[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Pages 30962-30963]
[FR Doc No: 2022-10924]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0766]

Hospira, Inc., et al.; Withdrawal of Approval of 21 Abbreviated
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 21 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of June 21, 2022.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].

SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
      Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040140...............  Diphenhydramine        Hospira, Inc., 275
                             Hydrochloride (HCl)    North Field Dr.,
                             Injection, 50          Building H1-3S, Lake
                             milligrams (mg)/       Forest, IL 60045.
                             milliliters (mL).
ANDA 040578...............  Benzphetamine HCl      ScinoPharm Taiwan,
                             Tablets, 50 mg.        Ltd., 909 N Ford
                                                    Ave., Fullerton, CA
                                                    92832.
ANDA 065267...............  Cefprozil Tablets,     Bionpharma Inc., 600
                             250 mg, and 500 mg.    Alexander Rd., Suite
                                                    2-4B, Princeton, NJ
                                                    08540.
ANDA 065284...............  Cefprozil Oral         Do.
                             Suspension, 125 mg/5
                             mL and 250 mg/5 mL.

ANDA 065301...............  Cefadroxil Tablets,    Do.
                             Equivalent to (EQ) 1
                             gram (g) base.
ANDA 065307...............  Cefadroxil Oral        Do.
                             Suspension, EQ 250
                             mg base/5 mL and EQ
                             500 mg base/5 mL.
ANDA 065309...............  Cefadroxil Capsules,   Do.
                             EQ 500 mg base.
ANDA 065326...............  Cephalexin Oral        Do.
                             Suspension, EQ 125
                             mg base/5 mL and EQ
                             250 mg base/5 mL.
ANDA 076720...............  Morphine Sulfate       Nesher
                             Extended Release       Pharmaceuticals
                             Tablets, 30 mg, and    (USA) LLC., 13910
                             60 mg.                 Saint Charles Rock
                                                    Rd., Bridgeton, MO
                                                    63044.
ANDA 076733...............  Morphine Sulfate       Do.
                             Extended Release
                             Tablets, 15 mg.
ANDA 077855...............  Morphine Sulfate       Do.
                             Extended Release
                             Tablets, 100 mg and
                             200 mg.
ANDA 080225...............  Potassium Chloride     Fresenius Kabi USA,
                             Injection, 2           LLC, Three Corporate
                             milliequivalent        Dr., Lake Zurich, IL
                             (mEq)/mL and 3 mEq/    60047.
                             mL.
ANDA 202393...............  Diclofenac Sodium      TWi Pharmaceuticals,
                             Topical Solution,      Inc., 536 Vanguard
                             1.5%.                  Way, Brea, CA 92821.
ANDA 203581...............  Glyburide Tablets,     Sunny Pharmtech Inc.,
                             1.25 mg, 2.5 mg, and   175 SW 166th Ave.,
                             5 mg.                  Pembroke Pines, FL
                                                    33027.
ANDA 204137...............  Omeprazole and Sodium  Unicorn
                             Bicarbonate            Pharmaceuticals, 5
                             Capsules, 20 mg; 1.1   Links Circle,
                             g.                     Durham, NC 27707.
ANDA 206588...............  Dextroamphetamine      Nesher
                             Sulfate Tablets, 5     Pharmaceuticals
                             mg, and 10 mg.         (USA) LLC.
ANDA 208263...............  Doxycycline Hyclate    Do.
                             Capsules, EQ 50 mg
                             base and EQ 100 mg
                             base.
ANDA 209111...............  Dextroamphetamine      Do.
                             Sulfate Extended
                             Release Capsules, 5
                             mg, 10 mg, and 15 mg.
ANDA 210079...............  Oxycodone and          Do.
                             Acetaminophen
                             Tablets, 325 mg; 2.5
                             mg, 325 mg; 5 mg,
                             325 mg; 7.5 mg, 325
                             mg; 10 mg.
ANDA 210080...............  Dextroamphetamine      Do.
                             Saccharate,
                             Amphetamine
                             Aspartate,
                             Dextroamphetamine
                             Sulfate, and
                             Amphetamine Sulfate
                             Extended Release
                             Capsules, 1.25 mg;
                             1.25 mg; 1.25 mg;
                             1.25 mg, 2.5 mg; 2.5
                             mg; 2.5 mg; 2.5 mg,
                             3.75 mg; 3.75 mg;
                             3.75 mg; 3.75 mg, 5
                             mg; 5 mg; 5 mg; 5
                             mg, 6.25 mg; 6.25
                             mg; 6.25 mg; 6.25
                             mg, 7.5 mg; 7.5 mg;
                             7.5 mg; 7.5 mg.
ANDA 211543...............  Butalbital,            Do.
                             Acetaminophen, and
                             Caffeine Tablets,
                             325 mg; 50 mg; 40 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of June
21, 2022. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of
products without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in
inventory on June 21, 2022, may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.

    Dated: May 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10924 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 4, 2010 (Volume 75, Number 213)]
[Proposed Rules]
[Page 67919-67925]
[DOCID:fr04no10-5]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 261

[EPA-R05-RCRA-2010-0843; SW-FRL-9221-2]

Hazardous Waste Management System; Proposed Exclusion for
Identifying and Listing Hazardous Waste

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule and request for comment.

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SUMMARY: The EPA (also, ``the Agency'' or ``we'' in this preamble) is
proposing to grant a petition submitted by Owosso Graphic Arts Inc.
(Owosso), in Owosso Michigan to exclude (or ``delist'') up to 244 cubic
yards of wastewater treatment sludge per year from the list of
hazardous wastes.
    The Agency has tentatively decided to grant the petition based on
an evaluation of waste-specific information provided by Owosso. This
proposed decision, if finalized, conditionally excludes the petitioned
waste from the requirements of hazardous waste regulations under the
Resource Conservation and Recovery Act.
    We conclude that Owosso's petitioned waste is nonhazardous with
respect to the original listing criteria and that there are no other
factors which would cause the waste to be hazardous when disposed of in
a Subtitle D landfill which is permitted, licensed, or registered by a
State to manage industrial solid waste.

DATES: Comments must be received on or before December 6, 2010.
Requests for an informal hearing must reach EPA by November 19, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. [EPA-R05-
RCRA-2010-0843] by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     Mail: to Christopher Lambesis, Environmental Protection
Agency, Land and Chemicals Division, (Mail Code: LR-8J), EPA Region 5,
77 West Jackson Boulevard, Chicago, IL 60604.
     Hand Delivery: to Christopher Lambesis, Land and Chemicals
Division, EPA Region 5, 8th Floor, 77 West Jackson Boulevard, Chicago,
IL 60604. Such deliveries are only accepted during normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. Please contact Christopher Lambesis at (312) 886-
3583.
    Instructions: Direct your comments to Docket ID No. [EPA-R05-RCRA-
2010-0843]. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Any person may request an informal hearing on this proposed
decision by filing a request with Bruce Sypniewski, Acting Director,
Land and Chemicals Division, Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604. The request must contain
the information prescribed in 40 CFR 260.20(d).
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at
the Records Center, 7th floor, U.S. EPA Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This facility is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. We
recommend you telephone Christopher Lambesis at<PHONE_NUMBER> before
visiting the Region 5 office. The public may copy material from the
regulatory docket at 15 cents per page.

FOR FURTHER INFORMATION CONTACT: Christopher Lambesis, Land and
Chemicals Division, (Mail Code: LR-8J), EPA Region 5, 77 W. Jackson
Boulevard, Chicago, IL 60604; telephone number:<PHONE_NUMBER>; fax
number<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The information in this section is organized
as follows:

I. Overview Information
II. Background
    A. What is a listed waste?
    B. What is a delisting petition?
    C. What factors must EPA consider in deciding whether to grant a
delisting petition?
III. EPA's Evaluation of the Waste Information and Data
    A. What waste did Owosso petition EPA to delist?
    B. How does Owosso generate the waste?
    C. How did Owosso sample and analyze the waste?
    D. What were the results of Owosso's analysis of the waste?
    E. How did EPA evaluate the risk of delisting this waste?
    F. What did EPA conclude about Owosso's waste?
IV. Conditions for Exclusion
    A. When would EPA finalize the proposed delisting exclusion?
    B. How will Owosso manage the waste if it is delisted?

    C. What are the maximum allowable concentrations of hazardous
constituents in the waste?
    D. How frequently must Owosso test the waste?
    E. What data must Owosso submit?
    F. What happens if Owosso's waste fails to meet the conditions
of the exclusion?
    G. What must Owosso do if the process changes?
V. How would this action affect states?
VI. Statutory and Executive Order Reviews

I. Overview Information

    The EPA is proposing to grant a petition submitted by Owosso
Graphic Arts Incorporated (Owosso) located in Owosso, Michigan to
exclude or delist an annual volume of 244 cubic yards of F006
wastewater treatment sludge from the lists of hazardous waste set forth
in Title 40 of the Code of Federal Regulations (40 CFR) 261.31. Owosso
claims that the petitioned waste does not meet the criteria for which
EPA listed it, and that there are no additional constituents or factors
which could cause the waste to be hazardous.
    Based on our review described in section III, we agree with the
petitioner that the waste is nonhazardous. We reviewed the description
of the process which generates the waste and the analytical data
submitted by Owosso. We believe that the petitioned waste does not meet
the criteria for which the waste was listed, and that there are no
other factors which might cause the waste to be hazardous.

II. Background

A. What is a listed waste?

    The EPA published an amended list of hazardous wastes from
nonspecific and specific sources on January 16, 1981, as part of its
final and interim final regulations implementing section 3001 of
Resource Conservation and Recovery Act (RCRA). The EPA has amended this
list several times and published it in 40 CFR 261.31 and 261.32.
    We list these wastes as hazardous because: (1) They typically and
frequently exhibit one or more of the characteristics of hazardous
wastes identified in subpart C of part 261 (that is, ignitability,
corrosivity, reactivity, and toxicity) or (2) they meet the criteria
for listing contained in Sec.  261.11(a)(2) or (3).

B. What is a delisting petition?

    Individual waste streams may vary depending on raw materials,
industrial processes, and other factors. Thus, while a waste described
in the regulations generally is hazardous, a specific waste from an
individual facility meeting the listing description may not be.
    A procedure to exclude or delist a waste is provided in 40 CFR
260.20 and 260.22 which allows a person, or a facility, to submit a
petition to the EPA or to an authorized state demonstrating that a
specific waste from a particular generating facility is not hazardous.
    In a delisting petition, the petitioner must show that a waste does
not meet any of the criteria for listed wastes in 40 CFR 261.11 and
that the waste does not exhibit any of the hazardous waste
characteristics of ignitability, reactivity, corrosivity, or toxicity.
The petitioner must present sufficient information for us to decide
whether any factors in addition to those for which the waste was listed
warrant retaining it as a hazardous waste. (See Sec.  260.22, 42 United
States Code--U.S.C.--6921(f) and the background documents for the
listed wastes.)
    If a delisting petition is granted, the generator remains obligated
under RCRA to confirm that the waste remains nonhazardous.

C. What factors must EPA consider in deciding whether to grant a
delisting petition?

    In reviewing this petition, we considered the original listing
criteria and the additional factors required by the Hazardous and Solid
Waste Amendments of 1984 (HSWA). See section 222 of HSWA, 42 U.S.C.
6921(f), and 40 CFR 260.22(d)(2)-(4). We evaluated the petitioned waste
against the listing criteria and factors cited in Sec.  261.11(a)(2)
and (3).
    Besides considering the criteria in 40 CFR 260.22(a), 261.11(a)(2)
and (3), 42 U.S.C. 6921(f), and in the background documents for the
listed wastes, EPA must consider any factors (including additional
constituents) other than those for which we listed the waste if these
additional factors could cause the waste to be hazardous.
    Our tentative decision to delist waste from Owosso's facility is
based on our evaluation of the waste for factors or criteria which
could cause the waste to be hazardous. These factors included: (1)
Whether the waste is considered acutely toxic; (2) the toxicity of the
constituents; (3) the concentration of the constituents in the waste;
(4) the tendency of the constituents to migrate and to bioaccumulate;
(5) the persistence in the environment of any constituents once
released from the waste; (6) plausible and specific types of management
of the petitioned waste; (7) the quantity of waste produced; and (8)
waste variability.
    EPA must also consider as hazardous wastes mixtures containing
listed hazardous wastes and wastes derived from treating, storing, or
disposing of listed hazardous waste. See 40 CFR 261.3(a)(2)(iv) and
(c)(2)(i), called the ``mixture'' and ``derived-from'' rules,
respectively. Mixture and derived-from wastes are also eligible for
exclusion but remain hazardous until excluded.

III. EPA's Evaluation of the Waste Information and Data

A. What waste did Owosso petition EPA to delist?

    In May 2005, Owosso petitioned EPA to exclude an annual volume of
244 cubic yards of F006 wastewater treatment sludges generated at its
facility located in Owosso, Michigan from the list of hazardous wastes
contained in 40 CFR 261.31. F006 is defined in Sec.  261.31 as
``Wastewater treatment sludges from electroplating operations * * *''
Owosso claims that the petitioned waste does not meet the criteria for
which F006 was listed (i.e., cadmium, hexavalent chromium, nickel and
complexed cyanide) and that there are no other factors which would
cause the waste to be hazardous.

B. How does Owosso generate the waste?

    Owosso Graphic Arts conducts chemical etching of magnesium plates
to produce photoengraved dies for the printing and foil stamping
industries. Owosso Graphic Arts also etches other metals using ferric
chloride to produce similar products. The magnesium etching process is
physically separated from that of the other metals and share no common
equipment, piping or waste handling procedures.
    A desired pattern is applied to a magnesium plate in the form of a
printed laminate sensitive to ultra-violet (UV) light. After UV
exposure, the magnesium plate is exposed to a spray of developing agent
in a self-contained unit that washes away areas of laminate where
etching is to occur. The solvent trichloroethylene (TCE) was used as
the developing agent until December 2007 when an aqueous solution
(Hydro-Coat) containing inorganic sodium salt and a surfactant replaced
TCE.
    The aqueous developer was used until September 2008 when Owosso
began using the solvent n-methyl 2-pyrrolidone (NMP) as the developing
agent.
    Nitric acid is used to etch the surface of magnesium plates to
create the contoured die surface. The developed plate is cleaned with a
mild (1-2 percent) nitric acid solution to remove the remaining
protective coating from

the plate. The cleaning solution is discharged to a publicly owned
treatment works (POTW) subject to the Clean Water Act.
    The plate is placed in one of several self-contained etching units
varying in size and equipped with reservoirs of nitric acid-based
etching solution (nitric acid, water, Mag-O 20 detergent). The
reservoir may contain between 200-400 liters of etching solution
depending on the size of the etching unit. Each magnesium plate is
weighed prior to entering the etching process and again once etching is
completed. The difference between the initial weight and the post-
etching weight is used to calculate the amount of magnesium residual
remaining in the etching solution reservoir. The amount of metal
residue introduced into the etching solution varies based on the size
of the plate being etched and depth of the etching required by
individual projects.
    Operators of the system may adjust the strength of the acid between
etching events to balance the acid content of the solution for optimal
etching performance. Once the metal concentration becomes too great to
provide optimal etching, the nitric acid solution is considered spent
and is transferred to a wastewater treatment process for
neutralization.
    Wastewater treatment sludge is produced in a batch process in which
spent etchant (nitric acid based etching solution described above) is
pumped to a holding tank to await treatment. Transfer of approximately
500 gallons of spent etchant into the holding tank occurs on a daily
basis.
    The used etchant is combined with sodium hydroxide and water to
neutralize the spent etchant prior to discharge to the City of Owosso's
POTW. The neutralization process requires a residence time of
approximately 30 minutes for complete neutralization of the spent acid
solution. The treated solution is allowed to settle for 12 hours to
allow solids to precipitate and settle to the bottom of the tank. The
supernatant liquid is decanted for discharge to the POTW.
    Dewatering of precipitate formed during wastewater treatment occurs
in a filter press adjacent to the tank containment area. The filter
press is emptied into three steel gondolas prior to being placed in a
lined roll-off container.

C. How did Owosso sample and analyze the petitioned waste?

    Owosso collected a sample of the waste in July 2004 for total oil
and grease (SW-846 Method 9071B), volatiles (SW-846 Method 8260B), semi
volatiles and pesticides (SW-846 Method 8270C), polychlorinated
biphenyls--PCBs--(SW-846 Method 8082), and metals (SW-846 Method 6010B
except for mercury--SW-846 Method 7471). Owosso sampled the sludge
again in August 2004 for oil and grease (SW-846 Method 9071B). Owosso
continued to characterize the waste based on a November 2004 Sampling
and Analysis Plan. Due to the small waste stream size, EPA and Owosso
agreed to conservatively estimate constituent leaching by dividing the
total result by 20. This simulates the TCLP test with the assumption
that all of the constituent in the total would leach. Owosso collected
five composite samples of the waste between December 2004 and March
2005 and analyzed them for bromomethane and chloromethane (SW-846
Method 8260B), cyanide (SW-846 Method 9012A), sulfide (SW-846 Method
9034), antimony and arsenic (SW-846 Method 6020B), cadmium, chromium,
copper, lead, nickel, and zinc (SW-846 Method 6010B). This subset of
constituents was comprised of waste constituents detected in prior
sampling events and the constituents for which the waste was listed.
    EPA later asked for additional analysis for trichloroethylene (TCE)
since Owosso's process includes TCE as a graphic image developer and
may be expected in the waste. Accordingly, Owosso collected additional
grab samples of the waste in November 2007 for full-scan total volatile
analysis (SW-846 Methods 5035 & 8260B). TCE was detected, however,
Owosso had replaced the TCE developer with the aqueous developing agent
by this time. To confirm that concentrations of TCE in the waste were
decreasing since TCE was no longer used and only residual TCE remained
in the process, Owosso collected three additional grab samples for
volatile analysis in April and May of 2008 (SW-846 Method 5035 &
8260B).
    Owosso collected four composite samples of the sludge and one
sample of the raw product NMP in March 2010. The samples were analyzed
by a modified SW-846 8270 method for tentatively identifies compounds
(TICs). The raw product NMP sample was used to determine the NMP
retention time in order to aid in the analysis of the composite
samples. The concentration of TICs with similar mass spectra and
retention time to NMP were added to the overall concentration because
they may be derivatives of NMP.

D. What were the results of Owosso's analysis of its waste?

    The table below presents the maximum observed total concentrations
for all detected constituents for which maximum allowable total and
leachate concentrations were available. Leachate concentrations were
estimated by dividing the total concentration by 20 (the dilution
factor from the TCLP test). Total concentrations are expressed in
milligrams per kilogram (mg/kg). Leachate concentrations are expressed
in milligrams per liter (mg/L). Owosso submitted a signed statement
certifying accuracy and responsibility of the results. See 40 CFR
260.22(i)(12).

----------------------------------------------------------------------------------------------------------------
                                  Maximum observed concentration         Maximum allowable
                                 --------------------------------          concentration
      Constituent detected        Total \1\ (mg/   TCLP \2\ (mg/ --------------------------------    GW (mg/L)
                                        kg)             L)         Total (mg/kg)    TCLP (mg/L)
----------------------------------------------------------------------------------------------------------------
                                           Volatile Organic Compounds
----------------------------------------------------------------------------------------------------------------
bromomethane....................             3.8            0.19         172,000            none           0.026
chloromethane...................             1.9           0.095            none             178            0.39
n-methyl,2-pyrrolidone..........         15.79 E            0.79            none             734            1.65
trichloroethylene...............             1.1           0.055         975,000         \4\ 0.5           0.005
----------------------------------------------------------------------------------------------------------------
                                                     Metals
----------------------------------------------------------------------------------------------------------------
antimony........................              47             2.4            none            3.15           0.006
arsenic.........................             2.0            0.10           4,580        \3\ 0.25      \3\ 0.0005
cadmium.........................             3.8            0.19         121,000         \4\ 1.0           0.005
chromium........................              35             1.8       \5\ 2,590         \4\ 5.0             0.1

copper..........................           1,020              51            none             700             1.3
cyanide.........................              20             1.0            none              91             0.2
lead............................              24             1.2            none         \4\ 5.0           0.015
nickel..........................              35             1.8         905,000             400           0.750
zinc............................          14,000             700            none           6,000            11.3
----------------------------------------------------------------------------------------------------------------
\1\ Converted to dry weight basis.
\2\ Estimated from the total concentration (Total/20).
\3\ Set at groundwater concentration corresponding to 1 x 10 -\5\ excess cancer risk.
\4\ Based on the toxicity characteristic in 40 CFR 261 subpart C.
\5\ Based on assuming 100% hexavalent chromium.
E--Estimated (Constituent not present in calibration standard. Calculated using total peak area from
  reconstructed ion chromatogram w/response factor of 1. Concentration converted to dry weight and represents
  the sum of NMP and NMP-like TICs).

E. How did EPA evaluate the risk of delisting this waste?

    For this delisting determination, we assumed that the waste would
be disposed in a Subtitle D landfill and we considered transport of
waste constituents through ground water, surface water and air. We
evaluated Owosso's petitioned waste using the Agency's Delisting Risk
Assessment Software (DRAS) to predict the concentration of hazardous
constituents that might be released from the petitioned waste and to
determine if the waste would pose a threat. To predict the potential
for release to groundwater from landfilled wastes and subsequent routes
of exposure to a receptor, the DRAS uses dilution attenuation factors
derived from EPA's Composite Model for leachate migration with
Transformation Products. From a release to ground water, the DRAS
considers routes of exposure to a human receptor of ingestion of
contaminated ground water, inhalation from groundwater while showering
and dermal contact from groundwater while bathing.
    From a release to surface water by erosion of waste from an open
landfill into storm water run-off, DRAS evaluates the exposure to a
human receptor by fish ingestion and ingestion of drinking water. From
a release of waste particles and volatile emissions to air from the
surface of an open landfill, DRAS considers routes of exposure of
inhalation of volatile constituents, inhalation of particles, and air
deposition of particles on residential soil and subsequent ingestion of
the contaminated soil by a child. The technical support document and
the user's guide to DRAS are included in the docket.
    At a target cancer risk of 1 x 10-\6\ and a target
hazard quotient of 1.0, the DRAS program determined maximum allowable
concentrations for each constituent in both the waste and the leachate
at an annual waste volume of 244 cubic yards. However, since naturally
occurring concentrations of arsenic are often higher than allowable
concentrations set by the DRAS at a risk of 1 x 10-\6\, EPA
set the allowable concentration of leachable arsenic at a target cancer
risk of 1 x 10-\5\, which corresponds to a concentration at
the point of exposure of approximately one twentieth of the existing
Safe Drinking Water Act (SDWA) Maximum Contaminant Level (MCL). Arsenic
is not expected to be a major constituent of concern in this waste.
    We used the maximum estimated annual waste volume and the maximum
reported total and estimated leachate concentrations as inputs to
estimate the constituent concentrations in the ground water, soil,
surface water or air. If, using an appropriate analytical method, a
constituent was not detected in any sample, it was considered not to be
present in the waste.

F. What did EPA conclude about Owosso's waste?

    The maximum reported concentrations of the hazardous constituents
found in this waste are presented in the table above. The table also
presents the maximum allowable concentrations. The concentrations of
all constituents in both the waste and the leachate are below the
allowable concentrations. We, therefore, conclude that Owosso's
wastewater treatment sludge is not a substantial or potential hazard to
human health and the environment when disposed of in a Subtitle D
landfill.
    We, therefore, propose to grant an exclusion for this waste. If
this exclusion is finalized, Owosso must dispose of this waste in a
Subtitle D landfill permitted or licensed by a state, and will remain
obligated to verify that the waste meets the allowable concentrations
set forth here. Owosso must also continue to determine whether the
waste is identified in subpart C of 40 CFR pursuant to Sec.  261.11(c).

IV. Conditions for Exclusion

A. When would EPA finalize the proposed delisting exclusion?

    HSWA specifically requires the EPA to provide notice and an
opportunity for comment before granting or denying a final exclusion.
Thus, EPA will not make a final decision or grant an exclusion until it
has addressed all timely public comments on today's proposal, including
any at public hearings.
    Since this rule would reduce the existing requirements for persons
generating hazardous wastes, the regulated community does not need a
six-month period to come into compliance in accordance with section
3010 of RCRA as amended by HSWA.

B. How will Owosso manage the waste if it is delisted?

    If the petitioned waste is delisted, Owosso must dispose of it in a
Subtitle D landfill which is permitted, licensed, or registered by a
state to manage industrial waste.

C. What are the maximum allowable concentrations of hazardous
constituents in the waste?

    Concentrations measured in the TCLP (or Oily Waste Extraction
Procedure, where appropriate) extract of the waste of the following
constituents must not exceed the following (mg/l): Antimony--3.15;
arsenic--0.25; cadmium--1; chromium--5; lead--5; and zinc--6,000.

D. How frequently must Owosso test the waste?

    Owosso must analyze a representative sample of the wastewater
treatment sludges on an annual basis to demonstrate that the
constituents of concern in the petitioned waste do not exceed the
concentrations of concern in section IV.C above. Owosso must use

methods with sufficient analytical sensitivity and appropriate quality
control procedures. SW-846 Method 1311 must be used for generation of
the leachate extract used in the testing of the delisting levels if oil
and grease comprise less than one percent of the waste. SW-846 Method
1330A must be used for generation of the leaching extract if oil and
grease comprise 1 percent or more of the waste. SW-846 Method 9071B
must be used for determination of oil and grease. SW-846 Methods 1311,
1330A, and 9071B are incorporated by reference in 40 CFR 260.11. A
total analysis of the waste (accounting for any filterable liquids and
the dilution factor inherent in the TCLP method) may be used to
estimate the TCLP concentration as provided for in section 1.2 of
Method 1311.

E. What data must Owosso submit?

    Owosso must submit the data obtained through annual verification
testing to U.S. EPA Region 5, 77 West Jackson Boulevard, Chicago, IL
60604, upon the anniversary of the effective date of this exclusion.
Owosso must compile, summarize, and maintain on site records of
operating conditions and analytical data. Owosso must make these
records available for inspection. All data must be accompanied by a
signed copy of the certification statement in 40 CFR 260.22(i)(12).

F. What happens if Owosso fails to meet the conditions of the
exclusion?

    If Owosso violates the terms and conditions established in the
exclusion, the Agency may start procedures to withdraw the exclusion.
    If the verification testing of the waste does not meet the
delisting concentrations described in section IV.C above or other data
(including but not limited to leachate data or groundwater monitoring
data) relevant to the delisted waste indicates that any constituent is
at a concentration in the leachate higher than the specified delisting
concentration, or is in the groundwater at a concentration higher than
the maximum allowable groundwater concentration (in the table in
Section III.D.), Owosso must notify the Agency within 10 days of first
possessing or being made aware of the data. The exclusion will be
suspended and the waste managed as hazardous until Owosso has received
written approval from the Agency to continue the exclusion. Owosso may
provide sampling results which support the continuation of the
delisting exclusion.
    The EPA has the authority under RCRA and the Administrative
Procedures Act, 5 U.S.C. 551 (1978) et seq. to reopen a delisting
decision if we receive new information indicating that the conditions
of this exclusion have been violated, or are otherwise not being met.

G. What must Owosso do if the process changes?

    If Owosso significantly changes the manufacturing or treatment
process or the chemicals used in the manufacturing or treatment
process, Owosso may not handle the wastewater treatment sludge
generated from the new process under this exclusion until it has
demonstrated to the EPA that the waste meets the concentrations set in
section IV.C and that no new hazardous constituents listed in Appendix
VIII of 40 CFR part 261 have been introduced. Owosso must manage wastes
generated after the process change as hazardous waste until Owosso has
received written notice from EPA that the delisting is reinstated.

V. How would this action affect the states?

    Because EPA is issuing today's exclusion under the federal RCRA
delisting program, only states subject to federal RCRA delisting
provisions would be affected. This exclusion may not be effective in
states which have received our authorization to make their own
delisting decisions.
    EPA allows states to impose their own non-RCRA regulatory
requirements that are more stringent than EPA's, under section 3009 of
RCRA. These more stringent requirements may include a provision that
prohibits a federally issued exclusion from taking effect in the state.
We urge petitioners to contact the state regulatory authority to
establish the status of their wastes under the state law.
    EPA has also authorized some states to administer a delisting
program in place of the federal program, that is, to make state
delisting decisions. Therefore, this exclusion does not apply in those
authorized states. If Owosso manages the waste in any state with
delisting authorization, Owosso must obtain delisting authorization
from that state before it can manage the waste as nonhazardous in that
state.

VI. Statutory and Executive Order Reviews

    Under Executive Order 12866, ``Regulatory Planning and Review ''
(58 FR 51735, October 4, 1993), this rule is not of general
applicability and therefore, is not a regulatory action subject to
review by the Office of Management and Budget (OMB). This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) because it
applies to a particular facility only. Because this rule is of
particular applicability relating to a particular facility, it is not
subject to the regulatory flexibility provisions of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.), or to sections 202, 204, and
205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).
Because this rule will affect only a particular facility, it will not
significantly or uniquely affect small governments, as specified in
section 203 of UMRA. Because this rule will affect only a particular
facility, this final rule does not have federalism implications. It
will not have substantial direct effects 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, as specified in Executive Order 13132, ``Federalism'', (64
FR 43255, August 10, 1999). Thus, Executive Order 13132 does not apply
to this rule.
    Similarly, because this rule will affect only a particular
facility, this final rule does not have tribal implications, as
specified in Executive Order 13175, ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000). Thus,
Executive Order 13175 does not apply to this rule. This rule also is
not subject to Executive Order 13045, ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997), because it is not economically significant as defined in
Executive Order 12866, and because the Agency does not have reason to
believe the environmental health or safety risks addressed by this
action present a disproportionate risk to children. The basis for this
belief is that the Agency used DRAS, which considers health and safety
risks to children, to calculate the maximum allowable concentrations
for this rule. This rule is not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355 (May 22, 2001)), because it
is not a significant regulatory action under Executive Order 12866.
This rule does not involve technical standards; thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3
of Executive Order 12988, ``Civil Justice Reform'', (61 FR 4729,
February 7, 1996), in issuing this rule,

EPA has taken the necessary steps to eliminate drafting errors and
ambiguity, minimize potential litigation, and provide a clear legal
standard for affected conduct.

List of Subjects in 40 CFR Part 261

    Hazardous waste, Recycling, and Reporting and recordkeeping
requirements.

    Authority:  Section 3001(f) RCRA, 42 U.S.C. 6921(f).

    Dated: October 26, 2010.
Bruce F. Sypniewski,
Acting Director, Land and Chemicals Division.

    For the reasons set out in the preamble, EPA proposes to amend 40
CFR part 261 as follows:

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

    1. The authority citation for part 261 continues to read as
follows:

    Authority:  42 U.S.C. 6905, 6912(a), 6921, 6922, and 6938.

    2. In Table 1 of Appendix IX to part 261 add the following waste
stream in alphabetical order by facility to read as follows:

Appendix IX to Part 261--Wastes Excluded Under Sec. Sec.  260.20 and
260.22

                               Table 1--Wastes Excluded From Non-Specific Sources
----------------------------------------------------------------------------------------------------------------
               Facility                        Address                          Waste description
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Owosso Graphic Arts..................  Owosso, Michigan.......  Wastewater treatment sludges, F006, generated at
                                                                 Owosso Graphic Arts (Owosso) facility in
                                                                 Owosso, Michigan at a maximum annual rate of
                                                                 244 cubic yards per year. The sludge must be
                                                                 disposed of in a Subtitle D landfill which is
                                                                 licensed, permitted, or otherwise authorized by
                                                                 a state to accept the delisted wastewater
                                                                 treatment sludge. The exclusion becomes
                                                                 effective as of [insert final publication
                                                                 date].
                                                                1. Delisting Levels: (A) The constituent
                                                                 concentrations measured in a leachate extract
                                                                 may not exceed the following concentrations (mg/
                                                                 L): antimony--3.15; arsenic--0.25; cadmium--1;
                                                                 chromium--5; lead--5; and zinc--6,000. (B)
                                                                 Maximum allowable groundwater concentrations
                                                                 (mg/L) are as follows: antimony--0.006;
                                                                 arsenic--0.0005; cadmium--0.005; chromium--0.1;
                                                                 lead--0.015; and zinc--11.3.
                                                                2. Annual Verification Testing: To verify that
                                                                 the waste does not exceed the specified
                                                                 delisting concentrations, Owosso must collect
                                                                 and analyze one waste sample on an annual basis
                                                                 using methods with appropriate detection
                                                                 concentrations and elements of quality control.
                                                                 SW-846 Method 1311 must be used for generation
                                                                 of the leachate extract used in the testing of
                                                                 the delisting levels if oil and grease comprise
                                                                 less than 1 percent of the waste. SW-846 Method
                                                                 1330A must be used for generation of the
                                                                 leaching extract if oil and grease comprise 1
                                                                 percent or more of the waste. SW-846 Method
                                                                 9071B must be used for determination of oil and
                                                                 grease. SW-846 Methods 1311, 1330A, and 9071B
                                                                 are incorporated by reference in 40 CFR 260.11.
                                                                 A total analysis of the waste (accounting for
                                                                 any filterable liquids and the dilution factor
                                                                 inherent in the TCLP method) may be used to
                                                                 estimate the TCLP concentration as provided for
                                                                 in section 1.2 of Method 1311.
                                                                3. Changes in Operating Conditions: Owosso must
                                                                 notify the EPA in writing if the manufacturing
                                                                 process, the chemicals used in the
                                                                 manufacturing process, the treatment process,
                                                                 or the chemicals used in the treatment process
                                                                 significantly change. Owosso must handle wastes
                                                                 generated after the process change as hazardous
                                                                 until it has: Demonstrated that the wastes
                                                                 continue to meet the delisting concentrations
                                                                 in section 1.; demonstrated that no new
                                                                 hazardous constituents listed in appendix VIII
                                                                 of part 261 have been introduced; and it has
                                                                 received written approval from EPA.
                                                                4. Data Submittals: Owosso must submit the data
                                                                 obtained through verification testing or as
                                                                 required by other conditions of this rule to
                                                                 U.S. EPA Region 5, RCRA Delisting Program (LR-
                                                                 8J), 77 W. Jackson Boulevard, Chicago, IL
                                                                 60604. The annual verification data and
                                                                 certification of proper disposal must be
                                                                 submitted upon the anniversary of the effective
                                                                 date of this exclusion. Owosso must compile,
                                                                 summarize, and maintain on site for a minimum
                                                                 of five years records of operating conditions
                                                                 and analytical data. Owosso must make these
                                                                 records available for inspection. All data must
                                                                 be accompanied by a signed copy of the
                                                                 certification statement in 40 CFR
                                                                 260.22(i)(12).

                                                                5. Reopener Language--(A) If, anytime after
                                                                 disposal of the delisted waste, Owosso
                                                                 possesses or is otherwise made aware of any
                                                                 data (including but not limited to leachate
                                                                 data or groundwater monitoring data) relevant
                                                                 to the delisted waste indicating that any
                                                                 constituent is at a concentration in the
                                                                 leachate higher than the specified delisting
                                                                 concentration, or is in the groundwater at a
                                                                 concentration higher than the maximum allowable
                                                                 groundwater concentration in paragraph (1),
                                                                 then Owosso must report such data, in writing,
                                                                 to the Regional Administrator within 10 days of
                                                                 first possessing or being made aware of that
                                                                 data. (B) Based on the information described in
                                                                 paragraph (A) and any other information
                                                                 received from any source, the Regional
                                                                 Administrator will make a preliminary
                                                                 determination as to whether the reported
                                                                 information requires Agency action to protect
                                                                 human health or the environment. Further action
                                                                 may include suspending, or revoking the
                                                                 exclusion, or other appropriate response
                                                                 necessary to protect human health and the
                                                                 environment. (C) If the Regional Administrator
                                                                 determines that the reported information does
                                                                 require Agency action, the Regional
                                                                 Administrator will notify Owosso in writing of
                                                                 the actions the Regional Administrator believes
                                                                 are necessary to protect human health and the
                                                                 environment. The notice shall include a
                                                                 statement of the proposed action and a
                                                                 statement providing Owosso with an opportunity
                                                                 to present information as to why the proposed
                                                                 Agency action is not necessary or to suggest an
                                                                 alternative action. Owosso shall have 30 days
                                                                 from the date of the Regional Administrator's
                                                                 notice to present the information. (D) If after
                                                                 30 days Owosso presents no further information
                                                                 or after a review of any submitted information,
                                                                 the Regional Administrator will issue a final
                                                                 written determination describing the Agency
                                                                 actions that are necessary to protect human
                                                                 health or the environment. Any required action
                                                                 described in the Regional Administrator's
                                                                 determination shall become effective
                                                                 immediately, unless the Regional Administrator
                                                                 provides otherwise.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2010-27886 Filed 11-3-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 10, 2006 (Volume 71, Number 6)]
[Notices]
[Page 1527-1530]
[DOCID:fr10ja06-29]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL06-30-000]

 California Electricity Oversight Board; People of the State of
California, ex rel., Bill Lockyer, Attorney General of the State of
California, and California Department of Water Resources v. Calpine
Energy Services, L.P.; Calpine Corporation; Power Contract Financing,
and Gilroy Energy Center, L.L.C.; Order Providing Interim Guidance

Issued January 3, 2006.

Before Commissioners: Joseph T. Kelliher, Chairman; Nora Mead
Brownell, and Suedeen G. Kelly.

    1. On December 19, 2005, the California Electricity Oversight
Board, the California Attorney General, and the California Department
of Water Resources (California State Parties) filed a Petition for
Emergency Declaratory Order Requiring Continuing Performance of
Jurisdictional Power Purchase Agreement and Complaint Requesting Fast
Track Processing (Petition). The Petition seeks a Commission order
requiring Calpine Energy Services, LP, and Calpine Corporation
(Calpine) to continue to supply power, and otherwise perform, under a
Master Power Purchase and Sale Agreement (Calpine 2 Contract). As
explained in more detail below, because of a recently issued Ex Parte
Temporary Restraining Order (TRO) against the Commission, we cannot
grant the relief requested. However, in the event the Commission
participates in the bankruptcy proceedings, we hereby provide interim
guidance to the parties regarding the standard to be applied in this
case, and require certain additional filings.

Background

    2. The California State Parties state in their Petition that they
expect Calpine to file for reorganization under Chapter 11 of the
United States Bankruptcy Code and, when it does, to request that the
Bankruptcy Court reject the Calpine 2 Contract. The California State
Parties state that, if the Commission does not act to require
performance of the

Calpine 2 Contract, the Bankruptcy Court may enjoin the Commission from
so acting. The Petition states that a similar result occurred when
Mirant Corporation filed for bankruptcy and the Bankruptcy Court
enjoined the Commission from taking certain actions with respect to
Mirant.
    3. The California State Parties argue that the Commission should
grant the relief requested because ``rejection of the Calpine 2
Contract would: (1) Force California consumers to bear significantly
higher costs; (2) undermine the parties' 2002 global settlement entered
in order to resolve the State's claims arising in its 2000-01 energy
crises; (3) jeopardize the State's efforts to put in place protections
to ensure that the health, safety and welfare of California ratepayers
are not adversely affected by a similar crisis in the future; and (4)
threaten the stability of California electricity markets and
potentially undermine the reliability of the California electricity
grid, particularly during summer 2006.'' Petition at 6. The California
State Parties state that an order granting this relief would be
consistent with the Commission's action in Blumenthal v. NRG Power
Marketing, Inc., 103 FERC ] 61,188 (2003), reh'g denied, 104 FERC ]
61,211 (2003) (orders requiring performance), and Blumenthal v. NRG
Power Marketing, Inc., 104 FERC ] 61,210 (2003) (order upholding
contract) (NRG).
    4. On December 21, 2005, Calpine filed for bankruptcy in the United
States Bankruptcy Court in the Southern District of New York. The
Bankruptcy Court immediately issued an Ex Parte Temporary Restraining
Order Against Federal Energy Regulatory Commission (TRO) that prohibits
the Commission from taking any action ``to require or coerce the
Debtors to continue performing under the executory contracts identified
in Schedule 1.'' One of the contracts identified in Schedule 1 of the
TRO is the Calpine 2 Contract.

Authority To Act

    5. Although the Bankruptcy Code provides that the filing of a
bankruptcy petition automatically stays certain actions against the
debtor,\1\ the Code also provides an exception from this automatic stay
for:
---------------------------------------------------------------------------

    \1\ 11 U.S.C. 362(a)(1).

    An action or proceeding by a governmental unit * * * to enforce
such governmental unit's or organization's police and regulatory
powers, including the enforcement of a judgment other than a money
judgment, obtained in an action or proceeding by the governmental
unit to enforce such governmental unit's or organization's police or
regulatory power.[\2\]
---------------------------------------------------------------------------

    \2\ 11 U.S.C. 362(b)(4).

    6. As noted earlier, the TRO entered on December 21, 2005 by the
Bankruptcy Court in the Southern District of New York precludes the
Commission from granting the relief requested. However the TRO does not
preclude the Commission from issuing this Interim Guidance Order.
Accordingly, this order provides guidance to the parties regarding the
standards that will be applied in this case. It does not ``require or
coerce'' Calpine to continue performing its executory contracts.

Discussion

    7. In NRG, the Commission addressed ``an issue of first impression:
Whether a bankruptcy court's approval of a public utility seller's
request to reject a contract between it and a buyer precludes the
Commission from making an independent determination, pursuant to the
Federal Power Act (FPA), as to whether that seller must continue [to]
fulfill its contractual obligations to provide service to the buyer.''
\3\ In answering that question, ``[t]he Commission found that, even if
a public utility files for bankruptcy, the utility still must meet its
obligations under the FPA.'' \4\ The Commission then proceeded to
address in a paper hearing whether NRG could meet the Mobile Sierra
standard applicable to a request to terminate the contract under
section 205 of the FPA. The Commission held that NRG could not do so
and therefore ordered it to perform under the contract.\5\
---------------------------------------------------------------------------

    \3\ 104 FERC ] 61,210 at P1.
    \4\ Id.
    \5\ NRG, 104 FERC ] 61,210.
---------------------------------------------------------------------------

    8. Subsequently to our decision in NRG, the United States Court of
Appeals for the Fifth Circuit decided Mirant Corp. v. Potomac Electric
Power Co. (In re Mirant).\6\ In Mirant, the 5th Circuit addressed the
same fundamental issue decided in NRG, namely whether a Bankruptcy
Court has the authority to reject a Commission-jurisdictional contract
without the seller first obtaining approval from the Commission to
terminate that contract under section 205. The court held, in pertinent
part, as follows:
---------------------------------------------------------------------------

    \6\ 378 F.3d 511 (5th Cir. 2004) (Mirant).

    It is clear that FERC has the exclusive authority to determine
wholesale rates, see Mississippi Power & Light, 487 U.S. at 371, and
Mirant does not contest that it would need FERC approval to either
modify the rates in the Back-to-Back Agreement or to completely
abrogate that agreement. Cf. 11 U.S.C. 362(b)(4) (creating exception
from automatic stay for agencies acting to enforce their regulatory
power). Under the Bankruptcy Code, however, Mirant's rejection of
the Back-to-Back Agreement is a breach of that contract. See 11
U.S.C. 365(g) (``The rejection of an executory contract * * *
constitutes a breach of such contract * * *.''); see also In re
Continental Airlines, 981 F.2d 1450, 1459 (5th Cir. 1993)
(``[section] 365(g)(1) speaks only in terms of `breach.' The statute
does not invalidate the contract, or treat the contract as if it did
not exist.''). Thus, whether the FPA preempts a district court's
jurisdiction over a bankruptcy rejection necessarily depends upon
whether the FPA generally preempts a district court's jurisdiction
over claims of breach related to executory power contracts.
    Outside of the bankruptcy context, the FPA does not provide FERC
with exclusive jurisdiction over the breach of a FERC approved
contract. While the FPA does preempt breach of contract claims that
challenge a filed rate, district courts are permitted to grant
relief in situations where the breach of contract claim is based
upon another rationale.
* * * * *
    We conclude that the FPA does not preempt Mirant's rejection of
the Back-to-Back Agreement because it would only have an indirect
effect upon the filed rate. When an executory contract is rejected
in bankruptcy, the non-breaching party receives an unsecured claim
against the bankruptcy estate for an amount equal to its damages
from the breach. See 11 U.S.C. 365(g)(1), 502(g). If Mirant's
rejection of the Back-to-Back Agreement was approved, then PEPCO's
unsecured claim against the bankruptcy estate would be based upon
the amount of electricity it would have otherwise sold to Mirant
under that agreement at the filed rate.
* * * * *
    The FPA does not preempt a district court's jurisdiction to
authorize the rejection of an executory contract subject to FERC
regulation as part of a bankruptcy proceeding. A motion to reject an
executory power contract is not a collateral attack upon that
contract's filed rate because that rate is given full effect when
determining the breach of contract damages resulting from the
rejection. Further, there is nothing within the Bankruptcy Code
itself that limits a public utility's ability to choose to reject an
executory contract subject to FERC regulation as part of its
reorganization process.

378 F.3d at 519-522 (emphasis in original).
    9. Moreover, as the Mirant court recognized, the Commission has a
number of regulatory responsibilities under the Federal Power Act that
continue while a bankruptcy case is pending, that do not necessarily
impact a debtor's ability to reject a contract.\7\
---------------------------------------------------------------------------

    \7\ See also Louisiana Pub. Serv. Comm'n v. Mabey (In re Cajun
Elec. Power Coop., Inc.), 185 F.3d 446, 453 (5th Cir. 1999) (noting
that Bankruptcy Code `` `indirectly suggests continued governmental
regulatory jurisdiction' during the pendency of the bankruptcy
proceeding'') (citation omitted), cited in Mirant, 378 F.3d at 523;
FCC v. Nextwave Personal Communications Inc., 537 U.S. 293, 307 n.5
(2003) (on review of FCC's regulatory decisionmaking, in case
involving both Bankruptcy Code and Communications Act, Court noted
that Second Circuit had, on appeal from bankruptcy court, denied
subject matter jurisdiction to decide whether FCC's regulatory
decision was proper exercise of its discretion, and that D.C.
Circuit, on petition for review of FCC decision, had ``recognized
and seemingly approved that distinction [between regulatory and
bankruptcy matters]'').

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

    10. The 5th Circuit also provided guidance on the standard to be
applied in determining whether rejection of an FPA-jurisdictional
contract by a bankruptcy court is appropriate. The court noted that the
standard ordinarily applicable is the ``business judgment rule,'' but
it found that the Supreme Court had given greater protection to certain
contracts affected with the public interest, such as collective
bargaining agreements. NLRB v. Bildisco & Bildisco, 465 U.S. 513
(1984). The 5th Circuit therefore held that a higher standard may be
---------------------------------------------------------------------------
appropriate for FPA-jurisdictional contracts, reasoning as follows:

    The nature of a contract for the interstate sale of electricity
at wholesale is also unique. Additionally, Congress found when it
passed the FPA that the public has an interest in the transmission
and sale of electricity. 16 U.S.C. 824(a). This includes an interest
in the continuity of electrical service to the customers of public
utilities. 16 U.S.C. 824a(g) * * *. Clearly the business judgment
standard normally applicable to rejection motions is more
deferential than the public interest standard applicable in FERC
proceedings to alter the terms of a contract within its
jurisdiction. Use of the business judgment standard would be
inappropriate in this case because it would not account for the
public interest inherent in the transmission and sale of
electricity.
    Therefore, upon remand, the district court should consider
applying a more rigorous standard to the rejection of the Back-to-
Back Agreement. If the district court decides that a more rigorous
standard is required, then it might adopt a standard by which it
would authorize rejection of an executory power contract only if the
debtor can show that it ``burdens the estate, [] that, after careful
scrutiny, the equities balance in favor of rejecting'' that power
contract, and that rejection of the contract would further the
Chapter 11 goal of permitting the successful rehabilitation of
debtors. See Bildisco, 465 U.S. at 526-27. When considering these
issues, the courts should carefully scrutinize the impact of
rejection upon the public interest and should, inter alia, ensure
that rejection does not cause any disruption in the supply of
electricity to other public utilities or to consumers. Cf. Id. at
527 (requiring the bankruptcy court to balance the interests of the
debtor, the creditors and the employees when determining what
constitutes a successful rehabilitation). The bankruptcy court has
already indicated that it would include FERC as a party in interest
for all purposes in this case under 11 U.S.C. 1109(b) and Fed. R.
Bankr. P. 2018. We presume that the district court would also
welcome FERC's participation, if this case is not referred back to
the bankruptcy court. Therefore, FERC will be able to assist the
court in balancing these equities.

378 F.3d at 525 (footnote omitted).\8\
---------------------------------------------------------------------------

    \8\ On remand, the district cout denied the rejection motion on
other grounds, and responded to the 5th Circuit by articulating a
heightened standard for rejection, under which the court would have
to determine whether rejection would compromise the public interest
(with input from the Commission, after affording it ``an opportunity
to engage in appropriate inquiry to enable it to evaluate the effect
* * * on the public interest''). In re Mirant Corp., 318 B.R. 100,
108 (N.D. Tex. 2004). An appeal from that order is pending before
the 5th Circuit. See Official Comm. of Unsecured Creditors v.
Potomac Elec. Power Co., et al. ( In re Mirant Corp.), Case No. 05-
10033 (5th Cir).
---------------------------------------------------------------------------

    11. Although the Commission reached a different result in NRG, a
federal court of appeals has now spoken to the issue addressed in NRG
and we intend to follow that authority. Under that authority, the
Commission is precluded from taking action under the FPA that impacts a
debtor's ability to reject an executory contract. A Bankruptcy Court
cannot reject a FERC-jurisdictional contract under the business
judgment rule ``because it would not account for the public interest
inherent in the transmission and sale of electricity.'' Id. Rather,
such a court must ``carefully scrutinize the impact of rejection upon
the public interest and * * * ensure that rejection does not cause any
disruption in the supply of electricity to other public utilities or to
consumers.'' Id.
    12. The Commission seeks comment on whether rejection of the
Calpine 2 Contract would impact the public interest,\9\ including
whether rejection of the Calpine 2 Contract would cause ``any
disruption in the supply of electricity to other public utilities or to
consumers.'' Id.\10\ By seeking comment on this issue, the Commission
does not intend to supplant the role of the Bankruptcy Court in
considering whether to reject the Calpine 2 Contract. Rather, the
purpose of our inquiry is to develop a record on which the Commission
can, as necessary, make a determination, and then inform the Bankruptcy
Court, of its views regarding potential rejection of the Calpine 2
Contract by the Bankruptcy Court. In the Mirant case, the 5th Circuit
``presume[d] that the district court would * * * welcome FERC's
participation'' and that ``FERC will be able to assist the court in
balancing the equities.'' \11\ In order to provide such assistance, we
need to develop an appropriate record to render a decision.
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    \9\ To the extent any party believes it should seek leave of the
Bankruptcy Court to submit further pleadings in this case, it should
do so.
    \10\ In Calpine's Memorandum of Law in Support of Debtors'
Motion for Declaratory Judgment, Ex Parte Temporary Restraining
Order, and Preliminary Injunction Against the Federal Energy
Regulatory Commission, at p. 5, Calpine asserts:
    If the Court permits the rejection of the energy contracts,
there will be no disruption in the supply of power. For its part,
Calpine will continue to produce all the energy that it may
profitably do so, and CDWR and the other counter-parties to the
contracts could readily obtain power from the national grid or from
Calpine, albeit at the market rates.
    See also Complaint for Declaratory Judgment, Ex Parte Temporary
Restraining Order, and Preliminary and Permanent Injunction Against
the Federal Energy Regulatory Commission, at P 15 (``If the Court
permits the rejection of the energy contracts, there will be no
disruption in the supply of power. Calpine will continue to supply
electricity to CDWR and the other counter-parties to the contracts,
albeit at the market rates.'').
    \11\ In re Mirant Corp., supra note 6.
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    13. In addressing the effect of rejection on the public interest,
the parties should not confine their arguments to the factors normally
considered in a Mobile-Sierra context. As the court in Mirant held,
rejection of an executory contract constitutes a breach of contract,
not approval to terminate it under section 205 of the FPA. See 378 F.3d
at 519 (``rejection of the Back-to-Back Agreement is a breach of that
contract'' for which damages lie) (emphasis in original). In a section
205 proceeding, the issue is whether a party can terminate its
obligations and thereafter have no liability to its counterparty. To
obtain such approval, a party with a Mobile Sierra clause must meet a
very high burden under the public interest test. In this case, however,
there is no request by Calpine to terminate its obligations and
thereafter be free of liability to the California State Parties.
Rather, the issue is how the public interest bears on the Bankruptcy
Court's determination of whether to permit Calpine to breach its
obligations and, if so, to pay damages for such breach as determined by
the Bankruptcy Court.
    14. We therefore direct the California State Parties to amend their
filing within fifteen (15) days to address the standard adopted in
Mirant. Intervenors shall have fifteen (15) days from the date of that
filing to file responses. Because we are also concerned whether
rejection of the Calpine 2 Contract may pose reliability concerns, we
also direct the California Independent System Operator Corporation
(California ISO) to address this issue in response to the California
State Parties' amended filing within 15 days of their amended filing.

The Commission will then be in a position to inform the Bankruptcy
Court, as necessary, of the impact on the public interest of a
potential rejection of the Calpine 2 Contract, or take such other
action as may be appropriate under the circumstances.\12\
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    \12\ In the Mirant case, the 5th Circuit ``presume[d] that the
district court would * * * welcome FERC's participation'' and that
``FERC will be able to assist the court in balancing the equities.''
Id.
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    15. Finally, consistent with the due date established above for
intervenors to submit responses to the California State Parties'
amended filing, interventions shall be due on or before 15 days after
the California State Parties submit their amended filing.\13\
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    \13\ On December 22, 2005, the Commission issued a notice of the
California State Parties' filing, with interventions and protests
due on or before January 19, 2006. However, the January 19 comment
date established by that notice is superseded by the comment
procedures established in this order.
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    The Commission orders:
    (A) The California State Parties are hereby directed to amend their
December 19, 2005 filing within 15 days of the date of this order, as
discussed in the body of this order.
    (B) Interventions and responses to the California State Parties'
amended filing will be due within 15 days after the California State
Parties submit their amended filing, as discussed in the body of this
order.
    (C) The California ISO is hereby directed to file a response to the
California State Parties' amended filing within 15 days after the
California State Parties submit their amended filing, as discussed in
the body of this order.
    (D) The December 22, 2005 notice of filing in Docket No. EL06-30-
000 is hereby superseded by the comment procedures established in
Ordering Paragraphs (A)-(C).
    (E) The Secretary shall promptly publish this order in the Federal
Register.

    By the Commission.
Magalie R. Salas,
Secretary.
 [FR Doc. E6-87 Filed 1-9-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: September 18, 2006 (Volume 71, Number 180)]
[Notices]
[Page 54645]
[DOCID:fr18se06-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2150-033]

Washington Puget Sound Energy, Inc.; Notice of Availability of a
Final Environmental Impact Statement for the Baker River Hydroelectric
Project

September 8, 2006.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR Part 380 (Order No. 486, 52 FR 47897), the Office
of Energy Projects has reviewed the application for a license for the
Baker River Hydroelectric Project (FERC No. 2150-033), located on the
Baker River in Whatcom and Skagit Counties, Washington and has prepared
a Final Environmental Impact Statement (EIS) for the project. The final
EIS was prepared in cooperation with the U.S. Army Corps of Engineers
pursuant to 40 CFR 1501.6 of the National Environmental Policy Act. The
Baker River Project occupies 5,207 acres of lands within the Mt. Baker-
Snoqualmie National Forest managed by the U.S. Forest Service.
    The final EIS, contains staff evaluations of the applicant's
proposal and the alternatives for relicensing the Baker River Project.
The final EIS documents the views of governmental agencies, non-
governmental organizations, affected Indian tribes, the public, the
license applicant, and Commission staff.
    A copy of the final EIS is available for review in the Commission's
Public Reference Branch, Room 2A, located at 888 First Street, NE.,
Washington, DC 20426. The final EIS also may be viewed on the
Commission's Web site at http://www.ferc.gov under the eLibrary link.

Enter the docket number excluding the last three digits in the docket
number field to access the document. For assistance, contact FERC
Online Support at<EMAIL_ADDRESS>or toll-free at (866) 208-
3676, or for TTY,<PHONE_NUMBER>.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    For Further Information Contact: Steve Hocking at<PHONE_NUMBER> or
at<EMAIL_ADDRESS>
Magalie R. Salas,
Secretary.
[FR Doc. E6-15384 Filed 9-15-06; 8:45 am]

BILLING CODE 6717-01-P