
provided in association with each identified application.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Special Permits and Approvals, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

Key to ``Reason for Delay''

    1. Awaiting additional information from applicant
    2. Extensive public comment under review
    3. Application is technically complex and is of significant impact
or precedent-setting and requires extensive analysis
    4. Staff review delayed by other priority issues or volume of
special permit applications

Meaning of Application Number Suffixes

    N--New application
    M--Modification request
    R--Renewal Request
    P--Party To Exemption Request

    Issued in Washington, DC, on November 4, 2015.
Donald Burger,
Chief, General Approvals and Permits.

----------------------------------------------------------------------------------------------------------------
                                                                                Reason for    Estimated date
              Application No.                             Applicant                    delay       of completion
----------------------------------------------------------------------------------------------------------------
                                         Modification to Special Permits
----------------------------------------------------------------------------------------------------------------
16142-M....................................  Nantong CIMC, Tank Equipment Co.                  4      11-20-2015
                                              Ltd., Jiangsu, Province.
14437-M....................................  Columbiana Boiler Company (CBCo)                  4      11-30-2015
                                              LLC, Columbiana, OH.
14808-M....................................  Amtrol-Alfa Metalomecanica, S.A.,                 4      12-05-2015
                                              West Warwick, RI.
----------------------------------------------------------------------------------------------------------------
                                         New Special Permit Applications
----------------------------------------------------------------------------------------------------------------
15767-N....................................  Union Pacific Railroad Company,                   3      11-20-2015
                                              Omaha, NE.
16220-N....................................  Americase, Waxahache, TX...........               4      11-20-2015
16249-N....................................  Optimized Energy Solutions, LLC,                  3      11-15-2015
                                              Durango, CO.
16337-N....................................  Volkswagen Group of America                       4      12-31-2015
                                              (VWGoA), Herndon, VA.
16366-N....................................  Department of Defense, Scott AFB,                 4      11-30-2015
                                              IL.
16371-N....................................  Volkswagen Group of America                       4      11-30-2015
                                              (VWGoA), Herndon, VA.
16416-N....................................  INOX India Limited, Gujarat, India.               4      12-31-2015
16465-N....................................  Helimax Aviation, Inc., McClellan,                4      11-30-2015
                                              CA.
16461-N....................................  Coastal Hydrotesting LLC,                         4      12-20-2015
                                              Baltimore, MD.
16452-N....................................  The Procter & Gamble Company,                     4      11-30-2015
                                              Cincinnati, OH.
16469-N....................................  ACS UE Testing LLC, Denver, CO.....               4      12-31-2015
16463-N....................................  Salco Products, Lemont, IL.........               3      12-31-2015
16001-N....................................  VELTEK Associates, Inc., Malvern,                 3      11-20-2015
                                              PA.
----------------------------------------------------------------------------------------------------------------
                                      Renewal Special Permits Applications
----------------------------------------------------------------------------------------------------------------
11860-R....................................  GATX Corporation, Chicago, IL......               4      12-31-2015
8009-R.....................................  NK Co., Ltd., Busan City, KR.......               4      11-30-2015
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-29937 Filed 11-25-15; 8:45 am]
BILLING CODE 4910-60-M


[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Rules and Regulations]
[Pages 43312-43313]
[FR Doc No: 2015-17880]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-1067; Airspace Docket No. 14-ANM-15]

Establishment and Amendment of Class E Airspace; Bremerton, WA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies and establishes Class E airspace at
Bremerton National Airport, Bremerton, WA, to accommodate new Standard
Instrument Approach Procedures (SIAPs) at Bremerton National airport
due to the decommissioning of the Kitsap non-directional radio beacon
(NDB). The FAA is taking this action to enhance the safety and
management of Instrument Flight Rules (IFR) operations at the airport.

DATES: Effective 0901 UTC, October 15, 2015. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Y, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. The Order is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15. For further
information, you can contact the Airspace Policy and ATC Regulations
Group, Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 29591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Steve Haga, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Bremerton National Airport,
Bremerton, WA.

History

    On May 8, 2015, the FAA published in the Federal Register a notice
of proposed rulemaking (NPRM) to establish Class E airspace extending
upward from 700 feet above the surface and modify Class E surface area
airspace at Bremerton National Airport, Bremerton, WA (80 FR 26497).
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received. Subsequent to publication, the FAA found a
typographical error in the Proposal section for the Class E surface
area airspace regarding the length of extension to the southwest, and
corrects it from 7 miles to 6.1 miles. Also, the geographic latitude
coordinate of the airport for the Class E airspace extending upward
from 700 feet above the surface is corrected from lat. 47[deg]29'34''
to lat. 47[deg]29'25''.
    Class E airspace designations are published in paragraph 6002 and
6005, respectively, of FAA Order 7400.9Y, dated August 6, 2014, and
effective September 15, 2014, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Y, airspace Designations and
Reporting Points, dated August 6, 2014, and effective September 15,
2014. FAA Order 7400.9Y is publicly available as listed in the
ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 modifies Class E surface area airspace and establishes Class E
airspace extending upward from 700 feet above the surface at Bremerton
National Airport, Bremerton, WA. Class E surface area airspace is
adjusted to be defined from the Bremerton National Airport reference
point versus the decommissioned Kitsap NDB, with segments extending
from the 4.1-mile radius of the airport to 6.1 miles southwest, and 6.1
miles northeast of the airport. Class E airspace extending upward from
700 feet above the surface would be established extending from the 6.1-
mile radius of the airport to 7.6 miles northeast of the airport, and
8.1 miles southwest of the airport. This action enhances the safety and
management of controlled airspace within the NAS.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y,
Airspace Designations and Reporting Points, dated August 6, 2014, and
effective September 15, 2014, is amended as follows:

Paragraph 6002 Class E Airspace Designated as Surface Areas

* * * * *

ANM WA E2 Bremerton, WA [Modified]

Bremerton National Airport, WA
    (Lat. 47[deg]29'25'' N., long. 122[deg]45'53'' W.)

    That airspace within a 4.1-mile radius of Bremerton National
Airport, and within 2 miles each side of the 33[deg] bearing from
the airport extending from the 4.1-mile radius to 6.1 miles
northeast of the airport, and within 2 miles each side of the
213[deg] bearing from the airport extending from the 4.1-mile radius
to 6.1 miles southwest of the airport.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANM WA E5 Bremerton, WA [New]

Bremerton National Airport, WA
    (Lat. 47[deg]29'25'' N., long. 122[deg]45'53'' W.)

    That airspace extending upward from 700 feet above the surface
within 2 miles each side of the 33[deg] bearing from Bremerton
National Airport extending from 6.1-miles to 7.6 miles northeast of
the airport, and within 2 miles each side of the 213[deg] bearing
from the airport extending from the 6.1-mile radius of the airport
to 8.1 miles southwest of the airport.

    Issued in Seattle, Washington, on July 9, 2015.
Christopher Ramirez,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2015-17880 Filed 7-21-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 162 (Monday, August 22, 2011)]
[Proposed Rules]
[Pages 52291-52292]
[FR Doc No: 2011-21288]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0556; Airspace Docket No. 11-ASO-21]

Proposed Amendment of Class E Airspace; Jacksonville, NC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E Airspace at
Jacksonville, NC, as new Standard Instrument Approach Procedures have
been developed at Albert J Ellis Airport. This action would enhance the
safety and airspace management of Instrument Flight Rules (IFR)
operations at the airport.

DATES: Comments must be received on or before October 6, 2011. The
Director of the Federal Register approves this incorporation by
reference action under title 1, Code of Federal Regulations, part 51,
subject to the annual revision of FAA, Order 7400.9 and publication of
conforming amendments.

ADDRESSES: Send comments on this rule to: U. S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey, SE., Washington, DC 20590-0001; Telephone: 1-
800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2011-0556; Airspace Docket No. 11-ASO-21, at the beginning of your
comments. You may also submit and review received comments through the
Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2011-0556; Airspace Docket No. 11-ASO-21) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Annotators wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2011-0556; Airspace Docket No. 11-ASO-21.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/

airports--airtraffic/air--traffic/publications/airspace--amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. An
informal docket may also be examined during normal business hours at
the office of the Eastern Service Center, Federal Aviation
Administration, room 210, 1701 Columbia Avenue, College Park, Georgia
30337.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
to request a copy of Advisory circular No. 11-2A, Notice of Proposed
Rulemaking distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class E surface area airspace and
Class E airspace extending upward from 700 feet above the surface to
support new standard instrument approach procedures developed at Albert
J Ellis Airport, Jacksonville, NC, and for continued safety and
management of IFR operations at the airport.
    Class E airspace designations are published in Paragraph 6002 and
6005, respectively, of FAA Order 7400.9U, dated August 18, 2010, and
effective September 15, 2010, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designation listed in this document will
be published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would amend Class E airspace at Albert J Ellis
Airport, Jacksonville, NC.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, effective September 15, 2010,
is amended as follows:

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

ASO NC E2 Jacksonville Albert J Ellis Airport, NC [Amended]

Jacksonville, Albert J. Ellis Airport, NC
    (Lat. 34[deg]49'45'' N., long. 77[deg]36'44'' W.)

    Within a 4.2-mile radius of Albert J. Ellis Airport. This Class
E airspace area is effective during the specific days and times
established in advance by a Notice to Airmen. The effective days and
times will thereafter be continuously published in the Airport/
Facility Directory.

Paragraph 6005 Class E Airspace Areas Extending Upward from 700
feet or More Above the Surface of the Earth.

* * * * *

ASO NC E5 Jacksonville, NC [Amended]

Jacksonville, New River MCAS, NC
    (Lat. 34[deg]42'31'' N., long. 77[deg]26'23'' W.)
Albert J. Ellis Airport
    (Lat. 34[deg]49'45'' N., long. 77[deg]36'44 '' W.)
Onslow Memorial Hospital Point In Space Coordinates
    (Lat. 34[deg]45'36'' N., long. 77[deg]22'28'' W.)

    That airspace extending upward from 700 feet or more above the
surface within a 7-mile radius of New River MCAS, and within a 6.7-
mile radius of Albert J. Ellis Airport, and within a 6-mile radius
of the point in space (lat. 34[deg]45'36'' N., long. 77[deg]22'28''
W.) serving Onslow Memorial Hospital.

    Issued in College Park, Georgia on August 12, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-21288 Filed 8-19-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Rules and Regulations]
[Pages 82936-82939]
[FR Doc No: 2020-26998]

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

40 CFR Part 131

[EPA-HQ-OW-2015-0804; FRL-10017-97-OW]
RIN 2040-AG00

Withdrawal of Certain Federal Water Quality Criteria Applicable
to Maine

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The United States Environmental Protection Agency (EPA or
Agency) is taking final action to amend the Federal regulations to
withdraw human health criteria (HHC) for toxic pollutants applicable to
waters in the State of Maine. EPA is taking this action because Maine
adopted, and EPA approved, HHC that the Agency determined are
protective of the designated uses for these waters. This final rule
amends the Federal regulations to withdraw certain HHC applicable to
Maine that the Agency had promulgated, as described in the September 3,
2020 proposed rule. The withdrawal of these certain federally
promulgated HHC will enable Maine to implement its EPA-approved HHC,
submitted on April 24, 2020, and approved on June 23, 2020, as
applicable criteria for Clean Water Act (CWA or the Act) purposes.

DATES: This final rule is effective December 21, 2020.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OW-2015-0804. All documents in the docket are listed on the
http://www.regulations.gov website. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
for which disclosure is restricted by statute. Certain other material,
such as copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jennifer Brundage, Office of Water,
Standards and Health Protection Division (4305T), Environmental
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>or visit https://www.epa.gov/wqs-tech/federal-water-quality-standards-applicable-maine.

SUPPLEMENTARY INFORMATION: This final rule is organized as follows:

I. General Information
    A. Does this action apply to me?
II. Background
    A. What are the applicable Federal statutory and regulatory
requirements?
    B. What are the applicable Federal water quality criteria that
EPA is withdrawing?
    C. Comments on the Proposed Rulemaking
    D. Effective Date of Withdrawal
III. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Executive Order 13771 (Reducing Regulations and Controlling
Regulatory Costs)
    C. Paperwork Reduction Act
    D. Regulatory Flexibility Act
    E. Unfunded Mandates Reform Act
    F. Executive Order 13132 (Federalism)
    G. Executive Order 13175 (Consultation and Coordination With
Indian Tribal Governments)
    H. Executive Order 13045 (Protection of Children From
Environmental Health and Safety Risks)
    I. Executive Order 13211 (Actions That Significantly Affect
Energy Supply, Distribution, or Use)
    J. National Technology Transfer and Advancement Act of 1995
    K. Executive Order 12898 (Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations)
    L. Congressional Review Act

I. General Information

A. Does this action apply to me?

    The State of Maine, as well as entities that discharge pollutants
to waters of the United States under the State of Maine's jurisdiction,
such as industrial facilities, stormwater and combined sewer overflow
(CSO) management districts, or publicly owned treatment works (POTWs),
may be interested in this final rule because it withdraws Federal water
quality standards (WQS) promulgated by EPA to allow the State of
Maine's WQS to become the applicable WQS for CWA purposes. Entities
discharging in Maine's waters and citizens concerned with water quality
in Maine, including members of the federally recognized Indian tribes,
may be interested in this final rule. If you have questions regarding
the applicability of this action to a particular entity, consult the
person identified in the preceding FOR FURTHER INFORMATION CONTACT
section.

II. Background

A. What are the applicable Federal statutory and regulatory
requirements?

    Consistent with the CWA, EPA's WQS program assigns to states and
authorized tribes the primary authority for adopting WQS.\1\ After
states adopt WQS, they must be submitted to EPA for review and action
in accordance with the CWA. The Act authorizes EPA to promulgate
Federal WQS following EPA's disapproval of state WQS or an
Administrator's determination that new or revised WQS are ``necessary
to meet the requirements of the Act.'' \2\
---------------------------------------------------------------------------

    \1\ 33 U.S.C. 1313(a), (c).
    \2\ 33 U.S.C. 1313(c)(4).
---------------------------------------------------------------------------

B. What are the applicable Federal water quality criteria that EPA is
withdrawing?

    On December 19, 2016, EPA promulgated Federal HHC for 96 toxic
pollutants for waters in Indian lands in Maine based on the Agency's
2015 disapproval of corresponding State-established HHC and an
Administrator's determination that new or revised WQS were necessary to
meet the requirements of the Act. 81 FR 92466 (December 19, 2016). EPA
also promulgated a phenol criterion to protect human health from
consumption of water plus organisms for waters outside of Indian lands
in Maine after disapproving the State's phenol criterion in 2015
because it contained a mathematical error.
    EPA's 2015 disapproval of the State's HHC for waters in Indian
lands was based on its decision that they were inadequate to protect
the sustenance

fishing designated uses that EPA interpreted and approved for waters in
Indian lands in the same 2015 action. On May 27, 2020, after a thorough
review of the applicable provisions of the CWA, implementing
regulations and longstanding EPA guidance, EPA withdrew its 2015
interpretation and improper approvals of the alleged sustenance fishing
designated uses and corresponding disapprovals of Maine's HHC that
flowed from the flawed designated use determinations.\3\ Also on that
date, EPA approved Maine's general fishing designated use for waters in
Indian lands without the interpretation that it means ``sustenance
fishing.'' \4\
---------------------------------------------------------------------------

    \3\ Letter from Dennis Deziel, Regional Administrator, EPA
Region 1, to Gerald D. Reid, Commissioner, Maine Department of
Environmental Protection, ``Re: Withdrawal of Certain of EPA's
February 2, 2015 Decisions Concerning Water Quality Standards for
Waters in Indian Lands'' (May 27, 2020).
    \4\ In 2019, Maine adopted, and EPA approved, a sustenance
fishing designated use (SFDU) subcategory of its general fishing
designated use for certain identified waters where sustenance
fishing or increased fish consumption is or may be occurring.
---------------------------------------------------------------------------

    On April 24, 2020, the Maine Department of Environmental Protection
submitted new and revised WQS in accordance with CWA Section 303(c).
The new and revised provisions included HHC. On June 23, 2020, EPA
approved the State's new and revised HHC as consistent with the
requirements of the CWA and applicable Federal regulations.\5\ There
are two sets of HHC in the State's newly approved criteria. One set
protects the statewide general ``fishing'' designated use, and the
other set protects the State's new ``sustenance fishing'' designated
use subcategory that applies to specifically identified waters where
sustenance fishing is or may be occurring. Between these two sets of
HHC, all the waters covered by EPA's promulgated Federal HHC for toxic
pollutants in 2016 are addressed. The new and revised HHC also address
all the toxic pollutants for which EPA promulgated Federal HHC in 2016.
All of EPA's prior decisions and action letters related to these Agency
actions are available in docket ID EPA-HQ-OW-2015-0804 at https://www.regulations.gov.
---------------------------------------------------------------------------

    \5\ Letter from Ken Moraff, Water Division Director, EPA Region
1, to Gerald D. Reid, Commissioner, Maine Department of
Environmental Protection, ``Re: Review and Action on Maine Water
Quality Standards, 06-096 Chapter 584'' (June 23, 2020).
---------------------------------------------------------------------------

    As provided in 40 CFR 131.21(c), federally promulgated WQS that are
more stringent than EPA-approved state WQS remain applicable for
purposes of the CWA until EPA withdraws the Federal WQS. EPA's 2016
federally promulgated HHC are as stringent or more stringent than the
State's newly approved HHC. Accordingly, EPA is amending the Federal
regulations to withdraw those federally promulgated HHC for which the
Agency has approved Maine's corresponding HHC.
    EPA's withdrawal of federally promulgated HHC following approval of
corresponding state HHC is consistent with the Federal and state roles
contemplated by the CWA. Consistent with the cooperative federalism
structure of the CWA, once EPA approves state WQS addressing the same
pollutants for which EPA has promulgated Federal WQS, it is incumbent
on EPA to withdraw the Federal WQS to enable EPA-approved state WQS to
become the applicable WQS for CWA purposes. This final rule will allow
Maine to implement its EPA-approved WQS. This final rule is consistent
with EPA's withdrawal of other federally promulgated WQS following the
Agency's approval of state-adopted WQS.\6\
---------------------------------------------------------------------------

    \6\ See e.g., Withdrawal of Certain Federal Water Quality
Criteria Applicable to California: Lead, Chlorodibromomethane, and
Dichlorobromomethane, 83 FR 52163 (October 16, 2018); Water Quality
Standards for the State of Florida's Lakes and Flowing Waters;
Withdrawal, 79 FR 57447 (September 25, 2014); Withdrawal of Certain
Federal Water Quality Criteria Applicable to California, New Jersey
and Puerto Rico, 78 FR 20252 (April 4, 2013).
---------------------------------------------------------------------------

    This final rule amends Federal regulations to withdraw all Federal
HHC for waters in Indian lands and the phenol criterion for waters
outside of Indian lands promulgated for Maine in December 2016 at 40
CFR 131.43. All other federally promulgated criteria at 40 CFR 131.43
remain in effect.
    EPA did not make any changes in response to the comments received
on the proposed rulemaking. EPA received eight unique comments on the
proposed rulemaking. EPA also held two public, online hearings on the
proposed rulemaking (September 30, 2020, and October 1, 2020). EPA
received no comments during these hearings. Brief summaries of the
comments and EPA's responses are provided in the next section. As noted
previously, a full accounting of the comments and the Agency's
responses can be found in the docket for this rulemaking.

C. Comments on the Proposed Rulemaking

i. Comments in Support of EPA's Proposal To Withdraw the Federal HHC
    EPA received several comments in support of the proposal to
withdraw the Federal HHC. EPA appreciates the comments in support of
this action. Several of these commenters also urged EPA to withdraw
other federally promulgated WQS, specifically relating to mixing zones
and aquatic life criteria for certain waters, which are not related to
the HHC for toxic pollutants that are the subject of this rulemaking.
EPA's proposal solicited comments only on withdrawing the Federal HHC
for toxic pollutants and these comments are outside the scope of this
proceeding.
ii. Comments in Opposition to EPA's Proposal To Withdraw the Federal
HHC
    EPA received two comments in opposition to EPA's proposal to
withdraw the Federal HHC. Both comments object to the proposal based on
the stringency, scope, and enforceability of the HHC that would remain
in place after the withdrawal, i.e., the State of Maine's federally
approved HHC. The protectiveness of the State's federally approved HHC,
however, is outside the scope of this rulemaking. EPA's June 23, 2020,
approval of the State's HHC was a separate, final agency action. EPA's
rationale for this approval is provided in detail in the attachment to
the approval letter. More information on EPA's action to approve
Maine's HHC can be accessed at https://www.epa.gov/sites/production/files/2020-06/documents/hhc_approval_decision_final.pdf.
    Given that EPA approved state HHC that correspond to the federally
approved HHC, the Agency is thus withdrawing its Federal criteria so
that the state criteria are the applicable WQS for CWA purposes. See 40
CFR 131.21(c).

D. Effective Date of Withdrawal

    Section 553(d)(3) of the Administrative Procedure Act (APA), 5
U.S.C. 553(d), provides that final rules shall not become effective
until 30 days after publication in the Federal Register ``except . . .
as otherwise provided by the agency for good cause.'' The purpose of
this provision is to ``give affected parties a reasonable time to
adjust their behavior before the final rule takes effect.'' Omnipoint
Corp. v. Fed. Commc'n Comm'n, 78 F.3d 620, 630 (D.C. Cir. 1996); see
also United States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977)
(quoting legislative history). Thus, in determining whether good cause
exists to waive the 30-day delay, an agency should ``balance the
necessity for immediate implementation against principles of
fundamental fairness which require that all affected persons be
afforded a reasonable amount of time to prepare for the effective date
of its ruling.'' Gavrilovic, 551 F.2d at 1105. In this case, EPA has
determined that there

is good cause for waiving the 30-day delayed effective date because the
final rule does not impose any new requirement on any affected entity,
rather it withdraws Federal WQS applicable to waters in the State of
Maine, thus allowing Maine's WQS to take effect for CWA purposes.
Because by itself this final rule does not impose new requirements on
affected entities, it is not necessary to provide affected entities
time to adjust to this final rule. Having this withdrawal take effect
upon publication in the Federal Register will help provide immediate
clarity for the State of Maine as it proceeds with creating its latest
list of impaired of waters under CWA Section 303(d), as well as in
issuing NPDES permits, developing TMDLs, and issuing water quality
certifications under CWA Section 401. For these reasons, the Agency
finds that good cause exists under APA Section 553(d)(3) to make this
rule withdrawing Federal WQS in Maine effective immediately upon
publication.

III. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Executive Order 13771 (Reducing Regulations and Controlling
Regulatory Costs)

    This action is a deregulatory action under Executive Order 13771.

C. Paperwork Reduction Act

    This action does not impose any new information-collection burden
under the Paperwork Reduction Act because it is administratively
withdrawing Federal requirements that are no longer needed in Maine. It
does not include any information collection, reporting, or
recordkeeping requirements. The OMB has previously approved the
information collection requirements contained in the existing
regulations 40 CFR part 131 and has assigned OMB control number 2040-
0049.

D. Regulatory Flexibility Act

    The Agency certifies that this action will not have a significant
economic impact on a substantial number of small entities under the
Regulatory Flexibility Act. This action will not impose any
requirements on small entities.

E. Unfunded Mandates Reform Act

    This action does not contain Federal mandates under the provisions
of Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-
1538, and does not significantly or uniquely affect small governments.
As this action withdraws certain federally promulgated criteria, the
action imposes no enforceable duty on any state, local, or tribal
governments, or the private sector.

F. Executive Order 13132 (Federalism)

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the National Government and the states, or on the distribution of power
and responsibilities among the various levels of government. This rule
imposes no regulatory requirements or costs on any state or local
governments. Thus, Executive Order 13132 does not apply to this action.

G. Executive Order 13175 (Consultation and Coordination With Indian
Tribal Governments)

    This action has tribal implications. However, it will neither
impose substantial direct compliance costs on federally recognized
tribal governments, nor preempt tribal law. In the State of Maine,
there are four federally recognized Indian tribes represented by five
tribal governments. As a result of the unique jurisdictional provisions
of the Maine Indian Claims Settlement Act, the State has jurisdiction
for setting WQS for all waters in Indian lands in Maine. This rule will
have no effect on that jurisdictional arrangement. This final rule
affects federally recognized Indian tribes in Maine because it changes
the WQS applicable to all waters in Indian lands.
    EPA initiated consultation with federally recognized tribal
officials under EPA's Policy on Consultation and Coordination with
Indian tribes early in the process of developing this rule to allow
meaningful and timely input into its development. A summary of that
consultation is provided in ``Summary of Tribal Consultations Regarding
Water Quality Standards Decisions on Remand Applicable to Waters in
Indian Lands within Maine,'' which is available in the docket for this
rulemaking.

H. Executive Order 13045 (Protection of Children From Environmental
Health and Safety Risks)

    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the Agency has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
Section 2-202 of the Executive order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk that may disproportionately affect children.

I. Executive Order 13211 (Actions That Significantly Affect Energy
Supply, Distribution, or Use)

    This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution or use of energy.

J. National Technology Transfer and Advancement Act of 1995

    This final rule does not involve technical standards.

K. Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations)

    The human health or environmental risk addressed by this action
will not have disproportionately high and adverse human health or
environmental effects on minority, low income or indigenous
populations. EPA has previously determined that Maine's state-adopted
and EPA-approved criteria are protective of human health.

L. Congressional Review Act

    This action is subject to the Congressional Review Act and EPA will
submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 131

    Environmental protection, Indians-lands, Intergovernmental
relations, Reporting and recordkeeping requirements, Water pollution
control.

Andrew Wheeler,
Administrator.

    For the reasons set forth in the preamble, EPA amends 40 CFR part
131 as follows:

PART 131--WATER QUALITY STANDARDS

0
1. The authority citation for part 131 continues to read as follows:

    Authority: 33 U.S.C. 1251 et seq.

Subpart D--Federally Promulgated Water Quality Standards

Sec.  131.43  [Amended]

0
2. Amend Sec.  131.43 by removing paragraphs (a) and (j) and
redesignating paragraphs (b) through (i) as paragraphs (a) through (h).

[FR Doc. 2020-26998 Filed 12-18-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Proposed Rules]
[Pages 75085-75089]
[FR Doc No: 2012-30355]

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

ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Part 721

[EPA-HQ-OPPT-2011-0577; FRL-9370-1]
RIN 2070-AB27

Proposed Significant New Use Rule on Ethoxylated, Propoxylated
Diamine Diaryl Substituted Phenylmethane Ester With Alkenylsuccinate,
Dialkylethanolamine Salt

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing a significant new use rule (SNUR) under the
Toxic Substances Control Act (TSCA) for the chemical substance
identified generically as ethoxylated, propoxylated diamine diaryl
substituted phenylmethane ester with alkenylsuccinate,
dialkylethanolamine salt, which was the subject of premanufacture
notice (PMN) P-01-384. This action would require persons who intend to
manufacture, import, or process this chemical substance for an activity
that is designated as a significant new use by this proposed 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: Comments must be received on or before January 18, 2013.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0577, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
ATTN: Docket ID Number EPA-HQ-OPPT-2011-0577. The DCO is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0577. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

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. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substance

generically identified as ethoxylated, propoxylated diamine diaryl
substituted phenylmethane ester with alkenylsuccinate,
dialkylethanolamine salt (generic). Potentially affected entities may
include:
     Manufacturers, importers, or processors of the subject
chemical substance (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec.  721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
    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;
see also 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 a final SNUR
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 that is the subject of a proposed or final SNUR, are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see Sec.  [emsp14]721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What action is the agency taking?

    EPA is proposing a SNUR under section 5(a)(2) of TSCA for the
chemical substance identified generically as ethoxylated, propoxylated
diamine diaryl substituted phenylmethane ester with alkenylsuccinate,
dialkylethanolamine salt, which was the subject of PMN P-01-384. This
SNUR would require persons who intend to manufacture, import, or
process the chemical substance 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 April 27, 2012 (77 FR 23236) (FRL-9343-
4), EPA issued a direct final rule which established a SNUR for
ethoxylated, propoxylated diamine diaryl substituted phenylmethane
ester with alkenylsuccinate, dialkylethanolamine salt (generic) in
accordance with the procedures at 40 CFR 721.160(c)(3)(i). EPA received
notice of intent to submit adverse comments on this SNUR. Therefore, as
required by Sec.  721.160(c)(3)(ii), EPA withdrew the direct final SNUR
in the Federal Register of July 25, 2012 (77 FR 43520) (FRL-9356-1),
and is now issuing this proposed rule on the chemical substance. The
record for the direct final SNUR on this substance was established as
docket EPA-HQ-OPPT-2011-0577. That record includes information
considered by the Agency in developing the direct final rule and the
notice of intent to submit adverse comments.

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 III. 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, import, or process the
chemical substance for that use. Persons who must report are described
in Sec.  [emsp14]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 rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec.  721.1(c), persons subject to this SNUR must comply with the
same notice 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. 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 substance that is the subject of this proposed SNUR, EPA
considered relevant information about the toxicity of the chemical
substance, likely human exposures and environmental releases associated
with possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this unit.

IV. Substance Subject to This Proposed Rule

    This proposed SNUR is for a PMN substance which EPA did not find
that the use scenario described in the PMN triggered the determinations
set forth under TSCA section 5(e). However, EPA does believe that
certain changes from the use scenario described in the PMN could result
in increased exposures, thereby constituting a ``significant new use.''
These so-called ``non-section 5(e) SNURs'' are promulgated pursuant to
Sec.  721.170. EPA has determined that every activity designated as a
``significant new use'' in all non-section 5(e) SNURs issued under
Sec.  721.170 satisfies the two requirements stipulated in Sec.
721.170(c)(2), i.e., these significant new use activities, ``(i) are
different from those described in the premanufacture notice for the
substance, including any amendments, deletions, and additions of
activities to the premanufacture notice, and (ii) may be accompanied by
changes in exposure or release levels that are significant in relation
to the health or environmental concerns identified'' for the PMN
substance.

PMN Number P-01-384

    Chemical name: Ethoxylated, propoxylated diamine diaryl substituted
phenylmethane ester with alkenylsuccinate, dialkylethanolamine salt
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a colorant for aqueous
ink applications. Based on ecological structure activity relationship
(EcoSAR) analysis of test data on analogous amphoteric dyes, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 70 parts per billion (ppb) of the PMN substance in surface
waters for greater than 20 days per year. This 20-day criterion is
derived from partial life cycle tests (daphnid chronic and fish early-
life stage tests) that typically range from 21 to 28 days in duration.
EPA predicts toxicity to aquatic organisms may occur if releases of the
PMN substance to surface water exceed releases from the use described
in the PMN. For the use described in the PMN, environmental releases
did not exceed 70 ppb for more than 20 days per year. Therefore, EPA
has not determined that the proposed manufacturing, processing, or use
of the substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance other than as described in the
PMN, or any release of a manufacturing waste stream containing the PMN
substance into the waters of the United States without prior chemical
destruction or conversion, may cause significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help to characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10308.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMN submitted for the chemical substance
generically identified as ethoxylated, propoxylated diamine diaryl
substituted phenylmethane ester with alkenylsuccinate,
dialkylethanolamine salt, EPA determined that one or more of the
criteria of concern established at Sec.  721.170 were met, as discussed
in Unit IV.
    Based upon comments received on the direct final rule, the proposed
SNUR for 40 CFR 721.10308, includes the following changes:
    1. Redesignation of paragraph (a)(2)(i) as (a)(2)(ii).
    2. Revision of the new paragraph (a)(2)(ii).
    3. Addition of new paragraph (a)(2)(i).

B. Objectives

    EPA is proposing this SNUR for ethoxylated, propoxylated diamine
diaryl substituted phenylmethane ester with alkenylsuccinate,
dialkylethanolamine salt, which has undergone PMN review, because the
Agency wants to achieve the following objectives with regard to the
significant new uses designated in this proposed rule:
     EPA would receive notice of any person's intent to
manufacture, import, or process this chemical substance for the
described significant new use before that activity begins.
     EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing this chemical substance for the described
significant new use.
     EPA would be able to regulate prospective manufacturers,
importers, or processors of this 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 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/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Applicability of the Proposed Rule to Uses Occurring Before
Effective Date of the Final Rule

    To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substance subject to this proposed
rule has undergone premanufacture review. EPA is soliciting comments on
whether any of the uses proposed as significant new uses are ongoing.
    As discussed in the final SNUR rule published in the Federal
Register issue of April 24, 1990, (55 FR 17376), EPA has decided that
the intent of TSCA section 5(a)(1)(B) is best served by designating a
use as a significant new use as of the date of publication of the
previous direct final rule rather than as of the effective date of this
final rule. If uses begun after publication of the direct final were
considered ongoing rather than new, it would be difficult for EPA to
establish SNUR notice requirements because a person could

defeat the SNUR by initiating the significant new use before this final
rule became effective, and then argue that the use was ongoing before
the effective date of the rule. Thus, persons who begin commercial
manufacture, import, or processing of the chemical substances regulated
through this SNUR will have to cease any such activity before the
effective date of this rule. To resume their activities, these persons
would have to comply with all applicable SNUR notice requirements and
wait until the notice review period, including any extensions, expires.
    EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person meets the conditions of
advance compliance under Sec.  [emsp14]721.45(h), the person is
considered exempt from the requirements of the SNUR.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing 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. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. would list those tests. Descriptions of tests are
provided for informational purposes. EPA strongly encourages persons,
before performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
    The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
    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 substance.
     Potential benefits of the chemical substance.
     Information on risks posed by the chemical substance
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to Sec.  [emsp14]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 submitted 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/opptintr/newchems.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substance during the development of the direct final rule.
EPA's complete economic analysis is available in the docket under
docket ID number EPA-HQ-OPPT-2011-0577.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish a SNUR for one chemical
substance that was the subject of a PMN. 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

    According to the Paperwork Reduction Act (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 proposed 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 would 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

    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
proposed rule.
    This proposed rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit IX. 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 would be impacted by this proposed
rule when promulgated as final. As such, EPA has determined that this
proposed rule, when promulgated as final, would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of sections
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).

E. Executive Order 13132

    This action would 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 proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would 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 proposed 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 proposed rule 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

    Since this action does not involve any technical standards, section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, (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).

List of Subjects in 40 CFR Part 721

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

    Dated: December 10, 2012.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.

    Therefore, it is proposed that 40 CFR part 721 be amended as
follows:

PART 721--[AMENDED]

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

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

    2. Add Sec.  721.10308 to subpart E to read as follows:

Sec.  721.10308  Ethoxylated, propoxylated diamine diaryl substituted
phenylmethane ester with alkenylsuccinate, dialkylethanolamine salt
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethoxylated, propoxylated diamine diaryl substituted phenylmethane
ester with alkenylsuccinate, dialkylethanolamine salt (PMN P-01-384) 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).
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(2)(v).
    (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), (i), and (k) are applicable to manufacturers,
importers, and processors of the substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2012-30355 Filed 12-18-12; 8:45 am]
BILLING CODE 6560-50-P