for dioxin/furan emissions and each subsequent performance test for
dioxin/furan emissions. If a subsequent dioxin/furan performance test
is being performed on only one affected facility at the MWC plant, as
provided in paragraph (g)(5)(iii) of this section, the owner or
operator may elect to apply the same estimated average carbon mass feed
rate from the tested facility for all the similarly designed and
operated affected facilities at the MWC plant.
    (2) During operation of the affected facility, the carbon injection
system operating parameter(s) that are the primary indicator(s) of the
carbon mass feed rate (e.g., screw feeder setting) shall be averaged
over a block 8-hour period, and the 8-hour block average must equal or
exceed the level(s) documented during the performance tests specified
under paragraphs (m)(1)(i) and (m)(1)(ii) of this section, except as
specified in paragraphs (m)(2)(i) and (m)(2)(ii) of this section.
    (i) During the annual dioxin/furan or mercury performance test and
the 2 weeks preceding the annual dioxin/furan or mercury performance
test, no limit is applicable for average mass carbon feed rate if the
provisions of paragraph (m)(2)(ii) of this section are met.
    (ii) The limit for average mass carbon feed rate may be waived in
accordance with permission granted by the Administrator for the purpose
of evaluating system performance, testing new technology or control
technologies, diagnostic testing, or related activities for the purpose
of improving facility performance or advancing the state-of-the-art for
controlling facility emissions.
* * * * *
    (4) Pneumatic injection pressure or other carbon injection system
operational indicator shall be used to provide additional verification
of proper carbon injection system operation. The operational indicator
shall provide an instantaneous visual and/or audible alarm to alert the
operator of a potential interruption in the carbon feed that would not
normally be indicated by direct monitoring of carbon mass feed rate
(e.g., continuous weight loss feeder) or monitoring of the carbon
system operating parameter(s) that are the indicator(s) of carbon mass
feed rate (e.g., screw feeder speed). The carbon injection system
operational indicator used to provide additional verification of carbon
injection system operation, including basis for selecting the

indicator and operator response to the indicator alarm, shall be
included in section (e)(6) of the site-specific operating manual
required under Sec.  60.54b(e) of this subpart.
    (n) In place of periodic manual testing of mercury, cadmium, lead,
or hydrogen chloride with EPA Reference Method 26, 26A, 29, or as an
alternative ASTM D6784-02 (as applicable), the owner or operator of an
affected facility may elect to install, calibrate, maintain, and
operate a continuous emission monitoring system for monitoring
emissions discharged to the atmosphere and record the output of the
system. The option to use a continuous emission monitoring system for
mercury takes effect on the date of approval of the site-specific
monitoring plan required in paragraph (n)(13) and (o) of this section.
The option to use a continuous emission monitoring system for cadmium,
lead, or hydrogen chloride takes effect on the date a final performance
specification applicable to cadmium, lead, or hydrogen chloride monitor
is published in the Federal Register or the date of approval of the
site-specific monitoring plan required in paragraphs (n)(13) and (o) of
this section. The owner or operator of an affected facility who elects
to continuously monitor emissions instead of conducting manual
performance testing shall install, calibrate, maintain, and operate a
continuous emission monitoring system and shall comply with the
requirements specified in paragraphs (n)(1) through (n)(13) of this
section.
    (1) Notify the Administrator one month before starting use of the
system.
    (2) Notify the Administrator one month before stopping use of the
system.
    (3) The monitor shall be installed, evaluated, and operated in
accordance with Sec.  60.13 of subpart A of this part.
    (4) The initial performance evaluation shall be completed no later
than 180 days after the date of initial startup of the affected
facility, as specified under Sec.  60.8 of subpart A of this part or
within 180 days of notification to the Administrator of use of the
continuous monitoring system if the owner or operator was previously
determining compliance by Method 26, 26A, 29, or as an alternative ASTM
D6784-02 (as applicable) performance tests, whichever is later.
    (5) The owner or operator may request that compliance with the
emission limits be determined using carbon dioxide measurements
corrected to an equivalent of 7 percent oxygen. The relationship
between oxygen and carbon dioxide levels for the affected facility
shall be established as specified in paragraph (b)(6) of this section.
    (6) The owner or operator shall conduct an initial performance test
for emissions as required under Sec.  60.8 of subpart A of this part.
Compliance with the emission limits shall be determined by using the
continuous emission monitoring system specified in paragraph (n) of
this section to measure emissions and calculating a 24-hour block
arithmetic average emission concentration using EPA Reference Method
19, section 12.4.1.
    (7) Compliance with the emission limits shall be determined based
on the 24-hour daily (block) average of the hourly arithmetic average
emission concentrations using continuous emission monitoring system
outlet data.
    (8) Beginning on April 28, 2008 for mercury and on the date two
years after final performance specifications for cadmium, lead or
hydrogen chloride monitors are published in the Federal Register or the
date two years after approval of a site-specific monitoring plan, valid
continuous monitoring system hourly averages shall be obtained as
specified in paragraphs (n)(8)(i) and (n)(8)(ii) of this section for at
least 90 percent of the operating hours per calendar quarter and 95
percent of the operating hours per calendar year that the affected
facility is combusting municipal solid waste.
    (i) At least two data points per hour shall be used to calculate
each 1-hour arithmetic average.
    (ii) Each 1-hour arithmetic average shall be corrected to 7 percent
oxygen on an hourly basis using the 1-hour arithmetic average of the
oxygen (or carbon dioxide) continuous emission monitoring system data.
    (9) The 1-hour arithmetic averages required under paragraph (n)(7)
of this section shall be expressed in micrograms per dry standard cubic
meter for mercury, cadmium, lead and parts per million dry volume for
hydrogen chloride corrected to 7 percent oxygen (dry basis) and shall
be used to calculate the 24-hour daily arithmetic (block) average
emission concentrations. The 1-hour arithmetic averages shall be
calculated using the data points required under Sec.  60.13(e)(2) of
subpart A of this part.
    (10) All valid continuous emission monitoring system data shall be
used in calculating average emission concentrations even if the minimum
continuous emission monitoring system data requirements of paragraph
(n)(8) of this section are not met.
    (11) The continuous emission monitoring system shall be operated
according to the performance specifications in paragraphs (n)(11)(i)
through (n)(11)(iii) of this section or the approved site-specific
monitoring plan.
    (i) For mercury, Performance Specification 12A in appendix B of
this part.
    (ii) [Reserved]
    (iii) [Reserved]
    (12) During each relative accuracy test run of the continuous
emission monitoring system required by the performance specifications
in paragraph (n)(11) of this section, mercury, cadmium, lead, hydrogen
chloride, and oxygen (or carbon dioxide) data shall be collected
concurrently (or within a 30- to 60-minute period) by both the
continuous emission monitors and the test methods specified in
paragraphs (n)(12)(i) through (n)(12)(iii) of this section.
    (i) For mercury, cadmium, and lead, EPA Reference Method 29 or as
an alternative ASTM D6784-02 shall be used.
    (ii) For hydrogen chloride, EPA Reference Method 26 or 26A shall be
used.
    (iii) For oxygen (or carbon dioxide), EPA Reference Method 3, 3A,
or 3B, as applicable shall be used.
    (13) The owner or operator who elects to install, calibrate,
maintain, and operate a continuous emission monitoring system for
mercury, cadmium, lead, or hydrogen chloride must develop and implement
a site-specific monitoring plan as specified in paragraph (o) of this
section. The owner or operator who relies on a performance
specification may refer to that document in addressing applicable
procedures and criteria.
    (14) When emissions data are not obtained because of continuous
emission monitoring system breakdowns, repairs, calibration checks, and
zero and span adjustments, parametric monitoring data shall be obtained
by using other monitoring systems as approved by EPA.
    (o) The owner or operator who elects to install, calibrate,
maintain, and operate a continuous emission monitoring system for
mercury, cadmium, lead, or hydrogen chloride must develop and submit
for approval by EPA, a site-specific mercury, cadmium, lead, or
hydrogen chloride monitoring plan that addresses the elements and
requirements in paragraphs (o)(1) through (o)(7) of this section.
    (1) Installation of the continuous emission monitoring system
sampling probe or other interface at a measurement location relative to
each affected process unit such that the measurement is representative
of

control of the exhaust emissions (e.g., on or downstream of the last
control device).
    (2) Performance and equipment specifications for the sample
interface, the pollutant concentration analyzer, and the data
collection and reduction system.
    (3) Performance evaluation procedures and acceptance criteria
(e.g., calibrations).
    (4) Provisions for periods when the continuous emission monitoring
system is out of control as described in paragraphs (o)(4)(i) through
(o)(4)(iii) of this section.
    (i) A continuous emission monitoring system is out of control if
either of the conditions in paragraphs (o)(4)(i)(A) or (o)(4)(ii)(B) of
this section are met.
    (A) The zero (low-level), mid-level (if applicable), or high-level
calibration drift exceeds two times the applicable calibration drift
specification in the applicable performance specification or in the
relevant standard; or
    (B) The continuous emission monitoring system fails a performance
test audit (e.g., cylinder gas audit), relative accuracy audit,
relative accuracy test audit, or linearity test audit.
    (ii) When the continuous emission monitoring system is out of
control as defined in paragraph (o)(4)(i) of this section, the owner or
operator of the affected source shall take the necessary corrective
action and shall repeat all necessary tests that indicate that the
system is out of control. The owner or operator shall take corrective
action and conduct retesting until the performance requirements are
below the applicable limits. The beginning of the out-of-control period
is the hour the owner or operator conducts a performance check (e.g.,
calibration drift) that indicates an exceedance of the performance
requirements established under this part. The end of the out-of-control
period is the hour following the completion of corrective action and
successful demonstration that the system is within the allowable
limits. During the period the continuous emission monitoring system is
out of control, recorded data shall not be used in data averages and
calculations or to meet any data availability requirements in paragraph
(n)(8) of this section.
    (iii) The owner or operator of a continuous emission monitoring
system that is out of control as defined in paragraph (o)(4) of this
section shall submit all information concerning out-of-control periods,
including start and end dates and hours and descriptions of corrective
actions taken in the annual or semiannual compliance reports required
in Sec.  60.59b(g) or (h).
    (5) Ongoing data quality assurance procedures for continuous
emission monitoring systems as described in paragraphs (o)(5)(i) and
(o)(5)(ii) of this section.
    (i) Develop and implement a continuous emission monitoring system
quality control program. As part of the quality control program, the
owner or operator shall develop and submit to EPA for approval, upon
request, a site-specific performance evaluation test plan for the
continuous emission monitoring system performance evaluation required
in paragraph (o)(5)(ii) of this section. In addition, each quality
control program shall include, at a minimum, a written protocol that
describes procedures for each of the operations described in paragraphs
(o)(7)(i)(A) through (o)(7)(i)(F) of this section.
    (A) Initial and any subsequent calibration of the continuous
emission monitoring system;
    (B) Determination and adjustment of the calibration drift of the
continuous emission monitoring system;
    (C) Preventive maintenance of the continuous emission monitoring
system, including spare parts inventory;
    (D) Data recording, calculations, and reporting;
    (E) Accuracy audit procedures, including sampling and analysis
methods; and
    (F) Program of corrective action for a malfunctioning continuous
emission monitoring system.
    (ii) The performance evaluation test plan shall include the
evaluation program objectives, an evaluation program summary, the
performance evaluation schedule, data quality objectives, and both an
internal and external quality assurance program. Data quality
objectives are the pre-evaluation expectations of precision, accuracy,
and completeness of data. The internal quality assurance program shall
include, at a minimum, the activities planned by routine operators and
analysts to provide an assessment of continuous emission monitoring
system performance, for example, plans for relative accuracy testing
using the appropriate reference method in Sec.  60.58b(n)(12) of this
section. The external quality assurance program shall include, at a
minimum, systems audits that include the opportunity for on-site
evaluation by the Administrator of instrument calibration, data
validation, sample logging, and documentation of quality control data
and field maintenance activities.
    (6) Conduct a performance evaluation of each continuous emission
monitoring system in accordance with the site-specific monitoring plan.
    (7) Operate and maintain the continuous emission monitoring system
in continuous operation according to the site-specific monitoring plan.
    (p) In place of periodic manual testing of dioxin/furan or mercury
with EPA Reference Method 23, 29, or as an alternative ASTM D6784-02
(as applicable), the owner or operator of an affected facility may
elect to install, calibrate, maintain, and operate a continuous
automated sampling system for determining emissions discharged to the
atmosphere. This option takes effect on the date a final performance
specification applicable to such continuous automated sampling systems
is published in the Federal Register or the date of approval of a site-
specific monitoring plan required in paragraphs (p)(10) and (q) of this
section. The owner or operator of an affected facility who elects to
use a continuous automated sampling system to determine emissions
instead of conducting manual performance testing shall install,
calibrate, maintain, and operate the sampling system and conduct
analyses in compliance with the requirements specified in paragraphs
(p)(1) through (p)(12) of this section.
    (1) Notify the Administrator one month before starting use of the
system.
    (2) Notify the Administrator one month before stopping use of the
system.
    (3) The initial performance evaluation shall be completed no later
than 180 days after the date of initial startup of the affected
facility, as specified under Sec.  60.8 of subpart A of this part or
within 180 days of notification to the Administrator of use of the
continuous monitoring system if the owner or operator was previously
determining compliance by manual performance testing using Method 23,
29, or as an alternative ASTM D6784-02 (as applicable), whichever is
later.
    (4) The owner or operator may request that compliance with the
emission limits be determined using carbon dioxide measurements
corrected to an equivalent of 7 percent oxygen. The relationship
between oxygen and carbon dioxide levels for the affected facility
shall be established as specified in paragraph (b)(6) of this section.
    (5) The owner or operator shall conduct an initial performance test
for emissions as required under Sec.  60.8 of subpart A of this part.
Compliance with the emission limits shall be determined by using the
continuous automated

sampling system specified in paragraph (p) of this section to collect
integrated samples and analyze emissions for the time period specified
in paragraphs (p)(5)(i) and (ii) of this section.
    (i) For dioxin/furan, the continuous automated sampling system
shall collect an integrated sample over each 2-week period. The
collected sample shall be analyzed using Method 23.
    (ii) For mercury, the continuous automated sampling system shall
collect an integrated sample over each 24-hour daily period and the
sample shall be analyzed according to the applicable final performance
specification or the approved site-specific monitoring plan required by
paragraph (q) of this section.
    (6) Compliance with the emission limits shall be determined based
on 2-week emission concentrations for dioxin/furan and on the 24-hour
daily emission concentrations for mercury using samples collected at
the system outlet. The emission concentrations shall be expressed in
nanograms per dry standard cubic meter (total mass) for dioxin/furan
and micrograms per dry standard cubic meter for mercury, corrected to 7
percent oxygen (dry basis).
    (7) Beginning on the date two years after the respective final
performance specification for continuous automated sampling systems for
dioxin/furan or mercury is published in the Federal Register or two
years after approval of a site-specific monitoring plan, the continuous
automated sampling system must be operated and collect emissions for at
least 90 percent of the operating hours per calendar quarter and 95
percent of the operating hours per calendar year that the affected
facility is combusting municipal solid waste.
    (8) All valid data shall be used in calculating emission
concentrations.
    (9) The continuous automated sampling system shall be operated
according to the final performance specification in paragraphs
(p)(9)(i) or (p)(9)(ii) of this section or the approved site-specific
monitoring plan.
    (i) [Reserved]
    (ii) [Reserved]
    (10) The owner or operator who elects to install, calibrate,
maintain, and operate a continuous automated sampling system for
dioxin/furan or mercury must develop and implement a site-specific
monitoring plan as specified in paragraph (q) of this section. The
owner or operator who relies on a performance specification may refer
to that document in addressing applicable procedures and criteria.
    (11) When emissions data are not obtained because of continuous
automated sampling system breakdowns, repairs, quality assurance
checks, or adjustments, parametric monitoring data shall be obtained by
using other monitoring systems as approved by EPA.
    (q) The owner or operator who elects to install, calibrate,
maintain, and operate a continuous automated sampling system for
dioxin/furan or mercury must develop and submit for approval by EPA, a
site-specific monitoring plan that has sufficient detail to assure the
validity of the continuous automated sampling system data and that
addresses the elements and requirements in paragraphs (q)(1) through
(q)(7) of this section.
    (1) Installation of the continuous automated sampling system
sampling probe or other interface at a measurement location relative to
each affected process unit such that the measurement is representative
of control of the exhaust emissions (e.g., on or downstream of the last
control device).
    (2) Performance and equipment specifications for the sample
interface, the pollutant concentration analytical method, and the data
collection system.
    (3) Performance evaluation procedures and acceptance criteria.
    (4) Provisions for periods when the continuous automated sampling
system is malfunctioning or is out of control as described in
paragraphs (q)(4)(i) through (q)(4)(iii) of this section.
    (i) The site-specific monitoring plan shall identify criteria for
determining that the continuous automated sampling system is out of
control. This shall include periods when the sampling system is not
collecting a representative sample or is malfunctioning, or when the
analytical method does not meet site-specific quality criteria
established in paragraph (q)(5) of this section.
    (ii) When the continuous automated sampling system is out of
control as defined in paragraph (q)(4)(i) of this section, the owner or
operator shall take the necessary corrective action and shall repeat
all necessary tests that indicate that the system is out of control.
The owner or operator shall take corrective action and conduct
retesting until the performance requirements are within the applicable
limits. The out-of-control period includes all hours that the sampling
system was not collecting a representative sample or was
malfunctioning, or hours represented by a sample for which the analysis
did not meet the relevant quality criteria. Emissions data obtained
during an out-of-control period shall not be used in determining
compliance with the emission limits or to meet any data availability
requirements in paragraph (p)(8) of this section.
    (iii) The owner or operator of a continuous automated sampling
system that is out of control as defined in paragraph (q)(4) of this
section shall submit all information concerning out-of-control periods,
including start and end dates and hours and descriptions of corrective
actions taken in the annual or semiannual compliance reports required
in Sec.  60.59b(g) or (h).
    (5) Ongoing data quality assurance procedures for continuous
automated sampling systems as described in paragraphs (q)(5)(i) and
(q)(5)(ii) of this section.
    (i) Develop and implement a continuous automated sampling system
and analysis quality control program. As part of the quality control
program, the owner or operator shall develop and submit to EPA for
approval, upon request, a site-specific performance evaluation test
plan for the continuous automated sampling system performance
evaluation required in paragraph (q)(5)(ii) of this section. In
addition, each quality control program shall include, at a minimum, a
written protocol that describes procedures for each of the operations
described in paragraphs (q)(7)(i)(A) through (q)(7)(i)(F) of this
section.
    (A) Correct placement, installation of the continuous automated
sampling system such that the system is collecting a representative
sample of gas;
    (B) Initial and subsequent calibration of flow such that the sample
collection rate of the continuous automated sampling system is known
and verifiable;
    (C) Procedures to assure representative (e.g., proportional or
isokinetic) sampling;
    (D) Preventive maintenance of the continuous automated sampling
system, including spare parts inventory and procedures for cleaning
equipment, replacing sample collection media, or other servicing at the
end of each sample collection period;
    (E) Data recording and reporting, including an automated indicator
and recording device to show when the continuous automated monitoring
system is operating and collecting data and when it is not collecting
data;
    (F) Accuracy audit procedures for analytical methods; and
    (G) Program of corrective action for a malfunctioning continuous
automated sampling system.
    (ii) The performance evaluation test plan shall include the
evaluation program objectives, an evaluation program summary, the
performance evaluation schedule, data quality

objectives, and both an internal and external quality assurance
program. Data quality objectives are the pre-evaluation expectations of
precision, accuracy, and completeness of data. The internal quality
assurance program shall include, at a minimum, the activities planned
by routine operators and analysts to provide an assessment of
continuous automated sampling system performance, for example, plans
for relative accuracy testing using the appropriate reference method in
60.58b(p)(3), and an assessment of quality of analysis results. The
external quality assurance program shall include, at a minimum, systems
audits that include the opportunity for on-site evaluation by the
Administrator of instrument calibration, data validation, sample
logging, and documentation of quality control data and field
maintenance activities.
    (6) Conduct a performance evaluation of each continuous automated
sampling system in accordance with the site-specific monitoring plan.
    (7) Operate and maintain the continuous automated sampling system
in continuous operation according to the site-specific monitoring plan.

0
17. Amend Sec.  60.59b by:
0
a. Revising paragraph (d)(2)(i) introductory text;
0
b. Revising paragraph (d)(2)(ii) introductory text;
0
c. Revising paragraph (d)(3);
0
d. Revising paragraph (d)(6) introductory text;
0
e. Revising paragraph (d)(6)(iv);
0
f. Revising paragraph (d)(6)(v);
0
g. Revising paragraph (d)(7);
0
h. Adding paragraph (d)(10);
0
i. Revising paragraph (d)(12) introductory text;
0
j. Revising paragraph (d)(14);
0
k. Revising paragraph (g) introductory text;
0
l. Revising paragraph (g)(1)(ii);
0
m. Revising paragraph (g)(1)(iv);
0
n. Revising paragraph (g)(1)(v);
0
o. Revising paragraph (g)(4);
0
p. Revising paragraph (h)(1);
0
q. Adding paragraph (d)(2)(i)(E);
0
r. Adding paragraph (d)(2)(ii)(E);
0
s. Adding paragraph (d)(2)(ii)(F);
0
t. Adding paragraph (d)(6)(vi);
0
u. Adding paragraph (d)(6)(vii);
0
v. Adding paragraph (d)(12)(iv);
0
w. Adding paragraph (g)(5);
0
x. Adding paragraph (m);
0
y. Adding paragraph (n); and
0
z. Adding paragraph (o) to read as follows:

Sec.  60.59b  Reporting and recordkeeping requirements.

* * * * *
    (d) * * *
    (2) * * *
    (i) The measurements specified in paragraphs (d)(2)(i)(A) through
(d)(2)(i)(F) of this section shall be recorded and be available for
submittal to the Administrator or review on site by an EPA or State
inspector.
* * * * *
    (E) For owners and operators who elect to continuously monitor
particulate matter, cadmium, lead, mercury, or hydrogen chloride
emissions instead of conducting performance testing using EPA manual
test methods, all 1-hour average particulate matter, cadmium, lead,
mercury, or hydrogen chloride emission concentrations as specified
under Sec.  60.58b(n).
    (ii) The average concentrations and percent reductions, as
applicable, specified in paragraphs (d)(2)(ii)(A) through (d)(2)(ii)(F)
of this section shall be computed and recorded, and shall be available
for submittal to the Administrator or review on-site by an EPA or State
inspector.
* * * * *
    (E) For owners and operators who elect to continuously monitor
particulate matter, cadmium, lead, mercury, or hydrogen chloride
emissions instead of conducting performance testing using EPA manual
test methods, all 24-hour daily arithmetic average particulate matter,
cadmium, lead, mercury, or hydrogen chloride emission concentrations as
specified under Sec.  60.58b(n).
    (F) For owners and operators who elect to use a continuous
automated sampling system to monitor mercury or dioxin/furan instead of
conducting performance testing using EPA manual test methods, all
integrated 24-hour mercury concentrations or all integrated 2-week
dioxin/furan concentrations as specified under Sec.  60.586(p).
    (3) Identification of the calendar dates when any of the average
emission concentrations, percent reductions, or operating parameters
recorded under paragraphs (d)(2)(ii)(A) through (d)(2)(ii)(F) of this
section, or the opacity levels recorded under paragraph (d)(2)(i)(A) of
this section are above the applicable limits, with reasons for such
exceedances and a description of corrective actions taken.
* * * * *
    (6) Identification of the calendar dates and times (hours) for
which valid hourly data specified in paragraphs (d)(6)(i) through
(d)(6)(vi) of this section have not been obtained, or continuous
automated sampling systems were not operated as specified in paragraph
(d)(6)(vii) of this section, including reasons for not obtaining the
data and a description of corrective actions taken.
* * * * *
    (iv) Municipal waste combustor unit load data;
    (v) Particulate matter control device temperature data; and
    (vi) For owners and operators who elect to continuously monitor
particulate matter, cadmium, lead, mercury, or hydrogen chloride
emissions instead of performance testing by EPA manual test methods,
particulate matter, cadmium, lead, mercury, or hydrogen chloride
emissions data.
    (vii) For owners and operators who elect to use continuous
automated sampling systems for dioxins/furans or mercury as allowed
under ``60.58b(p) and (q), dates and times when the sampling systems
were not operating or were not collecting a valid sample.
    (7) Identification of each occurrence that sulfur dioxide emissions
data, nitrogen oxides emissions data, particulate matter emissions
data, cadmium emissions data, lead emissions data, mercury emissions
data, hydrogen chloride emissions data, or dioxin/furan emissions data
(for owners and operators who elect to continuously monitor particulate
matter, cadmium, lead, mercury, or hydrogen chloride, or who elect to
use continuous automated sampling systems for dioxin/furan or mercury
emissions, instead of conducting performance testing using EPA manual
test methods) or operational data (i.e., carbon monoxide emissions,
unit load, and particulate matter control device temperature) have been
excluded from the calculation of average emission concentrations or
parameters, and the reasons for excluding the data.
* * * * *
    (10) An owner or operator who elects to continuously monitor
emissions instead of performance testing by EPA manual methods must
maintain records specified in paragraphs (10)(i) through (iii) of this
section.
    (i) For owners and operators who elect to continuously monitor
particulate matter instead of conducting performance testing using EPA
manual test methods), as required under appendix F of this part,
procedure 2, the results of daily drift tests and quarterly accuracy
determinations for particulate matter.
    (ii) For owners and operators who elect to continuously monitor
cadmium, lead, mercury, or hydrogen chloride instead of conducting EPA
manual test methods, the results of all quality evaluations, such as
daily drift tests and

periodic accuracy determinations, specified in the approved site-
specific performance evaluation test plan required by Sec.
60.58b(o)(5).
    (iii) For owners and operators who elect to use continuous
automated sampling systems for dioxin/furan or mercury, the results of
all quality evaluations specified in the approved site-specific
performance evaluation test plan required by Sec.  60.58b(q)(5).
* * * * *
    (12) The records specified in paragraphs (d)(12)(i) through
(d)(12)(iv) of this section.
* * * * *
    (iv) Records of when a certified operator is temporarily off site.
Include two main items:
    (A) If the certified chief facility operator and certified shift
supervisor are off site for more than 12 hours, but for 2 weeks or
less, and no other certified operator is on site, record the dates that
the certified chief facility operator and certified shift supervisor
were off site.
    (B) When all certified chief facility operators and certified shift
supervisors are off site for more than 2 weeks and no other certified
operator is on site, keep records of four items:
    (1) Time of day that all certified persons are off site.
    (2) The conditions that cause those people to be off site.
    (3) The corrective actions taken by the owner or operator of the
affected facility to ensure a certified chief facility operator or
certified shift supervisor is on site as soon as practicable.
    (4) Copies of the written reports submitted every 4 weeks that
summarize the actions taken by the owner or operator of the affected
facility to ensure that a certified chief facility operator or
certified shift supervisor will be on site as soon as practicable.
* * * * *
    (14) For affected facilities that apply activated carbon,
identification of the calendar dates when the average carbon mass feed
rates recorded under paragraph (d)(4)(iii) of this section were less
than either of the hourly carbon feed rates estimated during
performance tests for mercury emissions and recorded under paragraphs
(d)(4)(i) and (d)(4)(ii) of this section, respectively, with reasons
for such feed rates and a description of corrective actions taken. For
affected facilities that apply activated carbon, identification of the
calendar dates when the average carbon mass feed rates recorded under
paragraph (d)(4)(iii) of this section were less than either of the
hourly carbon feed rates estimated during performance tests for dioxin/
furan emissions and recorded under paragraphs (d)(4)(i) and (d)(4)(ii)
of this section, respectively, with reasons for such feed rates and a
description of corrective actions taken.
* * * * *
    (g) Following the first year of municipal waste combustor
operation, the owner or operator of an affected facility shall submit
an annual report that includes the information specified in paragraphs
(g)(1) through (g)(5) of this section, as applicable, no later than
February 1 of each year following the calendar year in which the data
were collected (once the unit is subject to permitting requirements
under title V of the Act, the owner or operator of an affected facility
must submit these reports semiannually).
    (1) * * *
    (ii) A list of the highest emission level recorded for sulfur
dioxide, nitrogen oxides, carbon monoxide, particulate matter, cadmium,
lead, mercury, hydrogen chloride, and dioxin/furan (for owners and
operators who elect to continuously monitor particulate matter,
cadmium, lead, mercury, hydrogen chloride, and dioxin/furan emissions
instead of conducting performance testing using EPA manual test
methods), municipal waste combustor unit load level, and particulate
matter control device inlet temperature based on the data recorded
under paragraphs (d)(2)(ii)(A) through (d)(2)(ii)(E) of this section.
* * * * *
    (iv) Periods when valid data were not obtained as described in
paragraphs (g)(1)(iv)(A) through (g)(1)(iv)(C) of this section.
    (A) The total number of hours per calendar quarter and hours per
calendar year that valid data for sulfur dioxide, nitrogen oxides,
carbon monoxide, municipal waste combustor unit load, or particulate
matter control device temperature data were not obtained based on the
data recorded under paragraph (d)(6) of this section.
    (B) For owners and operators who elect to continuously monitor
particulate matter, cadmium, lead, mercury, and hydrogen chloride
emissions instead of conducting performance testing using EPA manual
test methods, the total number of hours per calendar quarter and hours
per calendar year that valid data for particulate matter, cadmium,
lead, mercury, and hydrogen chloride were not obtained based on the
data recorded under paragraph (d)(6) of this section. For each
continuously monitored pollutant or parameter, the hours of valid
emissions data per calendar quarter and per calendar year expressed as
a percent of the hours per calendar quarter or year that the affected
facility was operating and combusting municipal solid waste.
    (C) For owners and operators who elect to use continuous automated
sampling systems for dioxin/furan or mercury, the total number of hours
per calendar quarter and hours per calendar year that the sampling
systems were not operating or were not collecting a valid sample based
on the data recorded under paragraph (d)(6)(vii) of this section. Also,
the number of hours during which the continuous automated sampling
system was operating and collecting a valid sample as a percent of
hours per calendar quarter or year that the affected facility was
operating and combusting municipal solid waste.
    (v) Periods when valid data were excluded from the calculation of
average emission concentrations or parameters as described in
paragraphs (g)(1)(v)(A) through (g)(1)(v)(C) of this section.
    (A) The total number of hours that data for sulfur dioxide,
nitrogen oxides, carbon monoxide, municipal waste combustor unit load,
and particulate matter control device temperature were excluded from
the calculation of average emission concentrations or parameters based
on the data recorded under paragraph (d)(7) of this section.
    (B) For owners and operators who elect to continuously monitor
particulate matter, cadmium, lead, mercury, or hydrogen chloride
emissions instead of conducting performance testing using EPA manual
test methods, the total number of hours that data for particulate
matter, cadmium, lead, mercury, or hydrogen chloride were excluded from
the calculation of average emission concentrations or parameters based
on the data recorded under paragraph (d)(7) of this section.
    (C) For owners and operators who elect to use continuous automated
sampling systems for dioxin/furan or mercury, the total number of hours
that data for mercury and dioxin/furan were excluded from the
calculation of average emission concentrations or parameters based on
the data recorded under paragraph (d)(7) of this section.
* * * * *
    (4) A notification of intent to begin the reduced dioxin/furan
performance testing schedule specified in Sec.  60.58b(g)(5)(iii) of
this section during the following calendar year and notification of
intent to apply the average carbon mass feed rate and associated carbon
injection system operating parameter levels as

established in Sec.  60.58b(m) to similarly designed and equipped units
on site.
    (5) Documentation of periods when all certified chief facility
operators and certified shift supervisors are off site for more than 12
hours.
    (h) * * *
    (1) The semiannual report shall include information recorded under
paragraph (d)(3) of this section for sulfur dioxide, nitrogen oxides,
carbon monoxide, particulate matter, cadmium, lead, mercury, hydrogen
chloride, dioxin/furan (for owners and operators who elect to
continuously monitor particulate matter, cadmium, lead, mercury, or
hydrogen chloride, or who elect to use continuous automated sampling
systems for dioxin/furan or mercury emissions, instead of conducting
performance testing using EPA manual test methods) municipal waste
combustor unit load level, particulate matter control device inlet
temperature, and opacity.
* * * * *
    (m) Owners and operators who elect to continuously monitor
particulate matter, cadmium, lead, mercury, or hydrogen chloride, or
who elect to use continuous automated sampling systems for dioxin/furan
or mercury emissions, instead of conducting performance testing using
EPA manual test methods must notify the Administrator one month prior
to starting or stopping use of the particulate matter, cadmium, lead,
mercury, hydrogen chloride, and dioxin/furan continuous emission
monitoring systems or continuous automated sampling systems.
    (n) Additional recordkeeping and reporting requirements for
affected facilities with continuous cadmium, lead, mercury, or hydrogen
chloride monitoring systems. In addition to complying with the
requirements specified in paragraphs (a) through (m) of this section,
the owner or operator of an affected source who elects to install a
continuous emission monitoring system for cadmium, lead, mercury, or
hydrogen chloride as specified in Sec.  60.58b(n), shall maintain the
records in paragraphs (n)(1) through (n)(10) of this section and report
the information in paragraphs (n)(11) through (n)(12) of this section,
relevant to the continuous emission monitoring system:
    (1) All required continuous emission monitoring measurements
(including monitoring data recorded during unavoidable continuous
emission monitoring system breakdowns and out-of-control periods);
    (2) The date and time identifying each period during which the
continuous emission monitoring system was inoperative except for zero
(low-level) and high-level checks;
    (3) The date and time identifying each period during which the
continuous emission monitoring system was out of control, as defined in
Sec.  60.58b(o)(4);
    (4) The specific identification (i.e., the date and time of
commencement and completion) of each period of excess emissions and
parameter monitoring exceedances, as defined in the standard, that
occurs during startups, shutdowns, and malfunctions of the affected
source;
    (5) The specific identification (i.e., the date and time of
commencement and completion) of each time period of excess emissions
and parameter monitoring exceedances, as defined in the standard, that
occurs during periods other than startups, shutdowns, and malfunctions
of the affected source;
    (6) The nature and cause of any malfunction (if known);
    (7) The corrective action taken to correct any malfunction or
preventive measures adopted to prevent further malfunctions;
    (8) The nature of the repairs or adjustments to the continuous
emission monitoring system that was inoperative or out of control;
    (9) All procedures that are part of a quality control program
developed and implemented for the continuous emission monitoring system
under Sec.  60.58b(o);
    (10) When more than one continuous emission monitoring system is
used to measure the emissions from one affected source (e.g., multiple
breechings, multiple outlets), the owner or operator shall report the
results as required for each continuous emission monitoring system.
    (11) Submit to EPA for approval, the site-specific monitoring plan
required by Sec.  60.58b(n)(13) and Sec.  60.58b(o), including the
site-specific performance evaluation test plan for the continuous
emission monitoring system required by Sec.  60.58(b)(o)(5). The owner
or operator shall maintain copies of the site-specific monitoring plan
on record for the life of the affected source to be made available for
inspection, upon request, by the Administrator. If the site-specific
monitoring plan is revised and approved, the owner or operator shall
keep previous (i.e., superseded) versions of the plan on record to be
made available for inspection, upon request, by the Administrator, for
a period of 5 years after each revision to the plan.
    (12) Submit information concerning all out-of-control periods for
each continuous emission monitoring system, including start and end
dates and hours and descriptions of corrective actions taken, in the
annual or semiannual reports required in paragraphs (g) or (h) of this
section.
    (o) Additional recordkeeping and reporting requirements for
affected facilities with continuous automated sampling systems for
dioxin/furan or mercury monitoring. In addition to complying with the
requirements specified in paragraphs (a) through (m) of this section,
the owner or operator of an affected source who elects to install a
continuous automated sampling system for dioxin/furan or mercury, as
specified in Sec.  60.58b(p), shall maintain the records in paragraphs
(o)(1) through (o)(10) of this section and report the information in
(o)(11) and (o)(12) of this section, relevant to the continuous
automated sampling system:
    (1) All required 24-hour integrated mercury concentration or 2-week
integrated dioxin/furan concentration data (including any data obtained
during unavoidable system breakdowns and out-of-control periods);
    (2) The date and time identifying each period during which the
continuous automated sampling system was inoperative;
    (3) The date and time identifying each period during which the
continuous automated sampling system was out of control, as defined in
Sec.  60.58b(q)(4);
    (4) The specific identification (i.e., the date and time of
commencement and completion) of each period of excess emissions and
parameter monitoring exceedances, as defined in the standard, that
occurs during startups, shutdowns, and malfunctions of the affected
source;
    (5) The specific identification (i.e., the date and time of
commencement and completion) of each time period of excess emissions
and parameter monitoring exceedances, as defined in the standard, that
occurs during periods other than startups, shutdowns, and malfunctions
of the affected source;
    (6) The nature and cause of any malfunction (if known);
    (7) The corrective action taken to correct any malfunction or
preventive measures adopted to prevent further malfunctions;
    (8) The nature of the repairs or adjustments to the continuous
automated sampling system that was inoperative or out of control;
    (9) All procedures that are part of a quality control program
developed and implemented for the continuous automated sampling system
under Sec.  60.58b(q);
    (10) When more than one continuous automated sampling system is
used to measure the emissions from one affected source (e.g., multiple
breechings, multiple outlets), the owner or operator

shall report the results as required for each system.
    (11) Submit to EPA for approval, the site-specific monitoring plan
required by Sec.  60.58b(p)(11) and Sec.  60.58b(q) including the site-
specific performance evaluation test plan for the continuous emission
monitoring system required by Sec.  60.58(b)(q)(5). The owner or
operator shall maintain copies of the site-specific monitoring plan on
record for the life of the affected source to be made available for
inspection, upon request, by the Administrator. If the site-specific
monitoring plan is revised and approved, the owner or operator shall
keep previous (i.e., superseded) versions of the plan on record to be
made available for inspection, upon request, by the Administrator, for
a period of 5 years after each revision to the plan.
    (12) Submit information concerning all out-of-control periods for
each continuous automated sampling system, including start and end
dates and hours and descriptions of corrective actions taken in the
annual or semiannual reports required in paragraphs (g) or (h) of this
section.

[FR Doc. 06-4197 Filed 5-9-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: December 19, 2008 (Volume 73, Number 245)]
[Notices]
[Page 77686-77687]
[DOCID:fr19de08-87]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8754-8; Docket ID No. EPA-HQ-ORD-2007-0517]

Draft Integrated Science Assessment for Particulate Matter

AGENCY: Environmental Protection Agency.

ACTION: Notice of Public Comment Period.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing
the availability of its ``First External Review Draft Integrated
Science Assessment for Particulate Matter'' (EPA/600/R-08/139 and EPA/
600/R-08/139A). The document was prepared by the National Center for
Environmental Assessment (NCEA) within EPA(s Office of Research and
Development as part of the review of the national ambient air quality
standards (NAAQS) for particulate matter.
    EPA is releasing this draft document to seek review by the Clean
Air Scientific Advisory Committee (CASAC) and the public (meeting date
and location to be specified in a separate Federal Register notice).
The draft document does not represent, and should not be construed to
represent, any final EPA policy, viewpoint, or determination. EPA will
consider any public comments submitted in response to this notice when
revising the document.

DATES: The public comment period begins on or about December 19, 2008.
Comments must be received on or before March 13, 2009.

ADDRESSES: The ``First External Review Draft Integrated Science
Assessment for Particulate Matter'' will be available primarily via the
Internet on the National Center for Environmental Assessment's home
page under the Recent Additions and Publications menus at http://
www.epa.gov/ncea. A limited number of CD-ROM or paper copies will be
available. Contact Ms. Debbie Wales by phone<PHONE_NUMBER>), fax (919-
541-5078), or e-mail<EMAIL_ADDRESS>to request either of
these, and please provide your name, your mailing address, and the
document title, ``First External Review Draft Integrated Science
Assessment for Particulate Matter'' (EPA/600/R-08/139 and EPA/600/R-08/
139A) to facilitate processing of your request.

FOR FURTHER INFORMATION CONTACT: For technical information, contact Dr.
Lindsay Wichers Stanek, NCEA; telephone:<PHONE_NUMBER>; facsimile: 919-
541-2985; or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About the Document

    Section 108(a) of the Clean Air Act directs the Administrator to
identify certain pollutants which, among other things, ``cause or
contribute to air pollution which may reasonably be anticipated to
endanger public health or welfare'' and to issue air quality criteria
for them. These air quality criteria are to ``accurately reflect the
latest scientific knowledge useful in indicating the kind and extent of
all identifiable effects on public health or welfare which may be
expected from the presence of [a] pollutant in the ambient air * * *''
Under section 109 of the Act, EPA is then to establish national ambient
air quality standards (NAAQS) for each pollutant for which EPA has
issued criteria. Section 109 (d) of the Act subsequently requires
periodic review and, if appropriate, revision of existing air quality
criteria to reflect advances in scientific knowledge on the effects of
the pollutant on public health or welfare. EPA is also to revise the
NAAQS, if appropriate, based on the revised air quality criteria.
    Particulate matter (PM) is one of six principal (or ``criteria'')
pollutants for which EPA has established NAAQS. Periodically, EPA
reviews the scientific basis for these standards by preparing an
Integrated Science Assessment (ISA) (formerly called an Air Quality
Criteria Document). The ISA and supplementary annexes, in conjunction
with additional technical and policy assessments, provide the
scientific basis for EPA decisions on the adequacy of the current NAAQS
and the appropriateness of possible alternative standards. The Clean
Air Scientific Advisory Committee (CASAC), an independent science
advisory committee whose existence and whose review and advisory
functions are mandated by Section 109 (d) (2) of the Clean Air Act, is
charged (among other things) with independent scientific review of
EPA's air quality criteria.
    On June 28, 2007 (72 FR 35462), EPA formally initiated its current
review of the air quality criteria for PM, requesting the submission of
recent scientific information on specified topics. A draft of EPA's
``Integrated Review Plan for the National Ambient Air Quality Standard
for Particulate Matter'' (EPA/452/P-08/006) was made available in
October 2007 for public comment and was discussed by the CASAC via a
publicly accessible teleconference consultation on November 30, 2007
(72 FR 63177). EPA finalized the plan and made it available in March
2008 (EPA/452/R-08/004; http://www.epa.gov/ttn/naaqs/standards/pm/s_
pm_2007_pd.html). In June 2008 (73 FR 30391), EPA held a workshop to
discuss, with invited scientific experts, initial draft materials
prepared in the development of the PM ISA and its supplementary
annexes.
    The first external review draft ISA for PM will be discussed at a
public meeting for review by CASAC, and public comments received will
be provided to the CASAC review panel. A future Federal Register notice
will inform the public of the exact date and time of that CASAC
meeting.

II. How to Submit Technical Comments to the Docket at http://
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2007-
0517, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, Room 3334 EPA West Building, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center 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>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    If you provide comments by mail or hand delivery, please submit
three copies of the comments. For attachments, provide an index, number
pages consecutively with the comments, and submit an unbound original
and three copies.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0517. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information through http://
www.regulations.gov or e-mail that you consider to be CBI or otherwise
protected. 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. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: 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 materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.

    Dated: December 11, 2008.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
 [FR Doc. E8-30197 Filed 12-18-08; 8:45 am]

BILLING CODE 6560-50-P


Response to Public Comment  National Pollutant Discharge Elimination System Regulations Addressing Cooling Water Intake Structures ( 40 CFR Parts 9, 122, 123, 124, and 125)

Docket #: W 00 03 Report of Comments Meeting The Following Criteria:

Author ID:

Comment ID: 316bNFR. 206.032 Subject Code:

Author Type:

Comment Keywords Response Keywords 1 Record( s) In Report Response to Comment: CWA Sec. 316( b) New Facility Rule For Deliberative Purposes Only Page 1 of 4 Thursday, June 19, 2003 NO VARIANCE PROCEDURE IS ALLOWED BECAUSE THE PHASE I RULE IS AKIN TO A NEW SOURCE PERFORMANCE STANDARD.

BTA standards for new facilities under section 316( b) are akin to new source performance standards ( NSPS) promulgated under Section 306. This is made clear by the mandate in Section 316( b) that standards established pursuant to Section 306 must require BTA for CWISs. Indeed, as the VEPCO court stated:

It bears emphasis that § 316( b) ... requires § 301 and § 306 standards to deal with cooling water intake structures. ... § 316( b) itself seems to indicate its limitations are to be adopted under § § 301 and 306...[ T] he regulations issued under § 316( b) are... closely related to the effluent limitations and new source standards of performance of § § 301 and 306. < FN 153>

There is, however, no variance procedure statutorily permissible for NSPS. The only variances from technology based standards allowed under the Act are in Sections 301( n) ( the " fundamentally different factors" variance) and 301( c) ( economic variance) both of which apply only to existing sources. The United States Supreme Court in E. I. DuPont v. Train found unequivocally that the Clean Water Act does not allow a variance procedure for new sources:

It is clear that Congress intended these regulations to be absolute prohibitions. The use of the word " standards" implies as much. So does the description of the preferred standard as one " permitting no discharge of pollutants." It is " unlawful for any owner or operator of any new source to operate such source in violation of any standard applicable to such source." § 306( e). In striking contrast to § 301( c), there is no statutory provision for variances, and a variance provision would be inappropriate in a standard that was intended to insure national uniformity and " maximum feasible control" of new sources. < FN 154>

As a result, the Clean Water Act does not permit EPA. in establishing national cooling water Intake regulations for new sources under Sections 316( b) and 306, to include a variance provision. Therefore, EPA's inclusion of a variance provision based on economic factors in the Proposed Regulation < FN 155> is not in accordance with law. Comment ID 316bNFR. 206.032 Author Name David K. Gordon & Reed W. Super Primary Subject Matter Code 16.4 Organization Riverkeeper, et al. Tone A Footnotes 153 Virginia Electric and Power Company v. Costle. 566 F .2d 446, 450 ( 4th Cir. 1977).

154 E. I. DuPont v. Train. 430 U. S. 112, 138 ( 1977).

155 40 C. F. R. § 125.85 ( proposed) ( entitled " May alternative requirements be imposed?)

Response See preamble section VII. H. In this rule, EPA believes that it is guided by section 306 of the CWA and section 304 with respect to taking a technology based approach to the rule, and the factors relevant to such an approach, but because the variance authorizations in the CWA are under section Environmental Organization Author Type Response to Comment: CWA Sec. 316( b) New Facility Rule For Deliberative Purposes Only Page 2 of 4 Thursday, June 19, 2003 301 governing effluent limitations and because section 316( b) is in a different portion of the CWA than sections 301, 304 or 306, section 301' s limitation of variances to existing sources do not control EPA in implementing section 316( b) for new facilities. In other words, the statute is silent with respect to variances for standards established under section 316( b). As such, where the statute is silent, a Chevron analysis applies. EPA believes that it is a reasonable interpretation of the act to allow for such a variance in establishing a rule implementing section 316( b) to provide for flexibility where EPA did not account for the types of costs a particular facility would face in the record for this rule. This could be the case where, for example, EPA did not consider a type of industry that has a cooling water intake and the costs of the rule are wholly disproportionate to the costs considered in this rulemaking. This is similar to the approach EPA undertook in implementing section 301( c) in Weyerhaeuser v. Costle, 590 F. 2d 1011, 1033 35 ( D. C. Cir. 1978). E. I. du Pont de Nemours & Co. v. Train, 430 U. S. 112 ( 1977) holding that section 306 does not authorize variances for new sources, is distinguishable, not only because that case was limited to new source performance standards for point source dischargers under section 306, but because Court's reasoning was based on the word " standards" in 306 as not providing any authority for difference. By contrast, in section 316( b), the word " standards" clearly refers to both new source performance standards and effluent limitations guidelines for existing sources, for which the CWA authorized variances. Thus, the use of the word " standards" could not be as limited in section 316( b) as it is in section 306; and therefore it is reasonable to interpret it to include flexibility not afforded to NSPS. Further, the Court looked toward ultimate objective of sections 301 and 306 as one " permitting no discharge of pollutants" which is different from the substantive standard articulated in 316( b) which is to " minimize" adverse environmental impact. Finally, section 316( b) is different than section 306 because it applies broadly to any cooling water intake structure, while each new source performance standard applies to a particular category that is fully considered during the rulemaking. It is more likely that this variance will be applied in the context of an industry that EPA did not consider at the time of this rulemaking.

Response to Comment: CWA Sec. 316( b) New Facility Rule For Deliberative Purposes Only Page 3 of 4 Thursday, June 19, 2003 Response to Comment: CWA Sec. 316( b) New Facility Rule For Deliberative Purposes Only Page 4 of 4 Thursday, June 19, 2003


[Federal Register: December 17, 2009 (Volume 74, Number 241)]
[Notices]
[Page 66986-66987]
[DOCID:fr17de09-57]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 10, 2010, from
8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy, Gaithersburg, MD. The hotel phone number is 301-977-
8900.
    Contact Person: Nicole Vesely, Pharm.D., Center for Drug Evaluation
and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
(for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD
20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512542. Please call the Information Line for up-to-date information
on this meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: On February 10, 2010, during the morning session, the
committee will discuss new drug application (NDA) 022-481, proposed
trade name PIXUVRI (pixantrone dimaleate) injection, manufactured by
Cell Therapeutics, Inc. The proposed indication (use) for this product
is as a single agent treatment for patients with recurring or
refractory (difficult to treat), aggressive non-Hodgkin's lymphoma
(NHL) who have received two or more prior lines of therapy.
    During the afternoon session, the committee will discuss NDA 022-
374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for
injection, manufactured by ChemGenex Pharmaceuticals. The proposed
indication (use) for this product is for the treatment of adults with
chronic myeloid leukemia (CML) bearing a genetic alteration known as
the Bcr-Abl T315I mutation, and who have failed prior therapy with the
drug IMATINIB.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written

submissions may be made to the contact person on or before January 27,
2010. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. Those
desiring to make formal oral presentations should notify the contact
person and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time
requested to make their presentation on or before January 19, 2010.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by January 20, 2010.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Nicole Vesely at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: December 11, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29989 Filed 12-16-09; 8:45 am]

BILLING CODE 4160-01-S


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD ROAD                            ANN ARBOR, MI  48105-2498

									          	OFFICE OF 										AIR AND RADIATION

December 16, 2010

MEMORANDUM

SUBJECT:	Meeting with Cummins

FROM:	Angela Cullen, Mechanical Engineer

TO:		Docket EPA-HQ-OAR-2010-0162

This memorandum documents a meeting held on Wednesday, December 15, 2010 between Cummins, EPA, and DOT and included the following individuals:

      Cummins: Jackie Yeager, Morgan Andreae, Michael Ruth, Jim Fier, Bill Martin, Shirish Shimpi, Jon Dickson, Gary Salemme, Aleksey Yezerets, Brian Mormino, Mike Cooper, Tom Grana, Melissa Zaczek, Jennifer Rumsey, and Bob Jorgensen              EPA: Byron Bunker, Cle Jackson, Houshan Zhang, Alan Stout, Don Kopinski, Julian Davis, Tony Fernandez and Angela Cullen              DOT: Maurice Hicks, Angel Jackson

The discussion focused primarily on clarifications of the regulatory language, engine GHG standards, hybrid test procedures, pickup truck certification, and GEM model inputs.