[Federal Register: October 21, 2009 (Volume 74, Number 202)]
[Rules and Regulations]
[Page 53883-53885]
[DOCID:fr21oc09-3]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2009-N-0472]

Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Cardiac Allograft Gene Expression
Profiling Test Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
classification of cardiac allograft gene expression profiling test
systems into class II (special controls). The special control that will
apply to the device is the guidance document entitled ``Class II
Special Controls Guidance Document: Cardiac Allograft Gene Expression
Profiling Test Systems.'' FDA classified the device into class II
(special controls) in order to provide a reasonable assurance of safety
and effectiveness of the device. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of the guidance document
that will serve as the special control for this device.

DATES: This final rule is effective November 20, 2009. The
classification was effective August 26, 2008.

FOR FURTHER INFORMATION CONTACT: Kellie B. Kelm, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5625, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in
commercial distribution before May 28, 1976, the date of enactment of
the Medical Device Amendments of 1976 (the amendments), generally
referred to as postamendments devices, are classified automatically by
statute into class III without any FDA rulemaking process. These
devices remain in class III and require premarket approval, unless the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the act, to a predicate device that
does not require premarket approval. The agency determines whether new
devices are substantially equivalent to predicate devices by means of
premarket notification procedures in section 510(k) of the act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.
    Section 513(f)(2) of the act provides that any person who submits a
premarket notification under section 510(k) of the act for a device
that has not previously been classified may, within 30 days after
receiving an order classifying the device in class III under section
513(f)(1), request FDA to classify the device under the criteria set
forth in section 513(a)(1). FDA shall, within 60 days of receiving such
a request, classify the device by written order. This classification
shall be the initial classification of the device. Within 30 days after
the issuance of an order classifying the device, FDA must publish a
notice in the Federal Register announcing this classification (section
513(f)(2) of the act).
    In accordance with section 513(f)(1) of the act, FDA issued an
order on August 8, 2008, classifying the XDx AlloMap Test in class III
because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device that was
subsequently reclassified into class I or class II. On August 15, 2008,
XDx, Inc., submitted a petition requesting

classification of the AlloMap Test under section 513(f)(2) of the act.
The manufacturer recommended that the device be classified into class
II (Ref. 1).
    In accordance with section 513(f)(2) of the act, FDA reviewed the
petition in order to classify the device under the criteria for
classification set forth in section 513(a)(1). Devices are to be
classified into class II if general controls, by themselves, are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the petition, FDA determined that the AlloMap
Test can be classified in class II with the establishment of special
controls. FDA believes these special controls, in addition to general
controls, will provide reasonable assurance of safety and effectiveness
of the device.
    The device is assigned the generic name ``Cardiac allograft gene
expression profiling test system.'' It is identified as a device that
measures the RNA expression level of multiple genes and combines this
information to yield a signature (pattern, classifier, index, score) to
aid in the identification of a low probability of acute cellular
rejection (ACR) in heart transplant recipients with stable allograft
function.
    FDA has identified the following issues of safety or effectiveness
requiring special controls for a cardiac allograft gene expression
profiling test system. Failure of this device to perform as indicated
may lead to erroneous test results. False positive results will
misclassify the patient into a higher risk group and false negative
results will misclassify the patient into a lower risk group.
Misclassification of ACR may lead to incorrect patient management with
attendant psychological distress, inaccurate counseling, and suboptimal
patient care.
    FDA believes the class II special controls guidance document
generally addresses the risks to health identified in the previous
paragraph and will aid in mitigating potential risks by providing
recommendations on labeling and validation of performance
characteristics. The guidance document also provides information on how
to meet 510(k) premarket notification submission requirements for the
device. FDA believes that the special controls, in addition to general
controls, provide reasonable assurances of the safety and effectiveness
of the device type. Therefore, on August 26, 2008, FDA issued an order
to the petitioner classifying the device into class II (Ref. 2). FDA is
codifying this classification by adding Sec.  862.1163.
    Any firm submitting a premarket notification submission for a
cardiac allograft gene expression profiling test system will need to
address the issues covered in the special controls guidance. However,
the firm need only show that its device meets the recommendations of
the guidance or in some other way provides equivalent assurance of
safety and effectiveness.
    Section 510(m) of the act provides that FDA may exempt a class II
device from the premarket notification requirements under section
510(k) if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, however, FDA has determined that
premarket notification is necessary to provide a reasonable assurance
of the safety and effectiveness of the device and, therefore, this type
of device is not exempt from premarket notification requirements.
Persons who intend to market this type of device must submit to FDA a
premarket notification, prior to marketing the device, which contains
information about the cardiac allograft gene expression profiling test
system they intend to market.

II. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because classification of this device into class II
will relieve manufacturers of the cost of complying with the premarket
approval requirements of section 515 of the act and may permit small
potential competitors to enter the marketplace by lowering their costs,
the agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain state requirements ``different from or in
addition to'' certain Federal requirements applicable to devices. 21
U.S.C. 360k; See Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v.
Medtronic, 128 S. Ct. 999 (2008). The special controls established by
this final rule create ``requirements'' for specific medical devices
under 21 U.S.C. 360k, even though product sponsors have some
flexibility in how they meet those requirements. See Papike v.
Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997).

V. Paperwork Reduction Act of 1995

    This final rule establishes as special controls a guidance document
that refers to previously approved collections of information found in
other FDA regulations. These collections of information are subject to
review by the Office of Management and

Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520) (the PRA). The collections of information in part 807, subpart E,
regarding premarket notification submissions, have been approved under
OMB Control No. 0910-0120. The collections of information in 21 CFR
part 801 and 21 CFR 809.10, regarding labeling, have been approved
under OMB Control No. 0910-0485. The collections of information in 21
CFR part 820 have been approved under OMB Control No. 0910-0073.

VI. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from XDx, Inc., dated August 15, 2008.
    2. Order classifying XDx AlloMap Test, dated August 26, 2008.

List of Subjects in 21 CFR Part 862

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for 21 CFR part 862 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 862.1163 is added to subpart B to read as follows:

Sec.  862.1163  Cardiac allograft gene expression profiling test
system.

    (a) Identification. A cardiac allograft gene expression profiling
test system is a device that measures the ribonucleic acid (RNA)
expression level of multiple genes and combines this information to
yield a signature (pattern, classifier, index, score) to aid in the
identification of a low probability of acute cellular rejection (ACR)
in heart transplant recipients with stable allograft function.
    (b) Classification. Class II (special controls). The special
control is FDA's guidance document entitled ``Class II Special Controls
Guidance Document: Cardiac Allograft Gene Expression Profiling Test
Systems.'' See Sec.  862.1(d) for the availability of this guidance
document.

    Dated: October 9, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-25315 Filed 10-20-09; 8:45 am]

BILLING CODE 4160-01-S


8. Remove and reserve Appendix A to Part 136.

Appendix C [Removed and Reserved]

    9. Remove and reserve Appendix C to Part 136.
    10. Revise Appendix D to Part 136 to read as follows:

Appendix D to Part 136--Precision and Recovery Statement for Methods
for Measuring Metals

    Two selected methods from ``Methods for Chemical Analysis of Water
and Wastes'', EPA-600/4-79-020 (1979) have been subjected to
interlaboratory method validation studies. The two selected methods are
Thallium and Zinc. The following precision and recovery statements are
presented in this appendix and incorporated into part 136:

Method 279.2

    For Thallium, Method 279.2 (Atomic Absorption, Furnace Technique)
replace the Precision and Accuracy Section statement with the
following:

Precision and Accuracy

    An interlaboratory study on metal analyses by this method was
conducted by the Quality Assurance Branch (QAB) of the Environmental
Monitoring Systems Laboratory--Cincinnati (EMSL-CI). Synthetic
concentrates containing various levels of this element were added to
reagent water, surface water, drinking water and three effluents. These
samples were digested by the total digestion procedure, 4.1.3 in this
manual. Results for the reagent water are given below. Results for
other water types and study details are found in ``EPA Method Study 31,
Trace Metals by Atomic Absorption (Furnace Techniques),'' National
Technical Information Service, 5285 Port Royal Road, Springfield, VA
22161 Order No. PB 86-121 704/AS, by Copeland, F.R. and Maney, J.P.,
January 1986.
    For a concentration range of 10.00-252 [micro]g/L

X = 0.8781(C)-0.715
S = 0.1112(X) + 0.669
SR = 0.1005(X) + 0.241

Where:

C = True Value for the Concentration, [micro]g/L
X = Mean Recovery, [micro]g/L
S = Multi-laboratory Standard Deviation, [micro]g/L
SR = Single-analyst Standard Deviation, [micro]g/L

Method 289.2

    For Zinc, Method 289.2 (Atomic Absorption, Furnace Technique)
replace the Precision and Accuracy Section statement with the
following:

Precision and Accuracy

    An interlaboratory study on metal analyses by this method was
conducted by the Quality Assurance Branch (QAB) of the Environmental
Monitoring Systems Laboratory--Cincinnati (EMSL-CI). Synthetic
concentrates containing various levels of this element were added to
reagent water, surface water, drinking water and three effluents. These
samples were digested by the total digestion procedure, 4.1.3 in this
manual. Results for the reagent water are given below. Results for
other water types and study details are found in ``EPA Method Study 31,
Trace Metals by Atomic Absorption (Furnace Techniques),'' National
Technical Information Service, 5285 Port Royal Road, Springfield, VA
22161 Order No. PB 86-121 704/AS, by Copeland, F.R. and Maney, J.P.,
January 1986.
    For a concentration range of 0.51-189 [micro]g/L

X = 1.6710(C) + 1.485
S = 0.6740(X)-0.342
SR = 0.3895(X)-0.384

Where:

C = True Value for the Concentration, [micro]g/L
X = Mean Recovery, [micro]g/L
S = Multi-laboratory Standard Deviation, [micro]g/L
SR = Single-analyst Standard Deviation, [micro]g/L

PART 260--HAZARDOUS WASTE MANAGEMENT SYSTEM: GENERAL

    11. The authority citation for part 260 continues to read as
follows:

    Authority:  42 U.S.C. 6905, 6912(a), 6921-6927, 6930, 6934,
6935, 6937, 6938, 6939, and 6974.

Subpart B--Definitions

    12. Section 260.11 is amended by revising paragraph (c)(2) to read
as follows:

Sec.  260.11  References.

* * * * *
    (c) * * *
    (2) Method 1664, Revision A and Revision B, N-Hexane Extractable
Material (HEM; Oil and Grease) and Silica Gel Treated n-Hexane
Extractable Material SGT-HEM; Non-polar Material) by Extraction and
Gravimetry, PB99-121949 and EPA-821-R-10-001, February 2010. IBR
approved for part 261, appendix IX.
* * * * *

PART 423--STEAM ELECTRIC POWER GENERATING POINT SOURCE CATEGORY

    13. The authority citation for part 423 continues to read as
follows:

    Authority:  Secs. 301; 304(b), (c), (e), and (g); 306(b) and
(c); 307(b) and (c); and 501, Clean Water Act (Federal Water
Pollution Control Act Amendments of 1972, as amended by Clean Water
Act of 1977) (the ``Act''; 33 U.S.C. 1311; 1314(b), (c), (e), and
(g); 1316(b) and (c); 1317(b) and (c); and 1361; 86 Stat. 816, Pub.
L. 92-500; 91 Stat. 1567, Pub. L. 95-217), unless otherwise noted.

    14. Section 423.11 is amended by revising paragraphs (a) and (l) to
read as follows:

Sec.  423.11  Specialized definitions.

* * * * *
    (a) The term total residual chlorine (or total residual oxidants
for intake water with bromides) means the value obtained using any of
the ``chlorine-total residual'' methods in Table IB 136.3(a), or other
methods approved by the permitting authority.
* * * * *
    (l) The term free available chlorine means the value obtained using
any of the ``chlorine-free available'' methods in Table IB 136.3(a)
where the method has the capability of measuring free available
chlorine, or other methods approved by the permitting authority.
* * * * *

PART 430--PULP, PAPER, AND PAPERBOARD POINT SOURCE CATEGORY

    15. The authority citation for part 430 continues to read as
follows:

    Authority: Secs. 301, 304, 306, 307, 308, 402, and 501, Clean
Water Act as amended, (33 U.S.C. 1311, 1314, 1316, 1317, 1318, 1342,
and 1361) and Section 112 of the Clean Air Act, as amended (42
U.S.C. 7412).

General Provisions

    16. Section 430.01 is amended by revising paragraph (a) and by
adding paragraphs (s) through (v) to read as follows:

Sec.  430.01  General definitions.

* * * * *
    (a) Adsorbable organic halides (AOX). A bulk parameter that
measures the total mass of chlorinated organic matter in water and
wastewater. The approved method of analysis for AOX is Method 1650,
listed in Table 1C at 40 CFR 136.3.
* * * * *
    (s) TCDD. 2,3,7,8-tetrachlorodibenzop-dioxin. The approved method
of analysis for TCDD is Method 1613B, listed in Table 1C at 40 CFR
136.3.
    (t) TCDF. 2,3,7,8-tetrachlorodibenzop-furan. The approved method of
analysis for TCDF is Method 1613B, listed in Table 1C at 40 CFR 136.3.
    (u) Chloroform is listed with approved methods of analysis in Table
1C at 40 CFR 136.3.
    (v) The approved method of analysis for the following chlorinated
phenolic compounds is Method 1653, listed in Table 1C at 40 CFR 136.3:
    (1) Trichlorosyringol.
    (2) 3,4,5-trichlorocatechol.
    (3) 3,4,6-trichlorocatechol.
    (4) 3,4,5-trichloroguaiacol.
    (5) 3,4,6-trichloroguaiacol.
    (6) 4,5,6-trichloroguaiacol.
    (7) 2,4,5-trichlorophenol.
    (8) 2,4,6-trichlorophenol.
    (9) Tetrachlorocatechol.
    (10) Tetrachloroguaiacol.
    (11) 2,3,4,6-tetrachlorophenol.
    (12) Pentachlorophenol.

PART 435--OIL AND GAS EXTRACTION POINT SOURCE CATEGORY

    17. The authority citation for part 435 continues to read as
follows:

    Authority:  33 U.S.C. 1311, 1314, 1316, 1317, 1318, 1342, and
1361.

    18. Section 435.11 is amended as follows:
    a. By revising paragraph (d).
    b. By revising paragraph (e).
    c. By revising paragraph (k)(2).
    d. By revising paragraph (o).
    e. By revising paragraph (t).
    f. By revising paragraph (u).
    g. By revising paragraph (x).
    h. By revising paragraph (ee).
    i. By revising paragraph (gg).
    j. By revising paragraph (hh).
    k. By revising paragraph (ss).
    l. By adding paragraph (uu).

Sec.  435.11  Specialized definitions.

* * * * *
    (d) Base fluid retained on cuttings as applied to BAT effluent
limitations and NSPS refers to the ``Determination of the Amount of
Non-Aqueous Drilling Fluid (NAF) Base Fluid from Drill Cuttings by a
Retort Chamber (Derived from API Recommended Practice 13B-2)'', EPA
Method 1674, which is published in ``Analytic Methods for the Oil and
Gas Extraction Point Source Category,'' EPA-821-R-09-013. See paragraph
(uu) of this section.
    (e) Biodegradation rate as applied to BAT effluent limitations and
NSPS for drilling fluids and drill cuttings refers to the ``Protocol
for the Determination of Degradation of Non Aqueous Base Fluids in a
Marine Closed Bottle Biodegradation Test System: Modified ISO
11734:1995,'' EPA Method 1647, supplemented with ``Procedure for Mixing
Base Fluids With Sediments,'' EPA Method 1646. Both EPA Method 1646 and
1647 are published in ``Analytic Methods for the Oil and Gas Extraction
Point Source Category,'' EPA-821-R-09-013. See paragraph (uu) of this
section.
* * * * *
    (k) * * *
    (2) Dry drill cuttings means the residue remaining in the retort
vessel after completing the retort procedure specified in EPA Method
1674, which is published in ``Analytic Methods for the Oil and Gas
Extraction Point Source Category,'' EPA-821-R-09-013. See paragraph
(uu) of this section.
* * * * *
    (o) Formation oil means the oil from a producing formation which is
detected in the drilling fluid, as determined by the GC/MS compliance
assurance method when the drilling fluid is analyzed before being
shipped offshore, and as determined by the RPE method, EPA Method 1670,
when the drilling fluid is analyzed at the offshore point of discharge.
The GC/MS compliance assurance method and the RPE method approved for
use with this part are published in the ``Analytic Methods for the Oil
and Gas Extraction Point Source Category,'' EPA-821-R-09-013. See
paragraph (uu) of this section. Detection of formation oil by the RPE
method may be confirmed by the GC/MS compliance assurance method, and
the results of the GC/MS compliance assurance method shall apply
instead of those of the RPE method.
* * * * *
    (t) Maximum weighted mass ratio averaged over all NAF well sections
for BAT effluent limitations and NSPS for base fluid retained on
cuttings means the weighted average base fluid retention for all NAF
well sections as determined by EPA Method 1674, which is published in
``Analytic Methods for the Oil and Gas Extraction Point Source
Category,'' EPA-821-R-09-013. See paragraph (uu) of this section.
    (u) Method 1654A refers to EPA Method 1654, Revision A, entitled
``PAH Content of Oil by HPLC/UV,'' December 1992, which is published in
``Analytic Methods for the Oil and Gas Extraction Point Source
Category,'' EPA-821-R-09-013. See paragraph (uu) of this section.
* * * * *
    (x) No discharge of free oil means that waste streams may not be
discharged that contain free oil as evidenced by the monitoring method
specified for that particular stream, e.g., deck drainage or
miscellaneous discharges cannot be discharged when they would cause a
film or sheen upon or discoloration of the surface of the receiving
water; drilling fluids or cuttings may not be discharged when they fail
EPA Method 1617 (Static Sheen Test), which is published in ``Analytic
Methods for the Oil and Gas Extraction Point Source Category,'' EPA-
821-R-09-013. See paragraph (uu) of this section.
* * * * *
    (ee) Sediment toxicity as applied to BAT effluent limitations and
NSPS for drilling fluids and drill cuttings refers to the ASTM E 1367-
92 method: ``Standard Guide for Conducting 10-day Static Sediment
Toxicity Tests with Marine and Estuarine Amphipods,'' 1992, with
Leptocheirus plumulosus as the test organism and sediment preparation
procedures specified in EPA Method 1646, which is published in
``Analytic Methods for the Oil and Gas Extraction Point Source
Category,'' EPA-821-R-09-013. See paragraph (uu) of this section. This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the American Society for Testing and Materials,
100 Barr Harbor Drive, West Conshohocken, PA, 19428. Copies may be
inspected at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/code_
of_federal_regulations/ibr_locations.html. A copy may also be
inspected at EPA's Water Docket, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
* * * * *
    (gg) SPP toxicity as applied to BAT effluent limitations and NSPS
for drilling fluids and drill cuttings refers to the bioassay test
procedure, ``Suspended Particulate Phase (SPP) Toxicity Test,''
presented in EPA Method 1619, which is published in ``Analytic Methods
for the Oil and Gas Extraction Point Source Category,'' EPA-821-R-09-
013. See paragraph (uu) of this section.
    (hh) Static sheen test means the standard test procedure that has
been developed for this industrial subcategory for the purpose of
demonstrating compliance with the requirement of no discharge of free
oil. The methodology for performing the static sheen test is presented
in EPA Method 1617, which is published in ``Analytic Methods for the
Oil and Gas Extraction Point Source Category,'' EPA-821-R-09-013. See
paragraph (uu) of this section.
* * * * *
    (ss) C16-C18 internal olefin drilling fluid
means a C16-C18 internal olefin drilling fluid
formulated as specified in Appendix 1 of Subpart A of this part.
* * * * *
    (uu) Analytic Methods for the Oil and Gas Extraction Point Source
Category is the EPA document, EPA-821-R-09-013, that compiles analytic
methods for this category. This incorporation by reference was approved
by the Director of the Federal Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies may be inspected at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html. A copy may also be inspected at EPA's

Water Docket, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    19. In Sec.  435.12, the first footnote to the table is revised to
read as follows:

Sec.  435.12  Effluent limitations guidelines representing the degree
of effluent reduction attainable by the application of the best
practicable control technology currently available (BPT).

* * * * *

                BPT Effluent Limitations--Oil and Grease

                                * * * * *

                               * * * * *

\1\ No discharge of free oil. See Sec.   435.11(x).

* * * * *
    20. In Sec.  435.13, footnotes 2, 3, and 5 through 11 to the table
are revised to read as follows:

Sec.  435.13  Effluent limitations guidelines representing the degree
of effluent reduction attainable by the application of the best
available technology economically achievable (BAT).

* * * * *

                        BAT Effluent Limitations

                                * * * *

\2\ As determined by the suspended particulate phase (SPP) toxicity
  test. See Sec.   435.11(gg).
\3\ As determined by the static sheen test. See Sec.   435.11(hh).
* * * * *
\5\ PAH mass ratio = Mass (g) of PAH (as phenanthrene)/Mass (g) of stock
  base fluid as determined by EPA Method 1654, Revision A, [specified at
  Sec.   435.11(u)] entitled ``PAH Content of Oil by HPLC/UV,'' December
  1992, which is published in ``Analytic Methods for the Oil and Gas
  Extraction Point Source Category,'' EPA-821-R-09-013. See Sec.
  435.11(uu).
\6\ Base fluid sediment toxicity ratio = 10-day LC50 of C16-C18 internal
  olefin/10-day LC50 of stock base fluid as determined by ASTM E 1367-92
  [specified at Sec.   435.11(ee)] method: ``Standard Guide for
  Conducting 10-day Static Sediment Toxicity Tests with Marine and
  Estuarine Amphipods,'' 1992, after preparing the sediment according to
  the procedure specified in EPA Method 1646, which is published in
  ``Analytic Methods for the Oil and Gas Extraction Point Source
  Category,'' EPA-821-R-09-013. See Sec.   435.11(uu).
\7\ Biodegradation rate ratio = Cumulative headspace gas production (ml)
  of C16-C18 internal olefin/Cumulative headspace gas production (ml) of
  stock base fluid, both at 275 days as determined by EPA Method 1647,
  which is published in ``Analytic Methods for the Oil and Gas
  Extraction Point Source Category,'' EPA-821-R-09-013. See Sec.
  435.11(e) and (uu).
\8\ Drilling fluid sediment toxicity ratio = 4-day LC50 of C16-C18
  internal olefin drilling fluid/4-day LC50 of drilling fluid removed
  from drill cuttings at the solids control equipment as determined by
  ASTM E 1367-92 method: ``Standard Guide for Conducting 10-day Static
  Sediment Toxicity Tests with Marine and Estuarine Amphipods,'' 1992,
  with Leptocheirus plumulosus as the test organism and sediment
  preparation procedures specified in EPA Method 1646, which is
  published in ``Analytic Methods for the Oil and Gas Extraction Point
  Source Category,'' EPA-821-R-09-013. See Sec.   435.11(ee) and (uu).
\9\ As determined before drilling fluids are shipped offshore by the GC/
  MS compliance assurance method (EPA Method 1655), and as determined
  prior to discharge by the RPE method (EPA Method 1670) applied to
  drilling fluid removed from drill cuttings. If the operator wishes to
  confirm the results of the RPE method (EPA Method 1670), the operator
  may use the GC/MS compliance assurance method (EPA Method 1655).
  Results from the GC/MS compliance assurance method (EPA Method 1655)
  shall supersede the results of the RPE method (EPA Method 1670). EPA
  Method 1655 and 1670 are published in ``Analytic Methods for the Oil
  and Gas Extraction Point Source Category,'' EPA-821-R-09-013. See Sec.
    435.11(uu).
\10\ Maximum permissible retention of non-aqueous drilling fluid (NAF)
  base fluid on wet drill cuttings averaged over drilling intervals
  using NAFs as determined by EPA Method 1674, which is published in
  ``Analytic Methods for the Oil and Gas Extraction Point Source
  Category,'' EPA-821-R-09-013. See Sec.   435.11(uu). This limitation
  is applicable for NAF base fluids that meet the base fluid sediment
  toxicity ratio (Footnote 6), biodegradation rate ratio (Footnote 7),
  PAH, mercury, and cadmium stock limitations (C16-C18 internal olefin)
  defined above in this table.
\11\ Maximum permissible retention of non-aqueous drilling fluid (NAF)
  base fluid on wet drill cuttings averaged over drilling intervals
  using NAFs as determined by EPA Method 1674, which is published in
  ``Analytic Methods for the Oil and Gas Extraction Point Source
  Category,'' EPA-821-R-09-013. See Sec.   435.11(uu). This limitation
  is applicable for NAF base fluids that meet the ester base fluid
  sediment toxicity ratio and ester biodegradation rate ratio stock
  limitations defined as:
(a) Ester base fluid sediment toxicity ratio = 10-day LC50 of C12-C14
  ester or C8 ester/10-day LC50 of stock base fluid as determined by
  ASTM E 1367-92 method: ``Standard Guide for Conducting 10-day Static
  Sediment Toxicity Tests with Marine and Estuarine Amphipods,'' 1992,
  with Leptocheirus plumulosus as the test organism and sediment
  preparation procedures specified in EPA Method 1646, which is
  published in ``Analytic Methods for the Oil and Gas Extraction Point
  Source Category,'' EPA-821-R-09-013. See Sec.   435.11(ee) and (uu);
(b) Ester biodegradation rate ratio = Cumulative headspace gas
  production (ml) of C12-C14 ester or C8 ester/Cumulative headspace gas
  production (ml) of stock base fluid, both at 275 days as determined by
  EPA Method 1647, which is published in ``Analytic Methods for the Oil
  and Gas Extraction Point Source Category,'' EPA-821-R-09-013. See Sec.
    435.11(e) and (uu); and (c) PAH mass ratio (Footnote 5), mercury,
  and cadmium stock limitations (C16-C18 internal olefin) defined above
  in this table.

    21. In Sec.  435.14, footnote 2 to the table is revised to read as
follows:

Sec.  435.14  Effluent limitations guidelines representing the degree
of effluent reduction attainable by the application of the best
conventional pollutant control technology (BCT).

* * * * *

                        BAT Effluent Limitations

                                 * * * *

\2\ As determined by the static sheen test. See Sec.   435.11(hh).

* * * * *
    22. In Sec.  435.15, footnotes 2, 3, and 5 through 11 to the table
are revised to read as follows:

Sec.  435.15  Standards of performance for new sources (NSPS).

* * * * *

                    New Source Performance Standards

                                * * * * *

\2\ As determined by the suspended particulate phase (SPP) toxicity
  test. See Sec.   435.11(gg).
\3\ As determined by the static sheen test. See Sec.   435.11(hh).
* * * * *
\5\ PAH mass ratio = Mass (g) of PAH (as phenanthrene)/Mass (g) of stock
  base fluid as determined by EPA Method 1654, Revision A, [specified at
  Sec.   435.11(u)] entitled ``PAH Content of Oil by HPLC/UV,'' December
  1992, which is published in ``Analytic Methods for the Oil and Gas
  Extraction Point Source Category,'' EPA-821-R-09-013. See Sec.
  435.11(uu).
\6\ Base fluid sediment toxicity ratio = 10-day LC50 of C16-C18 internal
  olefin/10-day LC50 of stock base fluid as determined by ASTM E 1367-92
  [specified at Sec.   435.11(ee)] method: ``Standard Guide for
  Conducting 10-day Static Sediment Toxicity Tests with Marine and
  Estuarine Amphipods,'' 1992, after preparing the sediment according to
  the procedure specified in EPA Method 1646, which is published in
  ``Analytic Methods for the Oil and Gas Extraction Point Source
  Category,'' EPA-821-R-09-013. See Sec.   435.11(uu).
\7\ Biodegradation rate ratio = Cumulative headspace gas production (ml)
  of C16-C18 internal olefin/Cumulative headspace gas production (ml) of
  stock base fluid, both at 275 days as determined by EPA Method 1647,
  which is published in ``Analytic Methods for the Oil and Gas
  Extraction Point Source Category,'' EPA-821-R-09-013. See Sec.
  435.11(e) and (uu).
\8\ Drilling fluid sediment toxicity ratio = 4-day LC50 of C16-C18
  internal olefin drilling fluid/4-day LC50 of drilling fluid removed
  from drill cuttings at the solids control equipment as determined by
  ASTM E 1367-92 method: ``Standard Guide for Conducting 10-day Static
  Sediment Toxicity Tests with Marine and Estuarine Amphipods,'' 1992,
  with Leptocheirus plumulosus as the test organism and sediment
  preparation procedures specified in EPA Method 1646, which is
  published in ``Analytic Methods for the Oil and Gas Extraction Point
  Source Category,'' EPA-821-R-09-013. See Sec.   435.11(ee) and (uu).

\9\ As determined before drilling fluids are shipped offshore by the GC/
  MS compliance assurance method (EPA Method 1655), and as determined
  prior to discharge by the RPE method (EPA Method 1670) applied to
  drilling fluid removed from drill cuttings. If the operator wishes to
  confirm the results of the RPE method (EPA Method 1670), the operator
  may use the GC/MS compliance assurance method (EPA Method 1655).
  Results from the GC/MS compliance assurance method (EPA Method 1655)
  shall supersede the results of the RPE method (EPA Method 1670). EPA
  Method 1655 and 1670 are published in ``Analytic Methods for the Oil
  and Gas Extraction Point Source Category,'' EPA-821-R-09-013. See Sec.
    435.11(uu).
\10\ Maximum permissible retention of non-aqueous drilling fluid (NAF)
  base fluid on wet drill cuttings averaged over drilling intervals
  using NAFs as determined by EPA Method 1674, which is published in
  ``Analytic Methods for the Oil and Gas Extraction Point Source
  Category,'' EPA-821-R-09-013. See Sec.   435.11(uu). This limitation
  is applicable for NAF base fluids that meet the base fluid sediment
  toxicity ratio (Footnote 6), biodegradation rate ratio (Footnote 7),
  PAH, mercury, and cadmium stock limitations (C16-C18 internal olefin)
  defined above in this table.
\11\ Maximum permissible retention of non-aqueous drilling fluid (NAF)
  base fluid on wet drill cuttings average over drilling intervals using
  NAFs as determined by EPA Method 1674, which is published in
  ``Analytic Methods for the Oil and Gas Extraction Point Source
  Category,'' EPA-821-R-09-013. See Sec.   435.11(uu). This limitation
  is applicable for NAF base fluids that meet the ester base fluid
  sediment toxicity ratio and ester biodegradation rate ratio stock
  limitations defined as:
(a) Ester base fluid sediment toxicity ratio = 10-day LC50 of C12-C14
  ester or C8 ester/10-day LC50 of stock base fluid as determined by
  ASTM E 1367-92 method: ``Standard Guide for Conducting 10-day Static
  Sediment Toxicity Tests with Marine and Estuarine Amphipods,'' 1992,
  with Leptocheirus plumulosus as the test organism and sediment
  preparation procedures specified in EPA Method 1646, which is
  published in ``Analytic Methods for the Oil and Gas Extraction Point
  Source Category,'' EPA-821-R-09-013. See Sec.   435.11(ee) and (uu);
(b) Ester biodegradation rate ratio = Cumulative headspace gas
  production (ml) of C12-C14 ester or C8 ester/Cumulative headspace gas
  production (ml) of stock base fluid, both at 275 days as determined by
  EPA Method 1647, which is published in ``Analytic Methods for the Oil
  and Gas Extraction Point Source Category,'' EPA-821-R-09-013. See Sec.
    435.11(e) and (uu); and (c) PAH mass ratio (Footnote 5), mercury,
  and cadmium stock limitations (C16-C18 internal olefin) defined above
  in this table.

    23. Subpart A of part 435 is amended by removing Appendices 1
through 7.
    24. Subpart A of part 435 is amended by redesignating Appendix 8 as
Appendix 1.

Subpart D--Coastal Subcategory

    25. Section 435.41 is amended,
    a. By revising paragraph (d).
    b. By revising paragraph (e).
    c. By revising paragraph (k).
    d. By revising paragraph (m)(2).
    e. By revising paragraph (q).
    f. By revising paragraph (r).
    g. By revising paragraph (y).
    h. By revising paragraph (ee).
    i. By revising paragraph (ff).
    j. By adding paragraph (mm).

Sec.  435.41  Specialized definitions.

* * * * *
    (d) Base fluid retained on cuttings as applied to BAT effluent
limitations and NSPS refers to the ``Determination of the Amount of
Non-Aqueous Drilling Fluid (NAF) Base Fluid from Drill Cuttings by a
Retort Chamber (Derived from API Recommended Practice 13B-2)'', EPA
Method 1674, which is published in ``Analytic Methods for the Oil and
Gas Extraction Point Source Category,'' EPA-821-R-09-013. See paragraph
(mm) of this section.
    (e) Biodegradation rate as applied to BAT effluent limitations and
NSPS for drilling fluids and drill cuttings refers to the ``Protocol
for the Determination of Degradation of Non Aqueous Base Fluids in a
Marine Closed Bottle Biodegradation Test System: Modified ISO
11734:1995,'' EPA Method 1647, supplemented with ``Procedure for Mixing
Base Fluids With Sediments,'' EPA Method 1646. Both EPA Method 1646 and
1647 are published in ``Analytic Methods for the Oil and Gas Extraction
Point Source Category,'' EPA-821-R-09-013. See paragraph (mm) of this
section.
* * * * *
    (k) Diesel oil refers to the grade of distillate fuel oil, as
specified in the American Society for Testing and Materials Standard
Specification for Diesel Fuel Oils D975-91, that is typically used as
the continuous phase in conventional oil-based drilling fluids. This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the American Society for Testing and Materials,
100 Barr Harbor Drive, West Conshohocken, PA 19428. Copies may be
inspected at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/code_
of_federal_regulations/ibr_locations.html. A copy may also be
inspected at EPA's Water Docket, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
* * * * *
    (m) * * *
    (2) Dry drill cuttings means the residue remaining in the retort
vessel after completing the retort procedure specified in EPA Method
1674, which is published in ``Analytic Methods for the Oil and Gas
Extraction Point Source Category,'' EPA-821-R-09-013. See paragraph
(mm) of this section.
* * * * *
    (q) Formation oil means the oil from a producing formation which is
detected in the drilling fluid, as determined by the GC/MS compliance
assurance method, EPA Method 1655, when the drilling fluid is analyzed
before being shipped offshore, and as determined by the RPE method, EPA
Method 1670, when the drilling fluid is analyzed at the offshore point
of discharge. The GC/MS compliance assurance method and the RPE method
approved for use with this part are published in the ``Analytic Methods
for the Oil and Gas Extraction Point Source Category,'' EPA-821-R-09-
013. See paragraph (mm) of this section. Detection of formation oil by
the RPE method may be confirmed by the GC/MS compliance assurance
method, and the results of the GC/MS compliance assurance method shall
supersede those of the RPE method.
    (r) Garbage means all kinds of victual, domestic, and operational
waste, excluding fresh fish and parts thereof, generated during the
normal operation of coastal oil and gas facility and liable to be
disposed of continuously or periodically, except dishwater, graywater,
and those substances that are defined or listed in other Annexes to
MARPOL 73/78. A copy of MARPOL may be inspected at EPA's Water Docket,
1200 Pennsylvania Ave., NW., Washington, DC 20460.
* * * * *
    (y) No discharge of free oil means that waste streams may not be
discharged that contain free oil as evidenced by the monitoring method
specified for that particular stream, e.g., deck drainage or
miscellaneous discharges cannot be discharged when they would cause a
film or sheen upon or discoloration of the surface of the receiving
water; drilling fluids or cuttings may not be discharged when they fail
EPA Method 1617 (Static Sheen Test), which is published in ``Analytic
Methods for the Oil and Gas Extraction Point Source Category,'' EPA-
821-R-09-013. See paragraph (mm) of this section.
* * * * *
    (ee) SPP toxicity as applied to BAT effluent limitations and NSPS
for drilling fluids and drill cuttings refers to the bioassay test
procedure, ``Suspended Particulate Phase (SPP) Toxicity Test,''
presented in EPA Method 1619, which is published in ``Analytic Methods
for the Oil and Gas Extraction Point Source Category,'' EPA-821-R-09-
013. See paragraph (mm) of this section.
    (ff) Static sheen test means the standard test procedure that has
been

developed for this industrial subcategory for the purpose of
demonstrating compliance with the requirement of no discharge of free
oil. The methodology for performing the static sheen test is presented
in EPA Method 1617, which is published in ``Analytic Methods for the
Oil and Gas Extraction Point Source Category,'' EPA-821-R-09-013. See
paragraph (mm) of this section.
* * * * *
    (mm) Analytic Methods for the Oil and Gas Extraction Point Source
Category is the EPA document, EPA-821-R-09-013, that compiles analytic
methods for this category. This incorporation by reference was approved
by the Director of the Federal Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies may be inspected at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html. A copy may also be inspected at EPA's
Water Docket, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    26. In Sec.  435.42, footnote 1 to the table is revised to read as
follows:

Sec.  435.42  Effluent limitations guidelines representing the degree
of effluent reduction attainable by the application of the best
practicable control technology currently available (BPT).

* * * * *
    \1\ No discharge of free oil. See Sec.  435.41(y).
* * * * *
    27. In Sec.  435.43, footnotes 2 and 4 are revised to read as
follows:

Sec.  435.43  Effluent limitations guidelines representing the degree
of effluent reduction attainable by the application of the best
available technology economically achievable (BAT).

* * * * *

                        Bat Effluent Limitations

                                * * * * *

\2\ As determined by the static sheen test. See Sec.   435.41(ff).
* * * * *
\4\ As determined by the suspended particulate phase (SPP) toxicity
  test. See Sec.   435.41(ee).

* * * * *
    28. In Sec.  435.44 footnote 2 to the table is revised to read as
follows:

Sec.  435.44  Effluent limitations guidelines representing the degree
of effluent reduction attainable by the application of the best
conventional pollutant control technology (BCT).

* * * * *

                        Bat Effluent Limitations

                                * * * * *

\2\ As determined by the static sheen test. See Sec.   435.41(ff).

* * * * *
    29. In Sec.  435.45, footnotes 2 and 4 to the table are revised to
read as follows:

Sec.  435.45  Standards of performance for new sources (NSPS).

* * * * *

                        NSPS Effluent Limitations

                                * * * * *

\2\ As determined by the static sheen test. See Sec.   435.41(ff).
* * * * *
\4\ As determined by the suspended particulate phase (SPP) toxicity
  test. See Sec.   435.41(ee).

* * * * *
[FR Doc. 2010-20018 Filed 9-22-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 22 (Tuesday, February 3, 2015)]
[Notices]
[Pages 5856-5858]
[FR Doc No: 2015-02016]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74166; File No. SR-EDGA-2015-04]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Make
Non-Substantive Amendments and Clarifications to the Fee Schedule

January 28, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 16, 2015, EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The Exchange filed a proposal to amend its fees and rebates
applicable to Members \5\ of the Exchange pursuant to EDGA Rule 15.1(a)
and (c) (``Fee Schedule'') to make several non-substantive amendments
and clarifications as part of its migration onto the same technology
platform as its affiliated exchanges, BATS Exchange, Inc. (``BZX'') and
BATS Y-Exchange, Inc. (``BYX'', collectively with BZX, ``BATS''). The
proposed rule change does not amend any existing fees or rebates, nor
do they alter the manner in which the Exchange assesses fees or
calculates rebates.
---------------------------------------------------------------------------

    \5\ The term ``Member'' is defined as ``any registered broker or
dealer, or any person associated with a registered broker or dealer,
that has been admitted to membership in the Exchange. A Member will
have the status of a ``member'' of the Exchange as that term is
defined in Section 3(a)(3) of the Act.'' See Exchange Rule 1.5(n).
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the

principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    Earlier this year, the Exchange and its affiliate, EDGX Exchange,
Inc. (``EDGX'') received approval to effect a merger (the ``Merger'')
of the Exchange's parent company, Direct Edge Holdings LLC, with BATS
Global Markets, Inc., the parent of BATS (together with BATS, EDGA and
EDGX, the ``BGM Affiliated Exchanges'').\6\ In the context of the
Merger, the BGM Affiliated Exchanges are working to migrate EDGX and
EDGA onto the BATS technology platform, and align certain system
functionality and rules, retaining only intended differences between
the BGM Affiliated Exchanges. As a result of these efforts, the
Exchange proposes to make several non-substantive amendments and
clarifications to its Fee Schedule as part of its migration onto the
BATS technology platform. The Exchange notes that none of these changes
substantively amend any fee or rebate, nor do they alter the manner in
which the Exchange assesses fees or calculates rebates. Specifically,
the Exchange is proposing the following:
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 71449 (January 30,
2014), 79 FR 6961 (February 5, 2014) (SR-EDGX-2013-43; SR-EDGA-2013-
34).
---------------------------------------------------------------------------

     To eliminate the lead-in text that reads, ``Download in
pdf format. Rebates & Charges for Adding, Removing or Routing Liquidity
per share for Tape A, B, & C securities \1\'' and replace it with the
heading, ``Transaction Fees.''
     Replace references to the term ``liquidity flag'' or
``flag'' with the term ``fee code'' throughout the Fee Schedule.
     Amend the bullets under the renamed section, Transactions
to: (i) Clarify that the rates apply to a Member's transactions by
adding the term ``transactions''; and (ii) add a statement to clarify
that, unless otherwise noted, all routing fees and rebates are for
removing liquidity from the destination venue.
     Rename the section entitled, ``Liquidity Flags'' as ``Fee
Codes and Associated Fees.'' The Exchange also proposes to: (i) Clarify
under this section which fee codes apply to removing or adding
liquidity on EDGA; (ii) amend certain terminology to ensure consistent
phrasing and to align with similar language included in the BATS fee
schedules; and (iii) amend: (a) Fee code O to clarify that it applies
to orders routed to the listing market opening or re-opening cross; (b)
fee codes T, and Z to clarify that the order must be routed to a non-
exchange destination; \7\ (c) fee code R to clarify that the order is
re-routed by the New York Stock Exchange, Inc. (``NYSE''); \8\ (d)
amend fee code RP to reflect a change to the name of the Route Peg
order to the Supplemental Peg order; \9\ and (e) fee codes BY, RR, and
SW to reflect the routing strategies that are to be added or removed
upon migration of the Exchange onto BATS technology.\10\
---------------------------------------------------------------------------

    \7\ The Exchange notes that the routing strategies listed in the
description of fee codes T and Z route orders to both exchange and
non-exchange destinations. The proposed rule change is intended to
clarify that fee codes T and Z will only be appended to an order
when routed to a non-exchange destination pursuant to one of the
listed routing strategies. Orders routed to an exchange destination
pursuant to one of the listed routing strategies will include a
different fee code.
    \8\ Previously, the Exchange would route re-routable orders to
other exchanges in addition to the NYSE. This change is designed to
reflect that the Exchange currently routes re-routable orders only
to the NYSE.
    \9\ See Securities Exchange Act Release Nos. 74023 (January 9,
2015), 80 FR 2163 (January 15, 2015) (SR-EDGX-2015-03); and 74028
(January 9, 2015), 80 FR 2125 (January 15, 2015) (SR-EDGA-2015-03).
    \10\ Id.
---------------------------------------------------------------------------

     Amend the definitions of Average Daily Volume (``ADV'')
and Total Consolidated Volume (``TCV'') to be substantially similar to
the definitions for these terms in the BATS fee schedules. The only
differences in the definitions are that the Exchange includes routed
volume in its calculation of ADV and will exclude from its calculation
of ADV and TCV shares added, removed, or routed on each trading day
from January 12, 2015 up to and including January 16, 2015.\11\
---------------------------------------------------------------------------

    \11\ After January 16, 2015, the Exchange intends to submit a
rule filing to the Commission to remove the provision to exclude
from its calculation of ADV and TCV shares added, removed, or routed
on each trading day from January 12, 2015 up to and including
January 16, 2015 from its definitions of TCV and ADV.
---------------------------------------------------------------------------

     Amend the section entitled General Notes to mirror a
similar section within the BATS fee schedules by: (i) Deleting the
first three bullets regarding added flags, removal flags, and routed
flags because, it is redundant as the description of each fee code
indicates whether is it for added, removed or routed orders; (ii)
adding a bullet stating that rebates and charges for adding, removing
or routing liquidity are listed as per share rebates and charges; and
(iii) making certain non-substantive changes to the current fifth
bullet.
     Amend footnotes 1, 2, and 3 to amend the description of
the each tier's criteria to align with similar description in the BATS
fee schedules.
     Amend footnote 4 entitled Add Volume Tiers to amend the
description of the each tier's criteria to align with similar
description in the BATS fee schedules. The Exchange also proposes to
amend Step-Up Tiers 1 and 2 to clarify that a Member's added ADV must
be more than the Member's added ADV as a percentage of TCV during the
month indicated in the tier. The Exchange also proposes to amend Step-
Up Tier 2 to correctly refer to [sic] second requirement of the tier's
criteria as a percentage and not a ratio as this portion of the
criteria is incorrectly categorized as a ratio.
     Amend footnotes 8 and 12 to reflect the routing strategies
that are to be added or removed upon migration of the Exchange onto
BATS technology.\12\
---------------------------------------------------------------------------

    \12\ See supra note 9.
---------------------------------------------------------------------------

Implementation Date
    The Exchange proposes to implement these amendments to its Fee
Schedule on January 16, 2015.\13\
---------------------------------------------------------------------------

    \13\ The Exchange notes that the date of the Fee Schedule was
amended to January 16, 2015 in a previously filed proposed rule
change. See SR-EDGA-2015-01 (filed January 16, 2015).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\14\ in general, and
furthers the objectives of Section 6(b)(4),\15\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities. The Exchange also notes that it operates in a highly-
competitive market in which market participants can readily direct
order flow to competing venues if they deem fee levels at a particular
venue to be excessive. The Exchange believes that the proposed rates
are equitable and

non-discriminatory in that they apply uniformly to all Members.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78f.
    \15\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the non-substantive clarifying changes
to its Fee Schedule are reasonable because they are designed to provide
greater transparency to Members with regard to how the Exchange
assesses fees and provides rebates. The Exchange notes that none of the
proposed non-substantive clarifying changes are designed to amend any
fee or rebate, nor alter the manner in which it assesses fees or
calculates rebates. In particular, the proposed amendments to Step-Up
Tiers 1 and 2 are reasonable and equitable because they conform to
existing practice and do not modify the fees that the Exchange charges
its Members that satisfy the tier's criteria. The Exchange has
historically in practice and will continue to require a Member's added
ADV be more than the Member's added ADV as a percentage of TCV during
the month indicated in the tier when determining the Member satisfied
the tier's criteria. The Exchange believes that Members would benefit
from clear guidance in its Fee Schedule that describes the manner in
which the Exchange would assess fees and calculate rebates. The
proposed rule change is also designed, in part, to align terminology
and definitions with that included in the current BATS fee schedules in
order to use consistent fee schedules across the BGM Affiliated
Exchanges. These changes to the Fee Schedule are intended to provide
greater harmonization between Exchange, BYX, and BZX fee schedules and
make the Fee Schedule clearer and less confusing for investors, thereby
eliminating potential investor confusion. As such, the proposed rule
change would remove impediments to and perfect the mechanism of a free
and open market and a national market system, and, in general, protect
investors and the public interest.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
Exchange reiterates that the proposed rule change is being proposed in
the context of the technology integration of the BGM Affiliated
Exchanges and that the changes are entirely non-substantive. The
proposed changes are not designed to have any impact on competition.
Rather, they are intended to provide greater harmonization between
Exchange, BYX, and BZX fee schedules and make the Fee Schedule clearer
and less confusing for investors. As stated above, the Exchange notes
that it operates in a highly competitive market in which market
participants can readily direct order flow to competing venues if the
deem fee structures to be unreasonable or excessive.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from Members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \16\ and paragraph (f) of Rule 19b-4
thereunder.\17\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-EDGA-2015-04 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-EDGA-2015-04. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGA-2015-04, and should be
submitted on or before February 24, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-02016 Filed 2-2-15; 8:45 am]
BILLING CODE 8011-01-P


Panel Member List for the Federal Insecticide, Fungicide and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to Consider and Review "Integrated Approaches to Testing and Assessment Strategies: Use of New Computational and Molecular Tools"

                                May 24-26, 2011

EPA-HQ-OPP-2011-0284			OPP Docket Tel:<PHONE_NUMBER>

FIFRA SAP Chair

Kenneth Portier, Ph.D.
Program Director, Statistics
American Cancer Society
National Home Office
Atlanta, GA

Designated Federal Official

Fred Jenkins, Jr., Ph.D.
US Environmental Protection Agency
Office of Science Coordination & Policy
FIFRA Scientific Advisory Panel
EPA East Building, MC 7201M
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Tel:<PHONE_NUMBER>, Fax:<PHONE_NUMBER><EMAIL_ADDRESS>
FIFRA Scientific Advisory Panel Members

Janice Chambers, Ph.D., DABT, ATS
William L. Giles Distinguished Professor
Director
Center for Environmental Health Sciences
College of Veterinary Medicine
Mississippi State University
Mississippi State, MS

Stephen Klaine, Ph.D.
Professor
Department of Biological Sciences
Director Clemson Institute of Environmental Toxicology
Clemson University
Clemson, SC

Carey Pope, Ph.D.
Professor, Head & Sitlington Chair of Toxicology
Department of Physiological Sciences
Center for Veterinary Health Sciences
Oklahoma State University College of Veterinary Medicine
Stillwater, OK

Martha Sandy, Ph.D.
Senior Toxicologist and Chief
Office of Environmental Health Hazard Assessment
California Environmental Protection Agency
Oakland, CA

Daniel Schlenk, Ph.D.
Professor of Aquatic Ecotoxicology & Environmental Toxicology
Department of Environmental Sciences
University of California, Riverside
Riverside, CA

FQPA Science Review Board Members

Mitchell Cheeseman, Ph.D.
Acting Director
Office of Food Additive Safety
US Food and Drug Administration
College Park, MD

Robert Denver, Ph.D.
Professor
Departments of Molecular, Cellular & Developmental Biology and
Ecology & Evolutionary Biology
University of Michigan
Ann Arbor, MI

J. David Furlow, Ph.D.
Associate Professor
Section of Neurobiology, Physiology and Behavior
University of California, Davis
Davis, CA

Roberta Grant, Ph.D.
Toxicology Division
Chief Engineer's Office
Texas Commission on Environmental Quality
Austin, TX

Richard Greenwood, Ph.D.
Professor Emeritus of Environmental Science
School of Biological Sciences
University of Portsmouth
Portsmouth, UK

William Hayton, Ph.D.
Professor Emeritus
Division of Environment Health Science
College of Pharmacy, School of Medicine and Public Health
Ohio State University
Columbus, Ohio

Nelson Horseman, Ph.D.
Professor
Departments of Molecular and Cellular Physiology
University of Cincinnati
Cincinnati, OH

David Jacobson-Kram, Ph.D.
Assoc. Dir. of Pharmacology and Toxicology
Center for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, MD

Teresa Leavens, Ph.D.
Research Assistant Professor
Department of Population Health and Pathology
College of Veterinary Medicine
North Carolina State University
Raleigh, NC

Bette Meek, Ph.D.
Associate Director - Chemical Risk Assessment
McLaughlin Institute for Population Health Risk Assessment
University of Ottawa
Ottawa, Canada

Reynaldo Patino, Ph.D.
Research Scientist/Professor
U.S. Geological Survey
Texas Tech University
Texas Cooperative Fish and Wildlife Research Unit
Lubbock, TX

Terry Schultz, Ph.D.
Professor Emeritus
Department of Comparative Medicine
College of Veterinary Medicine
University of Tennessee
Knoxville, TN

Geoffrey Scott, Ph.D.
Director
National Oceanic and Atmospheric Administration
National Center for Ocean Science
Center for Coastal Environmental Health & Biomolecular Research
Charleston, SC