[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Rules and Regulations]
[Pages 4891-4896]
[FR Doc No: 2016-01569]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2012-0434; FRL-9941-51-Region 6]

Approval and Promulgation of Implementation Plans; Louisiana

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is finalizing its
proposal to approve revisions to the State Implementation Plan (SIP)
for Louisiana. These rule revisions are the 2007 General Revisions, and
2008-2010 Miscellaneous Rule Revisions to the SIP that were submitted
by the State of Louisiana. The overall intended outcome is to make the
approved Louisiana SIP consistent with current Federal and State
requirements. This action is in accordance with the federal Clean Air
Act (the Act).

DATES: This rule is effective on February 29, 2016.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R06-OAR-2012-0434. All documents in the docket are
listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information or other information whose 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 either electronically through www.regulations.gov or in hard
copy at the Air Planning Section (6MM-AA), Environmental Protection
Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. The file
will be made available by appointment for public inspection in the
Region 6 FOIA Review Room between the hours of 8:30 a.m. and 4:30 p.m.
weekdays except for legal holidays.

FOR FURTHER INFORMATION CONTACT: Mr. Alan Shar (6MM-AA), telephone
(214) 665-2164, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Throughout this document ``we,'' ``us,'' and ``our'' refer to EPA.

I. Background

    On November 5, 2015 (80 FR 68481) we proposed to approve revision
to the Louisiana SIP that the Louisiana Department of Environmental
Quality (LDEQ) submitted to EPA on August 14, 2009, and August 29,
2013.
    The Louisiana rule revisions submittals, corresponding Chapters,
and type of action that we proposed are in Table 1 below.

                       Table 1--Submittals, Their Corresponding Chapters, and Action Type
----------------------------------------------------------------------------------------------------------------
                                                            Revisions to LAC 33:III
               Submittals                  Calendar year   chapters being acted upon            Action
----------------------------------------------------------------------------------------------------------------
Miscellaneous rules.....................       2008-2010  7, 13.....................  Proposed Approval.
General revisions.......................            2007  1, 9, 11, 13, 14, 21, 22,   Proposed Approval.
                                                           23, and 25.
----------------------------------------------------------------------------------------------------------------

    On October 2, 2015 LDEQ submitted a letter withdrawing its
revisions to Louisiana Administrative Code (LAC) 33:III, Chapter 15.
    The revisions to rules adopt the most recent Particulate Matter
standards and make numerous other administrative and ministerial
changes. As discussed in our proposal, there is no increase in the
amount of emissions or number of sources affected as a result of these
ministerial or administrative rules revisions; therefore, section
110(l) of the Act has been complied with. Details of these submittals,
their evaluation, and individual chapter-specific conclusions were
explained in our proposal, and its corresponding Technical Supporting
Document.
    Certain provisions of the Louisiana SIP (Sec. Sec.  1107(A),
1507(A)(1), 1507(B)(1), 2153(B)(1)(i), 2201(C)(8), 2307(C)(1), and
2307(C)(2)) are affected by EPA's June 12, 2015 National SIP Call (80
FR 33967). Approval of amendments to LAC 33:III, Chapters 11, 21, 22,
and 23 here should not, in any way, be construed as explicitly or
implicitly voiding or minimizing any concerns or inadequacies
identified in EPA's National SIP Call with respect to the above
referenced provisions. We continue to expect that issues raised within
the context of the EPA's National SIP Call to be addressed in a timely
fashion. See section 110(k)(5) of the Act.

II. Public Comments

    The public comment period for the November 5, 2015 (80 FR 68481)
proposal expired on December 7, 2015, and we did not receive any
comments on the proposed actions during this period. Therefore, we are
finalizing the November 5, 2015 (80 FR 68481) proposal without any
changes into the Louisiana SIP.

III. Final Actions

    We are approving rule revisions to LAC 33:III, Chapter 1, section
111; Chapter 7, sections 701, 703, and 711; Chapter 9, sections 918,
and 919; Chapter 11, sections 1105, and 1107; Chapter 13, sections
1323, 1325, 1327,

1329, 1331, and 1333; Chapter 14, sections 1410, and 1434; Chapter 21,
sections 2103, 2108, 2113, 2116, 2121, 2122, 2123, 2132, 2153, and
2159; Chapter 22, section 2201; Chapter 23, sections 2301, 2302, and
2307; and Chapter 25, sections 2511, 2521, and 2531. Our approval will
incorporate these changes into the SIP for Louisiana.

IV. Incorporation by Reference

    In this rule, we are finalizing regulatory text that includes
incorporation by reference. In accordance with the requirements of 1
CFR 51.4, we are finalizing the incorporation by reference of the
revisions to the Louisiana regulations as described in the Final Action
section above. We have made, and will continue to make, these documents
generally available electronically through www.regulation.gov, Docket
ID. No. EPA-R06-OAR-2012-0434.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. If a portion of the plan revision meets
all the applicable requirements of this chapter and Federal
regulations, the Administrator may approve the plan revision in part.
42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions,
EPA's role is to approve state choices that meet the criteria of the
Act, and to disapprove state choices that do not meet the criteria of
the Act. Accordingly, this final action approves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this final action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act;
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994); and
     Does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
is not approved to apply in Indian country located in the state, and
EPA notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law.
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by March 28, 2016. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposed of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Hydrocarbons,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: January 13, 2016.
Ron Curry,
Regional Administrator, Region 6.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart T--Louisiana

0
2. The table in Sec.  52.970(c) entitled ``EPA Approved Louisiana
Regulations in the Louisiana SIP'' is amended as follows:
0
a. Under Chapter 1, General Provisions, by revising the entries for
Section 111;
0
b. Under Chapter 7, Ambient Air Quality, by adding in numerical order
an entry for Section 701 and by revising the entries for Sections 703
and 711;
0
c. Under Chapter 9, General Regulation on Control of Emissions and
Emission Standards, by revising the entry for Section 918 and adding in
numerical order an entry for Section 919.;
0
d. Under Chapter 11, Control of Emissions of Smoke, by revising the
entries for Sections 1105.A and 1107.A;
0
e. Under Chapter 13, Emission Standards for Particulate Matter, by
adding in numerical order entries for Sections 1323, 1325, 1327, 1329,
1331, and 1333;
0
f. Under Chapter 14, Conformity, by revising the entries for Sections
1410.A.5.a.i and 1434.
0
g. Under Chapter 21, Control of Emissions of Organic Compounds,
``Subchapter A--General'' by revising the entries for Sections
2103.D.4.a, 2108.F.1, 2113.A.4, adding an entry for Section 2116, and
revising entries for 2121.F, and 2122.G;
0
h. Under Chapter 21, Control of Emissions of Organic Compounds,
``Subchapter B--Organic Solvents'' by revising the entry for Section
2123.D.1;
0
i. Under Chapter 21, Control of Emissions of Organic Compounds,
``Subchapter F--Gasoline Handling'' by by adding entries for Sections
2132.B.6, 2132.B.8, 2132.D.1, 2132.D.3;
0
j. Under Chapter 21, Control of Emissions of Organic Compounds,
``Subchapter M--Limiting Volatile Organic Compound Emissions from
Industrial Wastewater'' by adding entries for Sections 2153.G.4.b-c,
and 2153.G.5.a-c;
0
k. Under Chapter 21, Control of Emissions of Organic Compounds,
``Subchapter N--Method 43 Capture Efficiency Test Procedures'' by
revising the entry for Section 2159;
0
l. Under Chapter 22, Control of Emissions of Nitrogen Oxides
(NOX), by revising the entry for Section 2201. F.7.a;
0
m. Under Chapter 23, Control of Emissions from Specific Industries,
``Subchapter A--Chemical Woodpulping Industry'' by revising the entry
for Section 2301.D.4.a and under ``Subchapter B--Aluminum Plants by
revising the entry for Section 2303.E;

0
n. Under Chapter 23, Control of Emissions from Specific Industries,
``Subchapter D--Emission Standards for the Nitric Acid Industry'' by
revising the entry for Section 2307.C.1.a and 2307.C.2.a;
0
o. Under Chapter 25, Miscellaneous Incinerator Rules, ``Subchapter B--
Biomedical Waste Incinerators'' by revising the entry for Section 2511;
0
p. Under Chapter 25, Miscellaneous Incinerator Rules, ``Subchapter C--
Refuse Incinerators'' by revising the entry for Section 2521;
0
q. Under Chapter 25, Miscellaneous Incinerator Rules, ``Subchapter D--
Crematories'' by adding an entry for Section 2531.
    The revisions and additions read as follows:

Sec.  52.970  Identification of plan.

* * * * *
    (c) * * *

                             EPA Approved Louisiana Regulations in the Louisiana SIP
----------------------------------------------------------------------------------------------------------------
                                                          State approval
         State citation               Title/subject            date       EPA Approval date        Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                LAC Title 33. Environmental Quality Part III. Air
----------------------------------------------------------------------------------------------------------------
                                          Chapter 1--General Provisions
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 111....................  Definitions............        10/20/07  01/28/16 [Insert   SPOC
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                         Chapter 7--Ambient Air Quality
----------------------------------------------------------------------------------------------------------------
Section 701....................  Purpose................        03/20/08  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
Section 703....................  Scope..................        03/20/08  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
Section 711....................  Tables 1, 1a, and 2--          03/20/08  01/28/16 [Insert   PM2.5 and PM10
                                  Air Quality.                             Federal Register   standards.
                                                                           citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                  Chapter 9--General Regulations on Control of Emissions and Emission Standards
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 918....................  Recordkeeping and              10/20/07  01/28/16 [Insert   ...................
                                  Annual Reporting.                        Federal Register
                                                                           citation].

                                                  * * * * * * *
Section 919....................  Emission Inventory.....        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                   Chapter 11--Control of Emissions From Smoke
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 1105.A.................  Smoke from Flaring             10/20/07  01/28/16 [Insert   ...................
                                  Shall Not Exceed 20                      Federal Register
                                  Percent Opacity.                         citation].
Section 1107.A.................  Exemptions.............        10/20/07  01/28/16 [Insert   Administrative
                                                                           Federal Register   change here;
                                                                           citation].         1107(A) is subject
                                                                                to SIP Call.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                              Chapter 13--Emission Standards for Particulate Matter
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                         Subchapter F--Abrasive Blasting
----------------------------------------------------------------------------------------------------------------
Section 1323...................  Emissions from Abrasive        01/17/12  01/28/16 [Insert   ...................
                                  Blasting.                                Federal Register
                                                                           citation].
Section 1325...................  Definitions............        05/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].
Section 1327...................  Blasting Operations....        07/20/09  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].
Section 1329...................  Performance Standard...        05/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].
Section 1331...................  Best management                05/20/07  01/28/16 [Insert   ...................
                                  Practices (BMP) Plans.                   Federal Register
                                                                           citation].
Section 1333...................  Recordkeeping and              07/20/09  01/28/16 [Insert   ...................
                                  Reporting.                               Federal Register
                                                                           citation].
----------------------------------------------------------------------------------------------------------------
                                             Chapter 14--Conformity
----------------------------------------------------------------------------------------------------------------
    Subchapter A--Determining Conformity of General Federal Actions to State or Federal Implementations Plans
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 1410.A.5.a.i...........  Criteria for                   10/20/07  01/28/16 [Insert   ...................
                                  Determining Conformity                   Federal Register
                                  of General Federal                       citation].
                                  Actions.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
    Subchapter B--Conformity to State or Federal Implementation Plans of Transportation Plans, Programs, and
            Projects Developed, Funded, or Approved Under Title 23 U.S.C. or the Federal Transit Act
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 1434...................  Consultation...........        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                              Chapter 21--Control of Emissions of Organic Compounds
----------------------------------------------------------------------------------------------------------------
                                              Subchapter A--General
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 2103.D.4.a.............  Storage of Volatile            10/20/07  01/28/16 [Insert   ...................
                                  Organic Compounds.                       Federal Register
                                                                           citation].

                                                  * * * * * * *
Section 2108.F.1...............  Marine Vapor Recovery..        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
Section 2113.A.4...............  Housekeeping...........        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
Section 2116...................  Glycol Dehydrators.....        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
Section 2121.F.................  Fugitive Emission              10/20/07  01/28/16 [Insert   ...................
                                  Control.                                 Federal Register
                                                                           citation].

                                                  * * * * * * *
Section 2122.G.................  Fugitive Emission              10/20/07  01/28/16 [Insert   ...................
                                  Control for Ozone                        Federal Register
                                  Nonattainment Areas                      citation].
                                  and Specified Parishes.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                         Subchapter B--Organic Solvents
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 2123.D.1...............  Organic Solvents.......        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                         Subchapter F--Gasoline Handling
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 2132.B.6...............  Applicability..........        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
Section 2132.B.8...............  Applicability..........        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
Section 2132.D.1...............  Testing................        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
Section 2132.D.3...............  Testing................        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
              Subchapter M--Limiting Volatile Organic Compound Emissions From Industrial Wastewater
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 2153.G.4.b-c...........  Limiting Volatile              10/20/07  01/28/16 [Insert   ...................
                                  Organic Compound                         Federal Register
                                  Emissions from                           citation].
                                  Industrial Wastewater.

                                                  * * * * * * *
Section 2153.G.5.a-c...........  Limiting Volatile              10/20/07  01/28/16 [Insert   ...................
                                  Organic Compound                         Federal Register
                                  Emissions from                           citation].
                                  Industrial Wastewater.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                           Subchapter N--Method 43 Capture Efficiency Test Procedures
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 2159.A-C...............  Recordkeeping and              10/20/07  01/28/16 [Insert   ...................
                                  Reporting.                               Federal Register
                                                                           citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                            Chapter 22--Control of Emissions of Nitrogen Oxides (NOX)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 2201.F.7.a.............  Permits................        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                            Chapter 23--Control of Emissions From Specific Industries
----------------------------------------------------------------------------------------------------------------
                                   Subchapter A--Chemical Woodpulping Industry
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 2301.D.4.a.............  Control of Emissions           10/20/07  01/28/16 [Insert   ...................
                                  From Chemical                            Federal Register
                                  Woodpulping Industry.                    citation].
                                  Compliance.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                          Subchapter B--Aluminum Plants
----------------------------------------------------------------------------------------------------------------
Section 2303.E.................  Standards for                  10/20/07  01/28/16 [Insert   ...................
                                  Horizontal Stud                          Federal Register
                                  Soderberg Primary                        citation].
                                  Aluminum Plants and
                                  Prebake Primary
                                  Aluminum Plants.
                                  Monitoring.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                       Subchapter D--Nitric Acid Industry
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 2307.C.1.a.............  Start-Up Provisions....        10/20/07  01/28/16 [Insert   Administrative
                                                                           Federal Register   change here;
                                                                           citation].         2307(C)(1) is
                                                                                subject to SIP
                                                                                Call.
Section 2307.C.2.a.............  On-Line Operating              10/20/07  01/28/16 [Insert   Administrative
                                  Adjustments.                             Federal Register   change here;
                                                                           citation].         2307(C)(2) is
                                                                                subject to SIP
                                                                                Call.
----------------------------------------------------------------------------------------------------------------
                                   Chapter 25--Miscellaneous Incinerator Rules
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                   Subchapter B--Biomedical Waste Incinerators
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 2511...................  Standards of                   10/20/07  01/28/16 [Insert   ...................
                                  Performance for                          Federal Register
                                  Biomedical Waste                         citation].
                                  Incinerators.
                                  Registration.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                        Subchapter C--Refuse Incinerators
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 2521...................  Refuse Incinerators....        10/20/07  01/28/16 [Insert   ...................
                                                                           Federal Register
                                                                           citation].
----------------------------------------------------------------------------------------------------------------
                                            Subchapter D--Crematories
----------------------------------------------------------------------------------------------------------------
Section 2531...................  Standards of                   10/20/07  01/28/16 [Insert   ...................
                                  Performance for                          Federal Register
                                  Crematories.                             citation].

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

* * * * *

[FR Doc. 2016-01569 Filed 1-27-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 16, 2005 (Volume 70, Number 241)]
[Notices]
[Page 74805]
[DOCID:fr16de05-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2153-012 California]

Notice of Public Meeting To Discuss the Environmental Assessment
Prepared for the Santa Felicia Hydropower Project; United Water
Conservation District

December 12, 2005.
    On November 28, 2005, the Commission staff issued an Environmental
Assessment (EA); prepared for the licensing of the Santa Felicia
Hydroelectric Project.
    Comments on the EA are due January 12, 2006. The EA evaluates the
environmental effects of the continued operation, and maintenance of
the project. The project occupies 174.5 acres of U.S. land,
administered by the U.S. Department of Agriculture, Forest Service, in
the Los Padres and Angeles National Forests.
    In the EA, Commission staff analyze the probable environmental
effects of relicensing the project and conclude that approval of the
project, with appropriate staff-recommended environmental measures,
would not constitute a major federal action significantly affecting the
quality of the human environment.
    A public meeting, which will be recorded by an official
stenographer, is scheduled for Thursday, January 5, 2006, from 9 a.m.
to 3 p.m. at the United Water Conservation District's office at 106
North Eighth Street, Santa Paula, CA 93060. We ask that persons in need
of directions or other assistance contact John Dickenson of United
directly at<PHONE_NUMBER> or via e-mail at<EMAIL_ADDRESS>    At this meeting, resource agency personnel and other interested
persons will have the opportunity to provide oral and written comments
and recommendations regarding the licensing of the Santa Felicia
Hydroelectric Project for the Commission's public record.
    Copies of the EA are available for review in Public Reference Room
2-A of the Commission's offices at 888 First Street, NE., Washington,
DC. The EA also may be viewed on the Commission's Internet Web site
(http://www.ferc.gov) using the ``eLibrary'' link. For assistance with eLibrary, contact<EMAIL_ADDRESS>or call toll-free at (866)

208-3676; for TTY contact<PHONE_NUMBER>.

Magalie R. Salas,
 Secretary.
 [FR Doc. E5-7423 Filed 12-15-05; 8:45 am]

BILLING CODE 6717-01-P


        PUBLIC COMMENTERS
                   U.S. ENVIRONMENTAL PROTECTION AGENCY (EPA)
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA)
SCIENTIFIC ADVISORY PANEL (SAP)
                      PUBLIC VIRTUAL PEER REVIEW MEETING
                             SEPTEMBER 15-18, 2020

                  FIFRA SAP WEB SITE: https://www.epa.gov/sap
                DOCKET ID NUMBER: EPA - HQ - OPP - 2020 - 0263

                     MEETING LOCATION: Phone and Webcast
   For Video Link and Audio Registration (to Receive call-in number) go to:
                            https://www.epa.gov/sap

          [Please note that all times are approximate as noted at the
     end of the Agenda. Agency speakers may change based on availability.]

        Title:  U.S. Environmental Protection Agency Peer Review for:
 The Use of New Approach Methodologies (NAMs) to Derive Extrapolation Factors and Evaluate Developmental Neurotoxicity for Human Health Risk Assessment

 Wednesday, September 16, 2020

                                  PUBLIC COMMENTERS- 1:00 P.M.

 Richard Reiss, ScD, On behalf of the OP Coalition of Registrants [10 minute comment]

 Kristie Sullivan, MS, Physicians Committee for Responsible Medicine [5 minute comment]

 Anna van der Zalm, MS, People for the Ethical Treatment of Animals [5 minute comment]


60386 Federal Register / Vol. 68, No. 204 / Wednesday, October 22, 2003 / Notices allergenic proteins, which typically are present at 1   80% of the total protein in an offending food, the average PMI concentration measured in raw grain derived from a line of transformed corn plants represents less than 0.00002% of the total protein. ( This calculation is based on corn grain containing 10% total protein by weight, and assumes 2 ppm PMI in the grain.) Additionally, due to degradation via food processing methods, PMI will not likely be present in processed food products, or will be present in only trace quantities. PMI produced in transformed plants is not targeted to a cellular pathway for glycosylation. PMI activity, and therefore tertiary protein structure, is lost upon heating at 65 degrees C for 30 minutes. PMI rapidly degrades upon exposure to simulated mammalian gastric and intestinal fluids. The genetic material occurring in the subject inert ingredient has been adequately characterized. This genetic material ( i. e., the nucleic acids deoxyribonucleic acid ( DNA) and ribonucleic acid ( RNA)), including regulatory regions, necessary for the production of PMI as an inert ingredient in all crops will not present a dietary safety concern. `` Regulatory regions'' are the DNA sequences such as promoters, terminators, and enhancers that control the expression of the genetic material encoding the protein. Based on the ubiquitous occurrence and established safety of nucleic acids in the food supply, a tolerance exemption under the FFDCA regulations has been established for residues of nucleic acids that are part of plant incorporated protectants or associated inert ingredients 40 CFR 174.475 ( 66 FR 37817) ( FRL   6057   5). Therefore, no mammalian toxicity is anticipated from dietary exposure to the genetic material necessary for the production of PMI protein in all crops.

D. Aggregate Exposure 1. Dietary exposure   i. Food. Due to the ubiquitous occurrence of PMI in nature, it is conceivable that the human diet has always contained small amounts of PMI proteins that are similar to that produced in plants transformed with the E. coli pmi gene. The levels of PMI measured in raw grain from a line of transformed corn plants averaged ca. 1   2 ppm. Processed plant products or by products used in food are unlikely to have measurable PMI protein, or will have only trace amounts. Oral exposure is not expected to result in adverse health effects, because of a demonstrated lack of toxicity to mammals and the rapid digestibility of the PMI protein. It is expected that any PMI protein consumed will be digested as conventional dietary protein. ii. Drinking water. Little to no exposure via drinking water is anticipated. Due to the demonstrated mammalian safety profile of PMI, such exposure would not present a risk. 2. Non dietary exposure. Non dietary exposure is not anticipated, due to the proposed use pattern of the product. Exposure via dermal or inhalation routes is unlikely because the inert ingredient is contained within plant cells. However, if exposure were to occur by non dietary routes, no risk would be expected because the PMI protein is not toxic to mammals.

E. Cumulative Exposure Because there is no indication of mammalian toxicity of the PMI protein or the genetic material necessary for its production, it is reasonable to conclude that there will be no cumulative effects for this inert ingredient.

F. Safety Determination 1. U. S. population. The lack of mammalian toxicity at high levels of exposure to the PMI protein demonstrates the safety of the product at levels well above possible maximum exposure levels anticipated via consumption of food products produced from pmi transformed plants. Moreover, little to no human dietary exposure to PMI protein is expected to occur via pmi transformed food crops. Due to the digestibility and lack of toxicity of the PMI protein, and its very low potential to become an allergen in food, dietary exposure is not anticipated to pose any harm for the U. S. population. No special safety provisions are applicable for consumption patterns or for any population sub groups. 2. Infants and children. Based on the mammalian safety profile of the inert ingredient and the proposed use pattern, there is ample evidence to conclude a reasonable certainty of no harm to infants and children.

G. Effects on the Immune and Endocrine Systems The inert ingredient is derived from sources that are not known to exert an influence on the endocrine or immune systems.

H. Existing Tolerances The registrant is not aware of any known existing tolerances or exemptions for PMI and the genetic material necessary for its production as an inert ingredient. I. International Tolerances The registrant is not aware that any Codex maximum residue levels exist for the PMI protein and the genetic material necessary for its production. [ FR Doc. 03   26412 Filed 10   21   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPPT   2003   0034; FRL   7331   2]

Draft Instructions for Reporting for the 2006 Partial Updating of the TSCA Chemical Inventory Database; Request for Comment; Notice of Public Meeting AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: EPA is convening a 1   day public meeting to receive comments from persons reporting data required by the Inventory Update Rule ( IUR) on the draft instructions for reporting in 2006. The instructions have been revised in response to amendments to 40 CFR part 710 promulgated on January 7, 2003, which substantially modify the information which must be reported for the partial updating of the Toxic Substances Control Act ( TSCA) Chemical Inventory Database beginning in 2006. DATES: The public meeting will commence at 9: 30 a. m. on Wednesday, October 22, 2003, and end at approximately 2 p. m. ADDRESSES: The public meeting will be held at the Sheraton Suites Houston, 2400 West Loop South, Houston, TX 77027. Persons planning to attend the public meeting are encouraged to register with the technical contact person identified below. Persons registering for the meeting will receive by e mail a copy of the draft instructions prior to the meeting. Prior registration is not required to attend the public meeting. FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Director, Environmental Assistance Division ( 7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 554   1404; e mail address: TSCAHotline epa. gov. For technical information contact: Fredric C. Arnold, Economics, Exposure, and Technology Division ( 7406M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,

VerDate jul< 14> 2003 15: 28 Oct 21, 2003 Jkt 203001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 22OCN1. SGM 22OCN1 OPPT 2003 0034 0015 RECEIVED OPPT NCIC 2003 October 22 8: 15AM 60387 Federal Register / Vol. 68, No. 204 / Wednesday, October 22, 2003 / Notices Washington, DC 20460   0001; telephone number: ( 202) 564   8521; e mail address: arnold. fred@ epa. gov. SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you manufacture chemical substances currently subject to reporting under the IUR as amended on January 7, 2003, and codified as 40 CFR part 710. Persons who process chemical substances but who do not manufacture or import chemical substances are not required to comply with the requirements of 40 CFR part 710. Potentially affected entities may include, but are not limited to: Chemical manufacturers and importers currently subject to IUR reporting, including manufacturers and importers of inorganic chemical substances ( NAICS codes 325 and 32411). 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 at 40 CFR 710.48. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPPT   2003   0034. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at EPA's Docket Center, Rm. B102 Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. EPA's Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. EPA's Docket Center Reading Room telephone number is ( 202) 566   1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is ( 202) 566   0280. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the Federal Register listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background EPA is convening a public meeting to receive comments on the instructions for reporting to the 2006 partial updating of TSCA Chemical Substance Inventory Database. EPA is required by section 8( b) of TSCA to compile and update an inventory of chemical substances manufactured or imported in the United States. Every 4 years, manufacturers ( including importers) of certain chemical substances on the Chemical Substance Inventory have been required to report data specified in the TSCA section 8( a) IUR, 40 CFR part 710. Past updates included information on the chemical's production volume, site limited status, and plant site information. Amendments to the IUR promulgated on January 7, 2003 ( 68 FR 848) ( FRL   6767   4) expanded the data reported on certain chemicals to assist EPA and others in screening potential exposures and risks resulting from manufacturing, processing, and use of TSCA chemical substances. At the same time, EPA amended the IUR regulations to increase the production volume threshold, which triggers reporting requirements from 10,000 lbs per year to 25,000 lbs per year and established a new higher threshold of 300,000 lbs per year above which manufacturers must report additional information on downstream processing and use of their chemical substances. The 2003 amendments to the IUR also revoked the exemption from reporting for inorganic chemical substances, provided a partial exemption from reporting of processing and use information for chemical substances of low current interest, and continued the current exemption from reporting for polymers, microorganisms, and naturally occurring chemical substances. These changes modify requirements for information collected in calendar year 2005 and submitted in 2006 and thereafter. The public meeting may be of interest to persons currently reporting under the IUR and to manufacturers of inorganic chemical substances. The public meeting will include a series of presentations by representatives of EPA on the instructions for reporting for the 2006 partial updating of the TSCA Chemical Inventory Database. Presentation topics will include reporting requirements, instructions for completing the reporting form, how to assert confidentiality claims, and how to submit completed reports to EPA. After each presentation, persons attending the public meeting will be invited to comment on the clarity, completeness, and usefulness of the instructions. Comments may also be submitted in writing following the public meeting. Comments should be submitted within 30 days after the meeting to receive timely attention. The purpose of the public meeting is to receive input for improving the instructions; subsequent meetings are planned for 2004, to provide training to persons who must report in 2006, under the IUR. There is no charge for attending this public meeting.

List of Subjects Environmental protection, Chemicals, Reporting and recordkeeping requirements.

Dated: October 17,2003.

Charles M. Auer,

Director, Office of Pollution Prevention and Toxics. [ FR Doc. 03   26737 Filed 10   20   03; 2: 26 pm]

BILLING CODE 6560   50   S VerDate jul< 14> 2003 15: 28 Oct 21, 2003 Jkt 203001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 22OCN1. SGM 22OCN1


[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21241-21242]
[FR Doc No: 2020-08010]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3995]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Submission of
Information on Pediatric Uses of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 18,
2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0748. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Submission of Information on Pediatric Uses of Medical Devices;
Requirement for Submission of Information on Pediatric Subpopulations
That Suffer From a Disease or Condition That a Device Is Intended To
Treat, Diagnose, or Cure Under Section 515A of the Federal Food, Drug,
and Cosmetic Act--21 CFR 814

OMB Control Number 0910-0748--Extension

    Section 515A(a) of the Food, Drug, and Cosmetic Act (21 U.S.C.
360e-1) (FD&C Act) requires applicants who submit certain medical
device applications to include readily available information providing
a description of any pediatric subpopulations that suffer from the
disease or condition that the device is intended to treat, diagnose, or
cure, and the number of affected pediatric patients. The information
submitted will allow FDA to track the number of approved devices for
which there is a pediatric subpopulation that suffers from the disease
or condition that the device is intended to treat, diagnose, or cure
and the review time for each such device application.
    These requirements apply to applicants who submit humanitarian
device exemption requests (HDEs), premarket approval applications
(PMAs) or PMA amendments or supplements, or a product development
protocol (PDP).
    FDA expects to receive approximately 47 original PMA/PDP/HDE
applications each year, 1 of which FDA expects to be HDEs. This
estimate is based on the average of FDA's receipt of new PMA
applications. The Agency estimates that 11 of the estimated 47 original
PMA submissions will fail to provide the required pediatric use
information and their sponsors will therefore be required to submit PMA
amendments. The Agency also expects to receive approximately 928
supplements that will include the pediatric use information required by
section 515A(a) of the FD&C Act and part 814 (21 CFR part 814).
    All that is required is to gather, organize, and submit information
that is readily available, using any approach that meets the
requirements of section 515A(a) of the FD&C Act and part 814. We
believe that because the applicant is required to organize and submit
only readily available information, no more than 8 hours will be
required to comply. Furthermore, because supplements may include
readily available information on pediatric populations by referencing a
previous submission, FDA estimates the average time to obtain and
submit the required information is a supplement to be 2 hours. FDA
estimates that the total estimated burden is 2,392 hours.
    Additionally, the document entitled ``Providing Information About
Pediatric Uses of Medical Devices--Guidance for Industry and Food and
Drug Administration Staff'' describes how to

compile and submit the readily available pediatric use information
required under section 515A(a) of the FD&C Act. Respondents are
permitted to submit information relating to uses of the device outside
the approved or proposed indication if such uses are described or
acknowledged in acceptable sources of readily available information. We
estimate that 20 percent of respondents submitting information required
by section 515A(a) of the FD&C Act will choose to submit this
information and that it will take 30 minutes for them to do so.
    In the Federal Register of December 2, 2019 (84 FR 65986), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
    FDA estimates the burden of this collection of information as
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
             Activity/21 CFR part                 Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pediatric information in an original PMA or                11               1              11  8........................................              88
 PDP--814.20(b)(13).
Pediatric information in a PMA amendment--                  5               1               5  8........................................              40
 814.37(b)(2).
Pediatric information in a PMA supplement--               928               1             928  2........................................           1,856
 814.39(c)(2)(i).
Pediatric information in an HDE--                           1               1               1  8........................................               8
 814.104(b)(6).
Pediatric information for uses outside                    800               1             800  .5 (30 minutes)..........................             400
 approved indication.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................           2,392
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden and corresponding responses reflect the
requirements under section 515A(a) of the FD&C Act, in addition to the
submission of data related to pediatric uses outside an approved
indication, as described in the document entitled ``Providing
Information About Pediatric Uses of Medical Devices--Guidance for
Industry and Food and Drug Administration Staff.'' OMB previously
approved the information collection related to uses outside an approved
indication under OMB control number 0910-0762. As the information
collection uses the same data and relies upon the same legal authority
as OMB control number 0910-0748, we intend to discontinue OMB control
number 0910-0762 and consolidate the information collection
accordingly. Our estimated burden for the information collection
reflects an overall increase of 632 hours. Additionally, we have
altered the title of the collection to reflect all collections of
pediatric uses.
    Our estimated burden for the information collection reflects an
overall increase of 632 hours and a corresponding increase of
supplements and of uses outside of approved indications. We attribute
this adjustment to an increase in the number of supplements we received
over the last 5 years and merging data from discontinued OMB control
number 0910-0762.

    Dated: April 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08010 Filed 4-15-20; 8:45 am]
 BILLING CODE 4164-01-P