MEMO

TO:	James Brooks, Bureau Director, Bureau of Air Quality

FROM:	Marc Cone, Air Licensing Section; Tom Downs, Meteorology Section;
Jeff Crawford, Air Planning Section

DATE:	June 12, 2009

SUBJ:	BART Summary

************************************************************************

BART SUMMARY

BACKGROUND

The federal requirements that states must meet to achieve national
visibility goals are contained in the “Regional Haze Rule”.  These
regulations were adopted on July 1, 1999, and went into effect on August
30, 1999.  On June 15, 2005, EPA finalized the rule addressing a Court
remand.

The principle goal is: “Congress hereby declares as a national goal
the prevention of any future, and the remedying of any existing,
impairment of visibility in mandatory Class I Federal areas which
impairment results from man-made air pollution.”

Maine has three Class I areas: 1) Acadia National Park; 2) Moosehorn
National Wildlife Refuge Wilderness Area; and 3) Roosevelt Campobello
International Park

In consultation with the states and tribes, EPA designated five Regional
Planning Organizations (RPO) to assist with the coordination and
cooperation needed to address the haze issue.  The Mid-Atlantic /
Northeast states, including the District of Columbia, formed the
Mid-Atlantic / Northeast Visibility Union (MANE-VU)

Among the required elements of the SIPs, states must include
determinations of Best Available Retrofit Technology (BART) and long
term strategies to ensure that reasonable progress is being made to meet
the national goal by 2064.

The regional haze SIPs were due to EPA by December 17, 2007.

BEST AVAILABLE RETROFIT TECHNOLOGY (BART)

The Best Available Retrofit Technology (BART) requirement of Section
169A of the Clean Air Act (42 U.S.C.§7491(b)(2)(A)) and implementing
rules (40 C.F.R. Part 51, Appendix Y) are intended to reduce visibility
impairing pollutants emitted from existing stationary sources which were
grandfathered from the New Source Review (NSR).

The visibility impairing pollutants are defined by the EPA as sulfur
dioxide (SO2), oxides of nitrogen (NOx) and particles with an
aerodynamic diameter less than or equal to 10 and 2.5 μm (i.e., PM10
and PM2.5, respectively).

The BART requirements apply to existing facilities having any of 26
types of stationary sources which began operation between August 7, 1962
and August 7, 1977, with a cumulative potential to emit 250 tons per
year or more of any single visibility impairing pollutant and may
reasonably be anticipated to cause or contribute to any visibility
impairment in a Class I area.

Once the SIP is approved by the EPA, the BART facility has up to five
years to install the appropriate controls and comply with the
established emission standards.  Maine is requiring sources subject to
BART to install, operate and maintain BART rather than implement an
emissions trading program or other alternative measure.

In June 2005, EPA adopted the final BART rule.  The BART rule requires
states/tribes to develop an inventory of sources within each state or
tribal jurisdiction that would be eligible for controls.

The federal BART rule requires that, for each BART-eligible source
within the state, any BART determination must be based on an analysis of
the best system of continuous emission control technology available and
the associated emission reductions achievable.  In addition to
considering available technologies, this analysis must evaluate five
specific factors for each source (better known as the Five-Factor
Analysis):

The costs of compliance,

The energy and non-air quality environmental impacts of compliance,

Any existing pollution control technology in use at the source,

The remaining useful life of the source, and

The degree of visibility improvement which may reasonably be anticipated
from the use of BART.

BART STATUS

In an effort to establish a consistent BART determination for all
BART-eligible Maine sources and remove any existing statutory
limitations in regulating sulfur dioxide as part of a BART
determination, in 2007 the Maine Legislature enacted enabling
legislation establishing deadlines and control requirements for BART
eligible units in Maine.  38 MRSA §603-A, sub-§8 states:

“8.  Best available retrofit technology or BART requirements.  For
those BART eligible units determined by the department to need
additional sulfur air pollution controls to improve visibility, the
controls must:

A.  Be installed and operational no later than January 1, 2013; and

B.  Either:

(1) Require the use of sulfur oil having 1% or less of sulfur by weight;
or

(2) Be equivalent to a 50% reduction in sulfur emissions from a BART
eligible unit based on a BART eligible unit source emission baseline
determined by the department under 40 Code of Federal Regulations,
Section 51.308 (d)(3)(iii)(2006) and 40 Code of Federal Regulations,
Section 51 Appendix Y (2006).”

Pursuant to the above statute the Department issued air emission
licenses implementing the prescribed BART requirements.

The draft Regional Haze State Implementation Plan (SIP), including the
BART determinations, was submitted to EPA and federal land managers in
early 2009.

EPA and the Federal Land Managers provided the Department with comments
on the draft SIP; and both indicated the state’s legislation adopted
in 2007 and the BART license amendments did not fully meet the federal
BART rule requirements of the five factor analysis, and that the
proposed Maine regional haze SIP submittal did not address all of the
regional haze pollutants.

The Department is currently working with the BART-eligible sources, EPA,
and the federal land mangers to ensure completion of an approvable
Five-Factor Analysis.

FIVE FACTOR BART ANALYSIS

The first step is identifying the BART eligible sources:

The Department has identified 25 units at 11 sources as being BART
eligible (Appendix A).

The next step is determining if any source has the option to accept
federally enforceable emission restriction limits in their air emission
license to stay below 250 tons per year of SOx, NOx, or PM and thus no
longer be a BART-eligible source. The Department expects two sources to
utilize this option.

Every source that does not accept a federally enforceable emission
limit must perform the first four steps (engineering analyses) of the
Five Factor Analysis.

The first part of the analysis is a technical feasibility analysis
considering existing controls and possible controls.  Guidance is found
in 40 CFR Part 51 Appendix Y, Section IV.  Generally, if possible
controls versus existing controls are minimally better at controlling
emissions and the impacts of the units are relatively small as
determined by the NESCAUM modeling (Appendix B) with the existing
controls, BART can be determined to be the existing controls and the
analysis would be complete.  Sources with less than 0.1 deciview impact
on Class 1 areas are presumed to have small impacts.  In general, if
there are emission reduction strategies for units that have minimal
existing controls then possible further emission reduction control
options are modeled to determine the most cost effective visibility
emission reduction strategy that will be determined to be BART.

Using the first four factors plus the NESCAUM modeling the Department
has preliminarily determined that 18 of the 25 BART-eligible units have
existing controls that should satisfy BART technology requirements.
These units would not be subject to the fifth factor refined modeling
analysis.

The remaining sources must complete the fifth factor of the Five Factor
Analysis as detailed in the following table:

Modeling Protocol Options

1 YEAR CALPUFF ANALYSIS OPTION	3 YEAR CALPUFF ANALYSIS OPTION

SUBMIT A CALPUFF/CALMET/CALPOST MODELING PROTOCOL FOR REVIEW with
detailed discussions of the following elements:

Model version

Model switches and procedures

CALPUFF and CALGRID modeling domains

Proposed receptors

Meteorological data inputs

Geophysical data inputs

Emission data inputs

CALMET METEOROLOGICAL DATA SET

Use 1 year of MM5 data, with mandatory observational data (Mass DEP has
2002 data currently processed in this manner) – EPA and FLMs have
indicated they will accept this option.	Use 3 years of MM5 data with
observational data - highly recommended by both USEPA and FLMs.

PRE-CONTROL EMISSION INPUTS

Choose highest 24-hour emission rate during normal operating conditions
(i.e., excluding malfunctions, startups/shutdowns, etc.)

Choose highest 24-hour emission rate from 3 years of emissions data
using years representative of current existing controls

Examine emissions on a pollutant-by-pollutant basis for each BART
eligible unit (highest 24-hour emission rate could potentially be from
different days for different pollutants)

MODEL RUNS

For each BART-eligible unit, run CALPUFF at pre-control and all
post-control emission rates according to the accepted methodology in the
CALPUFF modeling protocol

Calculate, for each receptor, the change in deciview compared against
20% best visibility conditions (use new IMPROVE algorithm [CALPOST
Version 6.221 FLAG 2008 option (www.src.com)])	Calculate, for each
receptor, the change in deciview compared against natural visibility
conditions (use new IMPROVE algorithm [CALPOST Version 6.221 FLAG 2008
option (www.src.com)])

Use the highest daily predicted change-in-deciview for each
pre/post-control run	Use the 8th highest daily predicted
change-in-deciview in each year for each pre/post-control run

FINAL SUBMITTAL OF IMPACT ANALYSES

Submit the final modeling protocol and all model input, output and
diagnostic files

Develop a chart (or charts) displaying the following for each of the
alternatives:

1 - Expected emission rate (tons per year, pounds per hour)

2- Emissions performance level (e.g. percent pollutant removed,
emissions per unit product,

     lb/MMBtu, ppm)

3 - Expected emissions reductions (tons per year)

4 - Costs of compliance - total annualized costs ($), cost effectiveness
($/ton), and especially

      a cost-effectiveness measure ($/deciview)

5 - Modeled visibility impacts

6 - Compare results of potential BART controls

EPA FINDING OF FAILURE TO SUBMIT SIP

On January 9, 2009 EPA signed a Federal Register notice making a finding
of failure to submit all or a portion of their regional haze SIPs for 37
states, DC, and the Virgin Islands.  Maine is one of 34 states which
failed to submit SIPs that satisfy the basic program elements.

The FR notice initiates a 2-year deadline for EPA to issue a Federal
Implementation Plan (FIP); the 2-year period is referred to as the
“FIP clock”.  The FIP will provide the basic program requirements
for each state that has not completed an approved plan of their own by
January 15, 2011.  EPA must approve the State’s plan before the FIP
clock is turned off.  This notice does not initiate sanctions.

The Department expects to submit a complete regional haze plan well
before the FIP deadline.  Since EPA will need a number of months to
complete the review and approval of the regional haze plan, Maine will
need to submit the completed plan well in advance of the January 15,
2011 FIP deadline.  The Department is currently working with the Federal
Land Managers and EPA to address concerns with its preliminary draft
Regional Haze Plan, and expects to hold a public hearing and submit its
final Regional Haze Plan by January 31, 2010.  We believe that this
schedule will provide sufficient time for a complete review and approval
of the Maine SIP, including BART analyses.  Please submit your analyses
to the Department by September 15, 2009.

BART REFERENCES

“Five Factor Analysis of BART-Eligible Sources, Survey of Options for
Conducting BART Determinations”, June 1, 2007, NESCAUM

Informal guidance from EPA on Regional Haze Questions/Answers, August
25, 2006

“BART Resource Guide”, August 23, 2006, NESCAUM

“Assessment of Control Technology Options for BART-Eligible Sources,
Steam Electric Boilers, Industrial Boilers, Cement Plants and Paper and
Pulp Facilities”, March 2005, NESCAUM

MANE-VU Board decided in June 2004 that a BART determination would be
made for all sources, without exception.

“A Basis of Control for BART-Eligible Sources”, July 24, 2001,
NESCAUM

			Appendix A

BART Eligible Sources

Wyman Station		Boiler #3 (expect full 5 factor analysis)

				Boiler #4 (expect full 5 factor analysis)

Domtar Industries		Power Boiler #9

				Lime Kiln

Dragon Products		Kiln (expect full 5 factor analysis)

Red Shield Acquisition 	#4 Recovery Boiler

				Lime Kiln

Verso Paper Bucksport	Boiler #5 (expect 250 TPY restriction)

SAPPI Somerset		Lime Kiln

				Recovery Boiler

				Smelt Tanks #1 and #2

Verso Paper Jay		Power Boilers #1 and #2 (expect full 5 factor analysis)

				Waste Fuel Incinerator

				Recovery Boilers #1 and #2

				Smelt Tanks #1 and #2

				Lime Kilns A and B

				Flash Dryer

Katahdin Paper Millinocket	Power Boiler #4 (expect 250 TPY restriction)

Lincoln Paper and Tissue 	Recovery Boiler #2

Rumford Paper Company 	Power Boiler #5

APPENDIX B:  NESCAUM BART-ELIGIBLE SOURCE MODELING RESULTS

Facility Name	Stack Name	NWS CALPUFF	MM5 CALPUFF

 	 	Total	SO4	NO3	PM10	Total	SO4	NO3	PM10

 	 	24-hr dv impact	24-hr dv impact

Wyman Station	Boiler_4	0.1423	0.1276	0.0334	0.0010	0.4749	0.3846	0.1072
0.0005

Wyman Station	Boiler_3	0.2212	0.1715	0.0704	0.0004	0.3049	0.2545	0.0508
0.0014

Domtar Ind.	#9_Power_Boiler	1.3630	0.2828	0.7988	1.3134	1.6506	0.1815
0.7279	1.3717

Domtar Ind.	Lime_Kiln	0.5296	0.0559	0.4309	0.1207	0.4589	0.0427	0.3820
0.1048

Dragon Products	Kiln	2.0155	0.2434	1.7614	0.0604	1.8626	0.3208	1.7234
0.0413

Red Shield Acquisition, Old Town	#4_Recovery_Boiler	0.2425	0.0634	0.1633
0.0173	0.2631	0.0424	0.2070	0.0391

Red Shield Acquisition, Old Town	Lime_Kiln	0.0851	0.0171	0.0433	0.0278
0.1338	0.0138	0.0855	0.0463

Verso, Bucksport	Boiler_#5	0.0543	0.0260	0.0267	0.0021	0.1591	0.0817
0.0721	0.0098

SAPPI Somerset	Recovery_Boiler	0.2159	0.0151	0.1971	0.0087	0.4421	0.0179
0.4168	0.0158

SAPPI Somerset	Smelt_Tanks_#1_and_#2	0.0108	0.0034	0.0000	0.0095	0.0000
0.0000	0.0000	0.0000

SAPPI Somerset	Lime_Kiln	0.0380	0.0270	0.0105	0.0012	0.0651	0.0455
0.0187	0.0010

Verso, Jay	Power_Boiler_#1	0.6948	0.5720	0.1235	0.0094	1.7631	1.2176
0.5867	0.0290

Verso, Jay	Power_Boiler_#2	0.7223	0.5948	0.1287	0.0095	1.8289	1.2646
0.6105	0.0293

Verso, Jay	Waste_Fuel_Inc_	0.4256	0.0036	0.3651	0.0591	0.4956	0.0064
0.4544	0.0367

Verso, Jay	Recovery_Boiler_#1_and_#2	0.1101	0.0454	0.0598	0.0078	0.3856
0.0952	0.2723	0.0215

Verso, Jay	Smelt_Tank_#1	0.0139	0.0002	0.0000	0.0137	0.0122	0.0002
0.0000	0.0120

Verso, Jay	Smelt_Tank_#2	0.0129	0.0004	0.0000	0.0125	0.0135	0.0006
0.0000	0.0129

Verso, Jay	Lime_Kiln_A	0.0441	0.0001	0.0273	0.0167	0.0457	0.0004	0.0337
0.0123

Verso, Jay	Lime_Kiln_B	0.0296	0.0001	0.0197	0.0098	0.0293	0.0004	0.0228
0.0062

Verso, Jay	Flash_Dryer	0.0222	0.0044	0.0173	0.0005	0.0252	0.0097	0.0175
0.0003

Katahdin Paper Millinocket	PB_#4	0.8293	0.6630	0.1569	0.0210	0.4458
0.3832	0.1164	0.0216

Lincoln Paper and Tissue	Recovery_Boiler_#2	0.1151	0.0141	0.0806	0.0224
0.1200	0.0073	0.0882	0.0322

Lincoln Paper and Tissue	Boiler_#6	0.0182	0.0139	0.0047	0.0004	0.0119
0.0075	0.0051	0.0006

Rumford Paper	PB_#5	0.0369	0.0039	0.0327	0.0026	0.1025	0.0108	0.0897
0.0020

	> 0.1 dv TOTAL and a pollutant	> 0.1 dv TOTAL only

 PAGE

Maine DEP Bureau of Air Quality   DATE \@ "M/d/yyyy"  6/1/2010 	Page
PAGE  8  of   NUMPAGES  8

Maine DEP Bureau of Air Quality   DATE \@ "M/d/yyyy"  6/1/2010


[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Notices]
[Pages 50164-50165]
[FR Doc No: 2022-17501]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Actions on Special Permits

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

ACTION: Notice of actions on special permit applications.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein.

DATES: Comments must be received on or before September 14, 2022.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration U.S. Department of Transportation Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Donald Burger, Chief, Office of
Hazardous Materials Safety General Approvals and Permits Branch,
Pipeline and Hazardous Materials Safety Administration, U.S. Department
of Transportation, East Building, PHH-13, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-13, 1200 New
Jersey Avenue Southeast, Washington DC.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on August 9, 2022.
Donald P. Burger,
Chief, General Approvals and Permits Branch.

----------------------------------------------------------------------------------------------------------------
                                                                                Nature of the special permits
       Application No.                Applicant           Regulation(s) affected              thereof
----------------------------------------------------------------------------------------------------------------
                                          Special Permits Data--Granted
----------------------------------------------------------------------------------------------------------------
8995-M......................  BASF Corporation.........  173.315(a), 174.63(c)(1)  To modify the special permit
                                                                                to authorize an additional
                                                                                hazardous material.
15036-M.....................  UTLX Manufacturing         172.203(a), 172.302(c),   To modify the special permit
                               Incorporated.              173.244, 173.1, 173.3,    to remove the requirement
                                                          173.314, 173.31(e),       for visual inspection of
                                                          179.102-2, 179.102-3,     areas needing access via cut-
                                                          179.15, 179.16.           out ports in the support
                                                                                structure.
20599-M.....................  County of Orange.........  172.320, 173.56(b)......  To modify the special permit
                                                                                to authorize contractors
                                                                                under the direct control of
                                                                                the county to package and
                                                                                prepare shipments under the
                                                                                special permit.
21307-N.....................  Packaging And Crating      172.200, 172.300,         To authorize the manufacture,
                               Technologies, LLC.         172.400, 172.700(a).      mark, sale and use of
                                                                                packaging for purposes of
                                                                                ``offering or reoffering''
                                                                                lithium batteries for
                                                                                recycling, reuse,
                                                                                refurbishment, repurposing
                                                                                or evaluation without
                                                                                requiring shipping papers,
                                                                                marks, labels, or training.
21354-N.....................  Showa Chemicals of         173.304a................  To authorize the use of non-
                               America, Inc.                                        DOT specification cylinders
                                                                                similar to DOT 4BW
                                                                                specification cylinders.
21360-N.....................  ABG Bag, Inc.............  173.12(b)(2)(ii)(C),      To authorize the use of
                                                          178.707(d).               alternative packaging for
                                                                                the transportation in
                                                                                commerce of lab packs.

21400-N.....................  Advance Research           173.163(a)..............  To authorize the
                               Chemicals, Inc.                                      transportation in commerce
                                                                                of a DOT specification
                                                                                3AA2400 cylinder, containing
                                                                                anhydrous hydrogen fluoride,
                                                                                with a leak in the valve
                                                                                which has been repaired
                                                                                temporarily using a Cylinder
                                                                                Emergency ``A'' Kit.
21403-N.....................  Northrop Grumman Systems   173.185(a)(1),            To authorize the
                               Corporation.               173.185(a)(2).            transportation in commerce
                                                                                of prototype, low
                                                                                production, and production
                                                                                lithium ion batteries and
                                                                                lithium ion batteries
                                                                                contained in equipment
                                                                                (avionic computers).
21405-N.....................  PM4 Enterprises, Inc.....  172.101(j),               To authorize the
                                                          173.185(a)(1).            transportation in commerce
                                                                                of lithium ion batteries
                                                                                contained in equipment
                                                                                (Unmanned Ground Vehicle
                                                                                (UGV)) each with a battery
                                                                                net weight exceeding 35 kg
                                                                                aboard cargo-only aircraft.
----------------------------------------------------------------------------------------------------------------
                                          Special Permits Data--Denied
----------------------------------------------------------------------------------------------------------------
21389-N.....................  Honeywell International    178.44, 178.44, 178.44..  To authorize the manufacture,
                               Inc.                                                 mark, sell and use of non-
                                                                                DOT specification welded
                                                                                pressure vessels comparable
                                                                                to DOT 3HT cylinders with
                                                                                certain exceptions.
----------------------------------------------------------------------------------------------------------------
                                         Special Permits Data--Withdrawn
----------------------------------------------------------------------------------------------------------------
21332-N.....................  Advanced Material Systems  173.302(f)(1)...........  To authorize the
                               Corporation.                                         transportation in commerce
                                                                                of ISO 11119-2 cylinders
                                                                                containing oxygen via cargo-
                                                                                only aircraft.
21364-N.....................  Cenergy Solutions Inc....  172.101(i)(3), 173.302..  To authorize the
                                                                                transportation in commerce
                                                                                of methane contained in MC-
                                                                                331 cargo tanks via highway.
21372-N.....................  Solid Power, Inc.........  173.35(e)...............  To authorize the
                                                                                transportation in commerce
                                                                                of residue contained in IBCs
                                                                                where the closure nearest to
                                                                                the hazardous materials
                                                                                cannot be secured.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2022-17501 Filed 8-12-22; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11294-11295]
[FR Doc No: 2018-05130]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Applications for Special Permits

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

ACTION: List of applications for special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein. Each mode of transportation for which a
particular special permit is requested is indicated by a number in the
``Nature of Application'' portion of the table below as follows: 1--
Motor vehicle, 2--Rail freight, 3--Cargo vessel, 4--Cargo aircraft
only, 5--Passenger-carrying aircraft.

DATES: Comments must be received on or before April 13, 2018.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, Washington, DC
20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Approvals and Permits Division, 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>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-30, 1200 New
Jersey Avenue Southeast, Washington DC or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on March 1, 2018.
Donald Burger,
Chief, General Approvals and Permits Branch.

------------------------------------------------------------------------
                                                        Nature of the
 Application No.     Applicant      Regulation(s)      special permits
                                       affected            thereof
------------------------------------------------------------------------
                          Special Permits Data
------------------------------------------------------------------------
20604-N.........  ELSTER AMERICAN  173.185(c)(3)(i  To authorize the
                   METER COMPANY,   ).               transportation in
                   LLC.                              commerce of lithium
                                                     batteries contained
                                                     in equipment
                                                     without certain
                                                     markings on each
                                                     package. (modes 1,
                                                     2).
20607-N.........  The Greenbrier   179.100-12(c)..  To authorize the
                   Companies.                        manufacture, mark,
                                                     sale, and use of
                                                     tank cars with the
                                                     protective housing
                                                     mounted in an
                                                     alternate manner.
                                                     (mode 2).
20608-N.........  DEPARTMENT OF    173.302a(a)(1).  To authorize the
                   DEFENSE                           transportation in
                   (MILITARY                         commerce of
                   SURFACE                           compressed air in
                   DEPLOYMENT &                      non-DOT
                   DISTRIBUTION                      specification
                   COMMAND).                         cylinders. (modes
                                                     1, 2, 3, 4, 5).
20611-N.........  Deckload         172.101(j).....  To authorize the
                   Aviation LLC.                     transportation in
                                                     commerce of
                                                     hazardous materials
                                                     in excess of the
                                                     quantity limits
                                                     specified in Column
                                                     (9B) of the 172.101
                                                     when transported
                                                     via rotorcraft
                                                     external load
                                                     operations. (mode
                                                     5).
20614-N.........  USDA APHIS       172.101(i)(3)..  To authorize the
                   Veterinary                        transportation of
                   Services.                         depopulated
                                                     livestock and/or
                                                     poultry for
                                                     treatment and
                                                     disposal in bulk
                                                     packagings. (mode
                                                     1).
20615-N.........  FSTI, INC......  172.102(c)(7)..  To authorize the
                                                     transportation in
                                                     commerce of
                                                     hydrochloric acid
                                                     in portable tanks
                                                     fitted with bottom
                                                     outlets. (mode 1).
20616-N.........  TEMSCO           172.101(j),      To authorize the
                   HELICOPTERS      172.200,         transportation in
                   INC.             172.204(c)(3),   commerce of certain
                                    172.301(c),      hazardous materials
                                    173.27(b)(2),    by cargo aircraft,
                                    175.30(a)(1),    including 14 CFR
                                    175.75, 175.33.  Part 133 Rotorcraft
                                                     External Load
                                                     Operations
                                                     transporting
                                                     hazardous materials
                                                     attached to or
                                                     suspended from an
                                                     aircraft to remote
                                                     locations of the US
                                                     with out being
                                                     subject to hazard
                                                     communication
                                                     requirements,
                                                     quantity
                                                     limitations and
                                                     certain loading and
                                                     stowage
                                                     requirements. (mode
                                                     5).
20617-N.........  HILLWOOD         172.101(j),      To authorize the
                   AIRWAYS, LLC.    173.27(b)(2),    transportation of
                                    175.30(a)(1).    materials forbidden
                                                     for transportation
                                                     via air by cargo-
                                                     only aircraft.
                                                     (mode 5).
------------------------------------------------------------------------

[FR Doc. 2018-05130 Filed 3-13-18; 8:45 am]
 BILLING CODE 4909-60-P


[Federal Register: September 9, 2008 (Volume 73, Number 175)]
[Proposed Rules]
[Page 52226-52230]
[DOCID:fr09se08-17]

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

40 CFR Part 52

[EPA-R04-OAR-2005-0534-200816; FRL-8712-5]

Approval and Promulgation of Implementation Plans North Carolina:
Prevention of Significant Deterioration and Nonattainment New Source
Review Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve revisions to the North Carolina
State Implementation Plan (SIP) submitted by the State of North
Carolina in three submittals dated November 30, 2005, March 16, 2007,
and June 20, 2008. The proposed revisions modify North Carolina's
Prevention of Significant Deterioration (PSD) and Nonattainment New
Source Review (NNSR) permitting regulations in the SIP to address
changes to the federal New Source Review (NSR) regulations, which were
promulgated by EPA on December 31, 2002, and reconsidered with minor
changes on November 7, 2003 (collectively, these two final actions are
referred to as the ``2002 NSR Reform Rules''). In addition, the
proposed revisions address an update to the NSR regulations promulgated
by EPA on November 29, 2005 (``Ozone Implementation NSR update'')
relating to the implementation of the 1997 8-hour ozone National
Ambient Air Quality Standards (NAAQS). The proposed revisions include
provisions for baseline emissions calculations, an actual-to-projected-
actual methodology for calculating emissions changes, options for
plantwide applicability limits (PALs), recordkeeping and reporting
requirements, and provisions recognizing nitrogen oxides
(NOX) as a precursor to ozone. The June 20, 2008, SIP
submittal also contains proposed revisions that are not related to
EPA's 2002 NSR Reform Rules. EPA will propose action on those revisions
in a separate Federal Register notice.

DATES: Comments must be received on or before October 9, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2005-0534, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2005-0534'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Ms. Yolanda Adams, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960. Such deliveries are only accepted during
the Regional Office's normal hours of operation. The Regional Office's
official hours of business are Monday through Friday, 8:30 a.m. to 4:30
p.m., excluding federal holidays.
    Instructions: Direct your comments to Docket ID No. ``EPA-R04-OAR-
2005-0534.'' EPA's policy is that all comments received will be
included in the public 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 through http:/
/www.regulations.gov or e-mail, information that you consider to be CBI
or otherwise protected. The http://www.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 e-mail comment
directly to EPA without going through http://www.regulations.gov, your
e-mail address will be automatically captured and included as part of
the comment that is placed in the public 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. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI 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 in http://
www.regulations.gov or in hard copy at the Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. EPA requests that if at all
possible, you contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 a.m. to 4:30
p.m., excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: For information regarding the North
Carolina State Implementation Plan, contact Ms. Nacosta Ward,
Regulatory Development Section, Air Planning Branch, Air, Pesticides
and Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960.
Telephone number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
For information regarding New Source Review, contact Ms. Yolanda Adams,
Air Permits Section, at the same address above. Telephone number: (404)
562-9214; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, references to
``EPA,'' ``we,'' ``us,'' or ``our,'' are intended to mean the
Environmental Protection Agency. The supplementary information is
arranged as follows:

I. What action is EPA proposing today?
II. Why is EPA proposing this action?
III. What is EPA's analysis of North Carolina's NSR rule revisions?
IV. What action is EPA taking today?
V. Statutory and Executive Order Reviews

I. What action is EPA proposing today?

    On November 30, 2005, March 16, 2007, and June 20, 2008, the State
of North Carolina, through the North Carolina Department of Environment
and Natural Resources (DENR), submitted revisions to the North Carolina
SIP. The SIP submittals consist of revisions to North Carolina Air
Quality Rules, Subchapter 2D. Specifically, the November 30, 2005,
proposed SIP revisions include changes to Regulation 15A (North
Carolina Administrative Code) NCAC 2D .0531, ``Sources in Nonattainment
Areas.'' The March 16, 2007, submittal includes changes to Regulation
15A NCAC 2D .0530, ``Prevention of Significant Deterioration.'' The
June 20, 2008, submittal consists of additional changes to Regulations
15A NCAC 2D .0530, and .0531. DENR submitted these revisions in
response to EPA's December 31, 2002, November 7, 2003, and November 29,
2005, revisions to the Federal NSR program. Pursuant to section 110 of
the Clean Air Act (``CAA'' or ``Act''), EPA is now proposing to approve
these SIP revisions. The June 20, 2008, submittal also included
revisions to NCAC Subchapter 2D, Section .2400, Clean Air Interstate
Rules, which EPA is not taking action on at this time.

II. Why is EPA proposing this action?

    On December 31, 2002 (67 FR 80186), EPA published final rule
changes to 40 Code of Federal Regulations (CFR) parts 51 and 52,
regarding the CAA's PSD and NNSR programs. On November 7, 2003 (68 FR
63021), EPA published a notice of final action on the reconsideration
of the December 31, 2002, final rule changes. In that November 7, 2003,
final action, EPA added the definition of ``replacement unit,'' and
clarified an issue regarding PALs. The December 31, 2002, and the
November 7, 2003, final actions are collectively referred to as the
``2002 NSR Reform Rules.'' The purpose of this action is to propose to
approve the SIP submittals from the State of North Carolina that
include the provisions of EPA's 2002 NSR Reform Rules.
    The 2002 NSR Reform Rules are part of EPA's implementation of Parts
C and D of title I of the CAA, 42 U.S.C. 7470-7515. Part C of title I
of the CAA, 42 U.S.C. 7470-7492, is the PSD program, which applies in
areas that meet the NAAQS--``attainment'' areas--as well as in areas
for which there is insufficient information to determine whether the
area meets the NAAQS--``unclassifiable'' areas. Part D of title I of
the CAA, 42 U.S.C. 7501-7515, is the NNSR program, which applies in
areas that are not in attainment of the NAAQS--``nonattainment'' areas.
Collectively, the PSD and NNSR programs are referred to as the ``New
Source Review'' or NSR programs. EPA regulations implementing these
programs are contained in 40 CFR 51.165, 51.166, 52.21, 52.24, and part
51, Appendix S.
    The CAA's NSR programs are preconstruction review and permitting
programs applicable to new and modified stationary sources of air
pollutants regulated under the CAA. The NSR programs of the CAA include
a combination of air quality planning and air pollution control
technology program requirements. Briefly, section 109 of the CAA, 42
U.S.C. 7409, requires EPA to promulgate primary NAAQS to protect public
health and secondary NAAQS to protect public welfare. Once EPA sets
those standards, states must develop, adopt, and submit to EPA for
approval, a SIP that contains emissions limitations and other control
measures to attain and maintain the NAAQS. Each SIP is required to
contain a preconstruction review program for the construction and
modification of any stationary source of air pollution to assure that
the NAAQS are achieved and maintained; to protect areas of clean air;
to protect air quality related values (such as visibility) in national
parks and other areas; to assure that appropriate emissions controls
are applied; to maximize opportunities for economic development
consistent with the preservation of clean air resources; and to ensure
that any decision to increase air pollution is made only after full
public consideration of the consequences of the decision.
    The 2002 NSR Reform Rules made changes to five areas of the NSR
programs. In summary, the 2002 Rules: (1) Provide a new method for
determining baseline actual emissions; (2) adopt an actual-to-
projected-actual methodology for determining whether a major
modification has occurred; (3) allow major stationary sources to comply
with PALs to avoid having a

significant emissions increase that triggers the requirements of the
major NSR program; (4) provided a new applicability provision for
emissions units that are designated clean units; and (5) excluded
pollution control projects (PCPs) from the definition of ``physical
change or change in the method of operation.'' On November 7, 2003 (68
FR 63021), EPA published a notice of final action on its
reconsideration of the 2002 NSR Reform Rules, which added a definition
for ``replacement unit'' and clarified an issue regarding PALs. For
additional information on the 2002 NSR Reform Rules, see, 67 FR 80186
(December 31, 2002), and http://www.epa.gov/nsr.
    After the 2002 NSR Reform Rules were finalized and effective (March
3, 2003), industry, state, and environmental petitioners challenged
numerous aspects of the 2002 NSR Reform Rules, along with portions of
EPA's 1980 NSR Rules (45 FR 52676, August 7, 1980). On June 24, 2005,
the United States Court of Appeals for the District of Columbia Circuit
(D.C. Circuit Court) issued a decision on the challenges to the 2002
NSR Reform Rules. New York v. United States, 413 F.3d 3 (D.C. Cir.
2005). In summary, the D.C. Circuit Court vacated portions of the rules
pertaining to clean units and PCPs, remanded a portion of the rules
regarding recordkeeping, e.g. 40 CFR 52.21(r)(6) and 40 CFR
51.166(r)(6), and either upheld or did not comment on the other
provisions included as part of the 2002 NSR Reform Rules. On June 13,
2007 (72 FR 32526), EPA took final action to revise the 2002 NSR Reform
Rules to remove from federal law all provisions pertaining to clean
units and the PCP exemption that were vacated by the D.C. Circuit
Court.
    With regard to the remanded portions of the 2002 NSR Reform Rules
related to recordkeeping, on December 21, 2007, EPA took final action
and established that a ``reasonable possibility'' applies where source
emissions equal or exceed 50 percent of the CAA NSR significance levels
for any pollutant (72 FR 72607). The ``reasonable possibility''
provision identifies for sources and reviewing authorities the
circumstances under which a major stationary source undergoing a
modification that does not trigger major NSR must keep records.
    Also relevant to DENR's submittals, on November 29, 2005 (70 FR
71612), EPA promulgated implementation provisions for the 1997 8-Hour
Ozone NAAQS--Phase 2, which made changes to the NSR regulations. These
included, among other requirements, a requirement that emissions of
NOX be considered ozone precursors. States were required to
submit SIP revisions incorporating these changes by no later than June
15, 2007.
    The 2002 NSR Reform Rules require that state agencies adopt and
submit revisions to their SIP permitting programs implementing the
minimum program elements of the 2002 NSR Reform Rules no later than
January 2, 2006. (Consistent with changes to 40 CFR 51.166(a)(6)(i),
state agencies are now required to adopt and submit SIP revisions
within three years after new amendments are published in the Federal
Register.) State agencies may meet the requirements of 40 CFR part 51
and the 2002 NSR Reform Rules with different but equivalent
regulations.
    On November 30, 2005, March 16, 2007, and June 20, 2008, the North
Carolina DENR submitted revisions to EPA for the purpose of revising
the State's NSR permitting provisions to adopt EPA's NSR Reform Rules
and the Ozone Implementation NSR update. EPA is proposing to approve
these submittals pursuant to section 110 of the CAA.

III. What is EPA's analysis of North Carolina's NSR rule revisions?

    North Carolina currently has a SIP-approved NSR program for new and
modified stationary sources. EPA is now proposing to approve revisions
to North Carolina's existing NSR program. North Carolina's SIP
submittals consist of a compilation of amendments to State rules that
became State-effective between May 1, 2005, and May 1, 2008. Copies of
North Carolina's revised NSR rules, as well as the State's Technical
Support Document, can be obtained from the Docket, as discussed in the
ADDRESSES section above. A discussion of the specific changes to North
Carolina's rules comprising the proposed SIP revisions follows.
    North Carolina Regulation 15A NCAC 2D .0530, ``Prevention of
Significant Deterioration,'' contains the preconstruction review
program that provides for the prevention of significant deterioration
of ambient air quality as required under Part C of title I of the CAA
(the PSD program). The PSD program applies to sources that are major
stationary sources or undergoing major modifications in areas that are
designated as attainment or unclassifiable with regard to any NAAQS.
North Carolina's PSD program was originally approved into the SIP by
EPA on February 23, 1982, and has been revised several times since then
in order to remain consistent with federal rule changes.
    North Carolina's permitting requirements for major sources in or
impacting upon nonattainment areas are set forth at Regulation 15A NCAC
2D .0531, ``Sources in Nonattainment Areas'' (NNSR program). The North
Carolina NNSR program was originally approved into the North Carolina
SIP on July 26, 1982, and has been revised several times since then in
order to remain consistent with federal rule changes. The NNSR
requirements apply to the construction and modification of any major
stationary source of air pollution in a nonattainment area, as required
by Part D of title I of the CAA. To receive approval to construct, a
source that is subject to these requirements must show that it will not
cause a net increase in pollution, will not create a delay in meeting
the NAAQS, and that the source will install and use control technology
that achieves the lowest achievable emissions rate (LAER).
    The changes to North Carolina's NSR rules, which EPA is now
proposing to approve into the North Carolina SIP, were submitted to
update the existing North Carolina rules to meet the requirements of
the 2002 NSR Reform Rules and the Ozone Implementation NSR update.
These SIP revisions address baseline actual emissions, actual-to-
projected actual applicability tests, PALs, recordkeeping and reporting
requirements, and provisions recognizing NOX as a precursor
to ozone. North Carolina's NSR rules incorporate by reference (IBR) the
federal NSR rules at 40 CFR 51.166 and 51.165, as amended June 13,
2007, except for the definition of ``baseline actual emissions,'' the
stayed equipment replacement provisions (ERP) (69 FR 40274, July 1,
2004),\1\ the PAL adjustment provisions at 51.166(w)(10)(iv)(a) and
51.165(f)(10)(iv)(A), the recordkeeping and reporting requirements at
51.166(r)(6) and 51.165(a)(6), and the Ozone Implementation NSR update
provisions at 51.165(a)(8), (a)(9) and (a)(10).
---------------------------------------------------------------------------

    \1\ EPA promulgated the ERP on October 27, 2003 (68 FR 61248).
The ERP was challenged and the D.C. Circuit Court of Appeals stayed
the ERP on December 24, 2003. On March 17, 2006, the Court vacated
the ERP. See New York v. EPA, 443 F.3d 880 (D.C. Cir. 2006).
---------------------------------------------------------------------------

    EPA's evaluation of the North Carolina SIP submittals included a
line-by-line comparison of the proposed revisions with the federal
requirements. As a general matter, state agencies may meet the
requirements of 40 CFR part 51, and the 2002 NSR Reform Rules, with
different but equivalent regulations. As mentioned above, North
Carolina chose to IBR the federal rules with several changes. The
definition of

``baseline actual emissions'' at subchapter 2D .0530(b)(1) and
.0531(a)(1) was changed to remove the provision allowing emissions
units that are not electric utility steam generating units (EUSGUs) to
look back 10 years to select the baseline period. North Carolina rules
treat EUSGUs and non-EUSGUs the same by allowing a look back of only 5
years. However, North Carolina rules provide the option of allowing a
different time period, not to exceed 10 years, if the owner or operator
demonstrates that it is more representative of normal source operation.
In addition, North Carolina rules require EUSGUs to adjust downward the
baseline emissions to account for reductions required under the North
Carolina Clean Smokestack Act.
    With regard to the PAL adjustment provisions at
51.166(w)(10)(iv)(a) and 51.165(f)(10)(iv)(A), the federal regulations
provide the option that if the emissions level is equal to or greater
than 80 percent of the PAL level, the reviewing authority may renew the
PAL at the same level or it may set the PAL at a different level
considering other factors per 51.166(w)(10)(iv)(b) and 51.165(f)(iv)(B)
respectively. North Carolina rules at subchapter 2D .0530(i) and
.0531(h) require that the PAL be renewed at the same level if emissions
are greater than or equal to 80 percent of the PAL.
    With regard to the remanded portions of the 2002 NSR Reform Rules
related to recordkeeping and EPA's December 21, 2007, clarifications of
the term ``reasonable possibility'' (72 FR 72607), North Carolina did
not incorporate by reference all the provisions at 40 CFR 51.166(r)(6)
and 51.165(a)(6) or adopt the federal ``reasonable possibility''
standard. Instead, North Carolina adopted recordkeeping and reporting
requirements that apply to all modifications that use the actual-to-
projected-actual applicability test. Therefore, the North Carolina
provisions meet the minimum recordkeeping and reporting requirements of
the federal rule. Pursuant to the EPA December 21, 2007, rulemaking on
the ``reasonable possibility'' standard, North Carolina is required to
submit a notice to EPA within 3 years to acknowledge that its
regulations fulfill these requirements.
    With regard to the Ozone Implementation NSR update, North Carolina
incorporated by reference all the November 29, 2005, rule revisions
except for the provisions at 40 CFR 51.165(a)(8), (9) and (10). North
Carolina did not IBR 40 CFR 51.165(a)(10), which addresses
PM10 precursors in PM10 nonattainment areas,
because there are no PM10 nonattainment areas in North
Carolina. North Carolina did not IBR 40 CFR 51.165(a)(8) and (a)(9),
which relate to the applicability of NOX as a precursor for
ozone and offset ratios in nonattainment areas; however, North Carolina
rules have equivalent requirements at subchapter 2D .0531(c) and (f).
With respect to the offset ratios, North Carolina's rules only address
the offset ratio for moderate nonattainment areas, which is the current
``highest'' classification in the State. There is only one 8-hour ozone
nonattainment area in North Carolina--the Charlotte-Gastonia-Rock Hill
area--which is classified as moderate nonattainment. At the time that
any area(s) in North Carolina are reclassified to any level above
moderate during a future designation process, North Carolina rules will
have to be revised to address the appropriate offset ratios.
    In addition to incorporating the federal rules by reference with
several changes, North Carolina's rule revisions include two additional
provisions that do not directly relate to the 2002 NSR Reform rules,
including: (1) Incorporating by reference 40 CFR 52.21(r)(2) to clarify
the period of validity of approval to construct; and (2) requiring that
all new natural gas-fired electrical utility generating units install
best available control technology (BACT) or LAER, as appropriate. This
second requirement was included in the North Carolina rules for clarity
and consistency with restrictions on use of allowances imposed by an
agreement resulting from provisions of the North Carolina Clean
Smokestacks Act.\2\
---------------------------------------------------------------------------

    \2\ Any allowances for emissions reductions achieved under the
Clean Smokestacks Act are not available to the subject facilities,
nor any other sources, and may not be used to offset emissions and
avoid installation of BACT or LAER on new natural gas-fired units.
---------------------------------------------------------------------------

    After evaluation of the submittals and supporting documentation for
revisions to North Carolina's NSR regulations, EPA has determined that
the differences from the federal regulations discussed above do not
make North Carolina's NSR program less stringent than the federal
program. Therefore, EPA has determined that the proposed SIP revisions
are consistent with the federal program requirements for the
preparation, adoption and submittal of implementation plans for NSR set
forth at 40 CFR 51.165 and 51.166, and are therefore approvable.

IV. What action is EPA taking today?

    EPA is proposing to approve the changes made to North Carolina's
Regulations 15A NCAC 2D .0530 and .0531, as submitted by the North
Carolina DENR on November 30, 2005, March 16, 2007, and June 20, 2008,
as revisions to the North Carolina SIP.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed 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 CAA; and
     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).
    In addition, this rule 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.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

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

    Dated: August 29, 2008.
Russell L. Wright, Jr.,
Acting Regional Administrator, Region 4.
[FR Doc. E8-20874 Filed 9-8-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 155 (Monday, August 12, 2013)]
[Notices]
[Page 48917]
[FR Doc No: 2013-19405]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 31 and Form R31. SEC File No. 270-537, OMB Control No.
3235-0597.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for extension of the previously approved
collection of information discussed below.
    Section 31 of the Securities Exchange Act of 1934 (15 U.S.C. 78ee.)
(``Exchange Act'') requires the Commission to collect fees and
assessments from national securities exchanges and national securities
associations (collectively, ``self-regulatory organizations'' or
``SROs'') based on the volume of their securities transactions. To
collect the proper amounts, the Commission adopted Rule 31 (17 CFR
240.31) and Form R31 (17 CFR 249.11) under the Exchange Act whereby the
SROs must report to the Commission the volume of their securities
transaction and the Commission, based on that data, calculates the
amount of fees and assessments that the SROs owe pursuant to Section
31. Rule 31 and Form R31 require the SROs to provide this data on a
monthly basis.
    Currently, there are 22 respondents under Rule 31: 17 national
securities exchanges, two security futures exchanges, and one national
securities association subject to the collection of information
requirements of Rule 31; there are additionally two registered clearing
agencies that are required to provide certain data in their possession
needed by the SROs to complete Form R31, although these two entities
are not themselves required to complete and submit Form R31. The
Commission estimates that the total burden for all 22 respondents is
378 hours per year. The Commission notes that, based on previous and
current experience, it estimates an additional two new national
securities exchanges will become registered and subject to the
reporting requirements of Rule 31 over the course of the authorization
period and incur burden of 12 hours per year. Thus, the Commission
estimates the total burden for the existing and expected new
respondents to be 390 hours per year.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.
    The public may view background documentation for this information
collection at the following Web site, www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503, or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100
F Street NE., Washington, DC 20549 or send an email to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: August 6, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-19405 Filed 8-9-13; 8:45 am]
BILLING CODE 8011-01-P


1 February 24, 2006 MEMORANDUM Subject: Supporting Analysis for the Household Costs of Water Treatment From: Kira Smith, TAB Thru: Dan Olson Affordability Team Leader, TAB To: Record In its February Federal Register notice, Small Drinking Water Systems Variances   Revision of Existing National Level Affordability Methodology and Methodology to Identify Variance Technologies that are Protective of Public Health, EPA requests comment on a number of questions related to the methodology the Agency uses to evaluate the affordability of its National Primary Drinking Water Rules. The three key issues are as follows:  First, EPA is requesting comment upon the size of the system the Agency should consider as representative of each the system size categories specified under SDWA. This question is critical to determining the cost each household must pay for the treatment to comply with a new regulation. Smaller systems have fewer households over which the fixed costs of treatment can be distributed and therefore experience higher household costs. EPA is specifically asking if the median ( or middle sized) or tenth percentile ( a system that serves fewer people than 90 percent of the other systems in the category) should be selected as the representative system for the category.  Second, EPA is requesting comment upon the affordability threshold ( the maximum cost that is affordable to customers served by small systems). EPA is proposing to calculate the affordability threshold by taking a percentage of the median annual household income ( MHI) among small systems which as of September 2005 was between $ 40,000 and $ 44,000. EPA is requesting comment upon three different alternative thresholds equal to: 0.25% MHI ($ 100 to $ 110 under Sept. 2005 income estimates), 0.50% MHI ($ 200 to $ 220 under Sept. 2005 income estimates), or 0.75% MHI ($ 310 to $ 330 under Sept. 2005 income estimates) 2  Third, EPA is requesting comment upon whether or not EPA should evaluate affordability strictly on a national level, or to use a two step process that includes both a national level evaluation of affordability, and a second analysis conducted at the County level. EPA would perform this second step only when the first step found a standard to be affordable at the national level. EPA would evaluate economic data to identify economically disadvantaged Counties in the U. S. that cannot afford to comply regardless of the outcome of the national determination.

This memorandum provides supporting analysis for the first question, the size of the system the Agency should consider as representative of each the system size categories specified under SDWA. This memorandum describes how EPA calculates compliance costs at the system and household level and for different size systems. Additionally, it discusses treatment cost estimates for systems of varying size in terms of potential revisions to EPA's affordability methodology.

Key factors affecting treatment costs The Agency has observed that within and among the approximately 50,000 small systems in the U. S., population served and source water quality are the two most significant factors that drive the household costs associated with a given treatment technology. In general, larger systems have more customers over which to distribute fixed capital costs for treatment technologies and will have lower production costs per thousand gallons treated due to economiesof scale. Therefore, for most technologies, household costs are greater for small systems than for large systems. Thus, one of the Agency's options for public comment includes comparing the affordability threshold to a below median measure of expected treatment costs, i. e., the 10thpercentile system size. The cost of treatment a system must install is affected by the quality of the source water, including the concentration of the contaminant to be removed ( i. e., degree of treatment), pH, and the presence of other dissolved or suspended solids. To account for this, EPA typically determines a range of costs for expected source water qualities when listing Best Available Technologies and small system compliance technologies for compliance with National Primary Drinking Water Rules.

Treatment cost models EPA relies on treatment cost models and model systems to estimate compliance technology costs for different size water systems. Compliance technologies for recent rules include both central treatment and point of use ( POU) options. Under the central treatment options, all of the water supplied to the household is treated to meet the standard. Under the POU options, only the water at one tap within a residence is treated. The water accessed from other taps located in the house is not treated to reduce contaminant concentrations. The analyses described in this document assume that the POU devices are installed at kitchen taps. For central treatment options, three cost models have typically provided treatment cost estimates for the cost curves in the cost and technology documents. The cost models have different ranges of applicability based on system design flow. The design flow is related to the production capacity of the treatment unit and is larger than the peak daily flow for the system. 3 The cost models use design flow to estimate capital costs for the system and average daily flow to estimate operations and maintenance ( O& M) costs. Thus, production capacity determines the size of a treatment unit and the total volume of water treated for distribution determines the operating costs. The first cost model is for very small systems with a design flow below 270,000 gallons per day. The document entitled Very Small Systems Best Available Technology Document ( EPA, 1993) provides equations for estimating capital and O& M costs for these systems. 1 The second model is called " The Water Model" and consists of a set of cost curves for various technologies contained in the document entitled Small System Water Treatment Costs ( EPA, 1984). 2 The third model is the WATERCO$ T model ( Computer Software for Estimating Water and Wastewater Treatment Costs, Version 2.0, 1994). This is a computer model that estimates costs for systems with flows larger than one million gallons per day. The costing models generate discrete cost estimates corresponding to specific design and average daily flow inputs. Some of the technologies that treat drinking water contaminants also produce byproduct streams. These byproduct streams are typically associated with the treatment of inorganic contaminants. Coagulation/ filtration and lime softening produce sludges that require disposal. Membrane technologies produce a concentrate stream. Ion exchange and activated alumina produce brine streams. Two additional cost models were used to estimate the costs for disposing these residual byproduct streams. The document, Small Water Systems Byproducts Treatment and Disposal Cost Document ( EPA, 1993a) provides equations for capital and O& M costs for technologies to dispose of residual byproducts. These cost equations are intended for systems in the smaller of the two size categories ( serving 25  500 and 501  3,300 people). The equations for capital and O& M costs for systems serving 3,301  10,000 people came from the document entitled Water System Byproducts Treatment and Disposal Cost Document ( EPA, 1993b). For the POU options, the 1998 document, Cost Evaluation of Small System Compliance Options: Point of Use and Point of Entry Treatment Units ( EPA, 1998) provided cost equations. This document contains capital and O& M cost equations for a variety of POU and point of entry ( POE) options. Once design flows have determined capital costs and average daily flows have determined O& M costs, the capital costs are amortized over 20 years at an interest rate of 7.0 percent. Combining the annualized capital costs with the annual O& M costs determines the total production costs. The units for the total production cost are dollars per thousand gallons ($/ kgal). In order to derive capital and O& M costs for central treatment options in the Variance Technology Findings document for rules developed in the early 1990s ( EPA 1998a), design and average flows were needed for a typical system within each size class. Design and average daily flows were based on flows calculated for average sized systems without consideration for 1 Although this is the most current document, a new procedure is being developed. The arsenic rule used a hybrid of this new procedure and the older approach for the activated alumina and anion exchange costs.

2 As was noted earlier for another source, although this is the most current document, a new procedure is being developed. A hybrid of this new procedure and the older approach was used for the activated alumina and anion exchange costs for the arsenic rule. 4 differences in water source type or ownership category. Exhibit 1 lists the flow values derived for the pre 1996 regulations across the five CWSS size classes. The number of systems within each size class provided a weighting factor to determine flows for the consolidated SDWA small system size classes ( 25 500 and 501 3,300) that follow in Exhibit 2.

Exhibit 1. Design and Average Daily Flows for Pre 1996 Regulations System Size Class ( population served) Design Flow ( kgpd) Average Daily Flow ( kgpd)

25  100 24 5.6 101  500 87 24 501  1,000 270 86 1,001  3,300 650 230 3,301  10,000 1,800 700 Exhibit 2. Design and Average Daily Flows Consolidated Across System Size System Size Class ( population served) Design Flow ( kgpd) Average Daily Flow ( kgpd)

25  500 58 15 501  3,300 500 170 3,301  10,000 1,800 700 EPA has since refined its approach for analyzing system source type and ownership impacts on design average daily flow and has incorporated these factors into updated population/ flow regression equations, as shown in Exhibit 3. These equations form the basis of the method EPA uses for estimating treatment costs as part of making affordability determinations. Exhibit 4 then provides the design and average daily flows used in treatment cost estimates for composite public/ private ground water systems calculated with the 10th percentile and 50th percentile ( i. e., median) system size in each size class.

Exhibit 3. Population/ Flow Equations Used in Treatment Cost Estimation CWS Source/ Ownership Category Design Flow ( kgpd) Average Daily Flow ( kgpd)

Ground ( Public) Y = 0.54992 * ( X^ 0.95538) Y = 0.08575 * ( X^ 1.05839)

Ground ( Private) Y = 0.41682 * ( X^ 0.96078) Y = 0.06670 * ( X^ 1.06284) 5 Exhibit 3. Population/ Flow Equations Used in Treatment Cost Estimation CWS Source/ Ownership Category Design Flow ( kgpd) Average Daily Flow ( kgpd)

Surface ( Public) Y = 0.59028 * ( X^ 0.94573) Y = 0.14004 * ( X^ 0.99703)

Surface ( Private) Y = 0.35674 * ( X^ 0.96188) Y = 0.09036 * ( X^ 1.03338)

Purchased ( Public) Ground Y = 0.3191 * ( X^ 0.9946) Y = 0.04692 * ( X^ 1.10189)

Purchased ( Private) Ground Y = 0.3215 * ( X^ 0.9794) Y = 0.05004 * ( X^ 1.08339)

Purchased ( Public) Surface Y = 0.2092 * ( X^ 1.0452) Y = 0.04692 * ( X^ 1.10189)

Purchased ( Private) Surface Y = 0.2058 * ( X^ 1.0084) Y = 0.05004 * ( X^ 1.08339)

Source: U. S., EPA, Geometries and Characteristics of Public Water Systems, December 2000 ( under revision). Note: Y = flow ( kgpd) and X = population served Exhibit 4. Design and Average Daily Flows Used for Treatment Cost Estimates Under Revised Options ( kgpd) 10th Percentile System: 50th Percentile System: System Size Class ( population served) Design Average Daily Design Average Daily 25 500 15 3.5 44 11 501 3,300 230 70 440 140 3,301 10,000 1,300 480 1,900 720 Notes: 1. Representative system population used to calculate flow values within each size class for 10th percentile are 40, 600, and 3,609; for 50th percentile, the figures are 120, 1,195, and 5,325 based on SDWISFED December 2004 2. Flows are based on a weighted average for public and private non purchased ground water systems ( which make up approximately 77 percent of systems that serve 25 10,000 people) and are adjusted to two significant figures. These values fall within a range typical for residential water use.

The 1998 POU/ POE report compared costs for POU and POE options against central treatment costs. The costs for the centrally managed POU options had to be converted to the same flow basis to conduct this comparison and calculate treatment costs. The cost estimates for the centrally managed POU treatment options are presented in dollars per thousand gallons ($/ kgal) used per household. This is different than the cost per gallon ($/ gal) based on the volume treated by the POU device. By converting the cost per gallon treated into the cost per thousand gallons consumed by a household, the POU costs are comparable with central treatment costs. POU option cost equations use the number of households as the dependent variable. Exhibit 5 below shows the number of households used to derive POU treatment costs for the two system size approaches. 6 Exhibit 5. Number of Households by Size Category for POU Options Residential Households for System at: System Size Class ( population served) 10th Percentile 50th Percentile 25 500 16 47 501 3,300 230 460 3,301 10,000 1400 2100 Note: Estimated based on the 2004 U. S. Census mean of 2.57 persons per household.

Both the central treatment and the POU treatment costs provided the rate increase associated with installing a specific level of treatment. The treatment cost models produce rate increases measured in dollars per thousand gallons ($/ kgal). Exhibit 6 lists the median annual household water consumption rate ( kgal/ connection/ yr) for each system size class used to convert treatment technology costs into an increase in annual household water bills. These consumption rates are derived from the 1995 CWSS.

Exhibit 6. Residential Consumption for Small Water Systems System Size Class ( population served) Median Annual Household Consumption ( kgal/ connection/ yr)

25  500 72 501  3,300 74 3,301  10,000 77 The water consumption estimates in Exhibit 6 were multiplied by 1.15 to account for lost water due to leaks. Since the water lost to leaks is unbilled, the water bills for the actual water used were adjusted for the subsequent analyses in this document to cover this lost water by increasing the household consumption. Exhibit 7 below presents adjusted median annual consumption rates. The annual cost increase per household ($/ HH/ yr) was calculated by multiplying the adjusted consumption rates by the rate increase imposed by treatment ($/ kgal). The option for below median system size incorporates these adjusted median annual consumption rates and treatment costs based on 10th percentile system size to calculate annual cost increases per household. 7 Exhibit 7. Adjusted Residential Consumption for Small Water Systems System Size Class ( Population served) Median Annual Consumption ( kgal/ connection/ yr)

25   500 83 501  3,300 85 3,301  10,000 89 Treatment cost estimates for different size systems As noted earlier, treatment costs can vary significantly for systems serving different population sizes, even within the same size category. Exhibit 8 plots annual per household costs versus system population size for installing and operating a central treatment anion exchange technology. As Exhibit 8 illustrates, treatment costs decline rapidly as system population increases at the lower end of the range of system sizes per household. After that, reductions in costs are more gradual. At the higher end of the range, differences in per household costs across system sizes are fairly minor even between a system serving 600 people and one serving 10,000. Although the details of these relationships will vary across different rules and different compliance technologies, the general declining nature of per household treatment costs relative to system size is expected to hold true. 8 $ 0 $ 100 $ 200 $ 300 $ 400 $ 500 $ 600 0 1000 2000 3000 4000 5000 6000 System Size ( Population Served) Annual Per Household Treatment Costs ( Sep 2005 Dollars) Exhibit 8. Per Household Treatment Cost Estimates by System Size Anion Exchange Note: Costs are based on cost curve equations for anion exchange with source water containing less than 20 mg/ L sulfate in the document Technologies and Costs for Removal of Arsenic from Drinking Water ( EPA 815 R 00 0028). System sizes are determined from SDWISFED January 2004.

Household cost options As a key input, EPA's current national level affordability methodology has used the expected per household treatment costs for the system whose population places it at the median for its size class. The Agency's options for public comment include either retaining this focus on the median or instead using the treatment costs for the system whose population places it at the 10th percentile within its size class. In general, this change can be expected to increase the estimated treatment costs, and thereby find more compliance technologies unaffordable. The precise impact will vary significantly by drinking water rule, but overall small systems exhibit higher per household treatment costs than non small systems because of economies of scale. Hence the smaller the system, even within a particular class of small systems, the higher the treatment costs will be on average. Exhibit 8 above presents treatment cost estimates for systems of different sizes for a central anion exchange technology. Exhibit 9 provides an example of household costs for the 10thand the 50th percentile size systems within each of the small system size categories. This example demonstrates that the greatest difference in household costs are typically found in the 25 500 size category, as the estimated household cost for the 10th percentile size system is more than double 9 that for the 50th percentile ( median) size system. It is this smallest system size category where there is most likely to be an affordability concern.

Exhibit 9. Comparison of annual per household costs of ion exchange treatment (< 20 mg/ L sulfate). 10th Percentile Sized System 50th Percentile Sized System System Size Population Size Treatment Costs Population Size Treatment Costs 25   500 40 $ 540 120 $ 200 501   3,300 600 $ 72 1,195 $ 54 3,301   10,000 3,609 $ 40 5,325 $ 35 Note: Costs are based on cost curve equations in the document Technologies and Costs for Removal of Arsenic from Drinking Water ( EPA 815 R 00 028). System sizes are determined from SDWISFED January 2004.

Treatment cost estimates for different source water quality conditions Exhibits 8 and 9 present costs for anion exchange treatment when the water being treated contains less than 20 milligrams per liter ( mg/ L) of sulfate. Ion exchange is a physical/ chemical process by which an ion on the solid phase is exchange for an ion in the water being treated, or feed water. The solid phase is typically a synthetic resin. Once the resin is exhausted ( i. e., all sites available for ion exchange resin filled by contaminant ions), it must be regenerated. Higher sulfate concentrations in source water may affect the capacity of the anion exchange unit to affectively remove other contaminants. Therefore, if there are more sulfate ions in the source water, the anion exchange resin must be regenerated more frequently. This more frequent operation and maintenance will result in higher costs associated with implementing the technology. Exhibit 10 shows the impact on household costs for the same size water systems in Exhibit 9 that have sulfate between 20 and 50 mg/ L in their source water.

Exhibit 10. Comparison of annual per household costs of ion exchange treatment ( 20 50 mg/ L sulfate). 10th Percentile Sized System 50th Percentile Sized System System Size Population Size Treatment Costs Population Size Treatment Costs 25   500 40 $ 750 120 $ 270 501   3,300 600 $ 100 1,195 $ 73 3,301   10,000 3,609 $ 52 5,325 $ 46 References CWC Engineering Software, 1994. W/ W Costs and Design Criteria Guidelines ( WATERCO$ T Model) User Manual for Computer Software for Estimating Water and Wastewater Treatment Costs. Version 2.0.

EPA, 1984. Estimation of Small System Water Treatment Costs ( Water Model). Cincinnati, OH: EPA Office of Research and Development. 1984.

EPA. 1993. Very Small Systems Best Available Technology Cost Document. Prepared by Malcolm Pirnie, Inc. for the EPA. April 1993. 10 EPA 1993a. Small Water System Byproducts Treatment and Disposal Cost Document. Draft Final. Prepared by DPRA Inc. for the EPA. April 1993.

EPA, 1993b. Water System Byproducts Treatment and Disposal Cost Document. Draft Final. Prepared by DPRA Inc. for the EPA. April 1993.

EPA, 1998. Cost Evaluation of Small System Compliance Options: Point of Use and Point of Entry Treatment Units. Prepared by The Cadmus Group, Inc. for EPA. September 1998.

EPA, 1998a. Variance Technology Findings for Contaminants Regulated Before 1996. EPA 815 R 98 003. September 1998.


[Federal Register: March 9, 2009 (Volume 74, Number 44)]
[Notices]
[Page 10053-10055]
[DOCID:fr09mr09-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0098]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Evaluation of Potential Data Sources for the Sentinel
Initiative

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the proposed information collection through
a survey designed to identify potential data sources and/or data
environments that could participate in the Sentinel Initiative to
create a national, electronic distributed system, strengthening FDA's
ability to monitor the postmarket performance of a medical product.

DATES: Submit written or electronic comments on the collection of
information by May 8, 2009.

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

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information

Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>. To obtain a copy of the draft survey
instrument contact Tomeka Arnett on<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Evaluation of Potential Data Sources for the Sentinel Initiative

    In September 2005, the Secretary of Health and Human Services (the
Secretary) asked FDA to expand its current system for monitoring
medical product performance. The Secretary asked FDA to explore the
possibility of working in collaboration with multiple healthcare data
systems to augment FDA's capability of identifying and evaluating
product safety information beyond its existing voluntary reporting
systems. Such a step would strengthen FDA's ability, ultimately, to
monitor the performance of a product after marketing approval. The
Secretary recommended that FDA explore creating a public-private
collaboration as a framework for such an effort leveraging increasingly
available large, electronic healthcare databases and taking advantage
of emerging technologies and building on existing systems and efforts,
rather than creating new systems.
    In 2006, the Institute of Medicine (IOM) issued a report entitled
``The Future of Drug Safety--Promoting and Protecting the Health of the
Public.''\1\ Among other suggestions, this IOM report recommended FDA
identify ways to access other health-related databases and create a
public-private partnership to support safety and efficacy studies.
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    \1\ Institute of Medicine, ``The Future of Drug Safety--
Promoting and Protecting the Health of the Public,'' September 22,
2006, http://www.iom. edu/. (FDA has verified the Web site address,
but FDA is not responsible for any subsequent changes to the Web
site after this document publishes in the Federal Register.)
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    In 2007, Congress enacted the Food and Drug Administration
Amendments Act of 2007\2\ (FDAAA). Section 905 of FDAAA calls for the
Secretary to develop methods to obtain access to disparate data sources
and to establish an active postmarket risk identification and analysis
system that links and analyzes healthcare data from multiple sources.
The law sets a goal of access to data from 25 million patients by July
1, 2010, and 100 million patients by July 1, 2012. The law also
requires FDA to work closely with partners from public, academic, and
private entities. FDA views the Sentinel Initiative as a mechanism
through which this mandate can be carried out.
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    \2\ Food and Drug Administration Amendments Act of 2007, Public
Law 110-85, was signed into law in September 2007. See Title IX,
Section 905.
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    Consistent with FDA's mission to protect and promote the public
health, FDA is embarking on the Sentinel Initiative to create a
national, electronic distributed system, strengthening FDA's ability to
monitor the post-market performance of a product. As currently
envisioned, the Sentinel Initiative will enable FDA to capitalize on
the capabilities of multiple, existing data systems (e.g. electronic
health record systems and medical claims databases) to augment the
agency's current surveillance capabilities. The proposed system will
enable queries of distributed data sources quickly and securely for
relevant product safety information. Data will continue to be managed
by its owners, and only data of organizations who agree to participate
in this system will be included. Operations will adhere to strict
privacy and security safeguards.
    The success of this Initiative will depend largely on the content,
quality, searchability, and responsiveness of participating data
sources and/or data environments. It is essential that FDA understand
the strengths and limitations of potential data sources that might be
included in the Sentinel Initiative. This survey will be used to
collect information from potentially participating data sources and/or
environments. The data we are seeking will describe the characteristics
of the data available, not personally identifiable information. The
findings will help FDA plan for this proposed system and for future
work related to the Sentinel Initiative.
    This survey will collect information on the scope, content,
structure, quality, and timeliness of data; patient population(s),
duration of follow up, and capture of care across all settings;
availability, experience, and interest of investigators with knowledge
of the data in using it for post-market product safety surveillance as
well as plans for further data source enhancements; availability,
experience, and interest of investigators with knowledge of the data in
participating in a distributed data system; and barriers that exist to
including each data source in the Sentinel Initiative.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                      No. of         Annual Frequency       Total Annual        Hours per
   Activity        Respondents         per Response          Responses           Response         Total Hours
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Data Source                   250                     1                250               24.5              6,125
 and/or
 Environment
 Survey
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that approximately 250 respondents will participate
in this voluntary survey. These respondents will consist mostly of
other Federal agencies, health plan data sources, health information
exchanges, large multi-specialty medical groups and academic medical
centers, large hospital systems, pharmacies, medical societies,
consumer-oriented Web sites, commercial data sets, research networks,
lab data, and registries.
    Each respondent will extend approximately 24.5 hours to complete 1
survey for a total of 6,125 hours (250 x 1 x 24.5 = 6,125).

    Dated: February 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4830 Filed 3-6-09; 8:45 am]

BILLING CODE 4160-01-S