[Federal Register: November 22, 2006 (Volume 71, Number 225)]
[Notices]
[Page 67687-67689]
[DOCID:fr22no06-143]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54760; File No. SR-Phlx-2006-76]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Adopt Rule 185A, Intermarket Sweep Orders--Temporary

November 15, 2006.
    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 November 13, 2006, the Philadelphia Stock Exchange, Inc. (``Phlx''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II, below, which Items have been prepared by the Phlx. The Exchange
filed the proposal as a ``non-controversial'' rule change pursuant to
Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\
which rendered the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Phlx proposes to adopt Phlx Rule 185A, Intermarket Sweep
Orders--Temporary, which describes: (1) The obligations of the Exchange
sending orders to other market centers, and (2) the obligations of XLE
Participants sending Intermarket Sweep Orders (``ISOs'') \5\ or IOC
Cross Orders that are marked as meeting the requirement to route to
other market centers \6\ (both types of orders hereinafter are referred
to as ``Incoming Sweep Orders''). Specifically, before Rule 611 of
Regulation NMS \7\ is operative on the Exchange (the ``Trading Phase
Date''),\8\ Phlx would use away market obligations instead of
immediate-or-cancel intermarket sweep orders. An away market obligation
is an immediate or cancel limit order for an NMS stock generated by
Phlx in connection with

the execution of an order by Phlx and routed to one or more away market
centers to execute against all better-priced protected quotations
displayed by the other market centers up to their displayed size. If
the away market center is capable of receiving an intermarket sweep
order, the Exchange may generate and utilize an intermarket sweep order
as the away market obligation. In addition, before the Trading Phase
Date, the proposed new rule would expressly require XLE Participants
sending Incoming Sweep Orders to simultaneously send an intermarket
sweep order (or comparable order) for the full displayed size of the
top of book of every other market center displaying a better-priced
protected quotation. The text of the proposed rule change is available
on Phlx's Web site, http://www.phlx.com, at Phlx's principal office,

and at the Commission's Public Reference Room.
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    \5\ See Phlx Rule 185(b)(2)(C).
    \6\ See Phlx Rule 185(c)(2)(D).
    \7\ 17 CFR 242.611.
    \8\ The Trading Phase Date is February 5, 2007. SeeSecurities
Exchange Act Release No. 53829 (May 18, 2006), 71 FR 30038 (May 24,
2006) (File No. S7-10-04).
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

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

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

1. Purpose
    The purpose of the proposed rule change is to clarify the operation
of XLE's outbound routing and Incoming Sweep Orders before the Trading
Phase Date. Currently, Phlx Rules 185(b)(1)(C)(i)-(ii) and (b)(2)(B)
state that when routing out to away market centers, Phlx will use
``immediate-or-cancel intermarket sweep orders'' to execute against any
away market centers with better-priced quotations. However, prior to
the Trading Phase Date, not all away market centers will accept
intermarket sweep orders. Therefore, in order to implement away routing
before the Trading Phase Date, Phlx will use ``away market
obligations'' instead of ``immediate-or-cancel intermarket sweep
orders.'' In addition, before the Trading Phase Date, Phlx will require
XLE Participants who send Incoming Sweep Orders to the Exchange to
simultaneously send an intermarket sweep order (or comparable order)
for the full displayed size of the top of book of every other market
center displaying a better-priced protected quotation. This requirement
is intended to mirror the requirement, which will be operative after
the Trading Phase Date, that all such Incoming Sweep Orders meet the
requirement of intermarket sweep orders in Rule 600(b)(30) of
Regulation NMS.\9\ The Exchange notes that it has requested an
exemption from the provisions of the Intermarket Trading System Plan to
allow, among other things, the Exchange and its XLE Participants to
implement outbound routing and Incoming Sweep Orders in this manner
prior the Trading Phase Date.\10\
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    \9\ 17 CFR 242.600(b)(30).
    \10\ See Letter from John Dayton, Director and Counsel,Phlx, to
Nancy M. Morris, Secretary, Commission, dated November 9, 2006. See
also Letter from David Shillman, Associate Director, Division of
Market Regulation, Commission, to John Dayton, Director and Counsel,
Phlx, dated November 14, 2006.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \11\ in general, and furthers the objectives of Section
6(b)(5) of the Act \12\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No written comments were either solicited or received by the
Exchange.

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

    Because the foregoing rule (i) Does not significantly affect the
protection of investors or the public interest; (ii) does not impose
any significant burden on competition; and (iii) by its terms, does not
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest, provided that the
Exchange has given the Commission written notice of its intent to file
the proposed rule change at least five business days prior to the date
of filing of the proposed rule change or such shorter time as
designated by the Commission, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\ As required under Rule 19b-4(f)(6)(iii) under
the Act,\15\ Phlx provided the Commission with written notice of its
intent to file the proposed rule change, along with a brief description
and text of the proposed rule change, prior to the date of the filing
of the proposed rule change.
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
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    A proposed rule change filed under Rule 19b-4(f)(6) under the Act
\16\ normally may not become operative prior to 30 days after the date
of filing. However, Rule 19b-4(f)(6)(iii) under the Act \17\ permits
the Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay,
which would make the rule change effective and operative upon filing.
The Commission believes that waiver of the 30-day operative delay is
consistent with the protection of investors and the public interest,
because it allows the Exchange to implement this proposal without delay
in order to accommodate the Exchange's plans to commence operation of
XLE. The Commission notes that the Exchange has represented that the
proposed rule change is based upon a proposed rule change of the
American Stock Exchange LLC (``Amex'').\18\ For these reasons, the
Commission designates the proposal to be effective and operative upon
filing with the Commission.\19\
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    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ 17 CFR 240.19b-4(f)(6)(iii).
    \18\ See Securities Exchange Act Release No. 54709 (November 3,
2006), 71 FR 65847 (November 9, 2006) (SR-Amex-2006-72) (approval
order for Amex's new electronic trading system on a pilot basis,
specifically Amex Rules 126A-AEMI-One and 131-AEMI-One).
    \19\ For the purposes only of accelerating the operative date of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the

Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.\20\
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    \20\ See 15 U.S.C. 78s(b)(3)(C).
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IV. Solicitation of Comments

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

Electronic comments

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

File Number SR-Phlx-2006-76 on the subject line.

Paper comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-Phlx-2006-76. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of the
filing also will be available for inspection and copying at the
principal office of the Phlx. 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-Phlx-2006-76 and should be submitted on or before
December 13, 2006.
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    \21\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\21\
Nancy M. Morris,
Secretary.
[FR Doc. E6-19730 Filed 11-21-06; 8:45 am]

BILLING CODE 8011-01-P


Total
                                   > 90%
                                      23*
                                      17*
                                       4
                                       2
                                       0
                                    50-90%
                                       6
                                       5
                                       1
                                       0
                                       0
                                    10-50%
                                       6
                                       3
                                       1
                                       2
                                       0
                                   < 10%
                                     13**
                                      7**
                                      3**
                                       3
                                       0
Total
                                      48
                                      32
                                       9
                                       7
                                       0
* Four facilities have no (0) MACT level or facility-wide risk.
** Four facilities have no (0) MACT level risk, but non-zero facility-wide risk.

Multipathway
In evaluating the potential for multipathway effects from emissions of lead, modeled maximum annual lead concentrations were compared to the NAAQS for lead (0.15 ug/m[3]). Small amounts of lead emissions are reported from 14 facilities. Results of this analysis confirmed that the NAAQS for lead would not be exceeded by any facility.

Environmental
We conducted a screening-level evaluation of the potential adverse environmental risks associated with emissions of the environmental HAP hydrofluoric acid and lead from the Surface Coating of Metal Coil source category.

For hydrofluoric acid, each individual concentration (i.e., each off-site data point in the modeling domain) is below the ecological benchmarks for all facilities. For lead, we did not estimate any exceedances of the secondary lead NAAQS.

3.2.2	Risk assessment results based on allowable emissions

Inhalation
Potential differences between actual emissions levels and the maximum emissions allowable under the MACT standards (i.e., MACT-allowable emissions) were also calculated for the facilities. Emission estimates based on the actual emissions were then scaled up using a factor of 1.1 to develop the allowable emissions. See Appendix 1 of this document for a discussion of the development of the allowable factors. Risk results from the inhalation risk assessment using the MACT-allowable emissions indicate that the maximum lifetime individual cancer risk could be as high as 10-in-1 million with naphthalene and formaldehyde emissions from solvent storage driving the risks, and that the maximum chronic noncancer TOSHI value could be as high as 0.1 at the MACT-allowable emissions level with glycol ethers emissions from prime coating application and finish coating processes driving the TOSHI. The total estimated cancer incidence from this source category considering allowable emissions is expected to be about 0.006 excess cancer cases per year or one excess case in every 200 years. Based on allowable emission rates approximately 24,000 people were estimated to have cancer risks above 1-in-1 million, with 40 of those people estimated to have cancer risk above 10-in-1 million. No people are estimated to have a noncancer hazard index above 1.

 Post-control risk characterization
A post-control risk assessment is not warranted for this category because we did not identify any add-on control technologies, other equipment or work practices and procedures that had not previously been considered during development of the Surface Coating of Metal Coil NESHAP, nor did we identify any developments in the same since the promulgation of the NESHAP.

 General discussion of uncertainties in the risk assessment
The uncertainties in virtually all of the RTR risk assessments can be divided into three areas: 1) uncertainties in the emission data sets, 2) exposure modeling uncertainties, and 3) uncertainties in the dose-response relationships. Uncertainties in the emission estimates and in the air quality models lead to uncertainty in air concentrations. Uncertainty in exposure modeling can arise due to uncertain activity patterns, the locations of individuals within a census tract, and the microenvironmental concentrations as reflected in the exposure model. Finally, uncertainty in the shape of the relationship between exposure and effects, the URE and the RfC, also contributes to uncertainties in the risk assessment. These three areas of uncertainty are discussed below.
 Emissions inventory uncertainties
Although the development of the RTR emissions data set involves an extensive quality assurance/quality control process, the accuracy of emission values will vary depending on certain factors, for example, the source of the data, the degree to which data are incomplete or missing, the degree to which assumptions made to complete the data sets are accurate, and the extent to which there are errors in these emission estimates. The emission estimates used in the risk assessment generally are annual totals for certain years, and they do not reflect short-term fluctuations during the course of a year or variations from year to year.

For the acute effects screening assessment, therefore, in the absence of available specific estimates or measurements, we use estimates of peak hourly emission rates. These estimates typically are calculated by applying an acute emission adjustment factor to the annual emission rate from the inventory. The adjusted annual emission rate is then divided by 8,760 hours to determine the acute average annual hourly emission rate, which is intended to account for emission fluctuations due to normal facility operations. The adjustment factor can be based on actual fluctuations seen in the available emission data for sources in a category or on engineering judgment; in the absence of such information, a default factor is applied.

To prepare the emissions data set, EPA gathers the best available data on emissions, emission release parameters, and other relevant source category-specific parameters. EPA often begins with its National Emissions Inventory (NEI) database as the starting point for emission rates, emissions release characteristics, and locations of the emission release points for each facility in the source category. The NEI is a composite of emission measurements and estimates produced by state and local regulatory agencies, industry, and EPA. EPA's industry experts then review the data for consistency and completeness and conduct extensive quality assurance/quality control checks. Available information, which may include compliance data, information from project files, permits, and other sources regarding facilities and emission sources, are also incorporated into the data set. This additional information may be incorporated in addition to the NEI data or in place of the NEI data, depending on EPA's evaluation of the quality of the various sources of data. In order to fill data gaps, EPA may conduct a formal information collection request (ICR) under the authority of section 114 of the Clean Air Act to obtain current, complete emissions data and other data from the facility owners and operators associated with the source category under review.

Uncertainty in the emissions data set stems from data gaps, default assumptions, and the emission models used to develop emissions inventory estimates. A variety of methods, such as emission factors, material balances, engineering judgement, air permit information and source testing, are used to develop emission estimates. Other parameters that are part of the emissions data set, including facility location and emission point parameters, may also be a source of uncertainty. Some release point locations use an average facility location instead of the location of each specific unit within the facility. In some instances, default release point parameters may be in the inventory. Where fugitive release parameters are not available, default values are included. Another potential source of emission estimate uncertainty may be low or poor quality data (e.g., out-of-date parameter values). For more information on the uncertainties in the emission estimates for this source category see Appendix 1 (Emissions Inventory Support Documents) of this document.
 Exposure modeling uncertainties
4.2.1	Inhalation exposure modeling
Although every effort is made to identify all of the relevant facilities and emission points, as well as to develop accurate estimates of the annual emission rates for all relevant HAP, the uncertainties in our emission inventory likely dominate the uncertainties in the exposure assessment. The ambient air modeling uncertainties are considered relatively small in comparison, since we are using EPA's refined local dispersion model with site-specific parameters and reasonably representative meteorology. If anything, the population exposure estimates are biased high by not accounting for short- or long-term population mobility and by not addressing processes like deposition, plume depletion, and atmospheric degradation. Additionally, estimates of maximum individual risk (MIR) contain uncertainty because they are derived at census block centroid locations rather than actual residences. This uncertainty is known to create potential underestimates and overestimates of the actual MIR values for individual facilities; however, overall, it is not thought to have a significant impact on the estimated MIR for a source category. We also do not factor in the possibility of a source closure occurring during the 70-year chronic exposure period, leading to a potential upward bias in both the MIR and population risk estimates. Nor do we factor in the possibility of population growth during the 70-year chronic exposure period, which could lead to a potential downward bias in both the MIR and population risk estimates. Finally, we do not factor in time an individual spends indoors.

We did not include the effects of human mobility on exposures in the assessment. Specifically, short-term mobility and long-term mobility between census blocks in the modeling domain were not considered. (Short-term mobility is movement from one micro-environment to another over the course of hours or days. Long-term mobility is movement from one residence to another over the course of a lifetime.)  The approach of not considering short or long-term population mobility does not bias the estimate of the theoretical MIR (by definition), nor does it affect the estimate of cancer incidence because the total population number remains the same. It does, however, affect the shape of the distribution of individual risks across the affected population, shifting it toward higher estimated individual risks at the upper end and reducing the number of people estimated to be at lower risks, thereby increasing the estimated number of people at specific high risk levels (e.g., 1-in-10 thousand or 1-in-1 million).

In addition, the assessment predicted the chronic exposures at the centroid of each populated census block as surrogates for the exposure concentrations for all people living in that block. Using the census block centroid to predict chronic exposures tends to over-predict exposures for people in the census block who live farther from the facility and under-predict exposures for people in the census block who live closer to the facility. Thus, using the census block centroid to predict chronic exposures may lead to a potential understatement or overstatement of the true maximum impact, but is an unbiased estimate of average risk and incidence. We reduce this uncertainty by analyzing large census blocks near facilities using aerial imagery and adjusting the location of the block centroid to better represent the population in the block, as well as adding additional receptor locations where the block population is not well represented by a single location.

The assessment evaluates the cancer inhalation risks associated with pollutant exposures over a 70-year period, which is the assumed lifetime of an individual. In reality, both the length of time that modeled emission sources at facilities actually operate (i.e., more or less than 70 years) and the domestic growth or decline of the modeled industry (i.e., the increase or decrease in the number or size of domestic facilities) will influence the future risks posed by a given source or source category. Depending on the characteristics of the industry, these factors will, in most cases, result in an overestimate both in individual risk levels and in the total estimated number of cancer cases. However, in the unlikely scenario where a facility maintains, or even increases, its emissions levels over a period of more than 70 years, residents live beyond 70 years at the same location, and the residents spend more of their days at that location, then the cancer inhalation risks could potentially be underestimated. However, annual cancer incidence estimates from exposures to emissions from these sources would not be affected by the length of time an emissions source operates.

The exposure estimates used in these analyses assume chronic exposures to ambient (outdoor) levels of pollutants. Because most people spend the majority of their time indoors, actual exposures may not be as high, depending on the characteristics of the pollutants modeled. For many of the HAP, indoor levels are roughly equivalent to ambient levels, but for very reactive pollutants or larger particles, indoor levels are typically lower. This factor has the potential to result in an overestimate of 25 to 30 percent of exposures (USEPA, 2001).

A sensitivity analysis, discussed in "Risk and Technology Review (RTR) Risk Assessment Methodologies" (USEPA 2009a), found that the selection of the meteorology data set location could have an impact on the risk estimates. The analysis found that cancer MIR derived using different meteorological stations varied by as much as 63 percent below to 51 percent above the value derived using the nearest meteorological station. Cancer incidence estimated using different meteorological stations varied by as much as 68 percent below to 120 percent above the value estimated using the nearest meteorological station. Similarly, air concentrations estimated using different meteorological stations varied by as much as 49 percent below to 21 percent above the value estimated using the nearest meteorological station. Since this analysis was performed EPA has increased the number of meteorological stations used in our risk assessments; thus, we expect variability to be reduced.

For the acute screening assessment, the results are intentionally biased high, and thus health-protective, by assuming the co-occurrence of independent factors, such as hourly emission rates, meteorology and human activity patterns. Furthermore, in cases where multiple acute dose-response values for a pollutant are considered scientifically acceptable, we choose the most conservative of these dose-response values, erring on the side of overestimating potential health risks from acute exposures. In cases where these results indicate the potential for exceeding acute HQs, we refine our assessment by developing a better understanding of the geography of the facility relative to potential exposure locations.

4.2.2	Multipathway exposure modeling
In modeling the fate and transport of pollutants through the environment and the non-inhalation exposure (i.e., ingestion) to these pollutants, TRIM.FaTE uses simplified representations of many complex real-world processes. This simplified representation introduces uncertainty. Uncertainties arise from model assumptions and structure, as reflected in the algorithms that describe the environmental movement of pollutants, and in the input values for numerous environmental parameters.

Uncertainty in the algorithms is inherent to any model attempting to represent complex processes in the real world. How persistent, bioaccumulative chemicals such as mercury, cadmium, arsenic, PAHs, and dioxins behave in the environment is highly complex, and many natural processes are represented in a simplified manner by TRIM.FaTE, including, for example:

 gaseous and particulate deposition from air;
 biogeochemical cycling in the aquatic environment, particularly mercury transformations through methylation and demethylation at the sediment-surface interface;
 mixing processes in air, water, and sediment;
 suspended and benthic sediment dynamics in lakes; and
 biotic processes such as growth, reproduction, and predation.

Even though some processes, such as diffusion, are known to follow second-order dynamics, the TRIM.FaTE model represents all fate and transport processes in terms of first-order differential equations. TRIM.FaTE also does not explicitly deal with lateral or vertical dispersion in the air compartments. Some algorithms, such as those addressing methylation and sediment transport, for example, do not consider all of the factors known to affect the process. Biotic processes including chemical absorption, chemical elimination, growth, reproduction, predation, and death have been represented relatively simplistically in the model. Although the model's algorithms have been validated and are based on professional judgment, some level of uncertainty results from such simplifications.

The input values for parameters are also associated with uncertainty. Algorithms that describe the environmental movement of pollutants depend on numerous environmental parameters for which the values might be naturally variable and for which available data are often limited. Examples of parameters for which input values are variable and uncertain include aquatic food web structure (e.g., diet of each fish species), biokinetic parameters that influence bioaccumulation (e.g., assimilation efficiencies and elimination rates), topographic characteristics (e.g., lake depth, runoff rates, and erosion rates), meteorological parameters (e.g., evaporation and precipitation rates), chemical transformation rates (e.g., methylation and demethylation rates, in the case of mercury), and human exposure parameters (especially fish consumption rates).

For TRIM.FaTE modeling, we use central tendency values and combinations of values that would lead to estimates of reasonable maximum exposures to bound risk estimates. We have conducted analyses of the sensitivity of risk estimates to parameter input values. For those parameters to which the model is particularly sensitive, we have continued to collect additional data to better quantify the variability and distribution of input values.
A more comprehensive explanation of the uncertainties related to fate, transport, and exposure modeling using TRIM.FaTE is provided in Appendix 6 (Technical Support Document for TRIM-Based Multipathway Tiered Screening Methodology for RTR) of this report for the tiered assessments and Appendix 11 (Site-Specific Human Health Multipathway Residual Risk Assessment Report) of this report for a site-specific assessment if one was conducted.

4.2.3	Environmental risk screening assessment

For each source category, we generally rely on site-specific levels of environmental HAP emissions to perform an environmental screening assessment. The environmental screening assessment is based on the outputs from models that estimate environmental HAP concentrations. The same models, specifically the TRIM.FaTE multipathway model and the AERMOD air dispersion model, are used to estimate environmental HAP concentrations for both the human multipathway screening analysis and for the environmental screening analysis. Therefore, both screening assessments have similar modeling uncertainties. Two important types of uncertainty associated with the use of these models in RTR environmental screening assessments (and inherent to any assessment that relies on environmental modeling) are model uncertainty and input uncertainty.

Model uncertainty concerns whether the selected models are appropriate for the assessment being conducted and whether they adequately represent the movement and accumulation of environmental HAP emissions in the environment. For example, does the model adequately describe the movement of the pollutant through the soil?  This type of uncertainty is difficult to quantify. However, based on feedback received from previous EPA SAB reviews and other reviews, we are confident that the models used in the screening assessments are appropriate and state-of-the-art for the environmental risk assessments conducted in support of our RTR analyses.

Input uncertainty is concerned with how accurately the models have been configured and parameterized for the assessment at hand. For Tier 1 of the environmental screening assessment for PB-HAP, we configured the models to avoid underestimating exposure and risk to reduce the likelihood that the results indicate the risks are lower than they actually are. This was accomplished by selecting upper-end values from nationally-representative datasets for the more influential parameters in the environmental model, including selection and spatial configuration of the area of interest, the location and size of any bodies of water, meteorology, surface water and soil characteristics, and structure of the aquatic food web. In Tier 1, we use the maximum facility-specific emissions for the PB-HAP (other than lead compounds, which were evaluated by comparison to the Secondary Lead NAAQS) that are included in the environmental screening assessment and each of the media when comparing to ecological benchmarks. This is consistent with the conservative design of the Tier 1 screening assessment. In Tier 2 of the environmental screening assessment for PB-HAP, we refine the model inputs to account for meteorological patterns in the vicinity of the facility versus using upper-end national values, and we identify the locations of water bodies near the facility location. By refining the screening approach in Tier 2 to account for local geographical and meteorological data, we decrease the likelihood that concentrations in environmental media are overestimated, thereby increasing the usefulness of the screening assessment. To better represent widespread impacts, the modeled soil concentrations are averaged in Tier 2 to obtain one average soil concentration value for each facility and for each PB-HAP. For PB-HAP concentrations in water, sediment, and fish tissue, the highest value for each facility for each pollutant is used.

For the environmental screening assessment for acid gases, we employ a single-tiered approach. We use the modeled air concentrations and compare those with ecological benchmarks.

For both Tiers 1 and 2 of the environmental screening assessment, our approach to addressing model input uncertainty is generally cautious. We choose model inputs from the upper end of the range of possible values for the influential parameters used in the models, and we assume that the exposed individual exhibits ingestion behavior that would lead to a high total exposure. This approach reduces the likelihood of not identifying potential risks for adverse environmental impacts.

 Uncertainties in the dose-response relationships
 In the sections that follow, separate discussions are provided on uncertainty associated with cancer potency factors and for noncancer reference values. Cancer potency values are derived for chronic (lifetime) exposures. Noncancer dose-response values are generally derived for chronic exposures (up to a lifetime) but may also be derived for acute (less than 24 hours), short-term (from 24 hours up to 30 days), and subchronic (30 days up to 10 percent of lifetime) exposure durations, all of which are derived based on an assumption of continuous exposure throughout the duration specified. For the purposes of assessing all potential health risks associated with the emissions included in an assessment, we rely on both chronic (cancer and noncancer) and acute (noncancer) dose-response values, which are described in more detail below.

Although every effort is made to identify peer-reviewed dose-response values for all HAP emitted by the source category included in an assessment, some HAP have no peer-reviewed values. Since exposures to these pollutants cannot be included in a quantitative risk estimate, an understatement of risk for these pollutants at estimated exposure levels is possible. To help alleviate this potential underestimate, where we conclude similarity with a HAP for which a dose-response assessment value is available, we use that value as a surrogate for the assessment of the HAP for which no value is available. To the extent use of surrogates indicates appreciable risk, we may identify a need to increase priority for a new IRIS assessment of that substance. We additionally note that, generally speaking, HAP of greatest concern due to environmental exposures and hazards are those for which dose-response assessments have been performed, reducing the likelihood of understating risk. Further, HAP not included in the quantitative assessment are assessed qualitatively and considered in the risk characterization that informs the risk management decisions, including with regard to consideration of HAP reductions achieved by various control options.

Additionally, chronic dose-response values for certain compounds included in the assessment may be under EPA IRIS review. In those cases, revised assessments may determine in the future that these pollutants are more or less potent than currently thought.

For a group of compounds that are unspeciated (e.g., glycol ethers), we conservatively use the most protective reference value of an individual compound in that group to estimate risk. Similarly, for an individual compound in a group (e.g., ethylene glycol diethyl ether) that does not have a specified reference value, we apply the most protective reference value from the other compounds in the group to estimate risk.

Cancer assessment
The discussion of dose-response uncertainties in the estimation of cancer risk below focuses on the uncertainties associated with the specific approach currently used by the EPA to develop cancer potency factors. In general, these same uncertainties attend the development of cancer potency factors by CalEPA, the source of peer-reviewed cancer potency factors used where EPA-developed values are not yet available. To place this discussion in context, we provide a quote from the EPA's Guidelines for Carcinogen Risk Assessment (herein referred to as Cancer Guidelines). (USEPA, 2005d)  "The primary goal of EPA actions is protection of human health; accordingly, as an Agency policy, risk assessment procedures, including default options that are used in the absence of scientific data to the contrary, should be health protective."  The approach adopted in this document is consistent with this approach as described in the Cancer Guidelines.

For cancer endpoints EPA usually derives an oral slope factor for ingestion and a unit risk value for inhalation exposures. These values allow estimation of a lifetime probability of developing cancer given long-term exposures to the pollutant. Depending on the pollutant being evaluated, EPA relies on both animal bioassay and epidemiological studies to characterize cancer risk. As a science policy approach, consistent with the Cancer Guidelines, EPA uses animal cancer bioassays as indicators of potential human health risk when other human cancer risk data are unavailable.

Extrapolation of study data to estimate potential risks to human populations is based upon EPA's assessment of the scientific database for a pollutant using EPA's guidance documents and other peer-reviewed methodologies. The EPA Cancer Guidelines describe the Agency's recommendations for methodologies for cancer risk assessment. EPA believes that cancer risk estimates developed following the procedures described in the Cancer Guidelines and outlined below generally provide an upper bound estimate of risk. That is, EPA's upper bound estimates represent a plausible upper limit to the true value of a quantity (although this is usually not a true statistical confidence limit). In some circumstances, the true risk could be as low as zero; however, in other circumstances the risk could also be greater.   When developing an upper bound estimate of risk and to provide risk values that do not underestimate risk, EPA generally relies on conservative default approaches.   EPA also uses the upper bound (rather than lower bound or central tendency) estimates in its assessments, although it is noted that this approach can have limitations for some uses (e.g. priority setting, expected benefits analysis).

Such health risk assessments have associated uncertainties, some which may be considered quantitatively, and others which generally are expressed qualitatively. Uncertainties may vary substantially among cancer risk assessments associated with exposures to different pollutants, since the assessments employ different databases with different strengths and limitations and the procedures employed may differ in how well they represent actual biological processes for the assessed substance. Some of the major sources of uncertainty and variability in deriving cancer risk values are described more fully below.

(1) The qualitative similarities or differences between tumor responses observed in experimental animal bioassays and those which would occur in humans are a source of uncertainty in cancer risk assessments. In general, EPA does not assume that tumor sites observed in an experimental animal bioassay are necessarily predictive of the sites at which tumors would occur in humans.   However, unless scientific support is available to show otherwise, EPA assumes that tumors in animals are relevant in humans, regardless of target organ concordance. For a specific pollutant, qualitative differences in species responses can lead to either under-estimation or over-estimation of human cancer risks.

(2) Uncertainties regarding the most appropriate dose metric for an assessment can also lead to differences in risk predictions. For example, the measure of dose is commonly expressed in units of mg/kg/d ingested or the inhaled concentration of the pollutant. However, data may support development of a pharmacokinetic model for the absorption, distribution, metabolism and excretion of an agent, which may result in improved dose metrics (e.g., average blood concentration of the pollutant or the quantity of agent metabolized in the body). Quantitative uncertainties result when the appropriate choice of a dose metric is uncertain or when dose metric estimates are themselves uncertain (e.g., as can occur when alternative pharmacokinetic models are available for a compound). Uncertainty in dose estimates may lead to either over or underestimation of risk.

(3) For the quantitative extrapolation of cancer risk estimates from experimental animals to humans, EPA uses scaling methodologies (relating expected response to differences in physical size of the species), which introduce another source of uncertainty. These methodologies are based on both biological data on differences in rates of process according to species size and empirical comparisons of toxicity between experimental animals and humans. For a particular pollutant, the quantitative difference in cancer potency between experimental animals and humans may be either greater than or less than that estimated by baseline scientific scaling predictions due to uncertainties associated with limitations in the test data and the correctness of scaled estimates.

(4) EPA cancer risk estimates, whether based on epidemiological or experimental animal data, are generally developed using a benchmark dose (BMD) analysis to estimate a dose at which there is a specified excess risk of cancer, which is used as the point of departure (or POD) for the remainder of the calculation. Statistical uncertainty in developing a POD using a benchmark dose (BMD) approach is generally addressed though use of the 95 percent lower confidence limit on the dose at which the specified excess risk occurs (the BMDL), decreasing the likelihood of understating risk. EPA has generally utilized the multistage model for estimation of the BMDL using cancer bioassay data (see further discussion below).

(5) Extrapolation from high to low doses is an important source of uncertainty in cancer risk assessment. EPA uses different approaches to low dose risk assessment (i.e., developing estimates of risk for exposures to environmental doses of an agent from observations in experimental or epidemiological studies at higher dose) depending on the available data and understanding of a pollutant's mode of action (i.e., the manner in which a pollutant causes cancer). EPA's Cancer Guidelines express a preference for the use of reliable, compound-specific, biologically-based risk models when feasible; however, such models are rarely available. The mode of action for a pollutant (i.e., the manner in which a pollutant causes cancer) is a key consideration in determining how risks should be estimated for low-dose exposure. A reference value is calculated when the available mode of action data show the response to be nonlinear (e.g., as in a threshold response). A linear low-dose (straight line from POD) approach is used when available mode of action data support a linear (e.g., nonthreshold) response or as the most common default approach when a compound's mode of action is unknown. Linear extrapolation can be supported by both pollutant-specific data and broader scientific considerations. For example, EPA's Cancer Guidelines generally consider a linear dose-response to be appropriate for pollutants that interact with DNA and induce mutations. Pollutants whose effects are additive to background biological processes in cancer development can also be predicted to have low-dose linear responses, although the slope of this relationship may not be the same as the slope estimated by the straight line approach.

EPA most frequently utilizes a linear low-dose extrapolation approach as a baseline science-policy choice (a "default") when available data do not allow a compound-specific determination. This approach is designed to not underestimate risk in the face of uncertainty and variability. EPA believes that linear dose-response models, when appropriately applied as part of EPA's cancer risk assessment process, provide an upper bound estimate of risk and generally provide a health protective approach. Note that another source of uncertainty is the characterization of low-dose nonlinear, non-threshold relationships. The National Academy of Sciences (NAS, 1994) has encouraged the exploration of sigmoidal type functions (e.g., log-probit models) in representing dose-response relationships due to the variability in response within human populations. Another National Research Council report (NRC, 2006) suggests that models based on distributions of individual thresholds are likely to lead to sigmoidal-shaped dose-response functions for a population. This report notes sources of variability in the human population: "One might expect these individual tolerances to vary extensively in humans depending on genetics, coincident exposures, nutritional status, and various other susceptibility factors..."   Thus, if a distribution of thresholds approach is considered for a carcinogen risk assessment, application would depend on ability of modeling to reflect the degree of variability in response in human populations (as opposed to responses in bioassays with genetically more uniform rodents). Note also that low dose linearity in risk can arise for reasons separate from population variability: due to the nature of a mode of action and additivity of a chemical's effect on top of background chemical exposures and biological processes.

As noted above, EPA's current approach to cancer risk assessment typically utilizes a straight line approach from the BMDL. This is equivalent to using an upper confidence limit on the slope of the straight line extrapolation. The impact of the choice of the BMDL on bottom line risk estimates can be quantified by comparing risk estimates using the BMDL value to central estimate BMD values, although these differences are generally not a large contributor to uncertainty in risk assessment (Subramaniam et. al., 2006). It is important to note that earlier EPA assessments, including the majority of those for which risk values exist today, were generally developed using the multistage model to extrapolate down to environmental dose levels and did not involve the use of a POD. Subramaniam et. al. (2006) also provide comparisons indicating that slopes based on straight line extrapolation from a POD do not show large differences from those based on the upper confidence limit of the multistage model.

(6) Cancer risk estimates do not generally make specific adjustments to reflect the variability in response within the human population  --  resulting in another source of uncertainty in assessments. In the diverse human population, some individuals are likely to be more sensitive to the action of a carcinogen than the typical individual, although compound-specific data to evaluate this variability are generally not available. There may also be important life stage differences in the quantitative potency of carcinogens and, with the exception of the recommendations in EPA's Supplemental Cancer Guidance for carcinogens with a mutagenic mode of action, risk assessments do not generally quantitatively address life stage differences. However, one approach used commonly in EPA assessments that may help address variability in response is to extrapolate human response from results observed in the most sensitive species and sex tested, resulting typically in the highest URE which can be supported by reliable data, thus supporting estimates that are designed not to underestimate risk in the face of uncertainty and variability.

Chronic noncancer assessment
Chronic noncancer reference values represent chronic exposure levels that are intended to be health-protective. That is, EPA and other organizations, such as the Agency for Toxic substances and disease Registry (ATSDR), which develop noncancer dose-response values use an approach that is intended not to underestimate risk in the face of uncertainty and variability. When there are gaps in the available information, uncertainty factors (UFs) are applied to derive reference values that are intended to be protective against appreciable risk of deleterious effects. Uncertainty factors are commonly default values (e.g., factors of 10 or 3) used in the absence of compound-specific data; where data are available, uncertainty factors may also be developed using compound-specific information. When data are limited, more assumptions are needed and more default factors are used. Thus, there may be a greater tendency to overestimate risk -- in the sense that further study might support development of reference values that are higher (i.e., less potent) because fewer default assumptions are needed. However, for some pollutants it is possible that risks may be underestimated.

For noncancer endpoints related to chronic exposures, EPA derives a reference dose (RfD) for exposures via ingestion, and a reference concentration (RfC) for inhalation exposures. As stated in the IRIS Glossary, these values provide an estimate (with uncertainty spanning perhaps an order of magnitude) of daily oral exposure (RfD) or of a continuous inhalation exposure (RfC) to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. To derive values that are intended to be "without appreciable risk," EPA's methodology relies upon an uncertainty factor (UF) approach (USEPA, 1993b; USEPA, 1994b) which includes consideration of both uncertainty and variability.

EPA begins by evaluating all of the available peer-reviewed literature to determine noncancer endpoints of concern, evaluating the quality, strengths and limitations of the available studies. EPA typically chooses the relevant endpoint that occurs at the lowest dose, often using statistical modeling of the available data, and then determines the appropriate POD for derivation of the reference value. A POD is determined by (in order of preference): (1) a statistical estimation using the BMD approach; (2) use of the dose or concentration at which the toxic response was not significantly elevated (no observed adverse effect level --  NOAEL); or (3) use of the lowest observed adverse effect level (LOAEL).

A series of downward adjustments using default UFs is then applied to the POD to estimate the reference value (USEPA, 2002b). While collectively termed "UFs", these factors account for a number of different quantitative considerations when utilizing observed animal (usually rodent) or human toxicity data in a risk assessment. The UFs are intended to account for: (1) variation in susceptibility among the members of the human population (i.e., inter-individual variability); (2) uncertainty in extrapolating from experimental animal data to humans (i.e., interspecies differences); (3) uncertainty in extrapolating from data obtained in a study with less-than-lifetime exposure (i.e., extrapolating from subchronic to chronic exposure); (4) uncertainty in extrapolating from a LOAEL in the absence of a NOAEL; and (5) uncertainty when the database is incomplete or there are problems with applicability of available studies. When scientifically sound, peer-reviewed assessment-specific data are not available, default adjustment values are selected for the individual UFs. For each type of uncertainty (when relevant to the assessment), EPA typically applies an UF value of 10 or 3 with the cumulative UF value leading to a downward adjustment of 10-3000 fold from the selected POD. An UF of 3 is used when the data do not support the use of a 10-fold factor. If an extrapolation step or adjustment is not relevant to an assessment (e.g., if applying human toxicity data and an interspecies extrapolation is not required) the associated UF is not used. The major adjustment steps are described more fully below.

	1) Heterogeneity among humans is a key source of variability as well as uncertainty. Uncertainty related to human variation is considered in extrapolating doses from a subset or smaller-sized population, often of one sex or of a narrow range of life stages (typical of occupational epidemiologic studies), to a larger, more diverse population. In the absence of pollutant-specific data on human variation, a 10-fold UF is used to account for uncertainty associated with human variation. Human variation may be larger or smaller; however, data to examine the potential magnitude of human variability are often unavailable. In some situations, a smaller UF of 3 may be applied to reflect a known lack of significant variability among humans.

	2) Extrapolation from results of studies in experimental animals to humans is a necessary step for the majority of chemical risk assessments. When interpreting animal data, the concentration at the POD (e.g. NOAEL, BMDL) in an animal model (e.g. rodents) is extrapolated to estimate the human response. While there is long-standing scientific support for the use of animal studies as indicators of potential toxicity to humans, there are uncertainties in such extrapolations. In the absence of data to the contrary, the typical approach is to use the most relevant endpoint from the most sensitive species and the most sensitive sex in assessing risks to the average human. Typically, compound specific data to evaluate relative sensitivity in humans versus rodents are lacking, thus leading to uncertainty in this extrapolation. Size-related differences (allometric relationships) indicate that typically humans are more sensitive than rodents when compared on a mg/kg/day basis. The default choice of 10 for the interspecies UF is consistent with these differences. For a specific chemical, differences in species responses may be greater or less than this value.

      Pharmacokinetic models are useful to examine species differences in pharmacokinetic processing and associated uncertainties; however, such dosimetric adjustments are not always possible. Information may not be available to quantitatively assess toxicokinetic or toxicodynamic differences between animals and humans, and in many cases a 10-fold UF (with separate factors of 3 for toxicokinetic and toxicodynamic components) is used to account for expected species differences and associated uncertainty in extrapolating from laboratory animals to humans in the derivation of a reference value. If information on one or the other of these components is available and accounted for in the cross-species extrapolation, a UF of 3 may be used for the remaining component.

	3) In the case of reference values for chronic exposures where only data from shorter durations are available (e.g., 90-day subchronic studies in rodents) or when such data are judged more appropriate for development of an RfC, an additional UF of 3 or 10-fold is typically applied unless the available scientific information supports use of a different value.

      4) Toxicity data are typically limited as to the dose or exposure levels that have been tested in individual studies; in an animal study, for example, treatment groups may differ in exposure by up to an order of magnitude. The preferred approach to arrive at a POD is to use BMD analysis; however, this approach requires adequate quantitative results for a meaningful analysis, which is not always possible. Use of a NOAEL is the next preferred approach after BMD analysis in determining a POD for deriving a health effect reference value. However, many studies lack a dose or exposure level at which an adverse effect is not observed (i.e., a NOAEL is not identified). When using data limited to a LOAEL, a UF of 10 or 3-fold is often applied.

      5) The database UF is intended to account for the potential for deriving an underprotective RfD/RfC due to a data gap preventing complete characterization of the chemical's toxicity. In the absence of studies for a known or suspected endpoint of concern, a UF of 10 or 3-fold is typically applied.

Acute noncancer assessment
Many of the UFs used to account for variability and uncertainty in the development of acute reference values are quite similar to those developed for chronic durations. For acute reference values, though, individual UF values may be less than 10. UFs are applied based on chemical- or health effect-specific information or based on the purpose of the reference value. The UFs applied in acute reference value derivation include:  1) heterogeneity among humans; 2) uncertainty in extrapolating from animals to humans; 3) uncertainty in LOAEL to NOAEL adjustments; and 4) uncertainty in accounting for an incomplete database on toxic effects of potential concern. Additional adjustments are often applied to account for uncertainty in extrapolation from observations at one exposure duration (e.g., 4 hours) to arrive at a POD for derivation of an acute reference value at another exposure duration (e.g., 1 hour).

Not all acute dose-response values are developed for the same purpose and care must be taken when interpreting the results of an acute assessment of human health effects relative to the reference value or values being exceeded. Where relevant to the estimated exposures, the lack of dose-response values at different levels of severity should be factored into the risk characterization as potential uncertainties.

Environmental Risk Screening Assessment
Uncertainty also exists in the ecological benchmarks for the environmental risk screening assessment. We established a hierarchy of preferred benchmark sources to allow selection of benchmarks for each environmental HAP at each ecological assessment endpoint. In general, EPA benchmarks used at a programmatic level (e.g., Office of Water, Superfund Program) were used if available. If not, we used EPA benchmarks used in regional programs (e.g., Superfund Program). If benchmarks were not available at a programmatic or regional level, we used benchmarks developed by other agencies (e.g., NOAA) or by state agencies.

In all cases (except for lead compounds, which were evaluated through a comparison to the NAAQS), we searched for benchmarks at the following three effect levels, as described in Section 2.6 of this report and in Appendix 9 (Environmental Risk Screening Assessment) of this report:  a no-effect level (i.e., NOAEL), threshold-effect level (i.e., LOAEL), and probable-effect level (i.e., PEL).

For some ecological assessment endpoint/environmental HAP combinations, we could identify benchmarks for all three effect levels, but for most we could not. In one case, where different agencies derived significantly different numbers to represent a threshold for effect, we included both. In several cases, only a single benchmark was available. In cases where multiple effect levels were available for a particular PB-HAP and assessment endpoint, we used all of the available effect levels to help us determine whether risk exists if risks could be considered significant and widespread.

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Sills, R.C., Morgan, D.L., Herr, D.W., Little, P.B., George, N.M., Ton, T.V., Love, N.E., Maronpot, R.R., and Johnson, G.A., 2004. Contribution of magnetic resonance microscopy in the 12-week neurotoxicity evaluation of carbonyl sulfide in Fischer 344 rats. Toxicol. Pathol. 32:501-510, 2004.

USEPA, 1986. Guidelines for the Health Risk Assessment of Chemical Mixtures. EPA-630-R-98-002. https://www.epa.gov/risk/guidelines-health-risk-assessment-chemical-mixtures

USEPA, 1993a. Integrated Risk Information system Review of Manganese. https://cfpub.epa.gov/ncea/iris2/chemicalLanding.cfm?substance_nmbr=373

USEPA, 1993b. Reference Dose (RfC):  Description and Use in Health Risk Assessments.           https://www.epa.gov/iris/reference-dose-rfd-description-and-use-health-risk-assessments

USEPA, 1994a. US Environmental Protection Agency. Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry. EPA/600/8-90/066F. Office of Research and Development. Washington, DC: U.S.EPA.

USEPA, 1994b. Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry. https://www.epa.gov/risk/methods-derivation-inhalation-reference-concentrations-and-application-inhalation-dosimetry

USEPA, 1999. Residual Risk Report to Congress. 453R-99-001. https://www3.epa.gov/airtoxics/rrisk/risk_rep.pdf

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USEPA, 2009a. Risk and Technology Review (RTR) Risk Assessment Methodologies: For Review by the EPA's Science Advisory Board with Case Studies  -  MACT I Petroleum Refining Sources and Portland Cement Manufacturing. EPA-452/R-09-006. https://cfpub.epa.gov/si/si_public_record_report.cfm?dirEntryID=238928

USEPA, 2009b. Graphical Arrays of Chemical-Specific Health Effect Reference Values for Inhalation Exposures [Final Report]. EPA/600/R-09/061, 2009. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=211003

USEPA, 2010a. SAB's Response to EPA's RTR Risk Assessment Methodologies. https://yosemite.epa.gov/sab/sabproduct.nsf/0/b031ddf79cffded38525734f00649caf!OpenDocument&TableRow=2.3#2

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[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34448-34450]
[FR Doc No: 2012-14065]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67127; File No. SR-NSX-2012-08]

Self-Regulatory Organizations; National Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Temporarily Suspend the Requirements of NSX Rule 2.5 and Related NSX
ETP Holder Application Rules and Procedures in Order To Approve Apex
Clearing Corporation, f/k/a Ridge Clearing and Outsourcing Solutions,
Inc. (``Apex Clearing'') as an NSX ETP Holder

June 5, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 5, 2012, National Stock Exchange, Inc. filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change, as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comment on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    National Stock Exchange, Inc. (``NSX[supreg]'' or ``Exchange'') is
proposing to amend its rules to temporarily suspend the requirements of
NSX Rule 2.5 and related NSX ETP Holder application rules and
procedures in order to approve Apex Clearing Corporation, f/k/a Ridge
Clearing and Outsourcing Solutions, Inc. (``Apex Clearing'') as an NSX
ETP Holder, subject to Apex Clearing complying with Exchange ETP Holder
application rules and procedures within 30 calendar days of the date
that Apex Clearing is provisionally approved as an ETP Holder. The
Exchange is also proposing to accept Apex Clearing's assumption of all
of the existing clearing agreements and arrangements currently in
effect between Penson Financial Services Inc. (``PFSI'') and various
other ETP Holders by execution of a global agreement thereto.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nsx.com, at the principal office of the
Exchange, 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, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant 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 this rule filing to temporarily suspend the
requirements of NSX Rule 2.5 and related procedures regarding the
application process for ETP Holders in order to immediately approve
Apex Clearing as an NSX ETP Holder. The Exchange proposes this
temporary suspension on an emergency basis to ensure that Apex Clearing
can continue the clearing operations of PFSI without unnecessary
disruption, which could have a significant collateral impact to a
number of other ETP Holders. The proposed temporary suspension is
contingent upon Apex Clearing having complied with all Exchange ETP
Holder application rules and procedures within 30 calendar days of the
date Apex Clearing is provisionally approved as an NSX ETP Holder
pursuant to this filing.
    On May 31, 2012, Apex Clearing Holdings, LLC (``Apex Holdings''),
Apex Clearing Solutions, LLC, Broadridge Financial Solutions, Inc.
(``Broadridge''), PFSI and Penson Worldwide, Inc. (``PWI'') (together,
the ``Parties'') consummated a transaction resulting in a change in
ownership of Apex Clearing.\3\ Broadridge, Apex Holdings,

PWI and PFSI each made capital investments in Apex Holdings, the
holding company parent of Apex Clearing. PFSI also assigned all of its
U.S. clearing contracts and all customer and introducing broker
proprietary accounts along with key personnel to Apex Clearing (the
``Transferring Accounts'').\4\
---------------------------------------------------------------------------

    \3\ Prior to the Transaction, Apex Clearing's name was Ridge
Clearing & Outsourcing Solutions, Inc. Prior to the transaction,
Ridge Clearing & Outsourcing Solutions, Inc. contributed its
outsourcing operations and all associated personnel and systems to
its affiliated entity, Broadridge Securities Processing Solutions,
LLC (``BSPS'') where it will continue to provide operations support
and outsourcing services to a number of broker-dealers, including
Apex Clearing.
    \4\ See Penson Worldwide, Inc. Form 8-K dated May 31, 2012.
---------------------------------------------------------------------------

    As a result of the transaction, Apex Clearing, which is not an NSX
ETP Holder, will provide the clearing and execution services currently
provided to the Transferring Accounts by PFSI. On May 31, 2012, Apex
Clearing submitted an executed application for approval as an NSX ETP
Holder and an NSX User Agreement. However because of the expedited
nature of the transaction, Apex Clearing was unable to fully comply
with NSX Rule 2.5(a)(5) and related new ETP Holder application
procedures. Because of the need for seamless continuity with respect to
the Transferring Accounts, Apex Clearing has requested that the
Exchange temporarily suspend its new ETP Holder application rules and
procedures to the extent necessary in order to enable Apex Clearing's
approval as an ETP Holder on an expedited basis. Pursuant to its
request, Apex Clearing will fully comply with the Exchange's new ETP
Holder application rules and procedures within 30 calendar days after
provisional approval.
    NSX Rule 2.5 requires that applications for an Exchange Trading
Permit (``ETP'') shall be made to the Exchange and shall contain
certain specified documentation. Among other things, to be approved as
an NSX ETP Holder, the documentation must contain an agreement
regarding certain matters as specified in NSX Rule 2.5(a)(1) through
(4), which are generally contained in the Exchange's form User
Agreement required to be executed by an applicant, together with such
other reasonable information with respect to the applicant as the
Exchange may require. In addition, pursuant to NSX Rule 2.4, the
Exchange reviews whether the applicant meets federal and NSX capital
requirements and verifies that certain other application criteria are
satisfied.
    Due to the amount of information an applicant is required to
provide and have completed prior to being approved as an ETP Holder,
the ETP Holder approval process generally takes several weeks to
complete. The length of time varies based on the timing of the
applicant's response to requests for information and documentation.
    As proposed, Apex Clearing will continue the clearing and certain
other operations of PFSI as of June 6, 2012. In order to avoid
interruption of the services PFSI currently provides to other Exchange
ETP Holders, the Exchange believes that Apex Clearing should be
approved immediately as an NSX ETP Holder. The Exchange notes that Apex
Clearing is already a registered broker dealer and FINRA member, which
are prerequisites for becoming an NSX ETP Holder. See NSX Rule 2(a)(1).
    The Exchange therefore proposes providing Apex Clearing with a
temporary suspension of NSX Rule 2.5 and related ETP Holder application
rules and procedures as they relate to approval to operate an NSX ETP
Holder and approval of a proposed ETP Holder's approved persons, and
immediately provisionally approve Apex Clearing as an ETP Holder. As
proposed this temporary suspension is contingent upon:
     Apex Clearing providing the Exchange with sufficient
information to confirm that Apex Clearing will meet its capital
requirements as an NSX ETP Holder; and
     Within 30 calendar days of Apex Clearing's approval as an
NSX ETP Holder under this proposed filing, Apex Clearing and its
approved persons will have complied with the Exchange's ETP Holder
application requirements as set forth in NSX rules and related
application documents.
    As proposed, if Apex Clearing does not comply with all applicable
NSX ETP Holder application requirements within 30 calendar days of the
effective date of this filing, its status as an approved NSX ETP Holder
will no longer be effective.
    In addition, the Exchange proposes to permit Apex Clearing to
assume all existing clearing agreements and arrangements currently in
effect with other NSX ETP Holders. Notice of such assumption, and a
solicitation of consent with respect thereto, will be provided to
impacted ETP Holders through applicable notices prior to the effective
date thereof.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) \5\ of the Securities Exchange Act of 1934 (the ``Act''),
in general, and furthers the objectives of Section 6(b)(5) \6\ in
particular in that it is designed to promote just and equitable
principles of trade, to prevent fraudulent and manipulative acts, to
remove impediments to and to perfect the mechanism for a free and open
market and a national market system and, in general, to protect
investors and the public interest. The Exchange believes that
permitting the expeditious approval of Apex Clearing as an NSX ETP
Holder will avoid interruption of the services PFSI currently provides
to other Exchange ETP Holders. Based on information and representations
provided by Apex Clearing, a temporary suspension of certain NSX
membership rules and procedures is needed based on the expedited nature
of the transaction to enable seamless continuity with respect to the
transferring accounts. Consequently, the Exchange believes that
temporary suspension of its ETP Holder application requirements so that
Apex Clearing can be approved immediately as an NSX ETP Holder will
help to foster cooperation and coordination with persons engaged in
facilitating transactions in securities and is consistent with the Act.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any inappropriate burden on competition.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A)

of the Act \9\ and Rule 19b-4(f)(6)(iii) thereunder.\10\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires a self-regulatory organization to give the
Commission written notice of its intent to file the proposed rule
change at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Commission is waiving this five-day pre-filing
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\12\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the five-day pre-
filing requirement and the 30-day operative delay so that the proposed
rule change may become operative immediately upon filing. The
Commission notes that the Exchange is proposing that certain of its
rules relating to membership requirements be temporarily suspended so
that Apex Clearing can be provisionally approved as an NSX ETP Holder.
The proposed relief does not exempt Apex Clearing from Exchange rule
requirements governing NSX ETP Holders. Apex Clearing would have a 30
calendar day grace period within which to apply for and be approved
under relevant Exchange rules. Moreover, the Commission believes that
waiver of the 30-day operative delay is appropriate to ensure a smooth
transition of PFSI operations to Apex Clearing. In particular, given
the rapidity with which events have developed, waiver of the 30-day
operative delay is necessary to avoid significant disruption to PFSI's
existing customers and the market generally. Therefore, the Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest and designates the
proposed rule change as operative upon filing.\13\
---------------------------------------------------------------------------

    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

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-NSX-2012-08 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NSX-2012-08. 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 the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NSX-2012-08 and should be
submitted on or before July 2, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-14065 Filed 6-8-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Page 10315]
[FR Doc No: 2016-04247]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77209; File No. SR-BATS-2015-94]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proposed Rule
Change To List and Trade Shares of the SPDR DoubleLine Emerging Markets
Fixed Income ETF of the SSgA Active Trust

February 23, 2016.
    On December 28, 2015, BATS Exchange, Inc. (``Exchange'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares of the SPDR[supreg] DoubleLine[supreg] Emerging Markets Fixed
Income ETF of the SSgA Active Trust under BATS Rule 14.11(i). The
proposed rule change was published for comment in the Federal Register
on January 15, 2016.\3\ The Commission has not received any comments on
the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 76862 (Jan. 11,
2016), 81 FR 2282.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is February 29, 2016. The Commission is extending this 45-day time
period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider this proposed rule change. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\5\ designates
April 14, 2016, as the date by which the Commission shall either
approve or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-BATS-2015-94).
---------------------------------------------------------------------------

    \5\ Id.
    \6\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-04247 Filed 2-26-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 153 (Monday, August 10, 2015)]
[Notices]
[Pages 47918-47919]
[FR Doc No: 2015-19563]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: PR15-39-000.
    Applicants: Northern Illinois Gas Company.
    Description: Submits tariff filing per 284.123(b)(2) + (g):
Petition for Rate Approval to be effective 9/1/2015; Filing Type: 1310.
    Filed Date: 7/30/15.
    Accession Number: 20150730-5078.
    Comments Due: 5 p.m. ET 8/20/15.
    284.123(g) Protests Due: 5 p.m. ET 9/28/15.

    Docket Numbers: RP15-1176-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Compliance filing Report of Refund Transco's GSS LSS
Customer Share of DTI Penalty Revenue 2015.
    Filed Date: 8/3/15.
    Accession Number: 20150803-5204.
    Comments Due: 5 p.m. ET 8/17/15.

    Docket Numbers: RP15-1177-000.

    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Section 4(d) Rate Filing: Clean-Up Filing--2015 to be
effective 9/1/2015.
    Filed Date: 8/3/15.
    Accession Number: 20150803-5256.
    Comments Due: 5 p.m. ET 8/17/15.

    Docket Numbers: RP15-1178-000.
    Applicants: Cimarron River Pipeline, LLC.
    Description: Section 4(d) Rate Filing: Fuel Tracker 2015--Winter
Season Rates to be effective 11/1/2015.
    Filed Date: 8/4/15.
    Accession Number: 20150804-5000.
    Comments Due: 5 p.m. ET 8/17/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 4, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-19563 Filed 8-7-15; 8:45 am]
 BILLING CODE 6717-01-P