[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Rules and Regulations]
[Pages 69769-69772]
[FR Doc No: 2014-27679]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-HQ-OAR-2014-0337; FRL-9919-67-OAR]
RIN 2060-AS33

Findings of Failure To Submit a Complete State Implementation
Plan for Section 110(a) Pertaining to the 2010 Nitrogen Oxide
(NO2) Primary National Ambient Air Quality Standard

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action finding that the District of Columbia and seven states (Alaska,
Arkansas, Hawaii, Minnesota, New Jersey, Vermont and Washington) have
not submitted complete infrastructure State Implementation Plans (SIPs)
that provide the basic Clean Air Act (CAA) program elements necessary
to implement the 2010 nitrogen dioxide (NO2) primary
national ambient air quality standard (NAAQS). Three out of the seven
states (Alaska, Arkansas and Vermont) have not made any submittals. The
District of Columbia and the remaining four out of the seven states
(Hawaii, Minnesota, New Jersey and Washington) have made submittals
that are partially incomplete due to the lack of complete SIP approved
Prevention of Significant Deterioration (PSD) permit programs. The
purpose of an infrastructure SIP submission is to assure that a state,
local or tribal air agency's SIP contains the necessary structural
requirements for any new or revised NAAQS. The remaining 43 states have
made complete submissions. Each finding of failure to submit a complete
infrastructure SIP establishes a 24-month deadline for the EPA to
promulgate a Federal Implementation Plan (FIP) to address the
outstanding SIP elements unless, prior to the EPA promulgating a FIP,
the affected air agency submits, and the EPA approves, a revised SIP
that corrects the deficiency. In those areas without a state-adopted
PSD permit program, the FIP obligation has already been met through
federal regulations that govern PSD permits issued in some cases by the
EPA and in other cases by state or local agencies under delegation
agreements.

DATES: Effective date of this action is December 24, 2014.

FOR FURTHER INFORMATION CONTACT: General questions concerning this
document should be addressed to Ms. Mia South, Office of Air Quality
Planning and Standards, Air Quality Policy Division, Mail Code C504-2,
109 TW Alexander Drive, Research Triangle Park, NC 27709; telephone
(919) 541-5550; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Notice and Comment Under the Administrative Procedures Act (APA)

    Section 553 of the APA, 5 U.S.C. 553(b)(B), provides that, when an
agency for good cause finds that notice and public procedure are
impracticable, unnecessary or contrary to the public interest, the
agency may issue a rule without providing notice and an opportunity for
public comment. The EPA has determined that there is good cause for
making this rule final without prior proposal and opportunity for
comment because no significant EPA judgment is involved in making a
finding of failure to submit SIPs, or elements of SIPs, required by the
CAA, where states have made no submissions or incomplete submissions,
to meet the requirement. Thus, notice and public procedure are
unnecessary. The EPA finds that this constitutes good cause under 5
U.S.C. 553(b)(B).

B. How can I get copies of this document and other related information?

    The EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2014-0337. Publicly available docket materials are
available either electronically through https://www.regulations.gov or
in hard copy at the EPA Docket Center, EPA/DC, William Jefferson
Clinton West Building, Room 3334, 1301 Constitution Avenue NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER> and the telephone
number for the Office of Air and Radiation Docket and Information
Center is<PHONE_NUMBER>.

C. How is the preamble organized?

Table of Contents

I. General Information
    A. Notice and Comment Under the Administrative Procedures Act
(APA)
    B. How can I get copies of this document and other related
information?
    C. How is the preamble organized?
    D. Where do I go if I have specific state questions?
II. Background and Overview
    A. Infrastructure SIPs
    B. Mandatory Duty Suit for the EPA's Failure To Make Findings of
Failure To Submit for Areas That Did Not Submit Infrastructure SIPs
by January 22, 2013
    C. What elements are outside the scope of infrastructure SIP
actions?
III. Findings of Failure To Submit for States That Failed To Make an
Infrastructure SIP Submission in Whole or in Part for the 2010
NO2 NAAQS
IV. Environmental Justice Considerations
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act of 1995 (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority and Low Income Populations
    K. Congressional Review Act (CRA)
    L. Judicial Review

D. Where do I go if I have specific state questions?

    The table below lists the states and additional area (District of
Columbia) that failed to make an infrastructure SIP submittal in whole
or in part for the 2010 NO2 NAAQS. For questions related to
specific states or areas mentioned in this document, please contact the
appropriate EPA Regional Office:

------------------------------------------------------------------------
          Regional offices                          States
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EPA Region 1: Dave Conroy, Air        Vermont.
 Program Branch Manager, Air
 Programs Branch, EPA New England, 1
 Congress Street, Suite 1100,
 Boston, MA 02203-2211.<PHONE_NUMBER>.
EPA Region 2: Richard Ruvo, Chief,    New Jersey.
 Air Programs Branch, EPA Region II,
 290 Broadway, 21st Floor, New York,
 NY 10007-1866.<PHONE_NUMBER>.
EPA Region 3: Cristina Fernandez,     District of Columbia.
 Air Division Director, Air Quality
 Planning Branch, EPA Region III,
 1650 Arch Street, Philadelphia, PA
 19103-2187.<PHONE_NUMBER>.
EPA Region 5: John Mooney, Air        Minnesota.
 Program Branch Manager, Air
 Programs Branch, EPA Region 5, 77
 West Jackson Street, Chicago, IL
 60604-3590.<PHONE_NUMBER>.
EPA Region 6: Guy Donaldson, Chief,   Arkansas.
 Air Planning Section, EPA Region
 VI, 1445 Ross Avenue, Dallas, TX
 75202-2733.<PHONE_NUMBER>.
EPA Region 9: Matt Lakin, Air         Hawaii.
 Program Manager, Air Planning
 Office, EPA Region 9, 75 Hawthorne
 Street, San Francisco, CA 94105.
<PHONE_NUMBER>.
EPA Region 10: Debra Suzuki, Air      Alaska, Washington.
 Program Manager, Air Planning Unit,
 EPA Region X, Office of Air, Waste,
 and Toxics, Mail Code AWT-107, 1200
 Sixth Avenue, Seattle, WA 98101.
<PHONE_NUMBER>.
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II. Background and Overview

A. Infrastructure SIPs

    The CAA section 110(a) imposes an obligation upon states to submit
SIPs that provide for the implementation, maintenance and enforcement
of a new or revised NAAQS within 3 years following the promulgation of
the new or revised NAAQS. Section 110(a)(2) lists specific requirements
that states must meet in these SIP submissions, as applicable. The EPA
refers to this type of SIP submission as the ``infrastructure'' SIP
because the SIP ensures that states can implement, maintain and enforce
the air standards. States are required to develop and maintain an air
quality management program that meets various basic structural
requirements, including, but not limited to: Enforceable emission
limitations; an ambient air monitoring program; an enforcement program;
air quality modeling capabilities; and adequate personnel, resources
and legal authority.
    The contents of an infrastructure SIP submission may vary depending
upon the facts and circumstances. In particular, the data and
analytical tools available at the time the state develops and submits
the infrastructure SIP for a new or revised NAAQS necessarily affect
the content of the submission. The content of such an infrastructure
SIP submission may also vary depending upon what provisions the state's
existing SIP already contains.
    On January 22, 2010, the EPA strengthened the health-based primary
NAAQS for NO2. The EPA set a new 1-hour NO2
standard at the level of 100 parts per billion (ppb). This level
defines the allowable concentration in a nonattainment area. In
addition to establishing an averaging time and level, the EPA set a new
``form'' for the standard. The form is the air quality statistic used
to determine if an area meets the standard. The form for the 1-hour
NO2 standard is the 3-year average of the 98th percentile of
the annual distribution of daily maximum 1-hour average concentrations.
Finally, the EPA retained, with no change, the current annual average
NO2 standard of 53 ppb.\1\ The obligation to submit an
infrastructure SIP was triggered with the revision of the
NO2 NAAQS in 2010, and, because the EPA did not prescribe a
shorter deadline, January 22, 2013, was the applicable deadline for
such submissions. In the case of the 2010 NO2 NAAQS, the EPA
believes that many of the states have met many of the program elements
identified in this document required under section 110(a)(2) through
earlier SIP submissions in connection with previous NAAQS.
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    \1\ See 75 FR 6474, February 9, 2010, Primary National Ambient
Air Quality Standard for Nitrogen Dioxide, Final Rule.
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B. Mandatory Duty Suit for the EPA's Failure To Make Findings of
Failure To Submit for Areas That Did Not Submit Infrastructure SIPs by
January 22, 2013

    On October 9, 2013, WildEarth Guardians (WEG) filed a complaint in
the U.S. District Court for the District of Colorado to enforce the
EPA's mandatory duty to make findings of failure to submit with respect
to NO2 infrastructure SIPs for the following states:
Colorado, Idaho, New Mexico, Oklahoma, Oregon, South Dakota, Utah,
Washington and Wyoming.\2\ On January 24, 2014, Alaska and Hawaii were
added to the complaint. These infrastructure SIPs were due on January
22, 2013. Most states identified in the complaint have made complete
submissions as of the date of this document. In response to the WEG
complaint, the EPA is issuing a national finding of failure to submit
certain elements of NO2 infrastructure SIPs for the
requirements of CAA sections 110(a)(2)(A), (B), (C) (but not with
respect to the permitting program required by CAA title I subpart D),
(D)(i)(II), (D)(ii), (E)-(H) and (J)-(M), addressing all states (and
the District of Columbia) that have not made complete submissions.
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    \2\ Complaint, WildEarth Guardians v EPA, USDC Colorado, October
9, 2013, Case 1:13-cv-02748-RBJ. The complaint was amended on
January 24, 2014, to add Hawaii and Alaska.
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C. What elements are outside the scope of infrastructure SIP actions?

    Two elements identified in section 110(a)(2) are not governed by
the 3-year submission deadline because SIPs incorporating necessary
local nonattainment area requirements are not due within 3 years after
promulgation of a new or revised NAAQS, but rather are due at the time
the nonattainment area plan requirements are due. These requirements
are: (i) Submissions required by section 110(a)(2)(C) to the extent
that that subsection refers to a nonattainment area new source review
permit program for major sources as required in part D of title I of
the CAA; and (ii) submissions required by section 110(a)(2)(I) which
pertains to the nonattainment planning requirements of part D of title
I of the CAA. Therefore, this action does not cover these specific SIP
elements. Nonattainment area plans required by part D title I of the
CAA for the 2010 NO2 NAAQS are generally due 18 months after
the effective date of designation of an area as nonattainment.

However, in the case of NO2, no area has been designated
nonattainment.

III. Findings of Failure To Submit for States That Failed To Make an
Infrastructure SIP Submission in Whole or in Part for the 2010
NO2 NAAQS

    Forty-three states have made complete submittals for their
respective infrastructure SIPs for the 2010 NO2 NAAQS. With
respect to the remaining seven states and the District of Columbia, the
EPA is making findings of failure to submit.
    Alaska, Arkansas and Vermont have not made any submittal, and for
these the EPA is making a finding of failure to submit with respect to
CAA section 110(a)(2)(A), (B), (C) (but not with respect to the
permitting program required by CAA title I subpart D), (D)(i)(II),
(D)(ii), (E)-(H) and (J)-(M).
    The District of Columbia, Hawaii, New Jersey, Minnesota and
Washington have made complete submissions except with respect to the
PSD-related requirements of section 110, and for these states the EPA
is making a finding of failure to submit with respect to the
requirements of CAA sections 110(a)(2)(C), (D)(i)(II), (D)(ii) and (J)
to the extent these refer to PSD permitting programs required by part C
of title I of the CAA.
    To summarize, the EPA is finding that seven states and the District
of Columbia have not made a complete infrastructure SIP submission to
meet certain requirements of section 110(a)(2) that are relevant to
this action, as identified above, for the 2010 NO2 NAAQS.
The EPA is committed to working with the air agencies for these states
and the District of Columbia to expedite submissions as necessary, and
to working with all air agencies to review and act on their
infrastructure SIP submissions in accordance with the requirements of
the CAA.
    These findings establish a 24-month deadline for the promulgation
by the EPA of a FIP, in accordance with section 110(c)(1), for each of
those states for which the EPA is making a finding unless the EPA has
approved a SIP by that date. The District of Columbia, Hawaii,
Minnesota and Washington are currently subject to PSD FIPs. New Jersey
is currently subject to a combination of a SIP and a FIP for PSD. In
these areas, the FIP for PSD is either implemented by the EPA or
delegated to a state or local agency for implementation. In these
areas, the PSD FIP obligation has already been met through federal
regulations that govern PSD permits issued in some cases by the EPA and
in other cases by state or local agencies under delegation agreements.
The EPA recognizes that states may choose to continue to rely on the
existing PSD FIP or a combination of SIP and FIP PSD programs, which
will continue to govern the permitting of their sources without the
need for further action by the state. If so, then this rulemaking does
not require these areas to take further action.
    These findings of failure to submit do not impose sanctions, or set
deadlines for imposing sanctions as described in section 179 of the
CAA, because these findings do not pertain to the elements of a part D,
title I plan for nonattainment areas as required under section
110(a)(2)(I), and because these states have not failed to make
submissions in response to a SIP call pursuant to section 110(k)(5).

IV. Environmental Justice Considerations

    This document is making a procedural finding that certain states
have failed to submit a complete SIP that provides certain basic
program elements of section 110(a)(2) necessary to implement the 2010
NO2 NAAQS. Section 110(a)(1) of the CAA requires that states
submit SIPs that implement, maintain and enforce a new or revised NAAQS
which satisfy the requirements of section 110(a)(2) within 3 years of
promulgation of such standard, or such shorter period as the EPA may
provide. The EPA did not conduct an environmental analysis for this
rule because this rule would not directly affect the air emissions of
particular sources. The EPA notes that there are no areas of the U.S.
in nonattainment with the health-based NO2 NAAQS. Because
this rule will not directly affect the air emissions of particular
sources, it does not affect the level of protection provided to human
health or the environment. Therefore, this action will not have
potential disproportionately high and adverse human health or
environmental effects on minority, low-income or indigenous
populations.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
This final rule does not establish any new information collection
requirement apart from what is already required by law.

C. Regulatory Flexibility Act (RFA)

    This action is not subject to the RFA. The RFA applies only to
rules subject to notice and comment rulemaking requirements under the
Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute.
This rule is not subject to notice and comment requirements because the
agency has invoked the APA ``good cause'' exemption under 5 U.S.C.
553(b).

D. Unfunded Mandates Reform Act of 1995 (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action implements mandates specifically and
explicitly set forth in the CAA under section 110(a) without the
exercise of any policy discretion by the EPA.

E. Executive Order 13132: Federalism

    This action 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.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. This rule responds to the requirement in the CAA
for states to submit SIPs under section 110(a) to satisfy certain
elements required under section 110(a)(2) of the CAA for the 2010
NO2 NAAQS. Section 110(a)(1) of the CAA requires that states
submit SIPs that provide for implementation, maintenance and
enforcement of a new or revised NAAQS, and which satisfy the applicable
requirements of section 110(a)(2), within 3 years of promulgation of
such standard, or within such shorter period as the EPA may provide. No
tribe is subject to the requirement to submit an implementation plan
under section 110(a) within 3 years of promulgation of a new or revised
NAAQS. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes the human health or environmental risk addressed
by this action will not have potential disproportionately high and
adverse human health or environmental effects on minority, low-income
or indigenous populations because it does not affect the level of
protection provided to human health or the environment. The EPA's
evaluation of environmental justice considerations is contained in
section IV of this document.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

L. Judicial Review

    Section 307(b)(l) of the CAA indicates which federal Courts of
Appeal have venue for petitions of review of final agency actions by
the EPA under the CAA. This section provides, in part, that petitions
for review must be filed in the Court of Appeals for the District of
Columbia Circuit (i) when the agency action consists of ``nationally
applicable regulations promulgated, or final actions taken, by the
Administrator,'' or (ii) when such action is locally or regionally
applicable, if ``such action is based on a determination of nationwide
scope or effect and if in taking such action the Administrator finds
and publishes that such action is based on such a determination.''
    The EPA has determined that this final rule consisting of findings
of failure to submit certain of the required infrastructure SIP
provisions is ``nationally applicable'' within the meaning of section
307(b)(1). This rule affects the District of Columbia and seven states
across the country that are located in seven of the ten EPA Regions,
five different federal circuits, and multiple time zones. In addition,
the rule addresses a common core of knowledge and analysis involved in
formulating the decision and a common interpretation of the
requirements of 40 CFR part 51, Appendix V applied to determining the
completeness of SIPs in states across the country.
    This determination is appropriate because in the 1977 CAA
Amendments that revised CAA section 307(b)(l), Congress noted that the
Administrator's determination that an action is of ``nationwide scope
or effect'' would be appropriate for any action that has ``scope or
effect beyond a single judicial circuit.'' H.R. Rep. No. 95-294 at 323-
324, reprinted in 1977 U.S.C.C.A.N. 1402-03. Here, the scope and effect
of this action extends to the five judicial circuits that include the
states across the country affected by this action. In these
circumstances, section 307(b)(1) and its legislative history authorize
the Administrator to find the rule to be of ``nationwide scope or
effect'' and thus to indicate that venue for challenges lies in the
D.C. Circuit. Accordingly, the EPA is determining that this is a rule
of nationwide scope or effect. Under section 307(b)(1) of the CAA,
petitions for judicial review of this action must be filed in the
United States Court of Appeals for the District of Columbia Circuit
within 60 days from the date this final action is published in the
Federal Register. Filing a petition for review by the Administrator of
this final action does not affect the finality of the action for the
purposes of judicial review nor does it extend the time within which a
petition for judicial review must be filed, and shall not postpone the
effectiveness of such rule or action.

List of Subjects in 40 CFR Part 52

    Environmental protection, Approval and promulgation of
implementation plans, Administrative practice and procedures, Air
pollution control, Incorporation by reference, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: November 14, 2014.
Janet G. McCabe,
Acting Assistant Administrator.
[FR Doc. 2014-27679 Filed 11-21-14; 8:45 am]
BILLING CODE 6560-50-P


                    Questions Regarding the GE ABMet System
                                 February 2014

The following are questions for GE regarding the operation and performance of the ABMet system for the treatment of FGD wastewater.  These questions cover items raised as comments the proposed revisions to the Effluent Limitations Guidelines and Standards (ELGs) for the Steam Electric Power Generating Point Source Category.

Heat Exchanger
   Question: Is there a need for heating or indoor treatment systems at plants located in colder climates?  Does ABMet have any installations (full-scale or pilot systems) in any northern states (e.g., Maine, Michigan, Wisconsin, North/South Dakota, Montana) or Canada?  These installations can be for treating FGD wastewater or for other applications, like mining.
   At what temperature must the bugs be maintained to prevent them from dying off? How would GE propose to maintain this temperature in a cold climate during the winter if a plant was in a prolonged shut down (e.g., month-long) in which case warm FGD wastewater it not being transferred to the system?
   If the system operated near the bottom of the temperature limit, how much additional retention time would be needed to compare with the retention time assumed for the cost estimate previously provided?

   Background: Comments from EPRI cite the potential need for heat exchangers for winter operations in northern climates in order to maintain temperatures within the ideal range of 50°F-105°F.
   In previous contact with GE (2011), GE indicated that reduction in temperature will slow the biological kinetics resulting in a requirement for increased retention time in order to achieve the results specified in the design.  Development and validation work conducted in 2009 have verified that the retention times used in the costing specified in the 2011 quote should be sufficient for 99%+ of the potential FGD installations in the US.

Ammonia Generation within the Biotreatment System
   	Question: Comments to the proposed ELGs and performance data from Belews Creek and Allen indicate ammonia generation across the biotreatment system.  Has this been an issue with installed full-scale or pilot-scale systems in the past? Is GE aware of what mechanism is leading to this ammonia generation? Have you determined how much ammonia is typically generated in the system or a way to calculate how much would be generated?

   	Background: Performance data from EPA sampling and plant-provided data from Belews Creek and Allen show an average increase of approximately 66% in the ammonia concentration from biotreatment influent to biotreatment effluent.

Requests for Additional Performance Data
   Question: Does GE have any performance data for any of the pilot-scale installations of the ABMet system that could be provided to EPA?  Comments to the proposed rule raise several concerns about the ability of the ABMet system to handle high influent concentrations, meeting the specified nitrate/nitrite limits, and demonstrating performance under a variety of nitrate, selenium, chloride concentrations and ORP ranges. We are particularly interested in any pilot-scale testing done on wastewaters containing the following characteristics:
      a) Demonstration of the ABMet system treating higher influent concentrations of chlorides, mercury, nitrate/nitrite, and selenium than those seen at Belews Creek and Allen and still meeting the proposed limitations.  The maximum concentrations of these pollutants observed at Belews Creek and Allen are the following:
            * Chlorides: 11,000 mg/L
            * Mercury: 53,300 ng/L
            * Nitrate/Nitrite: 39 mg/L
            * Selenium: 2,940 ug/L
      b) More data demonstrating that the proposed nitrate/nitrite limit (0.17 mg/L daily max and 0.13 mg/L monthly average) and the proposed selenium limit (16 ug/L daily max and 10 ug/L monthly average) are achievable.
      c) Data demonstrating the ABMet system is capable of treating a variety of chloride, nitrate/nitrite, and selenium concentrations.  Values both above and below those specified in the design criteria.
      d) Does the ABMet system have a specific selenium loading limitation (e.g., can't treat wastewater with selenium concentrations above a certain level)?
      e) Data demonstrating the ABMet system is capable of treating wastewater at a variety of ORP levels.
      f) Data demonstrating the ABMet system is capable of operating at chlorides concentrations at or above 35,000 ppm.
      g) Data demonstrating that the ABMet system is capable of treating species of selenium other than selenite and selenate (e.g., selenocyanate and other species).
      h) Data demonstrating that the ABMet system can meet the proposed limits immediately after an extended shutdown of the system (e.g., the plant has a 4-week outages where no FGD wastewater is transferred to the system and the plant can still meet limits after starting back up).

Increased Costs for Different Influents
   Question: Would increased influent nitrate/nitrite and/or selenium concentrations result in any design changes to the biological treatment system?  If so, how would these design changes affect the cost of the system? Comments specifically cite nitrate/nitrite levels greater than 100ppm in the influent to the ABMet system.

   Background: The cost request sent to GE cites a maximum design nitrate/nitrite concentration of 160 mg/L (or ppm).  Pleasant Prairie sampling data includes nitrate/nitrate concentrations as high as 220 mg/L (at least 3 results are at or above the design concentration).
   Comments from We Energies cite a paper presented by GE at the 2010 IWC which specify a maximum design nitrate/nitrite concentration of 100 ppm.

Capital and O&M Costs
   Question: ERG would like to clarify whether specific cost elements are included or not included in the cost estimates provided in previous correspondence.
         1. Does the cost estimate include any costs for site prep work?  These would be costs for any site preparation work needed at the construction site, work such as clearing land or structural reinforcement needed to support the ABMet system.
         2. Does the cost estimate include costs for system start-up and operator training?  If so, how much support is provided by GE (e.g., how long will GE work with the plant on start-up and training)?
         3. Does the cost estimate include any additional margin to account for bonding and insurance and a margin for GE's profit?
         4. Are electrical costs included in the cost estimate? Costs to wire and connect any instruments or equipment requiring electricity within the ABMet system.
         5. Does the cost estimate include costs for the control equipment for the `island,' such that all FGD wastewater treatment equipment can be controlled from the control room?

   Background:  In previous contact with GE (April 2011), a list of cost assumptions was provided along with the cost curves for equipment and installation costs.  The costs provided by GE include the following items:
         * Assume unionized contractor labor is utilized,
         * Assume no special seismic criteria is incorporated into construction or design,
         * Costs are based on executing project structure as a consortium between GE and contractor with a balance of plant engineering as a sub-contractor,
         * Costs assume the ABMet system is an `island' with integration into the full power plant system not being included (e.g. DCS interfaces, tie-in with existing plant, etc. omitted),
         * Costs assume integration of ABMet following conventional physical/chemical treatment with ABMet backwash waste recycled to conventional solids removal system, and
         * Equipment and installation costs include costs to purchase and install the following elements:
               o All process pumps, valves, and instruments,
               o Process and instrument compressed air system, valves and lines,
               o Nutrient system, storage tank, and pumping,
               o All process piping and supports within the ABMet `island,'
               o Building for all process equipment with HVAC (concrete floor, block structure with steel roof),
               o Concrete bioreactor tank walls and floor with epoxy-coated rebar and epoxy flake-glass coating,
               o Concrete backwash supply and backwash waste tank walls and floor with epoxy-coated rebar and epoxy flake-glass coating,
               o Concrete process and utility sump with pumps,
               o Support steel, access stairs, walkways, grating, and handrails,
               o Engineering, commissioning, and project management labor for ABMet `island,' and
               o Construction equipment, materials and labor for ABMet `island.'

   The ABMet correspondence also calls out several items that are not included in the cost curves provided by GE.  The following items are listed as being omitted from the cost estimate;
      * Utility overhead and labor,
      * Plant tie-in/integration (e.g. DCS interface, feed water, effluent water line to discharge, etc.),
      * Pilings, caissons, etc,
      * Permitting,
      * Financing charges,
      * Other wastewater processes such as pre- or post-treatment, dewatering, and
      * Backwash waste disposal/solids handling.


[Federal Register: September 9, 2008 (Volume 73, Number 175)]
[Notices]
[Page 52357-52358]
[DOCID:fr09se08-88]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2006-P-0081 (formerly Docket No. 2006P-0178) and FDA-
2005-P-0369 (formerly Docket No. 2005P-0023)]

Determination That TEQUIN (Gatifloxacin) Was Withdrawn From Sale
for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that
TEQUIN (gatifloxacin) Tablets, Injection, and Oral Suspension, were
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not accept or approve abbreviated new
drug applications (ANDAs) for gatifloxacin oral tablets, injection, or
oral suspension that refer to any previously approved dosage forms and
strengths of TEQUIN (gatifloxacin).

FOR FURTHER INFORMATION CONTACT: Elena Cohen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6228, Silver Spring, MD 20993-0002, 301-
796-3602.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved under a new drug application
(NDA). ANDA applicants do not have to repeat the extensive clinical
testing otherwise necessary to gain approval of an NDA. The only
clinical data required in an ANDA are data to show that the drug that
is the subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)),
which requires FDA to publish a list of all approved drugs. FDA
publishes this list as part of the ``Approved Drug Products With
Therapeutic Equivalence Evaluations,'' which is generally known as the
``Orange Book.'' Drugs are removed from the list if the agency
withdraws or suspends approval of the drug's NDA or ANDA for reasons of
safety or effectiveness, or if FDA determines that the listed drug was
withdrawn from sale for reasons of safety or effectiveness (section
505(j)(7)(C) of the act; Sec.  314.162 (21 CFR 314.162)).
    FDA will not approve an ANDA if the listed drug has been withdrawn
from sale for safety or effectiveness reasons (section 505(j)(4)(I) of
the act). Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the agency
must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. A drug that has been withdrawn from the
market for safety or effectiveness reasons is not a listed drug (21 CFR
314.3(b)). FDA may not approve an ANDA that does not refer to a listed
drug. FDA currently has pending one or more ANDAs that refer to TEQUIN
(gatifloxacin).
    Bristol-Myers Squibb Co. (BMS) is the holder of three NDAs\1\ for
TEQUIN tablets, injection, and oral suspension as listed in the
following table:
---------------------------------------------------------------------------

    \1\ On December 17, 1999, FDA approved NDAs 21-061 and 21-062
for community-acquired pneumonia, acute bacterial exacerbation of
chronic bronchitis, acute bacterial sinusitis, uncomplicated urinary
tract infections, complicated urinary tract infections,
pyelonephritis, and uncomplicated gonorrhea. The December 17, 1999,
approval letter also stated that indications for uncomplicated skin
and skin structure infections were approvable pending the submission
of certain postmarketing data. For administrative purposes, the
agency assigned administrative NDAs 21-404 (TEQUIN Tablets) and 21-
405 (TEQUIN Injections) for the treatment of uncomplicated skin and
skin structure infections. BMS provided a complete response, and
upon approval on October 17, 2002, NDAs 21-404 and 21-405 were
retired by FDA. The approvals and all other submissions for the
treatment of uncomplicated skin and skin structure infections were
incorporated in the original NDAs, 21-061 and 21-062. NDAs 21-404
and 21-405 are not listed in the Orange Book, but can be found
through a search at Drugs@FDA.

                   Table 1.--Approved TEQUIN Products
------------------------------------------------------------------------
                    Active                                Dosage Form/
   NDA No.        Ingredients           Strength              Route
------------------------------------------------------------------------
21-061         Gatifloxacin      200 milligrams (mg)    Tablet; oral
------------------------------------------------------------------------
21-061         Gatifloxacin      400 mg                 Tablet; oral
------------------------------------------------------------------------
21-062         Gatifloxacin      Equivalent to 10 mg/    Injectable;
                                  milliliter (mL) (200   injection
                                  mg)
------------------------------------------------------------------------
21-062          Gatifloxacin     400 mg/40 mL (10 mg/    Injectable;
                                  mL)                    injection
------------------------------------------------------------------------
21-062         Gatifloxacin in   200 mg/100 mL (2 mg/    Injectable;
                dextrose 5% in    mL)                    injection
                plastic
                container
------------------------------------------------------------------------
21-062         Gatifloxacin in   400 mg/200mL (2 mg/    Injectable;
                dextrose 5% in    mL)                    injection
                plastic
                container
------------------------------------------------------------------------
21-678         Gatifloxacin      200 mg/5 mL            Suspension; oral
------------------------------------------------------------------------

    TEQUIN is an antibacterial drug indicated for the treatment of
infections due to susceptible strains of designated microorganisms in
the following conditions: Acute bacterial exacerbation of chronic
bronchitis; acute sinusitis;

community-acquired pneumonia; uncomplicated skin and skin structure
infections; uncomplicated and complicated urinary tract infections;
pyelonephritis; uncomplicated urethral and cervical gonorrhea; and
acute, uncomplicated rectal infections in women.
    In January 2003, FDA received revised product labeling relating to
several approved supplements for TEQUIN (gatifloxacin). This revised
labeling deleted references to TEQUIN injection, 10 milligrams/
milliliter (mg/mL) (200 mg), indicating that this product was no longer
being marketed; therefore, the product was moved from the prescription
drug product list to the ``Discontinued Drug Product List'' section of
the Orange Book. In response to a citizen petition from Apotex Corp.
(Docket No. FDA-2005-P-0369),\2\ FDA stated, in the Federal Register of
February 3, 2006 (71 FR 5858), that TEQUIN injection, 10 mg/mL (200
mg), was not withdrawn for reasons of safety and effectiveness.
---------------------------------------------------------------------------

    \2\ This citizen petition was originally assigned docket number
2005P-0023/CP1. The number was changed to FDA-2005-P-0369 as a
result of FDA's transition to its new docketing system
(Regulations.gov) in January 2008.
---------------------------------------------------------------------------

    On May 1, 2006, Public Citizen Research Group submitted a citizen
petition (Docket No. FDA-2006-P-0081),\3\ under 21 CFR 10.30,
requesting that FDA immediately ban TEQUIN because of the increased
risk of dysglycemia (hypoglycemia, low blood sugar, and hyperglycemia,
high blood sugar) in humans. Public Citizen states that it reached its
conclusion based on: (1) The relatively high numbers and rates of
gatifloxacin-associated dysglycemia adverse event reports calculated
from data collected by FDA's Adverse Event Reporting System (AERS) and
Health Canada's Adverse Drug Reaction Monitoring Program; (2) a study
by Park-Wyllie et al., published in March 2006 in the New England
Journal of Medicine, that showed that patients (diabetic and
nondiabetic) receiving gatifloxacin had approximately 17 times the odds
of having a hyperglycemic episode and 4 times the odds of having a
hypoglycemic episode compared to those taking macrolide antibiotics;
and (3) the relatively high numbers and rates of gatifloxacin-
associated dysglycemic events in the manufacturer's safety studies in
uninfected patients and other studies in infected patients, including
clinical trials, cohort studies, case-control studies, postmarketing
surveillance studies, and case reports.
---------------------------------------------------------------------------

    \3\ This citizen petition was originally assigned docket number
2006P-0178. The number was changed to FDA-2006-P-0081 as a result of
FDA's transition to its new docketing system (Regulations.gov) in
January 2008.
---------------------------------------------------------------------------

    In June 2006, BMS announced that it would no longer market TEQUIN.
In light of pending ANDAs and the citizen petition, FDA examined
whether all TEQUIN products, including TEQUIN (gatifloxacin) injection,
10 mg/mL (200 mg), were withdrawn from the market for reasons of safety
or effectiveness. After considering the citizen petition and reviewing
agency records concerning the drug product, analyses of AERS reports,
and relevant literature, FDA has determined under Sec.  314.161 that
TEQUIN was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will remove all TEQUIN products from the Orange
Book (Sec.  314.162). FDA will not accept or approve ANDAs that refer
to these drug products.
    Therefore, the agency has determined, under Sec.  314.161, that all
dosage forms and strengths of TEQUIN (gatifloxacin) listed in the table
of this document were withdrawn from sale for reasons of safety. TEQUIN
(gatifloxacin) will be removed from the list of drug products published
in the Orange Book. FDA will not accept or approve ANDAs that refer to
any dosage form or strength of TEQUIN (gatifloxacin).

    Dated: September 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20938 Filed 9-8-08; 8:45 am]

BILLING CODE 4160-01-S