[Federal Register Volume 82, Number 112 (Tuesday, June 13, 2017)]
[Rules and Regulations]
[Pages 26985-26987]
[FR Doc No: 2017-12077]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9553; Directorate Identifier 2016-NE-29-AD;
Amendment 39-18904; AD 2017-11-05]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Corporation Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Rolls-Royce Corporation (RRC) AE 3007C and 3007C1 turbofan engines.
This AD was prompted by analysis and by cracks found in the high-
pressure turbine (HPT) wheel during an inspection. This AD requires
replacement of the affected HPT wheels at new, lower life limits. We
are issuing this AD to correct the unsafe condition on these products.

DATES: This AD is effective July 18, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 18,
2017.

ADDRESSES: For service information identified in this final rule,
contact Rolls-Royce Corporation, 450 South Meridian Street, Mail Code
NB-01-06, Indianapolis, IN 46225; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet: www.rolls-royce.com. You
may view this service information at the FAA, Engine & Propeller
Directorate, 1200 District Avenue, Burlington, MA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>. It is
also available on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2016-9553.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9553; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kyri Zaroyiannis, Aerospace Engineer,
Chicago Aircraft Certification Office, Small Airplane Directorate, FAA,
2300 E. Devon Ave., Des Plaines, IL 60018; phone:<PHONE_NUMBER>; fax:
847-294-7834; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain RRC AE 3007C and
3007C1 model turbofan engines. The NPRM published in the Federal
Register on February 22, 2017 (82 FR

11327) (``the NPRM''). The NPRM was prompted by analysis and by cracks
found in the HPT wheel during an inspection. The NPRM proposed to
require replacement of the affected HPT wheels at new, lower life
limits. We are issuing this AD to prevent uncontained failure of the
HPT wheels, damage to the engine, and damage to the airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comment received. An individual
commenter supported the NPRM.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD as proposed.

Related Service Information Under 1 CFR Part 51

    We reviewed RRC Alert Service Bulletin (ASB) AE 3007C-A-72-318,
Revision 2, dated September 23, 2016. The ASB provides updated life
limits for the affected HPT wheels. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 307 engines installed on airplanes
of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                      Labor cost             Parts cost           product        operators
----------------------------------------------------------------------------------------------------------------
Replacement of HPT wheel (Part      0 work-hours x $85     $39,171 (pro-rated            $39,171      $3,838,758
 Number (P/N) 23062373, 23065891,    per hour = $0.         cost of part).
 or 23070664) at reduced life.
Replacement of HPT wheel (P/N       0 work-hours x $85     $21,911 (pro-rated             21,911       4,579,399
 23063462, 23065892, 23069116,       per hour = $0.         cost of part).
 23069592, or 23074643) at reduced
 life.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2017-11-05 Roll-Royce Corporation (Type Certificate previously held
by Allison Engine Company): Amendment 39-18904; Docket No. FAA-2016-
9553; Directorate Identifier 2016-NE-29-AD.

(a) Effective Date

    This AD is effective July 18, 2017.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to Rolls-Royce Corporation (RRC) AE 3007C
and 3007C1 turbofan engines with 1st stage high-pressure turbine
(HPT) wheels, part number (P/N) 23062373, 23065891, or 23070664; or
with 2nd stage HPT wheels, P/N 23063462, 23065892, 23069116,
23069592 (except those serial numbers (S/Ns) noted in paragraph
(c)(2) of this AD), or 23074643, installed.
    (2) This AD does not apply to RRC AE 3007C and 3007C1 turbofan
engines with 2nd stage HPT wheels, P/N 23069592, with S/Ns listed in
Table 6 of RRC Alert Service Bulletin (ASB) AE 3007C-A-72-318,
Revision 2, dated September 23, 2016, installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine/
turboprop Engine, Turbine Section.

(e) Unsafe Condition

    This AD was prompted by analysis and by cracks found in the HPT
wheel during an inspection. We are issuing this AD to prevent
uncontained failure of the HPT wheels, damage to the engine, and
damage to the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) For all RRC AE 3007C or C1 engines with an installed 1st
stage HPT wheel, P/N 23062373, 23065891, or 23070664, or 2nd stage
HPT wheel, P/N 23063462, 23065892, 23069116, 23069592 (except those
S/Ns excluded by paragraph (c)(2) of this AD) or 23074643, after the
effective date of this AD, remove the affected wheels before
exceeding the new life limits identified in paragraph C., Table 1 of
RRC ASB AE 3007C-A-72-318, Revision 2, dated September 23, 2016.

    (2) After the effective date of this AD, do not return to
service any engine with an HPT turbine wheel, with an affected P/N
and an S/N, with a wheel life that exceeds the new life limits
identified in paragraph C., Table 1 of RRC ASB AE 3007C-A-72-318,
Revision 2, dated September 23, 2016.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Chicago Aircraft Certification Office, FAA, may
approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19
to make your request.

(h) Related Information

    For more information about this AD, contact Kyri Zaroyiannis,
Aerospace Engineer, Chicago Aircraft Certification Office, Small
Airplane Directorate, FAA, 2300 E. Devon Ave., Des Plaines, IL
60018; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Rolls-Royce Corporation (RRC) Alert Service Bulletin AE
3007C-A-72-318, Revision 2, dated September 23, 2016.
    (ii) Reserved.
    (3) For RRC service information identified in this AD, contact
Rolls-Royce Corporation, 450 South Meridian Street, Mail Code NB-01-
06, Indianapolis, IN 46225; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet: www.rolls-royce.com.
    (4) You may view this service information at the FAA, Engine &
Propeller Directorate, 1200 District Avenue, Burlington, MA 01803.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (5) You may view this service information at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on May 17, 2017.
Robert J. Ganley,
Acting Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2017-12077 Filed 6-12-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 232 (Tuesday, December 3, 2013)]
[Notices]
[Page 72672]
[FR Doc No: 2013-28826]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL13-79-000]

Owensboro Municipal Utilities v. Louisville Gas and Electric
Company, Kentucky Utilities Company; Notice of Filing

    Take notice that on November 22, 2013, Louisville Gas and Electric
Company and Kentucky Utilities Company (collectively LG&E/KU) filed its
Refund Report in the above-docketed proceeding in compliance with the
October 25, 2013 Order on Complaint (Order), 145 FERC ] 61,072, issued
by the Commission.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on December 13, 2013.

    Dated: November 25, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-28826 Filed 12-2-13; 8:45 am]
BILLING CODE 6717-01-P


MEMORANDUM TO:		Toni Jones, U.S. Environmental Protection Agency FROM:  	Eastern Research Group, Inc.	 DATE:  	November 3, 2011 -------------------------------------------------------------------------------- SUBJECT:  	CISWI Emission Limit Calculations for Existing and New Sources for Reconsideration Proposal

Background The U.S. Environmental Protection Agency, under section 129 of the Clean Air Act (CAA), is required to regulate emissions of nine pollutants from Commercial and Industrial Solid Waste Incineration (CISWI) units: hydrogen chloride (HCl), carbon monoxide (CO), lead (Pb), cadmium (Cd), mercury (Hg), particulate matter (PM), dioxins/furans (PCDD/PCDF), nitrogen oxides (NOx), and sulfur dioxide (SO2).

On December 1, 2000, the EPA adopted new source performance standards (NSPS) and emission guidelines (EG) for CISWI units under Sections 111 and 129 of the Clean Air Act.  In 2001 the EPA granted a petition for reconsideration regarding the definitions of "commercial and industrial waste" and "commercial and industrial solid waste incineration unit."  In 2001, the United States Court of Appeals for the District of Columbia Circuit granted the EPA's voluntary remand, without vacatur, of the 2000 rule.  In 2005, the EPA proposed and finalized the commercial and industrial solid waste incineration definition rule which, among other things, revised the definitions of "commercial and industrial waste" and "commercial and industrial waste incineration unit."  In 2007, the United States Court of Appeals for the District of Columbia Circuit vacated and remanded the 2005 commercial and industrial solid waste incineration definition rule.   On March 21, 2011, the EPA promulgated revised NSPS and EG as its response to the voluntary remand that was granted in 2001 and the vacatur and remand of the commercial and industrial solid waste incineration definition rule in 2007.  In addition, the standards re-development included the 5-year technology review of the new source performance standards and emission guidelines required under Section 129.  Following that action, the Administrator received petition[s] for reconsideration and identified some issues that warranted further opportunity for public comment.  In addition, data were received that enabled the EPA to revise the CISWI inventory of waste-burning kilns and energy recovery units to more accurately reflect the definition of non-hazardous secondary materials.  For completeness, this memo retains the description of the maximum achievable control technology (MACT) floor determination and emission limit calculations for all subcategories.  However, the incinerator and small remote incinerator subcategory emission limits remain largely unchanged from those in the March 2011 CISWI rule.

The EPA has developed a series of MACT floor emission limits to support that reconsideration.  The purpose of this memorandum is to present the methodology and results of the MACT floor determinations and emission limit calculations for the CISWI source category. This memo is organized as follows:

I. 		Regulatory Options and Subcategories II.		Existing Sources  	A. MACT Floors 	B. Data Variability Analysis 	C. Determining Emission Limits  III.		New Sources 	A. MACT Floors 	B. Data Variability Analysis 	C. Determining Emission Limits  IV.		References

Appendix A	Emission Limits Summary Tables Appendix B	Supporting Tables for MACT Floor Analysis Appendix C	Supporting Tables for Data Variability Analysis for Existing Units Appendix D	Supporting Data for Waste-burning Kiln Mercury Analysis Appendix E	Supporting Tables for Data Variability Analysis for New Units Appendix F	CO Span Adjustments Appendix G	Method Detection Limit Guidance

I. 	Regulatory options and subcategories In the 2000 CISWI rule, there were no subcategories.  However, in the final and the reconsideration rulemakings, there are several different types of units that will now be subject to regulation as CISWI units that were previously not subject to CISWI standards.   At proposal, the EPA considered two regulatory options in proposing the CISWI standards: Option 1  -  Evaluate MACT floors assuming no subcategories (similar to the 2000 CISWI standards); or Option 2  -  Evaluate MACT floors for each subcategory of CISWI unit that will be subject to the proposed regulations.  Public comments received after proposal not only supported the need for subcategories, but indicated that additional subcategories were warranted.  The EPA found these comments to be persuasive as to the need for some additional subcategories.  Therefore, the CISWI inventory has been grouped into five primary subcategories.  The five subcategories that were developed are listed below, followed by an explanation of the reasons for creating each subcategory:       * Incinerators (general waste burning units without integral heat recovery),       * Energy recovery units  -  solids  (waste burning units that recover thermal energy),       * Energy recovery units  -  liquid/gas  (waste burning units that recover thermal energy),       * Waste-burning kilns (kilns burning solid waste, including tires classified as solid waste), and       * Small, remote incinerators (small incineration units located in remote areas).

Incinerators:  Incinerators, which are the units currently regulated by the 2000 CISWI rule, are used to dispose of solid waste materials and emissions are a function of the types of materials burned.  Incinerators are designed without integral heat recovery (but may include waste heat recovery).  While there are different designs, they all serve the same purpose; reduction in the volume of solid waste materials.  Incinerators can be operated on a batch or continuous basis.  The same types of add-on controls, including fabric filters, wet scrubbers, selective noncatalytic reduction (SNCR), and activated carbon injection, can be applied to most incinerators.  Although the composition of the materials combusted is highly variable and is a key factor in the profile of emissions, we determined it was not appropriate to further subcategorize incinerators because the sources in this subcategory are sufficiently similar such that the incinerators can achieve the same level of performance for the nine regulated pollutants.

Energy-recovery units (liquid/gas, solids, solids-biomass, solids-coal):   Energy recovery units (ERUs) combust solid waste materials as a percentage of their fuel mixture and are designed to recover thermal energy in the form of steam or hot water.  Energy recovery units include units that would be considered boilers and process heaters if they did not combust solid waste.  The design, operating, and emissions information that the EPA has reviewed indicates differences in unit design that distinguish different types of ERUs.  Data indicate that there are generally significant design and operational differences between units that burn coal, biomass, liquid, and gaseous fuels.  Energy recovery units are therefore designed for specific fuel types and will encounter problems if a fuel with characteristics other than those originally specified is fired.  Many ERUs in the database are indicated to co-fire liquids or gases with solid fuels, but, in actuality, most of these boilers commonly use fuel oil or natural gas as a startup fuel only and then operate on solid fuel during the remainder of their operation.  In contrast, some co-fired units are specifically designed to fire combinations of solids, liquids, and gases.  Changes to the fuel type would generally require extensive changes to the fuel handling and feeding system (e.g., a stoker using wood as fuel would need to be redesigned to handle fuel oil or liquid wastes).  Additionally, the burners and combustion chamber would need to be redesigned and modified to handle different fuel types and account for increases or decreases in the fuel volume.  In some cases, the changes may reduce the capacity and efficiency of the ERU.  An additional effect of these changes would be extensive retrofitting needed to operate using a different fuel; therefore, the design of the ERU impacts the degree of combustion.

In our investigations resulting from public commenters' statements, we concluded that the data were sufficient for determining that a distinguishable difference in performance exists based on unit design type.  Therefore, because different types of units have different emission characteristics which may influence the feasibility or effectiveness of emission control, they should be regulated separately (i.e., subcategorized) for affected pollutants.  Accordingly, we have subcategorized ERUs based on unit design in order to account for these differences in emissions and applicable controls.  The two primary ERU subcategories are units designed to burn solid wastes (solids) with other solid fuels, and units designed to burn liquid wastes with liquid or gaseous fuel (liquid/gas).  The ERU solids subcategory is further subcategorized into units designed to burn coal and units designed to burn biomass or predominantly non-coal solid materials for Cd, Pb, PCDD/PCDF, CO, NOx, and SO2 to address design differences and feasibility or effectiveness of emission control between these types of units as commenters have suggested.  The subcategorization for these pollutants is also compelled by the data available for the solid fuel sources.  Specifically, coal fired ERUs submitted exclusively CEMS data for CO, NOx, and SO2, and biomass fired ERUs submitted almost exclusively stack test data for these pollutants.  We are unable to convert the vast majority of CEMS data into equivalent stack test data and the converse is true as well.  Pursuant to CAA section 129(a)(2), the EPA must establish emission standards for existing sources based on the average emissions limitation achieved by the best-performing 12 percent of sources.  Because the data for CO, NOx, and SO2  from the biomass and coal fired ERUs are not in consistent formats, we would have to ignore a subset of the available data in establishing the floors for these pollutants if we did not further subcategorize solid fuel ERUs.  We therefore think it is reasonable to further subcategorize these units for CO, NOx, and SO2 so the standards are reflective of the data available to the EPA, and we are properly accounting for the different emissions characteristics associated with the different types of fuels.  Finally, we have also subcategorized emission limits for PM, Cd, Pb and PCDD/PCDF as combustion-based pollutants in an attempt to be consistent with subcategorization used in the major source boiler NESHAP.  After assessing the points raised by the petitioners, the EPA determined that PM and other metal emissions are influenced both by fuel type and design.  Therefore, it is appropriate to treat these pollutants as combustion-based pollutants.

These subcategories are based on the primary fuel that the ERU is designed to burn.  We are aware that some ERUs burn a combination of fuel types or burn a different fuel type as a backup fuel if the primary fuel supply is curtailed.  However, ERUs are designed based on the primary fuel type (and perhaps to burn a backup fuel) and can encounter operational problems if another fuel type that was not considered in its design is fired at more than 10 percent of the heat input to the unit.  Therefore, we subcategorized ERUs that burn at least 10 percent coal (on an annual heat input basis) as being in solid fuel/coal subcategory, with the remaining solid ERUs being in the biomass subcategory for ERUs.

Since promulgation, data were received that enabled us to determine that five ERUs at promulgation are no longer burning solid waste based on the current definition and those units have been removed from the CISWI inventory.  Furthermore, there were three units that were added to the CISWI inventory because they provided data indicating that they would likely be classified as CISWI units.

Waste-burning kilns:  Waste-burning kilns are fundamentally different than any other unit being regulated under CISWI.  Kilns of all types are physically larger than incinerators with comparable heat input.  Kiln design and operation are also different from those of incinerators.  For example, the design is typically a rotating cylindrical kiln with a fuel burner on one end and raw materials being fed in the other (cold) end.  Fuel (particularly solids such as tires) may also in some cases be fed at the mid kiln point.  Some kilns also have a large preheater tower with a precalciner that is an additional firing point for both fossil and waste fuels.  The temperature profile of kilns is critical in order to produce a saleable product, and differs from that of incinerators both in terms of residence time and absolute temperature.  Another key distinction from incinerators and other CISWI subcategories is that for cement kilns, the source of most of the emitted pollutants is typically the raw materials, not the fuels, and emissions from the raw materials and the solid wastes and fuels are comingled and emitted together.  As a result of all these distinctions, waste-burning kilns have a very different emissions profile than other CISWI subcategories, justifying separate standards.   See 74 FR at 21145 ("Normally, any basis for subcategorizing must be related to an effect on emission, rather than to some difference among sources which does not affect emissions performance").

Since promulgation, there were eleven additional kilns that were identified as being waste-burning kilns.  These kilns and their available data were added to the CISWI inventory for reanalysis of the waste-burning kiln subcategory.

We also reconsidered the comments that the kiln subcategory should be further subcategorized for one pollutant, CO.  We are proposing to subcategorize into two kiln types; long kilns (which include both dry and wet process kilns) and kilns that have preheaters (with or without precalciners).  This subcategorization is based on the demonstrated difference in combustion and CO formation characteristics of long kilns and preheater or preheater/precalciner kilns.  Of these 23 waste-burning kilns, 13 are long kilns and 10 are preheater/precalciner kilns. The memorandum "Waste-burning kiln design and carbon monoxide emission concentrations" discusses the data the EPA used in determining whether kiln design subcategories are justified with respect to carbon monoxide emissions.

Small, remote, incinerators:  These are batch-operated units that combust less than 3 tons of waste per day and are located more than 25 miles from the nearest municipal solid waste (MSW) landfill.  To the extent that these units are located in Alaska, a major difference in these types of units is the inability to operate a wet scrubber in the northern climates and the lack of availability of wastewater handling and treatment utilities.  We believe this would impact their ability to meet emission limits for pollutants controlled by wet scrubbers.  In addition, because of the remote location, these units do not have lower-cost alternative waste disposal options (i.e., landfills) nearby and emissions associated with transporting the solid waste could be significant.

II.	Existing Sources A. MACT Floors Emissions standards for existing units may be less stringent than standards for new units, but "shall not be less stringent than the average emissions limitation achieved by the best performing 12 percent of units in the category."  CAA section 129 (a)(2).  For existing sources, the MACT floor for each subcategory of sources was calculated by ranking the emission test results from units within the subcategory from lowest emissions to highest emissions (for each pollutant) and then taking the numerical average of the test results from the best performing (lowest emitting) 12 percent of sources.  That is, the overall 3-run test average values for each existing unit for each pollutant were compiled and ranked from lowest to highest to identify the best performing 12 percent of sources within the subcategory on a pollutant-by-pollutant basis. Because the number of units in different subcategories may be different, the number of units that represent the best performing 12 percent of units for different subcategories vary.  Also, mathematically, the number of units that represent the best performing 12 percent of the units in a subcategory will not always be an integer.  To ensure that each MACT standard is based on at least 12 percent of the units in a subcategory, the EPA has determined that it is appropriate to always round up to the nearest integer when 12 percent of a given subcategory is not an integer.  For example, in the incinerator subcategory, 12 percent of the 26 units is 3.12 units, so standards were established based on the best performing 4 units.

In developing standards for waste burning kilns for the final rule, we used best efforts to estimate which units would have been classified as CISWIs (i.e. units combusting solid waste) had the final definition of non-hazardous solid waste been in place at the time of the performance testing. The standards (and, necessarily, the pool of best performers establishing the floors for each standard) are based on the performance of this universe of sources. In evaluating which sources would have been classified as CISWI units had the new definition of solid waste been effective, the EPA used  the information currently available on which non-hazardous secondary materials the sources combust, as supplemented by information obtained from public comment and further information gathered by the EPA after the public comment period of this rule.This inventory was reevaluated following promulgation of the new definition of solid waste and, as a result, an additional 11 kilns were added to the CISWI waste-burning kiln inventory.

Table A-1 presents the results of the EG floors for the various statistical intervals considered and the final emission limits for each pollutant in each subcategory.  Subcategory-specific notes follow.  For additional reference, tables in Appendix B present all average pollutant concentrations and unit rankings for each pollutant.

1. Waste-burning Kilns Unit rankings for each pollutant are shown in Tables B-1. The top 3 cement kilns (12 percent of the 23 total existing cement kilns) were included in the MACT floor for all pollutants except CO.  Because kilns were further subcategorized for CO, CO MACT floors comprise the top 2 preheater/precalciner kilns (12 percent of the 10 existing preheater/precalciner kilns) and the top 2 long kilns (12 percent of the 12 existing long kilns). Note that the PM rankings are based on the lb/ton clinker values from each unit, weighted to reflect the percentage of time the raw mill is operated (if the unit has a raw mill).  The raw mill operating information comes from the Portland Cement NESHAP database for the cement kilns that would have been classified as waste-burning kilns had the revised definition of solid waste been promulgated and applicable to those kilns.  Appendix B-1 contains the spreadsheet showing how PM concentration data are converted to lb/ton clinker produced values.

2. Energy Recovery Units  -  Solids  Unit rankings for each pollutant are shown in Tables B-2 through B-4. The top 4 solids-burning energy recovery units (12 percent of the 26 existing ERUs) were included in the MACT floor for solids.  For solids-coal, the top unit was included (12 percent of 5 existing units), and for biomass, the top 3 units were included (12 percent of 21 existing units).  As discussed above, all pollutants except for Hg and HCl have limits based on whether the unit is in the ERU-coal or ERU-biomass subcategory.  The limits for CO2, NOX, and SO2 for the coal subcategory incorporate hourly continuous emissions monitoring data for one of the best performing units.  These were used in the analysis since test data were unavailable.  In these instances, each hour of data was treated as an individual test run.

3. Energy Recovery Units  -  Liquid/Gas Unit rankings for each pollutant are shown in Table B-5. The top energy recovery unit (12 percent of the 6 total existing energy recovery units) were included in the MACT floor.

4. Incinerators Unit rankings for each pollutant are shown in Tables B-6. The top 4 incinerators (12 percent of the 26 total existing incinerators) were included in the MACT floor.

5. Small, Remote Units Unit rankings for each pollutant are shown in Table B-7 The top 2 small, remote units (12 percent of the 14 total existing incinerators) were included in the MACT floor.

B. Data Variability Analysis Once the best 12 percent of units were identified for each source category and pollutant, the individual test run data for these units were compiled, and a statistical analysis was conducted to calculate the average and account for variability in order to determine the MACT floor emission limit.

The first step in the statistical analysis included a determination of the whether the data used for each MACT floor calculation were normally or log-normally distributed, followed by calculation of the average, the 99[th] percent upper limit (UL) for incinerators, and the 99[th] percent upper prediction limit (UPL) for energy recovery units and waste-burning kilns.  If the data were normally distributed (e.g., similar to a typical bell curve), then the equation to calculate UL was applied to the data.  If the data were not normally (i.e. log-normally) distributed (for example if the data were asymmetric or skewed to the right or left), then a data transformation was performed to normalize the data prior to computing the UL or UPL.  When the data distribution was found to be log-normal, the data were transformed by taking the natural log of the data prior to calculating the UL or UPL value.  Two statistical measures, skewness and kurtosis, were examined to determine if the data were normally or log-normally distributed.  Since proposal, the methodology has been revised to use the lognormal distribution when the normal distribution is not clearly indicated based on the skewness and kurtosis tests to be more consistent with the EPA's guidance in "Guidance for Data Quality Assessment: Practical Methods for Data Analysis" EPA/600/R-96/084, July 2000.  A summary of the variability analysis for existing units is presented in Table A-3.  Detailed analyses with run data can be found in Appendix C.

C. Determining Emission Limits  Emission limits for existing units were determined based on the 99[th] percent UL (for incinerators) and the 99[th] percent UPL (for energy recovery units and waste-burning kilns) of the compiled run data for each pollutant and are presented in Table 1 below.

Table 1.  Final CISWI MACT Floor Limits for Existing Sources                                Pollutant (units)                                   Subcategory                                                                         Incin-erators                         Energy recovery units  -  solids                       Energy recovery units  -  liquid/gas                               Waste-burning kilns                           Small, remote incin-erators HCl (ppmv) 29 0.50 14 3.0 220 CO (ppmv) 36 490 (biomass units) /46 (coal units) 36 120 (long kilns) /  410 (preheater/ precalciner) 20 Pb (mg/dscm) 0.0036 0.0019 (biomass units) / 0.0031 (coal units) 0.096 0.0043 2.7 Cd (mg/dscm) 0.0026 0.00078 (biomass units) / 0.058 (coal units) 0.023 0.00082 0.61 Hg (mg/dscm) 0.0054 0.0020 0.0013 0.011 0.0057 PM, filterable (mg/dscm) 34

11 (biomass units) / 86 coal units 110 9.2

230

PCDD/PCDF, total (ng/dscm) 4.6

0.52 (biomass units) / 0.51 (coal units) 2.9

3.6

1200 PCDD/PCDF, TEQ (ng/dscm) 0.13 0.12 (biomass units) / 0.075 (coal units) 0.32 0.075 57 NOx (ppmv) 53 290 (biomass units)/ 340 (coal units) 76 630 240 SO2 (ppmv) 11 7.3 (biomass units)/ 650 (coal units) 720 830 420

As discussed at proposal, the UL computation assumes that the data available represents the entire population of data from the best-performing CISWI units used to establish the standards.  We have concluded that this statement applies to the incinerator and small remote incinerator subcategories, since we believe our inventory of these units is more certain than is our inventory of ERUs and waste-burning kilns for several reasons.  In the 2000 CISWI rule, the EPA only regulated solid waste incineration units that operated for the sole purpose of disposing of waste.  Many incinerators subject to the 2000 CISWI rule ceased operation before the compliance date for those standards.  Once the revised CISWI standards are finalized, these types of solid waste incineration units (i.e., incinerators and small remote incinerators) will either comply with the revised CISWI standards or cease operation, much as they did in response to the 2000 standards.  The same is not necessarily correct for units in the ERUs and waste-burning kilns subcategories.  For those sources, once the CISWI standards are promulgated, they will likely either comply with the CISWI standards or cease burning solid waste and comply with the applicable NESHAP.  We think units in those subcategories will generally not cease operation.  Furthermore, because incinerator and small remote incinerator units' sole purpose is waste disposal, the only practical manner in which additional sources will be added to the inventory is through new construction.  Again, this is different than for ERUs and waste-burning kilns because, for those subcategories, additional units may be added if existing boilers (and process heaters) and cement kilns begin combusting solid waste and thereby become ERUs and waste-burning kilns, respectively.  For these reasons, we believe we have a complete inventory of units in the incinerators and small remote incinerators subcategories.

We sent Phase II testing requests to all incinerator and small remote incinerator units that are in our inventory.  We required testing for all incinerator and small remote incinerator units, making allowances for identical units from a facility to only test one unit, and not each identical unit.  Therefore, our data represent the entire population of data for these two subcategories.  For this reason, we believe the UL is the appropriate statistical approach for the incinerators and small remote incinerators subcategories.  The 99 percent UL represents a value that 99 percent of the data in the MACT floor population would fall below, and therefore accounts for the run-to-run and test-to-test variability observed in the MACT floor data set.

The UL was calculated by the following equation:

                                                 Where:              x 		=	average of the data.             t(0.99,n)	=	t-statistic.             n		=	number of data points in the population.             s 		=	standard deviation.

For ERUs and waste-burning kilns, however, we recognize that our data may not represent the entire population of units.  As stated above, there is greater uncertainty involved in determining the universe of sources in these two source categories because we cannot be certain that we have identified all the units that would be considered to be burning solid waste, had the newly-adopted definition fo solid waste been promulgated and effective at the time of testing.  We also  do not know whether the units we have identified will continue to burn waste after the final CISWI standards are issued.  Unlike incinerators and small remote incinerators, the primary purpose of waste-burning kilns and ERUs is the production of a product or generation of energy, not the disposal of waste.  Therefore, operators will decide whether it is economically feasible to continue or start combusting solid waste to support their industrial process and, if they decide that it is not, they will use traditional fuels or non-waste inputs instead of solid waste.  For example, an ERU that is combusting solid waste that has little or no cost may decide that compliance with CISWI is an economically viable option compared to purchasing traditional fuels at market rates; but, if the costs of compliance with CISWI exceed the costs of traditional fuel, the source will likely cease burning solid waste.  Conversely, a boiler that currently combusts only traditional fuels may be presented with a solid waste fuel option that makes it to their economic advantage to begin combusting solid waste.  For these reasons, the population of units in the ERU and waste-burning kiln subcategories is inherently uncertain.  We have for these reasons concluded that a prediction interval (e.g., UPL) is more appropriate for these two subcategories.

A prediction interval for a future observation is an interval that will, with a specified degree of confidence, contain the next (or some other pre-specified) randomly selected observation from a population.  In other words, the prediction interval estimates what the upper bound of future values will be, based upon present or past background samples taken.  The UPL consequently represents the value which we can expect the mean of future observations (3-run average) to fall below within a specified level of confidence, based upon the results of an independent sample from the same population.  In other words, if we were to select at random a future test condition from any of the top 12 percent (MACT floor pool) of sources (average of 3 runs), we can be 99 percent confident that the reported level will fall at or below the UPL value.  Use of the UPL is appropriate in this rulemaking for these two subcategories because it sets a limit any single or future source can meet based on the performance of members of the MACT floor pool.

The UPL was calculated by the following equation:

                                                 Where:             x¯ 	=	Mean of the sample data set             n	=	Number of test runs             m	=	Number of test runs in the compliance average             s2	=	Observed variance              t	=	Student t distribution statistic

The calculated existing source UL or UPL values (which are based on the emissions data from the best performing 12 percent of sources and account for variability) were selected as the final emission limits for the nine regulated pollutants in each subcategory.  In establishing the limits, the UL values were rounded up to two significant figures.  For example, a value of 1.42 would be rounded to 1.5 (as has been done for other CAA section 129 rules) because a limit of 1.4 would be lower than the calculated MACT floor value.  The summary results of the UL and UPL analysis and derivation of the final emission limits for existing units are presented in Table A-3.

At proposal, the EPA suggested that at very low emission levels where emissions tests result in nondetect values, the inherent imprecision in the pollutant measurement method has a large influence on the reliability of the data underlying the MACT floor emission limit.  See 75 FR 31943.  Because of sample and emission matrix effects, laboratory techniques, sample size, and other factors, MDLs normally vary from test to test for any specific test method and pollutant measurement.  The confidence level that a value measured at the detection level is greater than zero is about 99 percent.  The expected measurement imprecision for an emissions value occurring at or near the MDL is about 40 to 50 percent.  Pollutant measurement imprecision decreases to a consistent level of 10 to 15 percent for values measured at a level about three times the MDL.  The approach the EPA has used to account for measurement variability in t calculating the final limits begins by defining a MDL that is representative of the data used in the data pool.  The first step in the approach is to identify the highest test specific MDL reported in a data set that is also equal to or less than the average emission calculated for the data set.  This approach has the advantage of relying on the data collected to develop the MACT floor emission limit, while to some degree, minimizing the effect of a test(s) with an inordinately high MDL (e.g., the sample volume was too small, the laboratory technique was insufficiently sensitive or the procedure for determining the detection level was other than that specified).  The second step is to determine the value equal to three times the representative MDL and compare it to the calculated MACT floor emission limit.  If three times the representative MDL were less than the calculated MACT floor emission limit, we concluded that measurement variability is adequately addressed, and we did not adjust the calculated MACT floor emission limit.  If, on the other hand, the value equal to three times the representative MDL was greater than the calculated MACT floor emission limit, we concluded that the calculated MACT floor emission limit does not account entirely for measurement variability.  We therefore used the value equal to three times the MDL in place of the calculated MACT floor emission limit to ensure that the MACT floor emission limit accounts for measurement variability and imprecision.  The results of these analyses are presented in the summary tables of Appendix A as well as the individual variability calculation spreadsheets of Appendix C (and Appendix E for new sources).

In a similar concern, extremely low carbon monoxide values were reinvestigated to analyze whether the span of the test used was capable of accurately reading the reported value, and if not, were adjusted to provide a value in which there can be more confidence .  While this adjustment did not necessarily affect the floor calculations in every case, the results of this analysis and resulting changes to the database are presented in Appendix F.

The measurements for HCl from waste-burning kilns are very close to the detection limit for analytic Method 321 actually calculated in the field for HCl.  We have implemented a procedure for adjusting limits to account for measurement variability using data at the detection limit. A similar exercise was also performed for the Portland Cement NESHAP, which results in a floor of 3 ppmvd for both new and existing waste-burning kilns for HCl, adjusted to a dry basis at 7 percent oxygen.  This represents the lowest level that can be reliably measured using this test method.  See 75 FR at 54984.

Furthermore, since promulgation, the EPA has reviewed the reference method detection limits for Hg and PCDD/PCDF.  This review and analysis used the similar three times the detection limit as in the final CISWI rule, but instead relied on a much larger data set of emission test reports to generate a more widely applicable and standard set of method detection limits.  Appendix G presents the memorandum of this analysis, and the method detection limits.  In our analysis for CISWI, the industrial boiler data set were those that were used, and in every case, the four dry standard cubic meter concentrations were used.  Note however, that the Appendix G values are at zero percent oxygen, so these were adjusted to 7 percent oxygen based on the average stack oxygen level of each CISWI subcategory.  The Appendix A spreadsheets contain the average stack oxygen values used to make this adjustment.      The Hg standard for waste-burning kilns reflects 30 days of data for all Hg inputs, reasonable estimates of control device performance (for the few controlled sources), plus a reasonable statistical methodology to account for variability (including variability of Hg content of kiln inputs).  the EPA also used a pooled variability factor (pooling variability for all kilns in the MACT floor pool), which increased variability estimates.  This analysis is based upon data collected for development of the final Portland Cement NESHAP, but screened such that the CISWI analysis used only the data from kilns that would have been identified as  CISWI units had the newly-adopted solid waste definition been promulgated and effective at the time of performance testing and accounting for inter-quarry variability , and converted to a concentration basis for consistency with the CISWI standards.  The data used in this particular analysis are confidential business information, so the analysis presents randomly assigned identification for these data.  The limit calculated for existing sources is 35.081 lb/ million tons feed, which assuming 1.65 tons feed per ton clinker and 54,000 dry standard cubic feet per ton clinker, results in a limit of 0.011 mg/dscm at 7 percent oxygen.   The result for new sources is 0.0037 mg/dscm.  This analysis is presented separately in Appendix D.

III. 	New Sources A. MACT Floors The approach for new sources was similar to that used with the existing sources, except the best performing unit's data within a subcategory was used to calculate the MACT floor emission limit instead of the average of the best performing 12 percent of units.  In summary, the approach ranks individual CISWI units based on actual performance and establishes MACT floors based on the best performing source for each pollutant and subcategory, with an appropriate accounting for emissions variability.

Table A-2 presents the NSPS floors for each pollutant for each subcategory.

B. Data Variability Analysis Similar to the analysis performed to determine EG limits, run-specific data for the best performing unit were compiled on a pollutant-by-pollutant basis and assessed to account for variability.  A summary of the statistical results for the NSPS data variability analysis is shown in Table A-4.  For further reference, Appendix E presents individual run data and associated analyses for each pollutant within each subcategory.

C. Determining Emission Limits  Emission limits for new sources, also based on the 99[th] percent UL (for incinerators) and the 99[th] percent UPL (for energy recovery units and waste-burning kilns) of the compiled run data for each pollutant, are presented in Table 2 below.  For further reference, the summary results of the UL and UPL analysis and derivation of the final emission limits for new units are presented in Table A-2 in Appendix A.  Table A-4 in Appendix A shows the emission limit calculations for new sources.

As noted in Table A-2, there were certain instances where the calculated emission limit for new sources was actually greater (less stringent) than the limit calculated for that pollutant for existing sources.  In these cases, the limit for existing sources was also adopted for new sources.  In a couple instances for waste-burning kilns and energy recovery units, the data available for similar sources was determined to be better suited for calculating the new source limits.  Notably, this is the case for NOx for waste-burning kilns, and for Hg and PCDD/PCDF for ERU-liquid/gas units.

Table 2.  Final CISWI MACT Floor Limits for New Sources                                Pollutant (units)                                   Subcategory                                                                         Incin-erators                         Energy recovery units  -  solids                       Energy recovery units  -  liquid/gas                               Waste-burning kilns                           Small, remote incin-erators HCl (ppmv) 0.091 0.50 14 3.0 200 CO (ppmv) 12 160 (biomass units)/ 46 (coal units) 36 90 (long kilns) / 320 (preheater / precalciner) 12 Pb (mg/dscm) 0.0019 0.0019 (biomass units) /  0.0031 (coal units) 0.096 0.0043 0.26 Cd (mg/dscm) 0.0023 0.00014 (biomass units) / 0.058 (coal units) 0.023 0.00082 0.61 Hg (mg/dscm) 0.00084 0.0020 0.00091 0.0037 0.0035 PM, filterable (mg/dscm) 18 5.1 (biomass units) / 86 (coal units) 110 8.9 230 PCDD/PCDF, total (ng/dscm) 0.058

0.52 (biomass units) / 0.51 (coal units) No limit

0.51 1200 PCDD/PCDF, TEQ (ng/dscm) 0.13 0.076 (biomass units) / 0.075 (coal units) 0.093 0.075 31 NOX (ppmv) 23 290 (biomass units)/ 340 (coal units) 76 200 78 SO2 (ppmv) 11 7.3 (biomass units)/ 650 (coal units) 720 130 1.2


[Federal Register Volume 80, Number 166 (Thursday, August 27, 2015)]
[Notices]
[Pages 52068-52070]
[FR Doc No: 2015-21081]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75744; File No. SR-BX-2015-050]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing of Proposed Rule Change To Adopt a Kill Switch

August 20, 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 August 7, 2015, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the 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.
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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

    The Exchange proposes to amend Chapter VI, Section 6, entitled
``Acceptance of Quotes and Orders,'' of the BX rules to adopt an
optional Kill Switch protection.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxbx.cchwallstreet.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 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 filing is to adopt a new risk protection, a Kill
Switch, applicable to all BX Participants. The Kill Switch will allow
BX Participants to remove quotes and cancel open orders and prevent new
order submission. This feature provides firms with a powerful risk
management tool for immediate control of their quote and order
activity.
    The Exchange proposes to amend Chapter VI, Section 6, entitled
``Acceptance of Quotes and Orders,'' to add new section (d) to adopt
the Kill Switch. The BX Options Kill Switch will be an optional tool
that enables Participants to initiate a message(s) \3\ to the System
to: (i) Promptly remove quotes; and/or (ii) promptly cancel orders.
Participants may submit a request to the System to remove/cancel quotes
and/or orders based on certain identifiers on either a user or group
level. Participants may elect to remove quotes and cancel orders by
Exchange account, port, and/or badge or mnemonic (``Identifier'') or by
a group (one or more Identifier combinations),\4\ which are provided by
such Participant to the Exchange. Participants may not remove quotes/
orders by symbol. The System will send an automated message to the
Participant when a Kill Switch request has been processed by the
Exchange's System.
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    \3\ BX Participants will be able to utilize an interface to send
a message to the Exchange to initiate the Kill Switch or they may
contact the Exchange directly.
    \4\ The type of group permissible would be within a broker-
dealer. For example, this could be including but not limited to all
market maker accounts or all order entry ports.
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    If the Participant selects quotes to be cancelled utilizing the
Kill Switch, the BX Participant must send a message to the Exchange to
request the removal of all quotes requested for the certain specified
Identifier(s).\5\ The BX Participant will be unable to enter any
additional quotes for the affected Identifier(s) until re-entry has
been enabled pursuant to proposed section (d)(iii).\6\
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    \5\ See note 3.
    \6\ Sweeps will also be cancelled. A sweep is a one-sided
electronic quote submitted
    over the Specialized Quote Feed, which is the market making
quoting interface.
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    If the Participant selects orders to be cancelled utilizing the
Kill Switch, the BX Participant must send a message to the Exchange to
request the cancellation of all orders requested for the certain
specified Identifier(s).\7\ The BX Participant will be unable to enter
additional orders for the affected Identifier(s) until re-entry has
been enabled pursuant to section (d)(iii).
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    \7\ See note 3.
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    Proposed section (d)(iii) stipulates that after quotes and/or
orders are removed/cancelled by the BX Participant utilizing the Kill
Switch, the BX Participant will be unable to enter additional quotes
and/or orders for the affected Identifier(s) until the BX Participant
has made a request to the Exchange and Exchange staff has set a re-
entry indicator to enable re-entry.\8\ Once enabled for re-entry, the
System will send a Re-entry Notification Message to the BX Participant.
The applicable Clearing Participant for that BX Participant also will
be notified of the re-entry into the System after quotes and/or orders
are removed/cancelled as a result of the Kill Switch, provided the
Clearing Participant has requested to receive such notification.
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    \8\ The BX Participant must directly and verbally contact the
Exchange to request the re-set.
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    The Exchange offers many risk mitigation and management tools today
including, but not limited to, certain rapid fire risk controls,\9\
15c3-5 risk controls, Order Price Protections,\10\ and cancel on
disconnect and purge functionality for Specialized Quote Feed (SQF) and
FIX. The Kill Switch offers Participants a means to control their
exposure, through an interface which is not dependent on the integrity
of the Participant's own systems, should the Participant experience a
failure.
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    \9\ See BX Rules at Chapter VII, Section 6(f).
    \10\ See BX Rules at Chapter VI, Section 18.
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    The Exchange proposes to implement this rule within ninety (90)
days of the implementation date. The Exchange will issue an Options
Trader Alert in advance to inform market participants of such date.

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, by enhancing the risk protections available to Exchange
members. The proposal promotes policy goals of the Commission which has
encouraged execution venues, exchange and non-exchange alike, to
enhance risk protection tools and other mechanisms to decrease risk and
increase stability.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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    The individual firm benefits of enhanced risk protections flow
downstream to counter-parties both at the Exchange and at other options
exchanges, thereby increasing systemic protections as well.
Additionally, because the Exchange offers this risk tool to all BX
Participants, the Exchange believes it will encourage liquidity
generally and remove impediments to and perfect the mechanism of a free
and open market and a national market system and protect investors and
the public interest.
    This optional risk tool as noted above will be offered to all BX
Participants. The Exchange further represents that its proposal will
operate consistently with the firm quote obligations of a broker-dealer
pursuant to Rule 602 of Regulation NMS and that the functionality is
not mandatory. Specifically, any interest that is executable against a
BX Participant's quotes and orders that are received \13\ by the
Exchange prior to the time the Kill Switch is processed by the System
will automatically execute at the price up to the BX Participant's
size. The Kill Switch message will be accepted by the System in the
order of receipt in the queue and will be processed in that order so
that interest that is already accepted into the System will be
processed prior to the Kill Switch message.
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    \13\ The time of receipt for an order or quote is the time such
message is processed by the Exchange book.
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    A BX Market Makers' obligation to provide continuous two-sided
quotes on a daily basis is not diminished by the removal of such quotes
and/or orders by utilizing the Kill Switch. BX Market Makers will be
required to provide continuous two-sided quotes on a daily basis. BX
Market Makers that utilize the Kill Switch will not be relieved of the
obligation to provide continuous two-sided quotes on a daily basis, nor
will it prohibit the Exchange from taking disciplinary action against a
BX Market Maker for failing to meet the continuous quoting obligation
each trading day.
    With respect to providing information regarding the removal of
quotes and/or cancellation of orders as a result of the Kill Switch to
the Clearing Participant, each Member that transacts through a Clearing
Member on the Exchange executes a Letter of Guarantee wherein the
Clearing Member accepts financial responsibility for all Exchange
transactions made by the BX Participant on whose behalf the Clearing
Member submits the letter of guarantee. The Exchange believes that
because Clearing Members guarantee all transactions on behalf of a
Participant, and therefore bear the risk associated with those
transactions, it is appropriate for Clearing Members to have knowledge
of the utilization of the Kill Switch, should the Clearing Member
request such notification.

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 not necessary or appropriate in
furtherance of the purposes of the Act. The proposal does not impose an
undue burden on inter-market competition because all BX Participants
may avail themselves of the Kill Switch, which functionality will be
optional. The proposed rule change is meant to protect BX Participants
in the event the BX Participant is suffering from a systems issue or
from the occurrence of unusual or unexpected market activity that would
require them to withdraw from the market in order to protect investors.
The ability to control risk at either the user or group level will
permit the BX Participant to protect itself from inadvertent exposure
to excessive risk at the each level. Reducing such risk will enable BX
Participants to enter quotes and orders without any fear of inadvertent
exposure to excessive risk, which in turn will benefit investors
through increased liquidity for the execution of their orders. Such
increased liquidity benefits investors because they receive better
prices and because it lowers volatility in the options market. For
these reasons, the Exchange does not believe this proposal imposes an
undue burden on inter-market competition, rather, the proposed rule
change will have no impact on competition.

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.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be 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-BX-2015-050 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-BX-2015-050. 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-BX-2015-050 and should be
submitted on or before September 17, 2015.

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

    \14\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-21081 Filed 8-26-15; 8:45 am]
 BILLING CODE 8011-01-P


Aldicarb Docket EPA-HQ-OPP-2005-0163

Debbie Edwards/DC/USEPA/US

08/14/2007 03:56 PM

To

<EMAIL_ADDRESS><EMAIL_ADDRESS>
cc

Subject

meeting with Peg Cherny

Bob and Anne,

I met with Peg Cherny of Bayer this morning. We spoke briefly about
aldicarb and the following points were made:

1. I updated her on our schedule for completion of the RED and
cumulative assessment, i.e., we are aiming for completion in FY07 but
haven't yet briefed at the AA level.  I mentioned that the cumulative
assessment would be issued with a public comment period.

2. I said that our current assessments do not consider any expansion of
the potato use and that such consideration would need to occur post-RED
and post-tolerance reassessment.  I also pointed out that consideration
of any use expansion would need to take into account any potential for
an increase in the cumulative risk from all N-methyl carbamates.

3. Peg said that, for niche uses of aldicarb on certain minor crops (we
didn't discuss specific crops), Bayer would like the Agency to consider
allowing continued use with geographic restrictions so that use is only
permitted where there is a clear ongoing need for the product.  She said
it is her understanding that, for certain niche uses, the only
alternative would be to use a soil fumigant.  She also pointed out that,
by geographically limiting the use, the area of consideration for ESA
assessments would be reduced and clearly defined.

Thanks - Debbie


[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13373-13375]
[FR Doc No: 2016-05626]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4750]

Implementation of the ``Deemed To Be a License'' Provision of the
Biologics Price Competition and Innovation Act of 2009; Draft Guidance
for Industry; Availability and Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Implementation of the `Deemed to be a License' Provision of the
Biologics Price Competition and Innovation Act of 2009.'' This draft
guidance describes FDA's approach to implementation of the statutory
provision under which an application for a biological product approved
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) on or before
March 23, 2020, will be deemed to be a license for the biological
product under the Public Health Service Act (PHS Act) on March 23,
2020. Specifically, this draft guidance describes FDA's interpretation
of the ``deemed to be a license'' provision of the Biologics Price
Competition and Innovation Act of 2009 (BPCI Act) for biological
products that have been or will be approved under the FD&C Act on or
before March 23, 2020. This draft guidance also provides
recommendations to sponsors of proposed protein products intended for
submission in an application that may not receive final approval under
the FD&C Act on or before March 23, 2020, to facilitate alignment of
product development plans with FDA's interpretation the transition
provisions of the BPCI Act.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 13, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-4750 for ``Implementation of the `Deemed to be a License'
Provision of the Biologics Price Competition and Innovation Act of
2009; Draft Guidance for Industry; Availability and Request for
Comments.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be

made publicly available, submit your comments only as a written/paper
submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Janice Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6268, Silver Spring, MD 20993-0002, 301-
796-3601; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Implementation of the `Deemed to be a License' Provision of
the Biologics Price Competition and Innovation Act of 2009.'' This
draft guidance describes FDA's approach to implementation of the
provision of the BPCI Act under which an application for a biological
product approved under section 505 of the FD&C Act (21 U.S.C. 355) on
or before March 23, 2020, will be deemed to be a license for the
biological product under section 351 of the PHS Act (42 U.S.C. 262) on
March 23, 2020. Specifically, this draft guidance describes FDA's
interpretation of the ``deemed to be a license'' provision in section
7002(e) of the BPCI Act for biological products that have been or will
be approved under section 505 of the FD&C Act on or before March 23,
2020. This draft guidance also provides recommendations to sponsors of
proposed protein products intended for submission in an application
that may not receive final approval under section 505 of the FD&C Act
on or before March 23, 2020, to facilitate alignment of product
development plans with FDA's interpretation of section 7002(e) of the
BPCI Act.
    Although the majority of therapeutic biological products have been
licensed under section 351 of the PHS Act, some protein products
historically have been approved under section 505 of the FD&C Act. On
March 23, 2010, the BPCI Act was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act
changed the statutory authority under which certain protein products
will be regulated by amending the definition of a ``biological
product'' in section 351(i) of the PHS Act to include a ``protein
(except any chemically synthesized polypeptide).'' FDA has interpreted
the statutory terms ``protein'' and ``chemically synthesized
polypeptide'' to implement the amended definition of ``biological
product'' (see FDA's guidance for industry entitled ``Biosimilars:
Questions and Answers Regarding Implementation of the Biologics Price
Competition and Innovation Act of 2009,'' available on FDA's Web site
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm).
    The BPCI Act requires that a marketing application for a
``biological product'' be submitted under section 351 of the PHS Act;
this requirement is subject to certain exceptions during a 10-year
transition period ending on March 23, 2020 (see section 7002(e)(1)-(3)
and (e)(5) of the BPCI Act). On March 23, 2020, an approved application
for a biological product under section 505 of the FD&C Act shall be
deemed to be a license for the biological product under section 351 of
the PHS Act (see section 7002(e)(4) of the BPCI Act). Among other
things, because the BPCI Act provides only that an application that is
approved on March 23, 2020, shall be deemed to be a license, FDA
interprets section 7002(e) of the BPCI Act to mean that the Agency will
not approve any application under section 505 of the FD&C Act for a
biological product subject to the transition provisions that is pending
or tentatively approved ``on'' March 23, 2020, even though section
7002(e)(2) of the BPCI Act expressly permits submission of an
application under section 505 of the FD&C Act ``not later than'' March
23, 2020, if certain criteria are met. Such an application may, for
example, be withdrawn and resubmitted under section 351(a) or 351(k) of
the PHS Act, as appropriate. FDA recognizes that this interpretation
could have a significant impact on development programs for any
proposed protein products intended for submission under section 505 of
the FD&C Act that are not able to receive final approval by March 23,
2020, and provides recommendations to sponsors in the draft guidance.
    We invite comment on the Agency's approach to implementation of the
``deemed to be a license'' provision of the BPCI Act, as described in
the draft guidance.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on implementation
of the ``deemed to be a license'' provision of the BPCI Act. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by

the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collection of information in 21
CFR part 312 has been approved under 0910-0014; the collection of
information in 21 CFR part 314 has been approved under 0910-0001; the
collection of information in 21 CFR part 601 has been approved under
0910-0338; and the collection of information for applications submitted
under section 351(k) of the PHS Act has been approved under 0910-0719.
In accordance with the PRA, before publication of the final guidance
document, FDA intends to solicit public comment and obtain OMB approval
for any information collections recommended in this guidance that are
new or that would represent material modifications to previously
approved collections of information found in FDA regulations or
guidances.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05626 Filed 3-11-16; 8:45 am]
BILLING CODE 4164-01-P