[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Proposed Rules]
[Pages 62679-62686]
[FR Doc No: 2020-21741]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2016-0001; FRL-10014-83-Region 10]

Air Plan Approval; ID; 2010 Sulfur Dioxide NAAQS Infrastructure
Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) submission from the State of
Idaho (Idaho or the State) that addresses the

Clean Air Act (CAA or Act) interstate transport requirements for the
2010 1-hour Sulfur Dioxide (SO2) National Ambient Air
Quality Standards (NAAQS). In this action, the EPA is proposing to
determine that Idaho will not contribute significantly to nonattainment
or interfere with maintenance of the 2010 1-hour SO2 NAAQS
in any other state or the Fort Hall Reservation. Therefore, the EPA is
proposing to approve Idaho's December 24, 2015, SIP submission as
meeting the interstate transport requirements for the 2010 1-hour
SO2 NAAQS.

DATES: Written comments must be received on or before November 4, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2016-0001 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not electronically submit any
information you consider to be Confidential Business Information (CBI)
or other information the disclosure of which is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Claudia Vaupel at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, it is intended to refer to the EPA.

Table of Contents:

I. Background
II. Relevant Factors To Evaluate 2010 SO2 Interstate
Transport SIPs
III. State Submission and EPA Analysis
    A. State Submission
    B. EPA Analysis
    1. The EPA's Prong 1 Evaluation
    2. The EPA's Prong 2 Evaluation
IV. Proposed Action
V. Statutory and Executive Order Reviews

I. Background

    On June 2, 2010, the EPA established a new primary 1-hour
SO2 NAAQS of 75 parts per billion (ppb), based on a 3-year
average of the annual 99th percentile of 1-hour daily maximum
concentrations.\1\ The CAA requires states to submit, within 3 years
after promulgation of a new or revised NAAQS, SIPs meeting the
applicable ``infrastructure'' elements of sections 110(a)(1) and (2).
One of these applicable infrastructure elements, CAA section
110(a)(2)(D)(i), requires SIPs to contain ``good neighbor'' provisions
to prohibit certain adverse air quality effects on neighboring states
due to interstate transport of pollution.
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    \1\ 75 FR 35520 (June 22, 2010).
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    CAA section 110(a)(2)(D)(i) includes four distinct components,
commonly referred to as ``prongs,'' that must be addressed in
infrastructure SIP submissions. The first two prongs, which are
codified in CAA section 110(a)(2)(D)(i)(I), require SIPs to contain
adequate provisions that prohibit any source or other type of emissions
activity in one state from contributing significantly to nonattainment
of the NAAQS in another state (prong 1) and from interfering with
maintenance of the NAAQS in another state (prong 2). The third and
fourth prongs, which are codified in CAA section 110(a)(2)(D)(i)(II),
require SIPs to contain adequate provisions that prohibit emissions
activity in one state from interfering with measures required to
prevent significant deterioration of air quality in another state
(prong 3) or from interfering with measures to protect visibility in
another state (prong 4).
    In this action, the EPA is proposing to approve the prong 1 and
prong 2 portions of the State of Idaho's December 24, 2015 SIP
submission because, based on the information available at the time of
this rulemaking, the State demonstrated that Idaho will not contribute
significantly to nonattainment or interfere with maintenance of the
2010 SO2 NAAQS in any other state or the Fort Hall
Reservation. All other applicable infrastructure SIP requirements for
this SIP submission have been addressed in separate actions. See 79 FR
46707 (August 11, 2014).

II. Relevant Factors To Evaluate 2010 SO2 Interstate
Transport SIPs

    Although SO2 is emitted from a similar universe of point
and nonpoint sources, interstate transport of SO2 is unlike
the transport of fine particulate matter (PM2.5) or ozone,
in that SO2 is not a regional pollutant and does not
commonly contribute to widespread nonattainment over a large (and often
multi-state) area. The transport of SO2 is more analogous to
the transport of lead (Pb) because its physical properties result in
localized pollutant impacts very near the emissions source. However,
ambient concentrations of SO2 do not decrease as quickly
with distance from the source as Pb because of the physical properties
and typical release heights of SO2. Emissions of
SO2 travel farther and have wider ranging impacts than
emissions of Pb but do not travel far enough to be treated in a manner
similar to ozone or PM2.5. The approaches that the EPA has
adopted for ozone or PM2.5 transport are too regionally
focused and the approach for Pb transport is too tightly circumscribed
to the source to serve as a model for SO2 transport.
SO2 transport is therefore a unique case and requires a
different approach.
    In this proposed rulemaking, as in prior SO2 transport
analyses, the EPA focuses on a 50 km-wide zone because the physical
properties of SO2 result in relatively localized pollutant
impacts near an emissions source that drop off with distance. Given the
physical properties of SO2, the EPA selected the ``urban
scale''--a spatial scale with dimensions from 4 to 50 kilometers (km)
from point sources--given the usefulness of that range in assessing
trends in both area-wide air quality and the effectiveness of large-
scale pollution control strategies at such point sources.\2\ As such,
the EPA utilized an assessment up to 50 km from point sources in order
to assess trends in area-wide air quality that might impact downwind
states.
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    \2\ For the definition of spatial scales for SO2, see
40 CFR part 58, appendix D, section 4.4 (``Sulfur Dioxide
(SO2) Design Criteria''). For further discussion on how
the EPA is applying these definitions with respect to interstate
transport of SO2, see the EPA's proposal on Connecticut's
SO2 transport SIP. 82 FR 21351, 21352, 21354 (May 8,
2017).
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    As discussed in section III of this this document, the EPA reviewed
Idaho's analysis to assess how it evaluated SO2 transport to
other states, the types of information used in the analysis and the
conclusions drawn. The EPA then conducted a weight of evidence
analysis, reviewing the submission and other available information,
including air quality monitor data, emission sources and emission
trends within Idaho and in bordering states to which it could
potentially contribute or interfere with attainment or maintenance of
the 2010 SO2 NAAQS.\3\
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    \3\ This proposed approval action is based on the information
contained in the administrative record for this action and does not
prejudge any other future EPA action that may make other
determinations regarding any of the subject state's air quality
status. Any such future actions, such as area designations under any
NAAQS, will be based on their own administrative records and the
EPA's analyses of information that becomes available at those times.
Future available information may include, and is not limited to,
monitoring data and modeling analyses conducted pursuant to the Data
Requirements Rule for the 2010 1-Hour SO2 NAAQS (80 FR
51052, August 21, 2015) and information submitted to the EPA by
states, air agencies, and third party stakeholders such as citizen
groups and industry representatives.

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III. State Submission and EPA Analysis

    On December 24, 2015, Idaho submitted a SIP revision to the EPA
documenting that its SIP contains provisions that address CAA section
110(a)(2)(D)(i)(I) interstate transport requirements for the 2010
SO2 NAAQS. In this section, we provide an overview of
Idaho's 2010 SO2 interstate transport analysis, as well as
the EPA's evaluation of prongs 1 and 2.

A. State Submission

    Idaho conducted a weight of evidence analysis to examine whether
SO2 emissions from Idaho will adversely affect attainment or
maintenance of the 2010 SO2 NAAQS in downwind states. In the
submission, Idaho identified one 2010 SO2 nonattainment area
in Billings, Montana, within Yellowstone County, which has since been
redesignated to attainment.\4\ Idaho reviewed 2014 SO2
emissions data from the largest SO2 emissions sources in the
State and determined that emissions from those sources were hundreds of
miles from the SO2 nonattainment/maintenance areas. Idaho
also reviewed 2012-2014 monitoring data from the 3 SO2
monitoring sites in its monitoring network and from the 14
SO2 monitoring sites in neighboring states for years 2011-
2013. Idaho determined that all design values were below the 2010
SO2 NAAQS.\5\ In addition, Idaho provided 2009-2011
regional-scale modeling for the State and found that areas of increased
SO2 concentrations were localized in nature.
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    \4\ The Billings, Montana 2010 SO2 nonattainment area
was redesignated to attainment on May 10, 2016 following the state's
SIP submission (81 FR 28718).
    \5\ The design value is the annual 99th percentile of the daily
maximum 1-hour concentration values, averaged over three consecutive
years. (See 75 FR 35520, June 22, 2010).
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    Based on the weight of evidence analysis, Idaho concluded that
emissions within the State will not contribute significantly to
nonattainment or interfere with maintenance of the 2010 1-hour
SO2 NAAQS in any other state.

B. EPA Analysis

    The EPA proposes to find that Idaho's SIP meets the interstate
transport requirements of CAA section 110(a)(2)(D)(i)(I), prong 1 for
the 2010 SO2 NAAQS. We have analyzed the air quality,
emission sources and emission trends in Idaho and neighboring states,
i.e., Montana, Nevada, Oregon, Utah, Washington, Wyoming, and the Fort
Hall Reservation. Based on our analysis, we propose to find that Idaho
will not contribute significantly to nonattainment of the 2010
SO2 NAAQS in any other state or the Fort Hall Reservation.
1. The EPA's Prong 1 Evaluation
    The EPA reviewed SO2 emission data from 2005 to 2017 for
Idaho and the six neighboring states.\6\ As shown in Table 1 of this
document, SO2 emissions from Idaho and neighboring states
have decreased substantially over time, ranging from 37 to 89 percent.
Specifically, over this 13-year period, Idaho's statewide
SO2 emissions decreased by 72 percent.
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    \6\ We derived the emissions trends information from the EPA's
web page https://www.epa.gov/air-emissions-inventories/air-pollutant-emissions-trends-data.

                          Table 1--SO2 Emission Trends in Idaho and Neighboring States
                                               [In tons per year]
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                                                                                SO2 reduction,
            State                  2005         2008         2011         2014         2017       2005-2017 (%)

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Idaho........................       35,452       20,149       13,791       10,062       10,007                72
Montana......................       42,085       29,354       29,452       25,046       18,580                56
Nevada.......................       72,474       20,951       13,578       16,178        7,793                89
Oregon.......................       37,204       25,671       30,285       23,606       19,325                48
Utah.........................       52,999       31,609       27,839       26,964       15,442                71
Washington...................       59,651       34,826       30,492       38,973       37,488                37
Wyoming......................      122,454      112,791     83,256.1       56,772       52,354                57
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    We also reviewed the most recent certified air quality data
available for 1-hour SO2 design value concentrations at
monitors in Idaho and neighboring states. In Table 2 of this document,
we have included the most recent 2017-2019 design values for (1) all
monitors in Idaho; (2) the monitor with the highest design value in
each neighboring state; and (3) the monitor in each neighboring state
located closest to the Idaho border. The EPA notes that no neighboring
state has an SO2 monitor within 50 km of the Idaho border.
To assess how air quality has changed over time, we also reviewed 2014-
2016, 2015-2017, and 2016-2018 SO2 design values for these
monitors, as shown in Table 2.

             Table 2--SO2 Design Values \7\ in ppb for AQS Monitors in Idaho and Neighboring States
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                                                Distance to                      Design value
           State/area            AQS site ID   nearest Idaho ---------------------------------------------------
                                               border (km) *   2014-2016    2015-2017    2016-2018    2017-2019
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Idaho/Boise....................    160010010              55            4            3            3            3
Idaho/Pocatello................    160050004             102           39           38           38           40
Idaho/Caribou County...........    160290031              45           26           30           31           35
Montana/Helena.................    300490004             180            2            3            5            5

Montana/Billings...............    301110066             256           53           33           24           24
Nevada/Las Vegas...............    320030540             644            7            6            6            5
Nevada/Reno....................    320310016             362            5            5            5            4
Oregon/Portland................    410510080             447            3            3            3            3
Washington/Anacortes...........    530570011             412            5            4            3            3
Wyoming/Casper.................    560252601             393           25           20           19           19
Wyoming/Rock Springs...........    560370300             108           21           21           20           12
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* All distances throughout this notice are approximations.

    We reviewed ambient air quality data in Idaho and neighboring
states to see whether there were any monitoring sites, particularly
near the Idaho border, with elevated SO2 concentrations that
might warrant further investigation with respect to interstate
transport of SO2 from emission sources near any given
monitor. As shown in Table 2 of this document, there are no monitors
with violating design values in Idaho or neighboring states.
Additionally, the highest monitored 2017-2019 design value in Idaho or
neighboring states is 40 ppb, or approximately 54 percent of the level
of the 2010 SO2 NAAQS.
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    \7\ Design values are from monitors with sufficient data
available in the EPA's Air Quality System (AQS) to produce valid
design values. Data retrieved from the EPA's https://www.epa.gov/air-trends/air-quality-design-values#report.
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    As discussed previously, Idaho analyzed potential impacts to the
Billings, Montana area, which was still designated nonattainment at the
time of Idaho's submission. The EPA redesignated the former Billings
2010 SO2 nonattainment area to attainment following the
permanent closure of the PPL Corette Plant. See 81 FR 28718 (May 10,
2016). As noted by Idaho, the Billings, Montana area is located far
from the nearest Idaho border (256 km). Table 2 of this document also
shows that recent monitoring data in the Billings area do not approach
the level of the 2010 SO2 NAAQS. For these reasons, the EPA
agrees with Idaho's conclusion that the emissions from Idaho will not
contribute significantly to nonattainment in the Billings, Montana
area.
    The data presented in Table 2 of this document show that 2017-2019
1-hour SO2 design values in Idaho are between 4 and 54
percent of the 75-ppb level of the NAAQS. The Caribou County
SO2 monitor (AQS Site ID 160290031) is the only Idaho
SO2 monitor that is located within 50 km of a state border--
the Idaho-Wyoming border. The 2017-2019 design value at the Caribou
County SO2 monitor is 35 ppb or 47% of the NAAQS. However,
these air quality data do not, by themselves, indicate any particular
location that would warrant further investigation with respect to
SO2 emission sources in Idaho that might contribute
significantly to nonattainment in the bordering states. Because the
monitoring network is not necessarily designed to find all locations of
high SO2 concentrations, this observation indicates an
absence of evidence of impact at these locations but is not sufficient
evidence by itself of an absence of impact at all locations in the
neighboring states. We have therefore also conducted a source-oriented
analysis.
    As noted, the EPA finds that it is appropriate to examine the
impacts of emissions from stationary sources in Idaho in distances
ranging from 0 km to 50 km from the facility, based on the ``urban
scale'' definition contained in appendix D to 40 CFR part 58, section
4.4. Therefore, we assessed Idaho and neighboring state point sources
that emit 100 tons per year (tpy) of SO2 \8\ or more that
are located up to 50 km from an Idaho border.
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    \8\ We have limited our analysis to sources emitting at least
100 tpy of SO2 because in the absence of special factors,
for example the presence of a nearby larger source or unusual
physical factors, Idaho sources emitting less than 100 tpy can
appropriately be presumed to not be causing or contributing to
SO2 concentrations above the NAAQS.
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    There are four sources in Idaho that emit 100 tpy of SO2
or more. These sources are located in southeastern Idaho and are listed
in Table 3 of this document. Two of the sources, P4 Production and
Itafos Conda, are less than 50 km from the Idaho-Wyoming border, 45 km
and 40 km, respectively.

                       Table 3--Idaho SO2 Sources
                            [SO2 >= 100 tpy]
------------------------------------------------------------------------
                                         2017       Distance to nearest
          Idaho SO2 Source            Emissions     state border (km)/
                                       (tpy) 9         state border
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J.R. Simplot Company--Don Siding             748  101/ID-NV.
 Pocatello (Pocatello, ID).
The Amalgamated Sugar Company (Twin          635  61/ID-NV.
 Falls, ID).
P4 Production (Soda Springs, ID)...          488  45/ID-WY.
Itafos Conda (Conda, ID)...........          387  40/ID-WY.
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    The Naughton Generating Plant in Lincoln, Wyoming, is the closest
neighboring state source to P4 Production and Itafos Conda. The EPA has
therefore assessed potential SO2 impacts from these Idaho
sources to the Lincoln, Wyoming area. Table 4 of this document shows
SO2 emissions and approximate distances between the sources.
The EPA finds that the 131 to 134 km distance between the two Idaho
sources and the Wyoming source, more than twice the 50-km distance the
EPA has focused on for this analysis, makes it very unlikely that
SO2 emissions from

the Idaho sources will interact with SO2 emissions from the
Wyoming source in such a way as to contribute significantly
nonattainment in the Lincoln, Wyoming area.\10\
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    \9\ Point source emissions data throughout this document were
obtained through the EPA's Emissions Inventory System (EIS) Gateway
at https://www.epa.gov/air-emissions-inventories/emissions-inventory-system-eis-gateway.
    \10\ In round 3 of 2010 SO2 designations, the EPA
designated Lincoln County in Wyoming as attainment/unclassifiable
for the 2010 1-hour SO2 NAAQS based on modeling of the
Naughton source area. See ``Technical Support Document: Chapter 45
Final Round 3 Area Designations for the 2010 1-Hour SO2
Primary National Ambient Air Quality Standard for Wyoming'' at
https://www.epa.gov/sites/production/files/2017-12/documents/45-wy-so2-rd3-final.pdf. See also ``Technical Support Document: Chapter 45
Intended Round 3 Area Designations for the 2010 1-Hour
SO2 Primary National Ambient Air Quality Standard for
Wyoming'' at https://www.epa.gov/sites/production/files/2017-08/documents/45_wy_so2_rd3-final.pdf.

                            Table 4--Idaho SO2 Sources Within 50 km of a State Border
                                                [SO2 >= 100 tpy]
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                                                                                Neighboring
                                                  2017 SO2                                         state source
               Idaho SO2 source                   emissions     Distance to nearest neighboring      2017 SO2
                                                    (tpy)         state SO2 source (km)/source       emissions
                                                                                (tpy)
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Itafos Conda (Conda, Idaho)..................             387  134/Naughton Generating Plant,              4,048
                                                                Lincoln, WY.
P4 Production (Soda Springs, Idaho)..........             488  131/Naughton Generating Plant,              4,048
                                                                Lincoln, WY.
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    The EPA also reviewed the location of neighboring state sources
that emit 100 tpy of SO2 or more and are located within 50
km of the Idaho border. This is because SO2 emitted by
sources in Idaho are most likely to impact elevated levels of
SO2 in neighboring states near such sources. As shown in
Table 5 of this document, there are two sources in neighboring states
that are located within 50 km of an Idaho border, the previously
mentioned Naughton Generating Plant in Lincoln, Wyoming, located in
southeastern Idaho, and EP Minerals in Vale, Oregon, located in
southwestern Idaho. The shortest distance between any pair of these
sources is 131 km, between the Naughton Generating Plant and P4
Production. As just explained, this distance makes it unlikely that
SO2 emissions from the Idaho source will interact with
SO2 emissions from the Wyoming source. This indicates that
there is no location in any neighboring state that would warrant
further investigation with respect to Idaho SO2 emission
sources that might contribute to problems with attainment of the 2010
SO2 NAAQS.

                     Table 5--Neighboring State SO2 Sources Within 50 km of an Idaho Border
                                                [SO2 >= 100 tpy]
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                                                                                Idaho Source
                                          2017 SO2       Distance to   Distance to nearest Idaho     2017 SO2
     Neighboring state SO2 source         emissions     Idaho border        SO2 source (km)          Emissions
                                            (tpy)           (km)                                       (tpy)
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Naughton Generating Station, Lincoln,           4,048              46  131 (P4 Production, Soda              488
 WY.                                                                    Springs, ID).
EP Minerals, Vale, OR................             182              32  286/The Amalgamated Sugar             635
                                                                        Company, Twin Falls, ID.
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The Fort Hall Reservation
    On January 19, 2017, the EPA determined that the Shoshone-Bannock
Tribes of the Fort Hall Reservation were eligible to be treated in the
same manner as an affected downwind state for purposes of CAA sections
110(a)(2)(D) and 126.\11\ Idaho submitted the SO2 interstate
transport SIP before this determination and the submission did not
analyze SO2 transport to the Fort Hall Reservation.
Therefore, the EPA has conducted the following weight of evidence
analysis for potential Idaho SO2 transport to the Fort Hall
Reservation.
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    \11\ The EPA's determination that the Shoshone-Bannock Tribes
are eligible for treatment in the same manner as a state for CAA
sections 110(a)(2)(D) and 126 is available in the docket for this
action. See also https://www.epa.gov/tribal/tribes-approved-treatment-state-tas.
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    The Fort Hall Reservation is located in southeastern Idaho, mostly
on the high, flat, cultivated east banks of the Snake River Plain which
average around 4,500 feet above sea level. The east portion of the
Reservation rests on the northern reaches of the Pocatello range of
mountains. The Fort Hall Reservation is bordered on the east and south
by the rugged rocky hills of the Pocatello, Chesterfield, and Caribou
mountain ranges. These ranges run north-south with peaks rising from
6,000 to 9,000 feet above sea level, generally east and south of the
Reservation.
    The EPA reviewed ambient air quality data, particularly near the
Fort Hall Reservation borders, for any monitoring sites with elevated
SO2 concentrations that might warrant further investigation
with respect to interstate transport of SO2 from Idaho
sources. The nearest SO2 monitor to the Fort Hall
Reservation is in Pocatello, Idaho (AQS Site ID 160050004) and is
approximately 2 km from the nearest Reservation border. Another
SO2 monitor is located in Caribou County, Idaho (AQS Site ID
160290031) and is approximately 37 km from the southeastern border of
the Fort Hall Reservation. Although these monitors are not sited to
determine maximum impacts at the Fort Hall Reservation, monitoring data
listed in Table 6 of this document, indicate that SO2 levels
in those areas are relatively low. The 2017-2019 design values at the
Pocatello and Caribou County monitor

sites were 53 at 47 and percent of the 75-ppb level of the NAAQS,
respectively.

                               Table 6--Idaho SO2 Design Values 12 in ppb for AQS Monitors Near the Fort Hall Reservation
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                                                             Approximate                                    Design value
                                                             distance to   -----------------------------------------------------------------------------
           AQS monitor location  (AQS site ID)                Fort Hall
                                                             Reservation     2012-2014    2013-2015    2014-2016    2015-2017    2016-2018    2017-2019
                                                                 (km)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pocatello (160050004)....................................                2           51           41           39           38           38           40
Caribou County (160290031)...............................               37           30           26           26           30           31           35
--------------------------------------------------------------------------------------------------------------------------------------------------------

    These air quality data do not, by themselves, indicate any
particular location that would warrant further investigation with
respect to SO2 emission sources that might contribute
significantly to nonattainment at the Fort Hall Reservation. However,
data from this monitoring network is not necessarily representative of
SO2 levels throughout the Fort Hall Reservation and we have
therefore also conducted a source-oriented analysis.
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    \12\ Design values are from monitors with sufficient data
available in the EPA's Air Quality System (AQS) to produce valid
design values. Data retrieved from https://www.epa.gov/air-trends/air-quality-design-values#report.
---------------------------------------------------------------------------

    As discussed previously, the EPA finds that it is appropriate to
examine the impacts of emissions from stationary sources in Idaho in
distances ranging from 0 km to 50 km from the facility, based on the
``urban scale'' definition contained in appendix D to 40 CFR part 58,
section 4.4. Therefore, we assessed point sources with SO2
emissions of 100 tpy \13\ or more within 50 km of the Fort Hall
Reservation to evaluate trends and SO2 concentrations in
areawide air quality. We identified three such sources, listed in Table
7 of this document. We note that there are no sources within the Fort
Hall Reservation that emit more than 2 tpy of SO2.
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    \13\ We have limited our analysis to Idaho sources emitting at
least 100 tpy of SO2 because in the absence of special
factors, for example the presence of a nearby larger source or
unusual physical factors, Idaho sources emitting less than 100 tpy
can appropriately be presumed to not be causing or contributing to
SO2 concentrations above the NAAQS.

                    Table 7--SO2 Emissions Sources Within 50 km of the Fort Hall Reservation
                                                [SO2 >= 100 tpy]
----------------------------------------------------------------------------------------------------------------
                                                 2017 SO2     Distance to      Distance to        Distance to
                                                emissions      Fort Hall      Pocatello site     Caribou County
               SO2 Source 14 15                   (tpy)       Reservation      (AQS site ID     site  (AQS Site
                                                                 (km)           160050004)       ID 160290031)
----------------------------------------------------------------------------------------------------------------
J.R. Simplot Company--Don Siding Pocatello             748              <1                  1                 80
 (Pocatello, ID).............................
P4 Production (Soda Springs, ID).............          488              38                 80                  1
Itafos Conda (Conda, ID).....................          387              38                 82                  7
----------------------------------------------------------------------------------------------------------------

J.R. Simplot Company--Don Siding Pocatello
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    \14\ The Simplot Don Siding Plant, P4 Production, and Itafos
Conda are title V major stationary sources subject to the applicable
limits and controls in the Idaho SIP, including Idaho's SIP-approved
stationary source Permit to Construct program (IDAPA <IP_ADDRESS>
through 222). The Simplot Don Siding Plant is owned or operated by
J.R. Simplot Company, which is a party to a Federal Consent Decree
to resolve CAA violations at the company's sulfuric acid plants.
(Consent Decree, USA et al. v. J.R. Simplot Company, Case No. 1:15-
cv-00562-CWD (Dist. Idaho 2015). On August 19, 2019, the Idaho
Department of Environmental Quality issued a revised Permit to
Construct to incorporate the consent decree requirements into the
Simplot Don Siding Plant's permit. (P-2016-0055 Project 62103 issued
pursuant to IDAPA <IP_ADDRESS> through 222.)
    \15\ A schematic map of the sources and their proximity to the
Fort Hall Reservation is available in the docket for this action.
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    The J.R. Simplot Company--Don Siding Pocatello plant (Simplot Don
Siding Plant), in Pocatello, Idaho, is the closest SO2
source to the Fort Hall Reservation and has the highest SO2
emissions in the area with 748 tpy in 2017. The Simplot Don Siding
Plant is approximately 1 km from the boundary of the Fort Hall
Reservation and approximately 1 km from the Pocatello SO2
monitor (AQS Site ID 160050004). The EPA reviewed SO2
emissions data for the Simplot Don Siding Plant from 2010 through 2017.
As shown in Table 8 of this document, SO2 emissions have
decreased considerably over time and are less than half what they were
in 2010.

                                          Table 8--Simplot Don Siding Plant SO2 Emissions (tpy) From 2010-2017
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                         2010                               2011          2012          2013          2014          2015          2016          2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
1,634.................................................        1,647         1,563           803           795           732           735           748
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The EPA reviewed data from the meteorological station at the
Pocatello Regional Airport, which is approximately 6 km west of the
Simplot Don Siding Plant. Prevailing winds are from the southwest with
an average speed of 4.2 meters per second. Given the close distance of
the Pocatello SO2 monitor to the Simplot Don Siding Plant,
the low monitored SO2 concentrations, and the prevalent wind
direction, it is likely that SO2 emissions from the Simplot
Don Siding Plant will be sufficiently dispersed before reaching the
Fort Hall Reservation.

    In addition to reviewing the 2009-2011 regional scale
SO2 modeling in Idaho's submission, the EPA examined more
recent regional-scale SO2 modeling for the Pocatello area
using the same tool Idaho used with updated data from July 2014 to June
2017.\16\ The highest design concentration identified in the area is
about 6.8 ppb, well under the 1-hour SO2 NAAQS of 75 ppb. On
the Fort Hall Reservation, the highest design concentration identified
in the area is 6.3 ppb and occurs west of the Simplot Don Siding Plant.
This analysis indicates that SO2 emissions impacts from the
Simplot Don Siding Plant to the vicinity and the Fort Hall Reservation
are likely minimal. While this regional-scale modeling is not
dispositive as to the determination of whether impermissible
SO2 transport is occurring, it provides information that
along with other factors may be considered in a weight of evidence
evaluation.
---------------------------------------------------------------------------

    \16\ The EPA used a tool developed and operated by Washington
State University as part of the NW-AIRQUEST consortium. The tool
estimates design concentrations from a regionally optimized
photochemical air pollutant transport grid model that uses
meteorological data and computes air pollutant emissions, transport,
and chemistry using the EPA's CMAQ photochemical grid model. The
model simulates industrial source emissions from point sources,
including the Simplot Don Siding Plant, assuming a constant hourly
emission rate of air pollutants based on the annual tons-per-year
emissions provided in the 2014 National Emissions Inventory. The
technical support document in the docket for this action provides
additional information on the NW-AIRQUEST consortium's tool and the
EPA's analysis.
---------------------------------------------------------------------------

P4 Production and The Itafos Conda
    The EPA also assessed potential SO2 impacts from other
point sources near the Fort Hall Reservation, P4 Production and Itafos
Conda, which are approximately 7 km apart. These sources are located in
the Soda Springs region on the east side of the high Caribou Valley
plain, along the west flanks of the Caribou Range of mountains. The
rugged Blackfoot Lava Fields and high, rocky Chesterfield Range of
mountains lie between the Fort Hall Reservation and Soda Springs region
and rise to peaks exceeding 7,000 feet.
    As shown in Table 7 of this document, these sources are
approximately 38 km from the Fort Hall Reservation. The closest
SO2 monitor to these sources is the Caribou County monitor
(AQS Site ID 160290031), which is 1 km from P4 Production and 7 km from
Itafos Conda. The EPA reviewed SO2 emissions data for P4
Production and Itafos Conda from 2010 to 2017. As shown in Table 9 of
this document, SO2 emissions at P4 Production have decreased
by almost half since 2010. At Itafos Conda, SO2 emissions
have not changed substantially since 2010.

                                       Table 9--P4 Production and Itafos Conda SO2 Emissions (tpy) From 2010-2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
                    Facility                          2010         2011         2012         2013         2014         2015         2016         2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
P4 Production...................................          936         1169          643          615          456          467          478          488
Itafos Conda....................................          341          302          311          410          332          438          364          387
--------------------------------------------------------------------------------------------------------------------------------------------------------

    With a 38 km transport distance over complex, rugged terrain, and
the low monitored SO2 concentrations, it is likely that
SO2 emissions from P4 Production and Itafos Conda will be
sufficiently dispersed before impacting the Fort Hall Reservation, and
that any impacts to the Reservation from these sources would likely be
minimal.
    The EPA has reviewed SO2 sources with emissions of 100
tpy or more within 50 km of the Fort Hall Reservation. Based on the
available information, the EPA is proposing to find that Idaho will not
contribute significantly to nonattainment of the 2010 1-hour
SO2 NAAQS for purposes of CAA section 110(a)(2)(D)(i)(I) in
the Fort Hall Reservation.
    We are proposing to conclude that, based on our review of the Idaho
submission and our supplemental evaluation, Idaho's SIP meets the prong
1 requirements of CAA section 110(a)(2)(D)(i)(I) for purposes of the
2010 SO2 NAAQS. In summary, for interstate transport prong
1, we reviewed the Idaho submission and conducted a supplemental
analysis of ambient SO2 monitoring data and SO2
emission sources within Idaho, neighboring states, and the Fort Hall
Reservation. Based on this analysis, we propose to determine that Idaho
will not contribute significantly to nonattainment of the 2010
SO2 NAAQS in any other state or the Fort Hall Reservation,
per the requirements of CAA section 110(a)(2)(D)(i)(I).

2. The EPA's Prong 2 Evaluation

    The EPA has reviewed available information on SO2 air
quality and emission trends to evaluate Idaho's conclusion that
emissions from sources in the State will not interfere with maintenance
of the 2010 SO2 NAAQS in any downwind state. The EPA notes
that Idaho's analysis does not independently address whether the SIP
contains adequate provisions prohibiting emissions that will interfere
with maintenance of the 2010 SO2 NAAQS in any other state,
or the Fort Hall Reservation. In remanding the Clean Air Interstate
Rule (CAIR) to the EPA in North Carolina v. EPA, the D.C. Circuit
explained that the regulating authority must give the ``interfere with
maintenance'' clause of section 110(a)(2)(D)(i)(I) ``independent
significance'' by evaluating the impact of upwind state emissions on
downwind areas that, while currently in attainment, are at risk of
future nonattainment, considering historic variability.\17\ While Idaho
did not evaluate the potential impact of its emissions on areas that
are currently measuring clean data, but that may have issues
maintaining that air quality, the EPA reviewed additional information,
which builds on the analysis regarding significant contribution to
nonattainment (prong 1) to determine potential impacts on areas that
are measuring clean data. Specifically, because of the relatively low
monitored ambient concentrations of SO2 in Idaho and
neighboring states, the levels of SO2 emissions of Idaho
sources, and the large distances between cross-state SO2
sources, the EPA's weight of evidence evaluation shows that
SO2 levels in neighboring states near the Idaho border do
not indicate any inability to maintain the SO2 NAAQS that
could be attributed, even in part, to sources in Idaho.
---------------------------------------------------------------------------

    \17\ North Carolina v. EPA, 531 F.3d 896, 910-11 (D.C. Cir.
2008). The Court held that the EPA must give ``independent
significance'' to each prong of CAA section 110(a)(2)(D)(i)(I). Id.
---------------------------------------------------------------------------

    Based on our review of the EPA's emissions trends data, as shown in
Table 1 of this document, SO2 emissions from Idaho and
neighboring states have decreased substantially over time.\18\ From
2005 to 2017, total statewide SO2 emissions decreased by the
following

proportions: Idaho: 72% decrease, Montana: 56% decrease, Nevada: 89%
decrease, Oregon: 48% decrease, Utah: 71% decrease, Washington: 37%
Decrease, and Wyoming: 57% decrease. This trend of decreasing
SO2 emissions does not by itself demonstrate that areas in
Idaho and neighboring states will not have issues maintaining the 2010
SO2 NAAQS. However, as a piece of this weight of evidence
analysis for prong 2, it provides further indication (when considered
alongside low monitor values in neighboring states) that such
maintenance issues are unlikely. This is because the large decrease in
SO2 emissions covers a large geographic area, which strongly
suggests that it is not a transient effect from reversible causes and
that there is low likelihood that a strong upward trend in emissions
will occur that might cause areas that are presently in attainment to
violate the NAAQS.
---------------------------------------------------------------------------

    \18\ Additional emissions trends data are available at: https://www.epa.gov/air-emissions-inventories/air-pollutant-emissions-trends-data.
---------------------------------------------------------------------------

    The EPA notes that existing sources are subject to the control
requirements in the Idaho SIP discussed in our prong 1 evaluation, and
any future new and modified stationary sources of SO2
emissions will be subject to Idaho's SIP-approved pre-construction
permitting (``new source review'' or ``NSR'') program.\19\ The EPA
believes that the permitting regulations contained within these
programs will help ensure that ambient concentrations of SO2
in neighboring states will not be exceeded as a result of new facility
construction or modification occurring in Idaho.
---------------------------------------------------------------------------

    \19\ The EPA approved a consolidated pre-construction permitting
program, including both major and minor source NSR, into the Idaho
SIP on June 23, 1986 (51 FR 22810). Since that time, we have
approved revisions to the program as consistent with the CAA and
Federal NSR requirements codified at 40 CFR 51.160 through 40 CFR
51.166, most recently on August 20, 2018 (83 FR 42033).
---------------------------------------------------------------------------

    In conclusion, for interstate transport prong 2, the EPA has
incorporated additional information into our evaluation of Idaho's
submission, which did not include an independent analysis of prong 2.
In doing so, we have reviewed information about emission trends, as
well as the technical information considered for our interstate
transport prong 1 analysis. We find that the combination of low ambient
concentrations of SO2 in Idaho and neighboring states,
including near the Fort Hall Reservation, the large distances between
cross-state SO2 sources, the downward trend in
SO2 emissions from Idaho and surrounding states, and SIP-
approved control measures designed to limit SO2 emissions
from new and modified stationary sources in Idaho, indicates that Idaho
sources will not interfere with maintenance of the 2010 SO2
NAAQS in any other state or the Fort Hall Reservation. Accordingly, we
propose to determine that Idaho SO2 emission sources will
not interfere with maintenance of the 2010 SO2 NAAQS in any
other state or the Fort Hall Reservation, per the requirements of CAA
section 110(a)(2)(D)(i)(I).

IV. Proposed Action

    The EPA is proposing to approve the December 24, 2015 Idaho SIP as
meeting the interstate transport requirements of CAA section
110(a)(2)(D)(i)(I) for the 2010 SO2 NAAQS. The EPA is
proposing this approval based on our review of the information and
analysis provided by Idaho, as well as additional analyses conducted by
the EPA to verify and supplement the Idaho SIP, which indicates that
Idaho will not contribute significantly to nonattainment or interfere
with maintenance of the 2010 SO2 NAAQS in any other state or
the Fort Hall Reservation. This action is being taken under section 110
of the CAA.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     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 it does not involve technical standards; and
     Does not provide the 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).
    The proposed SIP would not be approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the proposed rule does not have tribal implications and
will not impose substantial direct costs on tribal governments or
preempt tribal law as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000). Consistent with EPA policy, the EPA provided a
consultation opportunity to the Shoshone-Bannock Tribes concerning the
EPA's action on this SIP submission in a letter dated March 7, 2018.
The EPA did not receive a request for consultation.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Particulate
Matter, Reporting and recordkeeping requirements, Sulfur dioxide,
Volatile organic compounds.

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

    Dated: September 25, 2020.
Christopher Hladick,
Regional Administrator, Region 10.
[FR Doc. 2020-21741 Filed 10-2-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 213 (Wednesday, November 4, 2015)]
[Notices]
[Pages 68377-68379]
[FR Doc No: 2015-28022]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76298; File No. SR-NASDAQ-2015-126]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Nasdaq Rule 7018

October 29, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 22, 2015, The NASDAQ Stock Market LLC (``Nasdaq'' or the
``Exchange'') filed with the Securities and Exchange

Commission (``Commission'') a proposed rule change as described in
Items I, II and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    Nasdaq is proposing changes to amend Nasdaq Rule 7018(a), governing
fees and credits assessed for execution and routing of securities.
    The text of the proposed rule change is available at
nasdaq.cchwallstreet.com at Nasdaq principal office, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of those statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Nasdaq Rule 7018, governing fees and
credits assessed for execution and routing of securities on Nasdaq,\3\
listed on the New York Stock Exchange (``NYSE'') \4\ and listed on
exchanges other than Nasdaq and NYSE \5\ (collectively, the ``Tapes'').
---------------------------------------------------------------------------

    \3\ Nasdaq Rule 7018(a)(1).
    \4\ Nasdaq Rule 7018(a)(2).
    \5\ Nasdaq Rule 7018(a)(3).
---------------------------------------------------------------------------

    Specifically, the Exchange proposes to amend the criteria for a
member to be eligible for the $0.0030 per share executed credit. Nasdaq
proposes to amend romanette (i) across all Tapes in order to reduce the
Consolidated Volume requirement during the month for a member from
0.60% to 0.20%. The Exchange also proposes to amend romanette (ii)
across all Tapes in order to include NOM Market Maker volume as part of
the qualifying volume and to reduce the volume threshold in Penny Pilot
and Non-Penny Pilot Options from 1.25% to 0.90%.
    Nasdaq also proposes to add new subsection (4) to Nasdaq Rule
7018(a) and entitle it ``Fees and Credits for Execution of Orders in
Select Symbols''.\6\ This new subsection will state that for members
receiving less than a $0.0029 per share executed credit in paragraphs
(1) through (3) of Nasdaq Rule 7018(a) for displayed quotes/orders
(other than Supplemental Orders or Designated Retail Orders) that
provide liquidity for certain enumerated securities, Nasdaq will
provide a credit of $0.0029 per share executed for the enumerated
securities: EEM, EWJ, GDX, IWM, NUGT, SPY, UWTI, VXX, XIV and XLF.
---------------------------------------------------------------------------

    \6\ This is not related to the previous Select Symbols program.
See Securities Exchange Act Release No. 73967 (December 30, 2014),
80 FR 594 (January 6, 2015) (SR-NASDAQ-2014-128) (creating the
unrelated Select Symbol program); see also Securities Exchange Act
Release No. 75261 (June 22, 2015), 80 FR 36877 (June 26, 2015) (SR-
NASDAQ-2015-062) (eliminating the unrelated Select Symbol program).
---------------------------------------------------------------------------

2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\7\ in general, and with
Sections 6(b)(4) and 6(b)(5) of the Act,\8\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility or system which Nasdaq operates or controls and is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest; and are not designed to
permit unfair discrimination between customers, issuers, brokers, or
dealers.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    Nasdaq believes that the proposed changes to Nasdaq Rule
7018(a)(1), (2) and (3) are reasonable because broadening the above
criteria so that this credit is applicable to more members falls within
the Exchange's efforts to draw additional order flow to the Exchange to
improve market quality for all market participants. The Exchange also
believes that the proposed rule change is equitable and not unfairly
discriminatory because the amended credit criteria applies uniformly to
securities across all Tapes and makes it easier for members to satisfy
the requirements for this credit tier.
    Nasdaq believes that the proposed credits of no less than $0.0029
per share executed for displayed orders to members for trading in the
Select Symbols are reasonable and equitably allocated as all members
are eligible for the credits and the Exchange believes it will improve
market quality, specifically in the trading of these symbols. These
credits for adding displayed liquidity only replace the credits
provided in paragraphs (1) through (3) of Nasdaq Rule 7018(a) when a
member would otherwise receive a credit of less than $0.0029 per share
executed. The Select Symbols include EEM, EWJ, GDX, IWM, NUGT, SPY,
UWTI, VXX, XIV and XLF. If members qualify for credits under Nasdaq
Rule 7014, such credits will continue to apply to these symbols.
    Nasdaq also believes that the proposed changes are not unfairly
discriminatory because they will apply uniformly to all member firms
that trade in the Select Symbols. Moreover, the proposed minimum credit
for all member firms that trade in the Select Symbols is not unfairly
discriminatory because the Exchange seeks to provide incentives to
member firms to direct order flow away from off-exchange venues and on
to Nasdaq and to improve the markets for these symbols. Additionally,
members that trade in the Select Symbols may still qualify for higher
credits in trading in these symbols and all members are entitled to
determine whether or not to trade in these Select Symbols. Also,
members will still be able to receive the credits they are otherwise
entitled to in other symbols and can only benefit from this additional
credit.

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

    Nasdaq does not believe that the proposed rule change will result
in a burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.\9\ Nasdaq notes
that it operates in a highly competitive market in which market
participants can readily favor competing venues if they deem fee and
credit levels at a particular venue to be excessive, or rebate
opportunities available at other venues to be more favorable. In such
an environment, Nasdaq must continually adjust its fees and credits to
remain competitive with

other exchanges and with alternative trading systems that have been
exempted from compliance with the statutory standards applicable to
exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, Nasdaq believes that the degree to which
changes to credits in this market may impose a burden on competition is
extremely limited or even non-existent. In this instance, the changes
to Nasdaq Rule 7018 to amend criteria to qualify for credits do not
impose a burden on competition because Nasdaq's execution services are
voluntary and subject to extensive competition both from other
exchanges and from off-exchange venues.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    Additionally, the Exchange does not believe the addition of credits
available to members that execute shares in Select Symbols will impose
a burden on competition, but rather may promote competition among
exchanges in trading in the Select Symbols. Moreover, the proposed
changes are reflective of the competition that exists between exchanges
and off-exchange venues that are subject to lesser regulatory burdens
than the exchanges, including transparency. Lastly, the proposed
changes are designed to enhance market quality.
    While the Exchange does not believe that the proposed changes will
result in burden on competition, if the changes proposed herein are
unattractive to market participants it is likely that Nasdaq will lose
market share as a result.

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

    Written comments were neither solicited nor received.

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

    The foregoing change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\10\ At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2015-126 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2015-126. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices of the Exchange.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-NASDAQ-2015-
126, and should be submitted on or before November 25, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-28022 Filed 11-3-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)]
[Notices]
[Pages 15407-15408]
[FR Doc No: 2017-06084]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32540; File No. 812-14677]

AB Bond Fund, Inc., et al.

March 22, 2017.
AGENCY:  Securities and Exchange Commission (``Commission'').

ACTION:  Notice.

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

    Notice of an application for an order pursuant to: (a) Section 6(c)
of the Investment Company Act of 1940 (``Act'') granting an exemption
from sections 18(f) and 21(b) of the Act; (b) section 12(d)(1)(J) of
the Act granting an exemption from section 12(d)(1) of the Act; (c)
sections 6(c) and 17(b) of the Act granting an exemption from sections
17(a)(1), 17(a)(2) and 17(a)(3) of the Act; and (d) section 17(d) of
the Act and rule 17d-1 under the Act to permit certain joint
arrangements and transactions. Applicants request an order that would
permit certain registered open-end management investment companies to
participate in a joint lending and borrowing facility.

Applicants: AB Bond Fund, Inc., AB Cap Fund, Inc., AB Core
Opportunities Fund, Inc., AB Corporate Shares, AB Discovery Growth
Fund, Inc., AB Equity Income Fund, Inc., AB Government Exchange
Reserves, AB Fixed-Income Shares, Inc., AB Global Bond Fund, Inc., AB
Global Real Estate Investment Fund, Inc., AB Global Risk Allocation
Fund, Inc., AB Sustainable Global Thematic, Inc., AB Relative Value
Fund, Inc., AB High Income Fund, Inc., AB Institutional Funds, Inc., AB
International Growth Fund, Inc., AB Large Cap Growth Fund, Inc., AB
Municipal Income Fund, Inc., AB Municipal Income Fund II, AB Trust, AB
Unconstrained Bond Fund, Inc., AB Variable Products Series Fund, Inc.,
Sanford C. Bernstein Fund, Inc., Sanford C. Bernstein Fund II, Inc.,
Bernstein Fund, Inc., The AB Pooling Portfolios, The AB Portfolios,
Alliance California Municipal Income Fund, Inc., Alliance Bernstein
Global High Income Fund, Inc., AllianceBernstein National Municipal
Income Fund, Inc. and AB Multi-Manager Alternative Fund, each an
investment company organized as a Maryland corporation or a
Massachusetts business trust and registered under the Act as an open-
end or closed-end management investment company,\1\ and
AllianceBernstein L.P. (the ``Adviser''), a Delaware limited
partnership registered as an investment adviser under the Investment
Advisers Act of 1940.
---------------------------------------------------------------------------

    \1\ The Funds (as defined below) that are closed-end management
investment companies will not participate as borrowers in the
interfund lending facility.

Filing Dates: The application was filed on July 22, 2016 and amended on
---------------------------------------------------------------------------
January 11, 2017.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on April 17, 2017 and should be accompanied by proof of
service on the applicants, in the form of an affidavit, or, for
lawyers, a certificate of service. Pursuant to Rule 0-5 under the Act,
hearing requests should state the nature of the writer's interest, any
facts bearing upon the desirability of a hearing on the matter, the
reason for the request, and the issues contested. Persons who wish to
be notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES:  Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC, 20549-1090; Applicants: Emile D. Wrapp,
AllianceBernstein L.P., 1345 Avenue of the Americas, New York, New York
10105 and Paul M. Miller, Seward & Kissel LLP, 901 K Street NW., Suite
800, Washington, DC 20001.

FOR FURTHER INFORMATION CONTACT:  Emerson S. Davis, Senior Counsel, at
(202) 551-6868 or Nadya Roytblat, Assistant Chief Counsel, at (202)
551-6823 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION:  The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Summary of the Application

    1. Applicants request an order that would permit the applicants to
participate in an interfund lending facility where each Fund could lend
money directly to and borrow money directly from other Funds to cover
unanticipated cash shortfalls, such as unanticipated redemptions or
trade fails.\2\ The Funds will not borrow under the facility for
leverage purposes and the loans' duration will be no more than 7
days.\3\
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    \2\ Applicants request that the order apply to the applicants
and to any existing or future registered open-end or closed-end
management investment company or series thereof for which the
Adviser or any successor thereto or an investment adviser
controlling, controlled by, or under common control with the Adviser
or any successor thereto serves as investment adviser (each a
``Fund'' and collectively the ``Funds'' and each such investment
adviser an ``Adviser''). For purposes of the requested order,
``successor'' is limited to any entity that results from a
reorganization into another jurisdiction or a change in the type of
a business organization.
    \3\ Any Fund, however, will be able to call a loan on one
business day's notice.
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    2. Applicants anticipate that the proposed facility would provide a
borrowing Fund with a source of liquidity at a rate lower than the bank
borrowing rate at times when the cash position of the Fund is
insufficient to meet temporary cash requirements. In addition, Funds
making short-term cash loans directly to other Funds would earn
interest at a rate higher than they otherwise could obtain from
investing their cash in repurchase agreements or certain other short
term money market instruments. Thus, applicants assert that the
facility would benefit both borrowing and lending Funds.
    3. Applicants agree that any order granting the requested relief
will be subject to the terms and conditions stated in the application.
Among others, the Adviser, through a designated committee, would
administer the facility as a disinterested fiduciary as part of its
duties under the investment management and administrative agreements
with the Funds and would receive no additional fee as compensation for
its services in connection with the administration of the facility. The
facility would be subject to oversight and certain approvals by the
Funds' Board, including, among others, approval of the interest rate
formula and of the method for allocating loans across Funds, as well as
review of the process in place to evaluate the liquidity implications
for the Funds. A Fund's aggregate outstanding interfund loans will not
exceed 15% of its net assets, and the Fund's loans to any one Fund will
not exceed 5% of the lending Fund's net assets.\4\
---------------------------------------------------------------------------

    \4\ Under certain circumstances, a borrowing Fund will be
required to pledge collateral to secure the loan.
---------------------------------------------------------------------------

    4. Applicants assert that the facility does not raise the concerns
underlying

section 12(d)(1) of the Act given that the Funds are part of the same
group of investment companies and there will be no duplicative costs or
fees to the Funds.\5\ Applicants also assert that the proposed
transactions do not raise the concerns underlying sections 17(a)(1),
17(a)(3), 17(d) and 21(b) of the Act as the Funds would not engage in
lending transactions that unfairly benefit insiders or are detrimental
to the Funds. Applicants state that the facility will offer both
reduced borrowing costs and enhanced returns on loaned funds to all
participating Funds and each Fund would have an equal opportunity to
borrow and lend on equal terms based on an interest rate formula that
is objective and verifiable. With respect to the relief from section
17(a)(2) of the Act, applicants note that any collateral pledged to
secure an interfund loan would be subject to the same conditions
imposed by any other lender to a Fund that imposes conditions on the
quality of or access to collateral for a borrowing (if the lender is
another Fund) or the same or better conditions (in any other
circumstance).\6\
---------------------------------------------------------------------------

    \5\ Applicants state that the obligation to repay an interfund
loan could be deemed to constitute a security for the purposes of
sections 17(a)(1) and 12(d)(1) of the Act.
    \6\ Applicants state that any pledge of securities to secure an
interfund loan could constitute a purchase of securities for
purposes of section 17(a)(2) of the Act.
---------------------------------------------------------------------------

    5. Applicants also believe that the limited relief from section
18(f)(1) of the Act that is necessary to implement the facility
(because the lending Funds are not banks) is appropriate in light of
the conditions and safeguards described in the application and because
the open-end Funds would remain subject to the requirement of section
18(f)(1) that all borrowings of the open-end Fund, including combined
interfund loans and bank borrowings, have at least 300% asset coverage.
    6. Section 6(c) of the Act permits the Commission to exempt any
persons or transactions from any provision of the Act if such exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act. Section 12(d)(1)(J) of the Act
provides that the Commission may exempt any person, security, or
transaction, or any class or classes of persons, securities, or
transactions, from any provision of section 12(d)(1) if the exemption
is consistent with the public interest and the protection of investors.
Section 17(b) of the Act authorizes the Commission to grant an order
permitting a transaction otherwise prohibited by section 17(a) if it
finds that (a) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (b) the proposed transaction is consistent with the policies
of each registered investment company involved; and (c) the proposed
transaction is consistent with the general purposes of the Act. Rule
17d-1(b) under the Act provides that in passing upon an application
filed under the rule, the Commission will consider whether the
participation of the registered investment company in a joint
enterprise, joint arrangement or profit sharing plan on the basis
proposed is consistent with the provisions, policies and purposes of
the Act and the extent to which such participation is on a basis
different from or less advantageous than that of the other
participants.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-06084 Filed 3-27-17; 8:45 am]
 BILLING CODE 8011-01-P


 Suitability of the Protocol:  The protocol has been revised to include additional methodology for preparing the test microbe, chemical and physical abrasion, details on materials and supplies, and quality control practices. Refer to Appendix A for an overview of the protocol changes. Please comment on the following issues:
 Do the revisions summarized in Appendix A provide a substantial improvement and technically sound approach for testing the antimicrobial properties and product durability of solid copper/copper alloy materials?  If not, please provide advice on any additional elements that should be addressed or modified.

 The approach appears to be sound.  However, unlike other disinfectant and sanitizers resistance does occur to some extent and a number of copper resistance genes have been identified (eg., copB, copC, copY, cueO, tcrA, tcrB, tcrZ, etc).  Should a cooper resistant/tolerant strain be included in the efficacy testing?

 What do we know about neutralizing capacity of the recovery medium Cu[2][+] so that any potential carry-over of copper into the culture media would not interfere with recovery of the test organisms.  Microbiologic methods from the enclosed studies are relatively lacking sufficient detail to ensure.  The references by Schmidt cite an early study (again lacks detail but looks like lecithin was used as a neutralizer).  Should recovery media include a known metal chelating agent (EDA, DETA, EDTA, thioglycollate or other known chelating agent).  Currently published studies do not appear to use a chelating agent.

 Should we incorporate thioglycollate (see:  Landeen LK, Yahya MT, Gerba CP.  Efficacy of copper and silver ions and reduced levels of free chlorine in inactivation of Legionella pneumophila.  Appl Environ Microbiol 1989;55(12):3045-3050 (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC203221/)

 Is the protocol of sufficient detail so that it may be conducted by a qualified testing laboratory and is likely to result in reproducible results when conducted in different testing facilities and/or at different times within the same laboratory?  If the protocol is not of sufficient detail, which areas require improvement?

            So if MB-25 is used with TSB as the growth medium do we know whether some small amount of copper that may end up in solution is not inhibitory to the test organisms leading to false results.  Should thioglycollate be included be incorporated?  Need to include a more detailed section regarding neutralization and give some examples of materials to be used in the neutralization of Cu[2][+].

 Is the protocol suitable for evaluating the antimicrobial efficacy of solid copper/copper alloy materials, as well as copper-impregnated or coated surface materials?

            Yes, once neutralization or chelation of residual Cu[2+] is addressed in sufficient detail to allow a standardized approach for different laboratories to use.

 If the protocol is not suitable for one or both, please provide advice on how to modify the protocol to cover both materials.
 Copper tolerance and resistance does occur in nature among strains representing several genera of both gram-negative and positive bacteria (see 3b). Including some strains of MRSA (see below Emergence of copper resistant MRSA in Irish hospitals).  This is especially true among strains among food animals (cows and pigs).  Its theoretically possible that some of these strains could colonize humans.
 Kinnevey PM, Shore AC, Brennan Gi, Sullivan DJ, Ehricht R, Monecke S, Slickers F, Coleman DC.  Emergence of sequence type 779 methicillin resistant Staphylococcus aureus harboring a novel pseudo staphylococcal cassette chromosome mec (SCCmec)-SSC-SCCCRISPR composite element in Irish hospitals.  Antimicrobial Agents Chemother 2013;57(1):524-531 (Available from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3535981)

 There is an interest in using the protocol to evaluate other types of hard non-porous surfaces impregnated with antimicrobial agents other than copper (other solid metals, metal alloys, fabricated materials etc.).  Is the protocol suitable for testing the antimicrobial activity of other types of hard, non-porous surfaces treated or impregnated with antimicrobial agents?

 The general protocol could serve as template for other surfaces.  The carriers for controls however, may not necessarily be stainless steel.  They may reflect the base (non-impregnated material).

 As for nonporous surfaces, until and agreed upon standardized method is available to test the efficacy of disinfectants against nonporous surfaces this is probably not ready to move forward as of yet.

            If not, please explain why and offer advice on how to change the protocol so that it would produce reliable, reproducible results when testing these other surface types.

 Is it possible to use a modified version of the AATCC TM 100 Antibacterial textile testing for some of the porous materials (American Association of Textile Chemists and Colorists).  This may require broader discussion.
 Even for EPA registered disinfectants there are no products registered for porous materials.  There are registered carpet and upholstery cleaners and

 Controls:  Stainless steel was selected as the control carrier material due to the inert nature of the material.  The final log reduction values are calculated by taking the log 10 difference between the stainless steel control carriers and the product test carriers.
 In the protocol, the stainless steel control carriers are not subjected to the mechanical surface abrasion or the chemical treatments (A, B, and C). Please comment on the suitability of this approach.  If this approach is not appropriate, please provide advice on how to address the management of the control carriers.
 The untreated stainless steel coupons provide a baseline control of organisms deposited onto an untreated surface.
 One should remember that different surface materials have different characteristics that can influence drying, persistence, and survival.  Some surface characteristics also impact bacterial recovery (eg., ability to remove some organisms from the surfaces) when other parameters are equivalent (temp, RH, matrices, etc).  This is true of most persistence studies (see studies on Ebola, Yersinia pestis, and others.
Cook BW, Cutts TA, Nikiforuk AM, Poliquin PG, Court DA, Strong JE, Theriault SS.  Evaluating environmental persistence and disinfection of the Ebola virus Makona variant. Viruses 201514;7(4):1975-86. (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4411685/)
Rose LJ, Donlan R, Banerjee SN, Arduino MJ.  Survival of Yersinia pestis on environmental surfaces.  Appl Environ Microbiol  2003;69(4):2166-2171 (http://www.ncbi.nlm.nih.gov/pmc/article/PMC154802)
Sagripanti JL, Rom AM, Holland LE.  Persistence in darkness of virulent alphaviruses, Ebola virus, and Lassa virus deposited on solid surfaces.   Arch Virol. 2010;155(12):2035-9 (http://link.springer.com/article/10.1007%2Fs00705-010-0791-0).

 Please comment on whether the comparative analyses of log reduction values (i.e., the difference in the level of microbes on exposed carriers vs. unexposed carriers and stainless steel control carriers) is a technically sound approach to the assessment of the antimicrobial activity of the copper and copper alloy products.

            One might also consider comparing surface abraded and chemically treated control stainless steel carriers to see how these compare to the exposed carriers.  While the Stainless steel control carriers base ideal (smooth surface, clean surface), a set of abraded, chemically treated carriers might represent an additional test comparable challenge to the exposed carriers.  This assumes that exposed carriers (physical and chemically treated) may provide areas where microbes would be harder to remove, or offer areas of protection when combined with soil.

 Contact Time:  EPA's current guidance requires that a hospital disinfectant kill between five to six logs (100,000 to 1,000,000) of the target microbe in a qualitative test system within the time frame specified on the product labeling.  The use of copper and copper alloy products in medical care facilities is a supplement to (not a replacement for) standard infection control practices and use of EPA registered hospital disinfectants.
 In a standard chemical disinfectant test, the microbe is applied to the carrier surface, allowed to dry, and then exposed to the disinfectant.  The contact time for the chemical disinfectant begins upon application of the disinfectant.  For copper and copper alloy materials, the surface serves as the antimicrobial agent.  The protocol specifies that the contact time begin upon application of the microbe to the surface, not after the microbe has dried on the surface.  Please comment on whether it is appropriate for the contact time to begin upon inoculation of the surface, and if not, please offer alternative approaches for this step in the protocol.
 The theory behind the copper impregnated surfaces is the the activity begins on contact with the surface.  So the activity begins at inoculation.  The current protocol accounts for this the initiation of contact time (CT) begins upon inoculation of the carrier and then the carrier is allowed to sit for 1 hr (EPA.  Protocol for the evaluation of bactericidal activity of Hard, non-porous copper/copper-alloy surfaces, rev 02/03/15) and is adequate.

 Similar studies are performed when evaluating the disinfection of pathogens in water, where the measurement of CT starts at the onset of inoculation.
 Please comment on whether a single inoculation per carrier (4-5 logs bacteria per carrier) for both Staphylococcus aureus and Pseudomonas aeruginosa provides adequate challenge to evaluate the level of antimicrobial activity.  A soil load (three-part) is also added to the inoculum before carrier inoculation.  If a single inoculation is not appropriate, explain why and provide suggestions on how to improve the inoculation procedure.

 A single inoculum per carrier should be sufficient as long as data from replicates are consistent.  By using 4-5 logs of test organisms one should be able to note a 3 log reduction.  If wanting to measure more than 3 logs one might use a single inoculum containing > 10[5]-10[6] CFU.

 There are organisms that exhibit heavy metal resistance/tolerance and in some of these are copper resistant or tolerant (eg. Strains of Cronobacter sakazakii, Cupriavidus, Enterococcus faecalis, Escherichia coli, Ralstonia, Salmonella etc.)  I've highlighted a few references:

Brown NL, Rouch DA, Lee BT. Copper resistance determinants in bacteria.  Plasmids 1992;27(1):41-51.

Cervantes C, Gutierrez-Corona F. Copper resistance mechanisms in bacteria and fungi.  FEMS Microbiol Rev 1994;14(2):121-137
Dupont CL, Grass G, Rensing C.  Copper toxicity and the origin of bacterial resistance -- new insights and applications.  Metallomics 2011;3(11):1109-18.
Silveira E, Freitas AR, Antunes P, Barros M, Campos J, Coque TM, Peixe L, Novais C.  Co-transfer of resistance to high concentrations of copper and first-line antibiotics among Enterococcus from different origins (humans, animals, the environment and foods) and clonal lineages. J Antimicrob Chemother 2014;69(4):899-906. (available from http://jac.oxfordjournals.org/content/69/4/899.long)

 Based on the Agency's experience in utilizing hard non-porous carriers in standard efficacy test methods, microbial populations on environmental surfaces decline naturally over time mainly due to desiccation.  This natural decline presents challenges in determining whether the decline in a microbial population is due to desiccation or antimicrobial activity. An antimicrobial surface such as copper should be capable of accelerating the decrease in the number of surface-associated bacteria.  The Agency expects that an antimicrobial effect due to the product should be measureable within a one hour timeframe. The original protocol specified a 99.9% reduction of viable bacteria within two hours of inoculation while the new protocol specifies a one hour timeframe.   Please comment on the suitability of reducing the timeframe from two hours to one hour, or if the specified timeframe is not reasonable, provide advice on a suitable timeframe.

 Including the use of the untreated controls may assist (stainless steel) in determining the loss upon drying and there actually may be no way to actually account for this loss.

 However, one must realize that survival on surfaces is a complex and involves suspending media (matrices), surface characteristics, organism factors, temperature and relative humidity.   Depending on the test organisms being used loss with in an hour may be minimal (in many of our ongoing studies of healthcare associated pathogens) > 3 log reduction has been seen after 24 hrs with the exception of Acinetobacter baumannii and the gram positive organisms (eg enterococci, staphylococci, and bacterial endospores).  We do know that Y. pestis has a more rapid decline.
            See:
Esteves DC, et al.  Influence of biological fluids in bacterial viability on different hospital surfaces and fomites.  Am J Infect Control 2015 Nov 12 (ahead of print)

Kramer A, Schwebke I, Kampf G.  How long do nosocomial pathogens persist on inanimate surfaces?  A systematice review.  BMC Infect Dis 2006;6:130 (available from http://www.ncbi.nlm.nih.gov/pmc/article/PMC1564025)

Rose LJ, Donlan R, Banerjee SN, Arduino MJ.  Survival of Yersinia pestis on environmental surfaces.  Appl Environ Microbiol  2003;69(4):2166-2171 (http://www.ncbi.nlm.nih.gov/pmc/article/PMC154802)

Shams AM, Rose LJ, Hodges L, Arduino MJ.  Survival of Burkholderia pseudomallei on environmental surfaces.  Appl Environ Microbiol 2007;73(24): 8001-4
(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2168135)

Zarpellon MN, et al. Survival of vancomycin-intermediate Staphylococcus aureus on hospital surfaces.  J Hosp Infect 2015;90(4):347-5.

 Please comment on whether copper and copper alloy products that kill 99.9% of target microbes within 1 hour would provide a significant benefit in reducing levels of target microbes in medical care facilities.  If you think that killing 99.9% of target microbes within 1 hour would not provide a significant benefit in reducing levels of target microbes in medical care facilities, please offer advice on the level of antimicrobial activity that would provide such benefits.  Please explain the basis for your conclusions

 Health outcomes data regarding the use of antimicrobial impregnated surfaces that products is still lacking.  Though there are published studies that claim that the use of these copper impregnated surfaces yield reductions in healthcare-associated infections have been published.  However, a recent review (Muller et al, 2016) finds the data quality of these studies to be quite low.

 More evidence is needed to show a link with log reduction on surfaces and prevention of HAIs.  So unknown whether a log reduction would have an effect, though it may predict the ability to recover certain HAI pathogens, eg., multiply drug resistant ornganisms from the patient care environment.

 From some of our studies of these "noncritical" surfaces" in patient rooms after routine and terminal cleaning is that contamination is quite broad (2014 IDSA Poster attached).

Shams A, Rose LJ, Edwards JR McDonald LC, Arduino MJ, Noble-Wang J.  Assessment of the overall and multi-drug resistant organism bioburden on environmental surfaces in healthcare facilities.  Open Forum Infect Dis 2014; 1(Suppl 1):S358,  (http://ofid.oxfordjournals.org.content/1/suppl_1)
McDonald LC, Arduino MJ.  Editorial commentary: climbing the evidentiary hierarchy for environmental infection control.  Clin Infect Dis 2013;56(1):36-9 (http://cid.oxfordjournals.org/content/56/1/36.long)
Muller MP, MacDougall C, Lim C, Ontario Agency for Health Protection, PIDAC-IPC. Antimicrobial surfaces to prevent healthcare-associated infections:  a systematic review.  J Hosp Infect 2016;92:7-13.
Environmental Hygiene in Healthcare Research (September 2015) http://www.cdc.gov/hai/research/eic-meeting.html

 Abrasion/Chemical Treatment: The proposed protocol includes a requirement that the carriers made from the copper or copper alloy undergo both an abrasion step and a chemical treatment step in order to simulate actual conditions of use and to evaluate how abrasion and/or chemical treatment might affect the level of antimicrobial activity.  Note that some disinfectant and sanitizer products, as well as some cleaning agents, contain chelating agents (e.g., EDTA) intended to bind free metal ions.
 Please comment on whether abrasion and/or chemical treatment is likely to affect the level of antimicrobial activity displayed by a product.  If not, please explain why.  If so, please comment on how well the proposed abrasion step and chemical treatment step reflect the likely range of actual use conditions.  To the extent that the simulated conditions do not reflect the likely range of actual use conditions, please comment on whether the additional requested information (quantitative and qualitative) about the durability of the product is sufficient to assess the potential for physical disruption of the product surface after long term use.
 The abrasion and chemical treatment steps would represent aging and potential changes to the surfaces with use over time.  Since these surfaces will be routinely cleaned on a daily basis followed by a more thorough cleaning after patient discharge at least cleaned daily and the a more thorough cleaning (terminal cleaning) after patient discharge.

 In this same vane it might be useful to know if there are changes in the amount of loss of active agent over time or improvement by releasing more copper ions.

 Does wiping surfaces (eg., commercially available disinfectant wipes; microfiber cleaning cloths with a hospital grade disinfectant, etc) and scratching the surface increase the likelihood of copper coming off in the leachate.  What is the average life span of these surfaces (especially of this is a coating). So abrasion and chemical treating would simulate the potential use of the product.  It may he helpful to look at the market and to pick the most common disinfectant  cleaners, disinfectants in use at healthcare facilities. (I would suspect that Sodium hypochlorite solutions, quats, and peroxide containing products would be the most widely used)

 If you think that abrasion and/or chemical treatment may affect antimicrobial efficacy, but that the proposed protocol does not adequately evaluate the potential for such effects, please offer advice on how to change the protocol (e.g., what process and/or chemical solutions should be used to treat a carrier) so that the protocol will adequately evaluate the level of antimicrobial activity of a product.  Please comment specifically on whether the use of products containing chelating agents is likely to affect the level of antimicrobial activity of solid metal and metal alloy products. Also, please comment specifically on whether the cleaning step (thoroughly rinse with DI water) between exposure cycles is sufficient to remove residual chemical solutions (solutions A, B and C).

 Have you considered measuring copper concentration in solutions (leachate) used to remove cells from the carriers.  Abrasion and scratching of the surfaces might release copper from the impregnated surfaces.

 I also believe that the protocol should employ a chelator (eg., thioglycollate, EDTA, etc) to remove any potential carry over of copper ions into the culture media thus preventing growth and yielding lower colony counts (so potentially greater log reduction).

 I think before going to far that a comparison of the method with and with out chelation would be necessary.  If the results of that comparison study are equivalent, then the use of chelators may not be necessary.

 Residual/Continuous Activity:  Residual/continuous activity over time is claimed to be one attribute inherent to copper and copper alloy products.
 Some technology developers would like to claim that solid copper and copper alloy products provide "residual/continuous activity."  Please comment on whether the proposed protocol is capable of determining if copper and copper alloy products provide such activity, and if not, what changes to the proposed protocol (e.g., instituting repeated inoculations of the carrier) would provide data to evaluate such activity

 Current protocol addresses the log reduction in within an hour however, these products claim to have continuous activity.  It would seem appropriate to re-challenge the coupons (re-inoculate) at some time period after their culture and determine whether the log reductions are similar log reductions over time.

 For antimicrobial containing dressings FDA recommend that manufacturers follow ASTM E2315-03 Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure or an equivalent method. Test results should demonstrate at least a 4 log reduction.  So this type of testing is performed on items such as antimicrobial impregnated respirators (eg., copper-silver, copper, iodine).  Efficacy for testing must show 4 log reduction within 1 hr (impregnated drapes, bandages, respirators, surgical masks, etc).

 The other testing that FDA accepts is performance testing (bench and animal) so for silver impregnated catheters they look at controls (not coated or impregnated) vs impregnated and evaluate colonization over time (difference here is that they are fluid based assessments, eg central venous or urinary catheters).
 So continuous activity might require a sequential re-inoculation of carriers to see whether the same log reduction occurs.