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Exposure 		Modeling Public Meeting (EMPM) Information and Products

Minutes of the October 3, 2006 Exposure Modeling Public Meeting

Minutes of the October 3, 2006 Exposure Modeling Public Meeting

Office of Pesticide Programs (OPP) Conference Room 4370

2777 Crystal Drive - Potomac Yard One, South

Arlington, VA 22202

On this Page

Attendees

Welcome and Introductions

Brief Updates

Major Presentations

Wrap up

Attendees

Name	Association

Marija Arsenovic		IR4

Lizanne Avon		PMRA

Reuben Baris		Environmental Turf Services

Michael Barrett		OPP/EFED

Steve Bedosky		LFR

Betsy Behl		OPP/EFED

Jim Breithaupt		OPP/EFED

Elizabeth Buckley	Pesticide and Toxic Chemical News

Katherine Carr		Monsanto

Wenlin Chen		Syngenta

James Cooper	Florida Dept. of Ag. and Consumer Svcs.

Mark Corbin		OPP/EFED

Marietta Echeverria		OPP/EFED

Tammara Estes		Stone Environmental

Kris Garber		OPP/EFED

Kurt Getsinger		USACE

Cathleen Hapeman		USDA-ARS

Paul Hendley		Syngenta

Erin Henry		OPP/EFED

Jim Hetrick		OPP/EFED

Scott Jackson		BASF

Russell Jones		Bayer Crop Science

RDavid Jones		OPP/EFED

Faruque Khan		OPP/EFED

Brian Kiernan		OPP/EFED

Jim Lin		OPP/EFED

Qingli Ma		Environmental Turf Services

Greg Malis		PMRA

Keara Moore		OPP/EFED

Andy Newcombe		LFR

Greg Orrick		OPP/EFED

Paul Paquin		Hydroqual

Ron Parker		OPP/EFED

Lucas Paz		LFR

T.S. Ramanarayanan		Bayer Crop Science

Amy Ritter		Waterborne Environmental

Mohammed Ruhman		OPP/EFED

Lucy Shanaman		OPP/EFED

Donald Stubbs		OPP/RD

Jane Tang		Bayer Crop Science

Michelle Thomson		Dupont

Nelson Thurman		OPP/EFED

Jayne Walz		Cerexagri

Tracy White		OPP/RD

Marty Williams		Waterborne Environmental

Dirk Young		OPP/EFED

Dial In Participants

Name	Association

Lars Anderson		USDA-ARS

Kevin Armbrust		State of MS

Monica Ball		Dupont

Mark Bookbinder		Bookbinder

Cecil Dharmasri		Syngenta

Tony Fristachi		USEPA-ORD

George Ghanem		IECIS

Daniel Hass		NYC health

Pat Haven		Dow Agrosciences

Heather Johnson		State of MN

Ian Kennedy		PMRA

Jim Knuteson		Dow Agrosciences

Bill Mahlburg		Nufarm

Elise McCoy		FMC

Roy Meyer		NJDEP

Natalia Peranginangin		Syngenta

George Sabbagh		Bayer Crop Science

John Troiano		CDPR

Katherine von Stackelburg		Menzie-Cura

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Welcome and Introductions

The Exposure Modeling Group hosts quarterly meetings that are open to the public to provide a forum for cooperative exchange of facts and technical information on technical issues related to pesticide exposure modeling between EFED and stakeholders with similar technical expertise. Keara Moore (OPP/EFED) chaired the meeting in the capacity of co-chair of the EFED Water Quality Tech Team (WQTT).

This meeting includes presentations which focused on exposure assessment for aquatic pesticides. All FIFRA EMWG agendas, minutes and presentations and be found at: http://www.epa.gov/oppefed1/models/water/emwg_top.htm

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Brief Updates

New WQTT co-chairs

Dirk Young and Greg Orrick will be the WQTT co-chairs for the upcoming year.

PRZM3.12.2 Evaluation

QA/QC of the new version of PRZM has been completed.  The report is being finalized to incorporate minor edits and will be released soon.  This update only addresses curve number and emergence dates issues.  QA/QC review of volatility/temperature issues will be handled as a separate project at a later date.  The new version of the EFED shell (PE5.pl) and the updated scenarios are ready and will be released when PRZM 3.12.2 is implemented.

EXPRESS

EFED is working with ORD on a QA/QC process for EXPRESS.  EXPRESS will be implemented when QA/QC is completed successfully.

Rice Model

T.S. Ramanarayanan asked about the status of the rice model and about the "interim" rice model.  Betsy Behl answered that the refined rice model development project was not completed due to EFED's increased workload to meet its reregistration deadlines.  The Agency agreed that the rice model has been "interim" for some time, and confirmed that it is the model that is used to assess aquatic exposure from pesticides used on rice.

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Major Presentations

Herbicides for Submersed Weed Control:  Understanding Aqueous Concentration and Exposure Time Relationships (Kurt Getsinger, U.S. Army Corp of Engineers)

Invasive aquatic plants have a number of negative consequences such as impeding navigation, curtailing recreation, clogging water intakes, degrading fish and wildlife habitat, decreasing biodiversity, and harming threatened and endangered species.  Herbicide treatments for aquatic plants can be made as emergent applications, treating the leaf surface, or as submersed application, treating the water body.  Herbicide efficacy is dependent on dose and contact time, with lower doses requiring longer exposure times.  Concentration and exposure time relationships (CETs) are unique to both herbicide and plant.  Laboratories, growth chambers, greenhouses, outdoor tanks, and ponds are used to test the CETs.  Herbicides should be selected based on the CET relationship; to have acceptable control, you must identify the target plant, determine the proper exposure time required for the herbicide/plant combination, and understand the water exchange characteristics of the treatment site.  Treatment areas include spot treatments, partial lake treatments, and large blocks or whole lakes.  As the treated area increases, the application rate may possibly be reduced because of the ratio of treated: non-treated water.  Contact time of herbicides is influenced by water column distribution, which is affected by water exchange processes, including gravity flow, wind-generated currents, and temperature factors (isothermal and stratified conditions).  To achieve the optimal contact time when applying submersed herbicides, apply in static/quiescent water and low-wind conditions, inject below water surface with variable length hoses, and apply when the water column is close to isothermal conditions.  In flowing water environments, there are different factors affecting the CETs.

Assessing Exposure to Aquatic Plant Pesticides (R David Jones & Nelson Thurman, USEPA - OPP/EFED)

The United States Environmental Protection Agency (USEPA) Office of Pesticide Programs (OPP) conducts both ecological and human health risk assessments for pesticides applied directly to aquatic systems.  The Environmental Fate and Effects Division (EFED) of OPP has primary responsibility for estimating exposure in aquatic systems from the direct application of pesticides.  EFED attempts to answer several general questions when conducting exposure assessments for aquatic pesticides, including what is the maximum expected concentration as specified on the label, how long will the pesticide persist in these systems above levels of concern (LOC), how far will the pesticide travel from the site of application at concentrations above the LOC, and how sufficient is the available data to answer these questions.  Examples of direct applications to aquatic systems, which EFED typically has evaluated, include application to rice paddies, application to reservoirs and ponds, and application to irrigation canals.  Commonly applied pesticides include herbicides for control of native and invasive weeds, insecticides, and piscicides.

Examples discussed in the presentation included application of fipronil to rice paddies for insect control, 2,4-D to reservoirs for weed control, xylene and acrolein to irrigation canals for weed control, and rotenone to ponds for control of invasive or undesirable fish.  The first examples of assessment techniques presented included the calculation of pesticide concentrations in rice paddy water at the point of release to surface water streams.  Comparison of predicted fipronil concentration in release water compared favorably with available monitoring data.  For 2,4-D, an assessment of potential setback distances between application for aquatic weed control and drinking water intakes was discussed.  In this example, a simple advection/dispersion model was used to evaluate an appropriate setback distance for labeling.  Using a simple model accounting for dilution, degradation and volatilization, Xylene was assessed to determine how long it would persist above the LOC after discharge from an irrigation system.  Rotenone was presented as an example of an assessment approach for a piscicide with limited fate data.  The intention of the assessment was to determine how long after treatment could native fish species be re-introduced to both lakes/reservoirs and streams/rivers.  Acrolein was another herbicide used in irrigation canals presented as an assessment example.  In this example, acrolein is applied to irrigation systems and is not intended to reach surface waters beyond the canal systems.  A proposed approach was presented for assessing under what conditions acrolein would not be expected to reach surface waters.  Finally, the presentation summarized future goals for EFED to develop new approaches for assessing other aquatic use scenarios, including a higher level rice model, cranberries and watercress, mosquito larvacides, and more advanced approaches for assessing piscicides.

Use of Visual PLUMES and EXAMS in the Development and Field Evaluation of Aquatic Herbicides (Scott Jackson, BASF)

Hydrilla was presented as an example of an invasive species. This plant is very difficult to control because it lives in a wide variety of water bodies and tolerates a wide variety of   salinity, temperature, nutrient and light conditions. The project evaluated the use of models on two types of systems: semi-static systems such as lakes and ponds and flowing systems such as streams, ditches and canals.

Because contact time is critical with chemical control techniques for plants, there is a time/concentration element required to effectively use aquatic herbicides. Because concentration must be maintained for a period of time, flowing water and stratified water bodies may become a complex challenge.

This evaluation project has been using two models in tandem to assess both risk and efficacy challenges for aquatic herbicides. They are the Exposure Analysis Modeling System (EXAMS) for semi-static systems and the EPA/ORD model, Visual PLUMES for flowing systems. EXAMS is an interactive software application for formulating aquatic ecosystem models and rapidly evaluating the fate, transport, and exposure concentrations of synthetic organic chemicals. The Visual Plumes model system is a Windows-based software application for simulating surface water jets and plumes. It also assists in the preparation of mixing zone analyses, Total Maximum Daily Loads (TMDLs), and other water quality applications.

Presently there are five models built into Visual Plumes platform. These are DKHW, NRFIELD/FRFIELD, UM3, PDSW, and DOS PLUMES. Although all the models have features that make them useful, the evaluation project focused on the UM3 model. Application inputs to the model are port diameter, elevation, vertical and horizontal angle, number, spacing and depth plus the acute/chronic mixing zone and effluent flow and concentration of the active ingredient. Ambient inputs include E-fate property information, speed and direction of the current, salinity, ambient temperature, background concentration, decay rate and far-field diffusion. The model uses a representative meteorological file for rainfall. The pond has turnover and outflow.

Visual Plumes and EXAMS allow straightforward determination of drinking water setback distances, calculation of eco exposure EEC values, calculation of human health EDWC values for dietary assessment and water holding times to estimate acceptable non-target plant exposure. Recent developments to the model include the ability to use daily meteorology data to more realistically simulate volume change and water body turn over,  which are important for calculating herbicide/plant contact time.

A 2-Dimensional Modeling Approach to Estimate Holding Time and Setback Distances in Generalized Canal and Lake Settings (Lucas W. Paz, Ph.D., LFR Inc./Syngenta)

Lucas Paz of LFR Inc. presented a 2-dimensional modeling approach to estimate holding time and setback distances at which compound concentrations in canals and lakes reach acceptable background levels.  The approach uses the Enhanced RMA Model Suite, which consists of RMA-GEN, a graphically interactive finite element geometric model; RMA-10, a finite element hydrodynamic model; RMA-11, a linked water quality model; and RMA-PLT, a post-processing module.  The methodology was conducted over sixty model runs that included five application rates and six treatment areas for two scenarios (canals and lakes). Results from each of the sixty model runs were evaluated separately by monitoring selected nodes at downstream intervals and by evaluating the detailed graphical output associated with each model run. A simplified file naming convention was established in accordance with the five application rates (L1-L5) and the six types of percent area applications (P5, P10, P20, P30, P40, and P50) for each scenario. The evaluation indicated that application rates/loading regimes and geometries as well as key physical and chemical input parameters strongly influence modeled results.  Estimates of holding time (T_e), at which concentrations are no longer of concern at loaded elements, were significantly longer than estimates of time to maximum downstream distance traveled by concentrations of concern (T_d) for canal scenario runs.  However, T_e estimates were significantly shorter than T_d estimates for most lake runs.  Detailed examination of graphical output files reveal that the downstream longitudinal extent of the canal plumes begin  to contract before the plume core leaves the application area (the loaded elements).  This difference in canal plume behavior was found to be primarily caused by larger canal dispersion coefficients, restricted canal geometry, and greater total mass loading for the lake scenario.  The presentation concluded with 1-minute animations of modeled concentration estimates over time in the canal and lake scenarios.

Dissipation of Aquatic Herbicides in Flowing Water - Lars Anderson, USDA-ARS Exotic and Invasive Weed Research, Davis, California

The United States Department of Agriculture (USDA) Agricultural Research Service (ARS) is responsible for conducting research into the effective methods for control of aquatic plants, including aquatic herbicides.  Aquatic herbicides are typically applied as either a foliar, aerial application or as a subsurface injection.  Aerial or surface applications are designed to control emerged aquatic plants, which can either be floating with roots in the water column, or plants which are rooted in the bottom of the system but with foliage emergent above the water surface.  Subsurface injection is intended to control submersed plants, which are typically rooted in bottom sediments.  When designing an aquatic herbicide application program, it is critical to understand the nature of the target plant.  In addition, an aquatic weed control program must be designed with optimal conditions for efficacy.  Key factors are correct placement of the pesticide, obtaining the proper pesticide concentration in the target zone, and insuring the appropriate contact time between the pesticide and the target plant.  Estimation of the necessary contact time is critical to understanding what concentration should be applied.  Studies have shown that increasing contact time can dramatically reduce the needed concentration to achieve efficacy.  In order to understand the appropriate contact time, the study design must take into account factors that could reduce or remove pesticide from the target zone.  Important factors to consider include diffusion (dilution), degradation, plant uptake, non-target organism uptake, adsorption, and interaction with other chemicals, volatilization, and currents in the system.  The geometry and nature of the target zone can have a profound influence on the potential removal of the pesticide from the desired application area.  Physical interaction of the target system can result in significant changes in flow through the target area.  Applications in flowing systems need to be targeted to the specifics of the system.  An understanding of the needed duration of exposure is critical to a successful treatment.  Specific examples of copper applications in flowing systems, including tidally influenced systems, were presented.  The conclusion of these specific examples is that dissipation can be reasonably predicted in "clean" conduits, but that plants, vertical mixing, and other variables of hydraulic condition can influence transport rates, and hence dissipation from a target zone.

Three Approaches to Modeling Dispersion of Aquatic Herbicides (Marty Williams and Amy Ritter, Waterborne Environmental)

Marty Williams of Waterborne Environmental presented several approaches to model dispersion of aquatic herbicides to estimate setback distances and timing restrictions in different environments.  In a canal environment, they used RIVWQ, a link-node finite dispersion model that simulates transport driven by river driven flows and dispersion processes.  The model was developed to fill a niche left by other commonly used models, which are steady state or not convenient for large modeling.  It can simulate a parent compound and up to four degradates in a variety of transformation processes.  Validation against field test results showed that the model reproduced observed concentrations well.  To model a lake environment, Waterborne used EXAMS, a surface water model developed by  EPA.  Instead of using it as a single compartment model, as EFED does for exposure assessment, they used a segment/compartment approach where the system is divided into a number of discrete volumes connected by advective and dispersive fluxes.  This model can simulate a large range of usage environments and conditions and can be used to graphically represent results for different areas of a system.  To model an estuary environment, Waterborne used the Environmental Fluid Dynamics Code (EFDC), a hydrodynamic model based on equations of unsteady flow.  EFDC includes a sophisticated sediment transport model to handle partitioning to sediment and can give spatial and temporal output.  Model selection is often a trade-off between the difficulty in obtaining a solution and the risk of not representing the system.  If modeling is accepted by regulatory agencies, it can be useful to discuss novel approaches in advance and to include field studies in the data package.

Exposure Modeling Approaches for Terrestrial and Aquatic Uses of Copper  (Jim Hetrick and Paige Doelling-Brown, USEPA - OPP/EFED)

Jim Hetrick, Senior Physical Scientist of the Environmental Fate and Effects Division, presented key highlights of the exposure modeling approach for the terrestrial and aquatic uses of copper.  The work was done for the ecological risk assessment conducted in support of the Coppers Registration Eligibility Decision (RED) and was harmonized with the Office of Water's approach for setting "aquatic life criteria."

A spatially-explicit risk assessment was conducted using site-specific USGS water quality monitoring data in conjunction with modeling.  For estimating potential exposures for terrestrial and aquatic uses, PRZM/EXAMS or EXAMS was used to simulate concentrations of total Cu.  The Office of Water's Biotic Ligand Model (BLM), an aqueous speciation model, was used to predict site-specific Cu2+ activity and site-specific toxicity endpoints (LC50s) using median water quality data from 811 USGS monitoring sites.   For indirect aquatic uses (e.g., "root killers"), the Office of Pollution Prevention and Toxics' Exposure and Fate Assessment Screening Tool (E-FAST) was used to estimate concentrations of total Cu, EPISuite was used to estimate a water treatment removal efficiency, and flow assumptions (7Q10 or 30Q5) were used to estimate concentrations in flowing water bodies.  In summary, the assessment demonstrated that sites with low pH, low DOC and/or low alkalinity were vulnerable to adverse effects to aquatic organisms from applications of copper.

Field and Modeling Support for Aquatic Pesticide Registrations (Jim Knuteson and Pat Havens, Dow AgroSciences)

Jim Knuteson of Dow AgroSciences presented field studies and modeling conducted in support of registration of the aquatic herbicide triclopyr.  Field dissipation studies in large lake environments found bulk dissipation rates of 0.5 to 4.8 days, while in whole pond environments, dissipation rates ranged from 5.9 to 7.5 days.  In one of these studies, rhodamine dye was applied as well as triclopyr, and the results were used to validate an EXAMSII modeling approach.  Measured dye concentrations were used to calibrate longitudinal dispersion and water velocity inputs.  The model was run using those inputs along with the environmental fate parameters for triclopyr.  Simulated dissipation was compared to the measured dissipation, and it was concluded that EXAMSII can be used to predict aquatic dissipation.  Dow also developed a shoreline model with EXAMS to examine triclopyr movement with scenarios representative of lakes and reservoirs and varying dispersion coefficients, application areas, and water velocities.  The model predicted setback distances, where the long-term annual average concentration would be below the level of concern, of 300 to 600 m.  EFED had an alternative approach for modeling setback distances using a Python program based on the analytical solution to the one-dimension convection-dispersion equation.  Modeling a water body based on the Index Reservoir with conservative assumptions about environmental parameters led to setback distances of 300 to 792 m for the same situations previously modeled with EXAMS.  The Python model is useful for Tier I modeling of simple chemical transport in slow moving water with minimum dispersion.  More advanced flow modeling needs to be attempted for more refined assessment.

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Wrap up

Next Meeting

EFED is looking into dates for the next meeting and will announce the date through the list server.

EFED is considering holding EMWG meetings three times a year instead of quarterly.  Comments were generally supportive of the change.  An official announcement will be made through the listserver if this change is adopted.

Paul Hendley suggested that meetings covering a range of general topics should be included as well as meetings focusing on particular themes.

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[Federal Register Volume 75, Number 129 (Wednesday, July 7, 2010)]
[Proposed Rules]
[Pages 38947-38950]
[FR Doc No: 2010-16553]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0675; Directorate Identifier 2010-NM-061-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A330-200 and A330-300
Series Airplanes, and Model A340-200, A340-300, A340-500, and A340-600
Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as: Investigation conducted by Thales on probes revealed oil
residue between the stator and the rotor parts of the AoA [angle of
attack] vane position resolvers. This oil residue was due to incorrect
cleaning of the machining oil during the manufacturing process of the
AoA resolvers. At low temperatures, this oil residue becomes viscous
(typically in cruise) causing lag of AoA vane movement. Such condition
could lead to discrepant AoA measurement. If not corrected, and if two
or three AoA probes were simultaneously affected and provided wrong
indications of the AoA to a similar extent, it could lead to a late
activation of the angle of attack protection, which in combination with
light at high angle of attack would constitute an unsafe condition. The
proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by August 23, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For Airbus service information identified in this proposed AD,
contact Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 45 80; e-mail<EMAIL_ADDRESS>Internet
http://www.airbus.com.
    For Thales Avionics service information identified in this proposed
AD, contact Thales--Aerospace Division, 105, avenue du General
Eisenhower--BP 63647, 31036 Toulouse Cedex 1, France; telephone +33
(0)5 61 19 65 00; fax +33 (0)5 61 19 66 00; Internet http://www.thalesgroup.com/aerospace.
    You may review copies of the referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1138; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-0675;
Directorate Identifier 2010-NM-061-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We have lengthened the 30-day comment period for proposed ADs that
address MCAI originated by aviation authorities of other countries to
provide adequate time for interested parties to submit comments. The
comment period for these proposed ADs is now typically 45 days, which
is consistent with the comment period for domestic transport ADs.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2010-0016R1, dated February 9, 2010 (referred
to after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    During Airbus Final Assembly Line reception flight tests, AoA
[angle of attack] data from two different aeroplanes were found
inaccurate. Inaccuracy was confirmed by flight data analysis.
    Investigation conducted by Thales on the removed probes revealed
oil residue between the stator and the rotor parts of the AoA vane
position resolvers. This oil residue was due to incorrect cleaning
of the machining oil during the manufacturing process of the AoA
resolvers. At low temperatures, this oil residue becomes viscous
(typically in cruise) causing lag of AoA vane movement.
    Such condition could lead to discrepant AoA measurement. If not
corrected, and if two or three AoA probes were simultaneously
affected and provided wrong indications of the AoA to a similar
extent, it could lead to a late activation of the angle of attack
protection, which in combination with flight at high angle of attack
would constitute an unsafe condition.
    Therefore, this [EASA] AD requires a one time inspection of the
Thales Avionics AoA probe P/N [part number] C16291AA in order to
identify the suspect parts and to remove them from service.
    This [EASA] AD revision is issued to specify that the
identification of the affected AoA probes is also possible in
accordance with aeroplane maintenance records data analysis.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Airbus has issued the service bulletins specified in the following
table. Thales Avionics has issued Service Bulletin C16291A-34-007,
Revision 01, dated December 3, 2009. The actions described in this
service information are intended to correct the unsafe condition
identified in the MCAI.

                                      Table--Applicable Service Information
----------------------------------------------------------------------------------------------------------------
                  Model                               Document                              Date
----------------------------------------------------------------------------------------------------------------
Model A330-200 and A330-300 series        Airbus Mandatory Service         January 20, 2010.
 airplanes.                                Bulletin A330-34-3232,
                                           including Appendix 01.
Model A340-200 and A340-300 series        Airbus Mandatory Service         January 20, 2010.
 airplanes.                                Bulletin A340-34-4239,
                                           including Appendix 01.
Model A340-500, and A340-600 series       Airbus Mandatory Service         January 20, 2010.
 airplanes.                                Bulletin A340-34-5072,
                                           including Appendix 01.
----------------------------------------------------------------------------------------------------------------

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 44 products of U.S. registry. (There are currently
no Model A340 airplanes on the U.S. Register.) We also estimate that it
would take about 3 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $11,220, or $255 per product.

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

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Airbus: Docket No. FAA-2010-0675; Directorate Identifier 2010-NM-
061-AD.

Comments Due Date

    (a) We must receive comments by August 23, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the airplanes identified in paragraphs
(c)(1) and (c)(2) of this AD.
    (1) Airbus Model A330-201, A330-202, A330-203, A330-223, A330-
243, A330-301, A330-302, A330-303, A330-321, A330-322, A330-323,
A330-341, A330-342 and A330-343 airplanes, certificated in any
category; all manufacturer serial numbers, equipped with Thales
Avionics angle of attack (AOA) probe having part number (P/N)
C16291AA.
    (2) Airbus Model A340-211, A340-212, A340-213, A340-311, A340-
312, A340-313, A340-541, and A340-642 airplanes, certificated in any
category, all manufacturer serial numbers, equipped with Thales
Avionics AOA probe having P/N C16291AA.

Subject

    (d) Air Transport Association (ATA) of America Code 34:
Navigation.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    During Airbus Final Assembly Line reception flight tests, AoA
data from two different aeroplanes were found inaccurate. Inaccuracy
was confirmed by flight data analysis.
    Investigation conducted by Thales on the removed probes revealed
oil residue between the stator and the rotor parts of the AoA vane
position resolvers. This oil residue was due to incorrect cleaning
of the machining oil during the manufacturing process of the AoA
resolvers. At low temperatures, this oil residue becomes viscous
(typically in cruise) causing lag of AoA vane movement.
    Such condition could lead to discrepant AoA measurement. If not
corrected, and if two or three AoA probes were simultaneously
affected and provided wrong indications of the AoA to a similar
extent, it could lead to a late activation of the angle of attack
protection, which in combination with flight at high angle of attack
would constitute an unsafe condition.
    Therefore, this [European Aviation Safety Agency (EASA)] AD
requires a one time inspection of the Thales Avionics AoA probe P/N
C16291AA in order to identify the suspect parts and to remove them
from service.
    This [EASA] AD revision is issued to specify that the
identification of the affected AoA probes is also possible in
accordance with aeroplane maintenance records data analysis.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Inspection of AOA Probes

    (g) Within 3 months after the effective date of this AD, perform
a detailed visual inspection of the Thales Avionics AOA probes
having P/N C16291AA for a serial number identification, in
accordance with the instructions of the applicable service
information identified in Table 1 of this AD. A review of airplane
maintenance records is acceptable in lieu of this inspection if the
serial number of the AOA probe can be conclusively determined from
that review. If no AOA probe having P/N C16291AA and a serial number
identified in Thales Service Bulletin C16291A-34-007, Revision 01,
dated December 3, 2009, is identified during the inspection required
by this paragraph of this AD, no further action is required by this
AD, except for paragraph (i) of this AD.

                                     Table 1--Applicable Service Information
----------------------------------------------------------------------------------------------------------------
                  Model                              Document                              Date
----------------------------------------------------------------------------------------------------------------
Model A330-200 and A330-300 series         Airbus Mandatory Service      January 20, 2010.
 airplanes.                                 Bulletin A330-34-3232.
Model A340-200 and A340-300 series         Airbus Mandatory Service      January 20, 2010.
 airplanes.                                 Bulletin A340-34-4239.
Model A340-500, and A340-600 series        Airbus Mandatory Service      January 20, 2010.
 airplanes.                                 Bulletin A340-34-5072.
----------------------------------------------------------------------------------------------------------------

Replacement of Identified AOA Probes

    (h) If the serial number of the AOA probe identified during the
inspection required by paragraph (g) of this AD corresponds to a
suspect AOA probe specified in Thales Service Bulletin C16291A-34-
007, Revision 01, dated December 3, 2009: At the applicable time
specified in paragraph (h)(1) or (h)(2) of this AD, replace the
affected AOA probe with a serviceable AOA probe in accordance with
one of the four options specified in and in accordance with the
Accomplishment Instructions of the applicable service bulletin
specified in Table 1 of this AD.
    (1) For airplanes on which Airbus Modification 53368 (back-up
speed scale) has been embodied in production or Airbus Service
Bulletin A330-34-3213, Airbus Service Bulletin A340-34-4213, or
Airbus Service Bulletin A340-34-5060, as applicable, has been
embodied in service: Within 3 months after the effective date of
this AD.
    (2) For airplanes on which Airbus Modification 53368 (back-up
speed scale) has not been embodied in production and Airbus Service
Bulletin A330-34-3213, Airbus Service Bulletin A340-34-4213, or
Airbus Service Bulletin A340-34-5060, as applicable, has not been
embodied in service: Within 15 months after the effective date of
this AD.

Parts Installation

    (i) As of the effective date of this AD, no person may install,
on any airplane, a Thales Avionics AOA probe having P/N C16291AA and
a serial number identified in Thales Service Bulletin C16291A-34-
007, Revision 01, dated December 3, 2009, unless the AOA is fitted
with an inspection label stating that Thales Service Bulletin
C16291A-34-007, Revision 01, dated December 3, 2009, has been
accomplished.

FAA AD Differences

    Note 1:  This AD differs from the MCAI and/or service
information as follows: No differences.

Other FAA AD Provisions

    (j) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN:
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (k) Refer to MCAI EASA Airworthiness Directive 2010-0016R1,
dated February 9, 2010, and the service information identified in
Table 2 of this AD, for related information.

                                      Table 2--Related Service Information
----------------------------------------------------------------------------------------------------------------
                 Document                            Revision                              Date
----------------------------------------------------------------------------------------------------------------
Airbus Mandatory Service Bulletin A330-34- Original....................  January 20, 2010.
 3232.
Airbus Mandatory Service Bulletin A340-34- Original....................  January 20, 2010.
 4239.
Airbus Mandatory Service Bulletin A340-34- Original....................  January 20, 2010.
 5072.
Thales Service Bulletin C16291A-34-007...  Revision 01.................  December 3, 2009.
----------------------------------------------------------------------------------------------------------------

    Issued in Renton, Washington, on June 25, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-16553 Filed 7-6-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Rules and Regulations]
[Page 71735]
[FR Doc No: 2023-22933]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-1747; Airspace Docket No. 23-ASW-15]
RIN 2120-AA66

Establishment of Class E Airspace; Uvalde, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace at Uvalde, TX. The
FAA is taking this action to support new public instrument procedures.

DATES: Effective date 0901 UTC, December 28, 2023. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: A copy of the Notice of Proposed Rulemaking (NPRM), all
comments received, this final rule, and all background material may be
viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval help and guidelines are available on the website.
It is available 24 hours each day, 365 days each year.
    FAA Order JO 7400.11H, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Raul Garza Jr., Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it establishes Class E airspace extending upward from 700
feet above the surface at Ox Ranch Airport, Uvalde, TX, to support
instrument flight rule operations at this airport.

History

    The FAA published an NPRM for Docket No. FAA 2023-1747 in the
Federal Register (88 FR 54955; August 14, 2023), proposing to establish
the Class E airspace at Uvalde, TX. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received.

Incorporation by Reference

    Class E airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11, Airspace Designations and Reporting Points, which
is incorporated by reference in 14 CFR 71.1 on an annual basis. This
document amends the current version of that order, FAA Order JO
7400.11H, dated August 11, 2023 and effective September 15, 2023. FAA
Order JO 7400.11H is publicly available as listed in the ADDRESSES
section of this document. These amendments will be published in the
next update to FAA Order JO 7400.11.
    FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This action amends 14 CFR part 71 by establishing Class E airspace
upward from 700 feet above the surface within a 7.5-mile radius of Ox
Ranch Airport, Uvalde, TX.
    This action supports new public instrument procedures.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (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);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11H, Airspace Designations and Reporting Points, dated August 11,
2023, and effective September 15, 2023, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASW TX E5 Uvalde, TX [Establish]

Ox Ranch Airport, TX
    (Lat 29[deg]27'41'' N, long 100[deg]06'51'' W)

    That airspace extending upward from 700 feet above the surface
within a 7.5-mile radius of the Ox Ranch Airport.
* * * * *

    Issued in Fort Worth, Texas, on October 12, 2023.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2023-22933 Filed 10-17-23; 8:45 am]
BILLING CODE 4910-13-P


1 June 26, 2003 Esteban Mujica Cotto, Esq. President Puerto Rico Environmental Quality Board P. O. Box 11488 San Juan, Puerto Rico 00910 1488 Dear Mr. Mujica:

The U. S. Environmental Protection Agency ( EPA) has completed its review of the revisions to the Puerto Rico Water Quality Standards Regulation ( PRWQSR) dated March 2003. These revisions were adopted by the Puerto Rico Environmental Quality Board ( PREQB), and submitted to EPA, on March 28, 2003. They became effective on June 5, 2003. By letter dated May 28, 2003, and received by EPA on June 11, 2003, Puerto Rico's Secretary of Justice certified that the 2003 revisions had been adopted in accordance with the law of the Ccommonwealth. In taking this action, EPA considered the following documents submitted in connection with the revised PRWQSR:

1. the letter from the Commonwealth's Secretary of Justice, Ms. Anabelle Rodriguez ( Attorney General), certifying that the standards were duly adopted pursuant to Commonwealth law ( dated May 28, 2003);

2. the applicable notices from the El Vocero, and the San Juan Star ( both dated February 6, 2002);

3. PREQB's Resolution and Notification R 03 5 regarding the amendments to the PRWQSR ( dated March 31, 2003); and,

4. The Responsiveness Summary ( Hearing Examiner's report) on the comments received during the public comment period and at the public hearing held on March 6, 2002 ( dated March 25, 2003).

Under Section 303( c) of the Clean Water Act ( CWA), 33 U. S. C. § 1313( c), states are required to conduct a triennial review of their water quality standards and submit any new or revised standards to EPA for review. Federal regulations at 40 C. F. R. § § 131.20 131.22 implement these requirements. Puerto Rico's previous review and revision of its water quality 2 standards regulations were adopted on July 20, 1990, and became effective on October 27, 1990. As part of the review process on the 2003 revisions, PREQB held a public hearing on March 6, 2002 to receive public input and comment on the proposed revisions to the PRWQSR. EPA considers the adoption of the 2003 revisions to the PRWQSR, along with the public review and comment process, to constitute the Commonwealth's triennial review of water quality standards. Based on our review, PREQB's procedures are consistent with, and satisfy the procedural requirements of 40 C. F. R. § 131.20.

The following constitute the revisions which are being addressed under this action. These revisions enhance the PRWQSR, and represent improvements in the PRWQSR.

° revisions to the Puerto Rico antidegradation policy, to include the protection of threatened and endangered species, which are approved as being consistent with the requirements under 40 C. F. R. § 131.12;

° the adoption of several new and revised definitions ( Article 1), including the definitions of " acute effect, existing uses, natural background concentration, pollutant, primary contact, and sewage," as well as the deletion of " pollute," which are approved as being consistent with the requirements under 40 C. F. R. § 131.3;

° the reclassification of 10 bays/ estuaries, which were previously classified as Class SC waters to Class SB ( Article 2.1.3), which are approved as being consistent with the requirements under 40 C. F. R. § 131.10( a)  ( e);

° the inclusion of the term " wetlands" in the introductory paragraph regarding the applicability of the Commonwealth's general water quality standards to the waters of Puerto Rico ( Article 3), which is approved as being consistent with the requirements under 40 C. F. R. § 122.2;

° the adoption of numerous chemical specific numeric criteria for toxic pollutants of concern in the Commonwealth ( Article 3.1.9 ( A)  ( E)), as required by Section 303( c)( 2)( B) of the CWA, which are approved as being consistent with the requirements under 40 C. F. R. § 131.11.

° the inclusion of the protection of threatened or endangered species as a designated use for Class SB, SC and SD waters ( Articles 3.2.2  3.2.4), which is approved as being consistent with the requirements under 40 C. F. R. § 131.10( a);

° the revision of the fecal coliform criteria for Class SD waters ( freshwaters) from 2000/ 100ml ( geometric mean) to 200/ 100ml, and 4000/ 100ml ( not to exceed) to 400/ 100ml, which are approved as being consistent with the requirements under 40 C. F. R. § 131.6( c) and, 40 C. F. R. § 131.11( a);

° revisions which further clarify the Commonwealth's policy on the requirements for 3 point sources to discharge to intermittent streams ( Article 4.3. L and 4.5.1. B), which are approved as being consistent with the requirements under 40 C. F. R. § 131.13;

° a revision to the mixing zone policy stating that mixing zones shall not be located areas which are habitat for threatened or endangered species ( Articles 5.4.11), which is approved as being consistent with the requirements under 40 C. F. R. § 131.13;

° revisions to the provisions for the granting of temporary exemptions ( variances) to specify that any approval by the Commonwealth of a temporary exemption will comply with the following terms and conditions: ( 1) the application must contain a justification for the requested variance consistent with 40 C. F. R. § 131.10( g)( 6), that the costs necessary to comply with the relevant water quality standard( s) would result in substantial economic and social impacts; ( 2) the variance shall be adopted only after completion of a public participation process, in conformity with Puerto Rican law and/ or regulation, as would apply to any revision to the PRWQSR; ( 3) the variance shall be submitted for EPA review and approval as a change to water quality standards before it may take effect ( 40 C. F. R. 131.21); and ( 4) if approved, the variance shall be published in the PRWQSR. ( Article 9). These revisions are approved as being consistent with the requirements under 40 C. F. R. § 131.13; and,

° inclusion of applicable technical, administrative, and/ or editorial corrections or clarifications to existing provisions throughout the PRWQSR, which are approved as being consistent with the requirements under 40 C. F. R. § 131.3.

By this letter, I am pleased to approve the above revisions to the PRWQSR pursuant to Section 303( c) of the CWA. Based upon EPA's review, it has been determined that all of the new and revised human health and aquatic life criteria adopted by PREQB in Article 3.1.9 ( a)  ( e) meet the requirements of the National Toxics Rule ( NTR). Therefore, these water quality criteria are approved as consistent with 40 C. F. R. § 131.11. EPA will begin the process of withdrawing Puerto Rico from the NTR for all such water quality criteria.

EPA initiated consultation with the U. S. Fish and Wildlife Service and the National Marine Fisheries Service ( Services) on July 17, 2002, under Section 7( a)( 2) of the Endangered Species Act. Section 7( a)( 2) requires that federal agencies, in consultation with the Services, insure that their actions are not likely to jeopardize the existence of federally listed species or result in the adverse modification of designated critical habitat of such species. In a letters dated May 27, 2003 and December 5, 2002, respectively, the U. S. Fish and Wildlife Service and the National Marine Fisheries Service provided written concurrence that the revisions to the PRWQSR are not likely to adversely affect threatened/ endangered species ( Enclosures 1 and 2). 4 EPA Region II looks forward to continuing to work with PREQB to further improve the PRWQSR. If you have any questions, please call me at ( 212) 637 3725 or have your staff contact Mr. Mario Del Vicario, Chief, Community and Ecosystem Protection Branch at ( 212) 637 3779.

Sincerely,

Walter Mugdan, Director Division of Environmental Planning and Protection Enclosures cc: Ruben Gonzalez, PREQB bcc: Carl Axel Soderberg, CEPD Jim Keating, OST Cara Lalley, OST M. E. Levine, OGC Kevin Bricke, DEPP Warren Llewellyn, ORC Richard Weisberg, ORC Mario Del Vicario, CEPB Felix Locicero, CEPB Wayne Jackson, CEPB G:\...\ SWQB\ TES\ WQS\ PR\ prwq. approv03. wpd


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4214-4216]
[FR Doc No: 2018-01640]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2530]

Determination of Regulatory Review Period for Purposes of Patent
Extension; GALLIPRANT

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for GALLIPRANT and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of U.S. Patent and Trademark Office (USPTO), Department
of Commerce, for the extension of a patent which claims that animal
drug product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and, ask for a redetermination by April
2, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by July 30, 2018. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 2, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2016-E-2530 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; GALLIPRANT.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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 Sec.  10.20 (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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For animal drug products, the
testing phase begins on the earlier date when either a major
environmental effects test was initiated for the drug or when an
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the animal drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for an animal
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(4)(B).
    FDA has approved for marketing the animal drug product GALLIPRANT
(grapiprant). GALLIPRANT is indicated for the control of pain and
inflammation associated with osteoarthritis in dogs. Subsequent to this
approval, the USPTO received a patent term restoration application for
GALLIPRANT (U.S. Patent No. 7,960,407) from AskAt Inc., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated September 26, 2016, FDA
advised the USPTO that this animal drug product had undergone a
regulatory review period and that the approval of GALLIPRANT
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
GALLIPRANT is 1,688 days. Of this time, 1,636 days occurred during the
testing phase of the regulatory review period, while 52 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: August 8, 2011. The applicant claims July 7, 2009, as the
date the investigational new animal drug application (INAD) became
effective. However, FDA records indicate that the INAD effective date

was August 8, 2011, which was the date a major health or environmental
effects test was begun.
    2. The date the application was initially submitted with respect to
the animal drug product under section 512 of the FD&C Act (21 U.S.C.
360b): January 29, 2016. The applicant claims January 25, 2016, as the
date the new animal drug application (NADA) for GALLIPRANT (NADA 141-
455) was initially submitted. However, FDA records indicate that NADA
141-455 was submitted on January 29, 2016.
    3. The date the application was approved: March 20, 2016. The
applicant claims that NADA 141-455 was approved on March 21, 2016,
however, FDA records indicate that NADA 141-455 was approved on Sunday,
March 20, 2016.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 899 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01640 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: July 26, 2010 (Volume 75, Number 142)]
[Notices]
[Page 43612-43613]
[DOCID:fr26jy10-110]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2010-0042]

Pipeline Safety: Request for Special Permit

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

ACTION: Notice.

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SUMMARY: Pursuant to the Federal Pipeline Safety Laws, PHMSA is
publishing this notice of a special permit request we have received
from Dominion Transmission, Inc., a natural gas pipeline operator,
seeking relief from compliance with certain requirements in the Federal
Pipeline Safety Regulations. This notice seeks public comments on this
request, including comments on any safety or environmental impacts. At
the conclusion of the 30-day comment period, PHMSA will evaluate the
request and determine whether to grant or deny a special permit.

DATES: Submit any comments regarding this special permit request by
August 25, 2010.

ADDRESSES: Comments should reference the docket number for this
specific special permit request and may be submitted in the following
ways:
     E-Gov Web Site: http://www.Regulations.gov. This site
allows the public to enter comments on any Federal Register notice
issued by any agency.
     Fax: 1-202-493-2251.
     Mail: Docket Management System: U.S. Department of
Transportation (DOT), Docket Operations, M-30, West Building Ground
Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: DOT Docket Management System: U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590 between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    Instructions: You should identify the docket number for the special
permit request you are commenting on at the beginning of your comments.
If you submit your comments by mail, please submit two copies. To
receive confirmation that PHMSA has received your comments, please
include a self-addressed stamped postcard. Internet users may submit
comments at http://www.Regulations.gov.

    Note:  Comments are posted without changes or edits to http://
www.Regulations.gov, including any personal information provided.
There is a privacy statement published on http://
www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: General: Dana Register by telephone at
202-366-0490; or, e-mail at<EMAIL_ADDRESS>    Technical: Joshua Johnson by telephone at<PHONE_NUMBER>; or, e-mail
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: PHMSA has received this request for a
special permit from Dominion Transmission Inc., seeking relief from
compliance

with certain pipeline safety regulations. Dominion's request includes a
technical analysis. This request can be found at Regulations.gov under
docket number PHMSA-2010-0121. We invite interested persons to
participate by reviewing this special permit request at http://
www.Regulations.gov, and by submitting written comments, data or other
views. Please include any comments on potential environmental impacts
that may result if this special permit is granted.
    Before acting on this special permit request, PHMSA will evaluate
all comments received on or before the comments closing date. Comments
will be evaluated after this date if it is possible to do so without
incurring additional expense or delay. PHMSA will consider each
relevant comment we receive in making our decision to grant or deny a
request.
    PHMSA has received the following special permit request:

----------------------------------------------------------------------------------------------------------------
          Docket No.                Requester          Regulation              Nature of special permit
----------------------------------------------------------------------------------------------------------------
PHMSA-2010-0121...............  Dominion           49 CFR 192.611...  To authorize DTI to engage in an
                                 Transmission                          alternative approach to conduct risk
                                 Incorporated                          control activities based on Integrity
                                 (DTI).                                Management Program principles rather than
                                                                       lowering the MAOP or replacing the
                                                                       subject pipe segment. This application is
                                                                       for one segment of the DTI Line TL-465 in
                                                                       Prince William County, Virginia. This
                                                                       segment has changed from a Class 1
                                                                       location to a Class 3 location due to an
                                                                       expanded housing development. The
                                                                       pipeline is 24-inches in diameter and has
                                                                       a MAOP of 1,250 psig. The segment that
                                                                       has changed Class Location is 3,478 feet
                                                                       in length and is located at MP 1085+81
                                                                       ft. to MP 1,120+59 ft.
----------------------------------------------------------------------------------------------------------------

    Authority: 49 U.S.C. 60118(c)(1) and 49 CFR 1.53.

    Issued in Washington, DC, on July 16, 2010.
Linda Daugherty,
Deputy Associate Administrator for Policy and Programs.
[FR Doc. 2010-18238 Filed 7-23-10; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 3042-3044]
[FR Doc No: 2013-00660]

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

[Release No. IC-30347; 812-14094]

J.P. Morgan Securities LLC, et al.; Notice of Application and
Temporary Order

January 9, 2013.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Temporary order and notice of application for a permanent order
under section 9(c) of the Investment Company Act of 1940 (``Act'').

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Summary of Application:  Applicants have received a temporary order
exempting them from section 9(a) of the Act, with respect to an
injunction entered against J.P. Morgan Securities LLC (``JPMS''), EMC
Mortgage, LLC (``EMC''), Bear Stearns Asset Backed Securities I, LLC
(``BSABS''), Structured Asset Mortgage Investments II, Inc. (``SAMI''),
SACO I Inc. (``SACO'') and J.P. Morgan Acceptance Corporation I
(``JPMAC'') (together, the ``Defendants'') on January 8, 2013, by the
United States District Court for the District of Columbia
(``Injunction'') until the Commission takes final action on an
application for a permanent order. Applicants also have applied for a
permanent order.

Applicants: JPMS, EMC, BSABS, SAMI, SACO, JPMAC, Bear Stearns Asset
Management Inc. (``BSAM''), Bear Stearns Health Innoventures
Management, L.L.C. (``BSHIM''), BSCGP Inc. (``BSGCP''), Constellation
Growth Capital LLC (``Constellation''), Constellation Ventures
Management II, LLC (``Constellation II''), Highbridge Capital
Management, LLC (``Highbridge''), JF International Management Inc.
(``JFIMI''), JPMorgan Distribution Services, Inc. (``JPMDS''), J.P.
Morgan Institutional Investments, Inc. (``JPMII''), J.P. Morgan
Investment Management Inc. (``JPMIM''), J.P. Morgan Partners, LLC
(``JPMP''), J.P. Morgan Private Investments Inc. (``JPMPI''), OEP Co-
Investors Management II, Ltd. (``OEP II''), OEP Co-Investors Management
III, Ltd. (``OEP III,'' and together with OEP II, the ``OEP
Entities''), Security Capital Research & Management Incorporated
(``Security Capital''), Sixty Wall Street GP Corporation (``Sixty Wall
GP'') and Sixty Wall Street Management Company, LLC (``Sixty Wall
Management'') (each an ``Applicant'' and collectively, the
``Applicants'').\1\
---------------------------------------------------------------------------

    \1\ Applicants request that any relief granted pursuant to the
application also apply to any other company of which any Defendant
is or may become an affiliated person within the meaning of section
2(a)(3) of the Act (together with the Applicants, the ``Covered
Persons'').

Filing Date: The application was filed on November 16, 2012, and
---------------------------------------------------------------------------
amended on January 8, 2013.

Hearing or Notification of Hearing: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on February 4, 2013, and should be accompanied by proof of service
on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Elizabeth M. Murphy, Secretary, U.S. Securities and Exchange
Commission, 100 F Street NE., Washington, DC 20549-1090; Applicants:
JPMS, BSABS, SAMI, SACO and JPMAC, 383 Madison Avenue, New York, NY
10179; EMC, 2780 Lake Vista Drive, Lewisville, TX 75067; BSAM, BSHIM,
BSCGP, Constellation II, JPMII, JPMIM, JPMP, JPMPI, Sixty Wall GP and
Sixty Wall Management, 270 Park Avenue, New York, NY 10017;
Constellation and Highbridge, 40 West 57th Street, 32nd Floor, New
York, NY 10019; JFIMI, 21st Floor, Chater House, 8 Connaught Road
Central, Hong Kong; JPMDS, 1111 Polaris Parkway, Columbus, OH 43240;
OEP Entities, 320 Park Avenue, 18th Floor, New York, NY

10022; and Security Capital, 10 South Dearborn Street, Suite 1400,
Chicago, IL 60603.

FOR FURTHER INFORMATION CONTACT: Jaea F. Hahn, Senior Counsel, at 202-
551-6870 or Janet M. Grossnickle, Assistant Director, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

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

Applicants' Representations

    1. JPMS, a limited liability company organized under the laws of
Delaware, is registered as a broker-dealer under the Securities
Exchange Act of 1934, as amended (the ``Exchange Act'') and is
registered as an investment adviser under the Investment Advisers Act
of 1940, as amended (the ``Advisers Act''). EMC and BSABS are each
Delaware limited liability companies; neither is registered as a
broker-dealer under the Exchange Act or as an investment adviser under
the Advisers Act. SAMI, SACO and JPMAC are each Delaware corporations,
none of which is registered as a broker-dealer under the Exchange Act
or as an investment adviser under the Advisers Act. The Defendants do
not currently serve as investment adviser, sub-adviser, or depositor of
any registered investment company, or principal underwriter for any
registered open-end investment company, registered unit investment
trust (``UIT'') or registered face amount certificate company, or
investment adviser of any employees' securities company, as defined in
section 2(a)(13) of the Act (``ESC'') (``Fund Service Activities,'' and
the Applicants that do serve in such capacities, ``Fund Servicing
Applicants''). ``Funds'' refers to the registered investment companies
or ESCs for which a Covered Person provides Fund Service Activities.
    2. The ultimate parent of each Defendant is J.P. Morgan Chase & Co.
(``JPMC''). JPMC is a financial services holding company whose
businesses provide a broad range of financial services to consumer and
corporate customers. JPMC is also the ultimate parent of each of the
Fund Servicing Applicants, who, as majority-owned and wholly-owned
subsidiaries of the same ultimate parent, are under common control with
the Defendants.
    3. BSAM is registered as an investment adviser under the Advisers
Act and serves as investment adviser or sub-adviser to various Funds,
including as a general partner that provides investment advisory
services to various ESCs, which provide investment opportunities for
highly compensated key employees, officer, directors and current
consultants of JPMC and its affiliates.\2\ BSHIM, BSCGP, Constellation
II and the OEP Entities also serve as general partners that provide
investment advisory services to various ESCs. Constellation serves as a
sub-adviser to various ESCs. Highbridge, JFIMI, JPMIM, JPMPI, and
Security Capital are registered as investment advisers under the
Advisers Act and serve as investment advisers or sub-advisers to
various Funds. JPMP, Sixty Wall GP, Sixty Wall Management are
registered as investment advisers under the Advisers Act and serve as
investment advisers or sub-advisers to ESCs. JPMDS is registered as a
broker-dealer under the Exchange Act and serves as principal
underwriter to various Funds. JPMII is registered as a broker-dealer
under the Exchange Act and serves as placement agent to various
Funds.\3\
---------------------------------------------------------------------------

    \2\ Every Applicant that is a general partner that provides
investment advisory services to one or more ESCs believes, for
purposes of the application, that it is performing a function that
falls within the definition of ``investment adviser'' in section
2(a)(20) of the Act.
    \3\ JPMII serves as placement agent to JPMorgan Institutional
Trust (``Trust'') with respect to three of its series. The Trust is
an open-end investment company registered under the Act, but its
shares are not registered under the Securities Act of 1933, as
amended. JPMII believes, for purposes of the application, that it is
performing a function that falls within the definition of principal
underwriter in section 2(a)(29) of the Act.
---------------------------------------------------------------------------

    4. On January 8, 2013, the United States District Court for the
District of Columbia entered a judgment, which included the Injunction,
against the Defendants (``Judgment'') in a matter brought by the
Commission.\4\ The Commission alleged in the complaint (``Complaint'')
that the Defendants violated Sections 17(a)(2) and (3) of the
Securities Act of 1933 in connection with alleged false and misleading
disclosures involving offerings of certain residential mortgage-backed
securities (``RMBS''). Without admitting or denying any of the
allegations in the Complaint (other than those relating to the
jurisdiction of the District Court over it and the subject matter,
solely for purposes of this action), the Defendants consented to the
entry of the Injunction and other relief, including disgorgement,
prejudgment interest, and civil monetary penalties.
---------------------------------------------------------------------------

    \4\ U.S. Securities and Exchange Commission v. J.P. Morgan
Securities LLC, EMC Mortgage, LLC, Bear Stearns Asset Backed
Securities I, LLC, Structured Asset Mortgage Investments II, Inc.,
SACO I Inc., and J.P. Morgan Acceptance Corporation I, Case No.
1:12-cv-01862-RLW (D.D.C. Jan. 8, 2013).
---------------------------------------------------------------------------

Applicants' Legal Analysis

    1. Section 9(a)(2) of the Act, in relevant part, prohibits a person
who has been enjoined from engaging in or continuing any conduct or
practice in connection with the purchase or sale of a security, or in
connection with activities as an underwriter, broker or dealer, from
acting, among other things, as an investment adviser or depositor of
any registered investment company or a principal underwriter for any
registered open-end investment company, registered UIT, or registered
face-amount certificate company or as investment adviser of an ESC.
Section 9(a)(3) of the Act makes the prohibition in section 9(a)(2)
applicable to a company, any affiliated person of which has been
disqualified under the provisions of section 9(a)(2). Section 2(a)(3)
of the Act defines ``affiliated person'' to include, among others, any
person directly or indirectly controlling, controlled by, or under
common control, with the other person. Applicants state that the
Defendants are affiliated persons of each of the other Applicants
within the meaning of section 2(a)(3) of the Act. Applicants state
that, as a result of the Injunction, they would be subject to the
prohibitions of section 9(a) of the Act.
    2. Section 9(c) of the Act provides that the Commission shall grant
an application for exemption from the disqualification provisions of
section 9(a) of the Act if it is established that these provisions, as
applied to the Applicants, are unduly or disproportionately severe or
that the conduct of the Applicants has been such as not to make it
against the public interest or the protection of investors to grant the
exemption. Applicants have filed an application pursuant to section
9(c) seeking a temporary and permanent order exempting them and other
Covered Persons from the disqualification provisions of section 9(a).
    3. Applicants believe they meet the standard for exemption
specified in section 9(c). Applicants state that the prohibitions of
section 9(a) as applied to them would be unduly and disproportionately
severe and that the conduct of the Applicants has been such as not to
make it against the public interest or the protection of investors to
grant the exemption from section 9(a).
    4. Applicants state that the alleged conduct giving rise to the
Injunction did not involve any of the Applicants

engaging in Fund Service Activities. Applicants also state to the best
of their knowledge (i) none of the current directors, officers, or
employees of the Applicants (other than the Defendants) that are
involved in providing Fund Service Activities (or any other persons in
such roles during the time period covered by the Complaint)
participated in the conduct alleged in the Complaint to have
constituted the violations that provide a basis for the Injunction; and
(ii) the personnel at the Defendants who participated in the conduct
alleged in the Complaint to have constituted the violations that
provide a basis for the Injunction have had no, and will not have any,
involvement in providing Fund Service Activities to the Funds on behalf
of the Applicants or other Covered Persons.
    5. Applicants state that the inability of the Applicants to engage
in Fund Service Activities would result in potentially severe financial
hardships for the Funds they serve and the Funds' shareholders or
unitholders. Applicants state that they will distribute written
materials, including an offer to meet in person to discuss the
materials, to the boards of directors of the Funds (excluding for this
purpose the ESCs) (the ``Boards''), including the directors who are not
``interested persons,'' as defined in section 2(a)(19) of the Act, of
such Funds, and their independent legal counsel as defined in rule 0-
1(a)(6) under the Act, if any, describing the circumstances that led to
the Injunction, any impact on the Funds,\5\ and the application.
Applicants state that they will provide the Boards with the information
concerning the Injunction and the application that is necessary for the
Funds to fulfill their disclosure and other obligations under the
federal securities laws.
---------------------------------------------------------------------------

    \5\ Applicants state that several Funds may have owned certain
series of the RMBS which are the subject of the Injunction.
Applicants further state that these RMBS were acquired from
unaffiliated parties, generally in secondary market transactions. To
the extent that any of these Funds suffered losses from their
investment in the RMBS, the Funds will be able to participate in the
Fair Fund to the extent available to any other investor.
---------------------------------------------------------------------------

    6. Applicants also state that, if they were barred from providing
Fund Service Activities to registered investment companies and ESCs,
the effect on their businesses and employees would be severe.
Applicants state that they have committed substantial resources to
establish an expertise in providing Fund Service Activities. Applicants
further state that prohibiting them from providing Fund Service
Activities would not only adversely affect their businesses, but would
also adversely affect approximately 940 employees that are involved in
those activities. Applicants also state that disqualifying certain
Applicants from continuing to provide investment advisory services to
ESCs is not in the public interest or in furtherance of the protection
of investors. Because the ESCs have been formed for the benefit of key
employees, officers and directors of JPMC and its affiliates, it would
not be consistent with the purposes of the ESC provisions of the Act or
the terms and conditions of the ESC orders to require another entity
not affiliated with JPMC to manage the ESCs. In addition, participating
employees of JPMC and its affiliates likely subscribed for interests in
the ESCs with the expectation that the ESCs would be managed by an
affiliate of JPMC.
    7. Applicants state that Applicants and certain other affiliated
persons of the Applicants have previously received orders under section
9(c) of the Act, as the result of conduct that triggered section 9(a),
as described in greater detail in the application.

Applicants' Condition

    Applicants agree that any order granting the requested relief will
be subject to the following condition:
    Any temporary exemption granted pursuant to the application shall
be without prejudice to, and shall not limit the Commission's rights in
any manner with respect to, any Commission investigation of, or
administrative proceedings involving or against, Covered Persons,
including without limitation, the consideration by the Commission of a
permanent exemption from section 9(a) of the Act requested pursuant to
the application or the revocation or removal of any temporary
exemptions granted under the Act in connection with the application.

Temporary Order

    The Commission has considered the matter and finds that the
Applicants have made the necessary showing to justify granting a
temporary exemption.
    Accordingly,
    It is hereby ordered, pursuant to section 9(c) of the Act, that
Applicants and any other Covered Persons are granted a temporary
exemption from the provisions of section 9(a), solely with respect to
the Injunction, subject to the condition in the application, from
January 8, 2013, until the Commission takes final action on their
application for a permanent order.

    By the Commission.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-00660 Filed 1-14-13; 8:45 am]
BILLING CODE 8011-01-P