RESPONSE TO COMMENTS OF THE OHIO ENVIRONMENTAL COUNCIL TO EPA’S
PROPOSED RULE TO CONDITIONALLY APPROVE OHIO’S CHANGES TO ITS NEW
SOURCE REVIEW RULES.

The Ohio Environmental Council (OEC) commented on Environmental
Protection Agency’s proposal to conditionally approve Ohio’s new
source review (NSR) rule changes.  OEC primarily commented on the
requirements of the federal NSR rules, not Ohio’s application of the
federal requirements in its own rules.  The more appropriate venue for
these comments would have been when EPA public noticed the rule changes
at the federal level.  However, this response to comment document
responds to the entire range of comments in the comment letter submitted
by OEC on the May 11, 2005 proposal to conditionally approve Ohio’s
new source review rule changes.  Following an italicized statement or
summary of each major point made by OEC, EPA responses to the comment
are set forth.

1.  As an initial matter, the Ohio Environmental Council states that the
final New

Source Review rules promulgated by the EPA on December 31, 2002, violate
the

Clean Air Act (CAA) and are less protective of the public health and the
environment than the NSR regulations which they replaced. Consequently,
Ohio’s revisions to its NSR program, which incorporate the federal
revisions, are also less protective and violate the CAA.

EPA responds that EPA’s rules were upheld by the court which reviewed
them, in the case titled State of New York et al. v. EPA, No. 02-1387,
2005 WL 1489698, with the exception of the pollution control project and
clean unit provisions.  Therefore, EPA’s rules (with the exception
noted) have been found lawful. Ohio’s rules are being approved for the
reasons stated in the notice of final rulemaking.

2.  In addition, and for the sake of consistency, clarity and certainty,
the OEC recommends that EPA and Ohio EPA should not replace “actual
emissions” and “representative actual annual emissions” as
formerly defined at Ohio Adm. Code 3745-

31-01(C) and (SSS) with the definition of “projected actual
emissions” that is currently utilized in 40 CFR 51.165(a)(1)(xxviii).
Adding another definition, “projected actual emissions,” to an
already confusing, cumbersome and rather unwieldy regulatory program
would result in the expenditure of more time and resources than Ohio EPA
currently has, thereby lengthening the permitting process to the
detriment of human health and the environment.

EPA responds that Ohio’s rules follow the federal program requirements
on this point.  This comment could have been raised in the previous
federal rulemaking action on this point.  Since Ohio’s rules follow
the federal program requirements on this point, and for the reasons
stated in the preamble, EPA finds the Ohio rule approvable.

3.  The United States District Court for the Southern District of Ohio
has already issued an opinion that discusses the definitions of
“modification,” “actual emissions,” “representative actual
annual emissions,” “net emissions increase” and
“contemporaneous.” See United States v. Ohio Edison, Case No.
2:99-CV-1181 (August,

2003).  This opinion provides for regulatory certainty and establishes
legal precedent.

Adding another definition, “projected actual emissions,” to an
already confusing and cumbersome regulatory program, for which
regulatory certainty and legal precedent have been established, would
add more confusion and required time to process permits in Ohio, thereby
being detrimental to human health and the environment.

EPA responds that Ohio’s rules follow the federal program requirements
on this point.  This comment could have been raised in the previous
federal rulemaking action on this point.  Since Ohio’s rules follow
the federal program requirements on this point, and for the reasons
stated in the preamble, EPA finds the Ohio rule approvable.

4. OAC 3745-31-01, Definitions

a. Paragraph (C), definition of “actual emissions.”

i. Limiting the definition of “actual emissions” in paragraph (C)
only to “regulated NSR pollutant” is too narrow.  All references to
“NSR pollutant” should be deleted because the concept excludes many
types of polluting emissions from regulation.  For example, many types
of toxic emissions would escape regulation under the proposed rule.
Moreover, the term “regulated NSR pollutant” is not consistent with
the statutory definitions of “air contaminant” and “air
pollution” that are contained in Ohio Revised Code Chapter 3704.

EPA responds that the Ohio’s definition of “projected actual
emission” is required by the federal rule at 40 CFR 51.165, therefore,
this definition is necessary for approval.  Since Ohio’s rules follow
the federal program requirements on this point, and for the reasons
stated in the preamble, EPA finds the Ohio rule approvable.

ii. Paragraph (C) refers to determining the actual rate of emissions
“in accordance with paragraphs (C)(1) to (C)(4)” yet there is no
paragraph (C)(4).

EPA responds that the use of the term “regulated NSR pollutant” and
phrasing of the definition are consistent with 40 CFR 51.165 and 51.166.
 Furthermore, on November 3, 2006, the Ohio Environmental Protection
Agency (OEPA) removed the reference to (C)(4).

iii. Paragraph (C)(1) should read “allow the use of a different time
period if the Director determines.” As currently written, anyone who
makes such an alternative determination would necessarily force the
Director to use the different time period in calculating actual
emissions.

EPA responds that Ohio’s definition of “projected actual emission”
is required by 40 CFR 51.165, therefore, this definition is necessary
for approval.  Since Ohio’s rules follow the federal program
requirements on this point, and for the reasons stated in the preamble,
EPA finds the Ohio rule approvable.

b. Paragraph (O), definition of “baseline actual emissions.”

i. The definition of “regulated NSR pollutant” is too narrow.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including “regulated NSR pollutant” is identical to
the federal definition in 40 CFR 51.165 and 51.166. Since Ohio’s rules
are consistent with the federal program and for the reasons stated in
the preamble, no changes are necessary for the rules to be approved by
EPA.

ii. “Any consecutive 24-month period selected by the owner or operator
within the 5-year period” should be changed to read “the consecutive
24-month period.” A five year “look back” is not representative of
actual emissions and would only serve to remove more emissions from any
netting equation that could be used to determine that a “major
modification” has occurred. Moreover, a consecutive 24-month look back
provides just as much “certainty” as does a 5-year look back.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including the phrase “Any consecutive 24-month period
selected by the owner or operator within the 5-year period”  is
identical to the federal definition in 40 CFR 51.165 and 51.166. Since
Ohio’s rules are consistent with the federal program and for the
reasons stated in the preamble, no changes are necessary for the rules
to be approved by EPA.

iii. The phrase in (O)(1)(a) that reads “and emissions associated with
startups, shutdowns and malfunctions” should be deleted.  As the
prefatory language of “baseline actual emissions” expressly states,
an average rate of emissions should be the focus of this determination
and there is no way to determine the “average rate” of emissions
associated with startups, shutdowns and malfunctions.  Moreover,
implicit in the definition of “baseline actual emissions” is that
such emissions should be “representative” of the source’s
“normal” operation, and emissions associated with startups,
shutdowns and malfunctions are not at all representative of normal
operations.  In addition, including emissions from startups, shutdowns
and malfunctions in a baseline determination results in an artificial
baseline.   Finally, emissions from startups and shutdowns are not
included in a source’s “actual” emissions for purposes of
determining compliance with the source’s allowable emission limit, so
they should not be included in determining any baseline emission level
for the source.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including the phrase “and emissions associated with
startups, shutdowns and malfunctions” is identical to the federal
definition in 40 CFR 51.165 and 51.166. Since Ohio’s rules are
consistent with the federal program and for the reasons stated in the
preamble, no changes are necessary for the rules to be approved by EPA.

iv. Subsection (O)(1)(b) fails to address the situation where an entity
has not yet received the requisite permits at the time construction of
the project commences. A situation could thus develop whereby an
unpermitted source could exclude from its “baseline actual
emissions” all of its non-complying emissions, thus making the netting
and the major modification determination meaningless. This section
should be rewritten to address this scenario.

EPA responds that Ohio’s definition of “baseline actual emissions”
is identical to the federal definition in 40 CFR 51.165 and 51.166. The
federal rules do not require the definition to address an unpermitted
source.  Since Ohio’s rules are consistent with the federal program
and for the reasons stated in the preamble, no changes are necessary for
the rules to be approved by EPA.

v. The phrase in (O)(1)(c)  “For a regulated NSR pollutant” should
be deleted.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including the phrase “for a regulated NSR pollutant,”
is identical to the federal definition in 40 CFR 51.165 and 51.166.
Since Ohio’s rules follow the federal program requirements on this
point and for the reasons stated in the preamble, EPA finds the Ohio
rule approvable.

vi. The sentence in (O)(1)(c) “A different consecutive 24- month
period can be used for each regulated NSR pollutant” should be deleted
in its entirety.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including the phrase  “A different consecutive 24- month
period can be used for each regulated NSR pollutant,” is identical to
the federal definition in 40 CFR 51.165 and 51.166. Since Ohio’s rules
follow the federal program requirements on this point and for the
reasons stated in the preamble, EPA finds the Ohio rule approvable.

vii. Subsection (O)(1)(d) should be deleted in its entirety.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including (O)(1)(d) is identical to the federal definition
in 40 CFR 51.165 and 51.166. Since Ohio’s rules follow the federal
program requirements on this point and for the reasons stated in the
preamble, EPA finds the Ohio rule approvable.

viii. The phrase in (O)(2) “any consecutive 24-month period selected
by the owner or operator within the 10-year period” should be changed
to read “the consecutive 24-month period.” A ten year “look
back” is not representative of actual emissions and would only serve
to remove more emissions from any netting equation that could be used to
determine that a “major modification” has occurred. Moreover, a
consecutive 24-month look back provides just as much “certainty” as
does a 10-year look back.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including the phrase “any consecutive 24-month period
selected by the owner or operator within the 10-year period,” is
identical to the federal definition in 40 CFR 51.165 and 51.166. Since
Ohio’s rules are consistent with the federal program and for the
reasons stated in the preamble, no changes are necessary for the rules
to be approved by EPA.

ix. The end of the sentence in (O)(2) that begins with “either the
date the owner or operator begins actual construction” should be
deleted in its entirety and replaced with “on which the owner or
operator begins actual construction of the project. The reviewing
authority shall allow the use of a different time period upon a
determination that it is more representative of normal source
operation.” As a result of this change and the change suggested above,
section (O)(2) should read: “For an existing emission unit (other than
an electric utility steam generating unit), baseline actual emissions
means the average rate, in tons per year, at which the emissions unit
actually emitted the pollutant during the consecutive 24-month period
immediately preceding the date on which the owner or operator begins
actual construction of the project. The reviewing authority shall allow
the use of a different time period upon a determination that it is more
representative of normal source operation.”

EPA responds that Ohio’s definition of “baseline actual emissions”
including the phrase “either the date the owner or operator begins
actual construction,” is identical to the federal definition in 40 CFR
51.165 and 51.166. Since Ohio’s rules are consistent with the federal
program and for the reasons stated in the preamble, no changes are
necessary for the rules to be approved by EPA.

x. The phrase in (2)(a)  “and emissions associated with startups,
shutdowns and malfunctions” should be deleted.  As the prefatory
language of “baseline actual emissions” expressly states, an average
rate of emissions should be the focus of this determination and there is
no way to determine the “average rate” of emissions associated with
startups, shutdowns and malfunctions.  Moreover, implicit in the
definition of “baseline actual emissions” is that such emissions
should be “representative” of the source’s “normal” operation,
and emissions associated with startups, shutdowns and malfunctions are
not at all representative of normal operations.  In addition, including
emissions from startups, shutdowns and malfunctions in a baseline
determination results in an artificial baseline.  Finally, emissions
from startups and shutdowns are not included in a source’s
“actual” emissions for purposes of determining compliance with the
source’s allowable emission limit, so they should not be included in
determining any baseline emission level for the source.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including the phrase “and emissions associated with
startups, shutdowns and malfunctions” is identical to the federal
definition in 40 CFR 51.165 and 51.166. Since Ohio’s rules are
consistent with the federal program and for the reasons stated in the
preamble, no changes are necessary for the rules to be approved by EPA.

xi. Subsection (2)(b) also fails to address the situation where an
entity has not yet received the requisite permits at the time
construction of the project commences. A situation could thus develop
whereby an unpermitted source could exclude from its “baseline actual
emissions” all of its non-complying emissions, thus making the netting
and the major modification determination meaningless. This section
should be rewritten to address this scenario.

EPA responds that Ohio’s definition of “baseline actual emissions”
is identical to the federal definition in 40 CFR 51.165 and 51.166. The
federal rules do not require the definition to address an unpermitted
source.  Since Ohio’s rules are consistent with the federal program
and for the reasons stated in the preamble, no changes are necessary for
the rules to be approved by EPA.

xii. The phrase in (2)(c)  “or maintenance plan” should be deleted.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including the phrase “or maintenance plan,” is
identical to the federal definition in 40 CFR 51.165 and 51.166. Since
Ohio’s rules are consistent with the federal program and for the
reasons stated in the preamble, no changes are necessary for the rules
to be approved by EPA.

xiii. The phrase in (2)(d)  “For a regulated NSR pollutant” should
be deleted.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including the phrase “For a regulated NSR pollutant”
is identical to the federal definition in 40 CFR 51.165 and 51.166.
Since Ohio’s rules are consistent with the federal program and for the
reasons stated in the preamble, no changes are necessary for the rules
to be approved by EPA.

xiv. The sentence in (2)(d)  “A different consecutive 24-month period
can be used for each regulated NSR pollutant” should be deleted in its
entirety.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including the phrase “A different consecutive 24-month
period can be used for each regulated NSR pollutant,” is identical to
the federal definition in 40 CFR 51.165 and 51.166. Since Ohio’s rules
are consistent with the federal program and for the reasons stated in
the preamble, no changes are necessary for the rules to be approved by
EPA.

xv. Subsection (2)(e) should be deleted in its entirety.

EPA responds that Ohio’s definition of “baseline actual
emissions,” including (2)(e) is identical to the federal definition in
40 CFR 51.165 and 51.166. Since Ohio’s rules are consistent with the
federal program and for the reasons stated in the preamble, no changes
are necessary for the rules to be approved by EPA.

c. Paragraph (Q), definition of “baseline concentration.”

i. Since this definition incorporates the definition of “actual
emissions,” the comments above also apply to this definition.
Baseline concentration should be calculated in accordance with “actual
emissions” as changed by the above comments.

See response above to the comments regarding the definition of “actual
emissions”.

d. Paragraph (Y), definition of “clean unit.”

i. OEC’s comments on the “clean unit” rule, 3745-31-30, are
applied to this provision.

EPA responds that in a November 15, 2005 letter, the Ohio withdrew its
request for approval of the definition for “clean unit” found in OAC
3745-31-01(Y).  Furthermore, on June 2, 2008, OEPA removed OAC
3745-31-01(Y) from its rules.  The action became effective on June 30,
2008.  EPA is not approving this definition into the SIP.

e. Paragraph (MM), definition of “emissions unit.”

i. The definition potentially excludes units that emit hazardous air
pollutants (HAPs) (addressed by OEPA’s air toxics policy).  This
creates the novelty of having air toxics being unregulated as an
“emissions unit.”

EPA responds that the regulations at 40 CFR 51.165 and 51.166 do not
require HAPs be considered in the definition of “emissions unit.”

f. Paragraph (III), definition of “major modification.”

i. The definition is flawed because only a significant net emissions
increase from a “NSR pollutant” triggers the major modification
provisions.  The proposed definition does not address the situation in
which a hazardous air pollutant not previously emitted is now emitted
because of the physical change.

EPA responds that the regulations at 40 CFR 51.165 and 51.166 do not
require HAPs be considered in the definition of “major
modification.”

g. Paragraph (KKK), definition of “major stationary source.”

i. again, the definition is too narrow because it addresses only “NSR
pollutants” and not hazardous air pollutants. Under the proposed
definition, an air contaminant source that emits more than 10 tons per
year of a single HAP or 25 tons per year of a combination of HAPs would
not constitute a major stationary source.

EPA responds that the regulations at 40 CFR 51.165 and 51.166 do not
require HAPs be considered in the definition of “major stationary
source.”

h. Paragraph (SSS), definition of “net emissions increase.”

i. since this definition incorporates the definition of “actual
emissions,” the comments above apply to this definition as well. A
“net emissions increase” should be calculated in accordance with
“actual emissions” as changed by the comments to that definition.

EPA refers here to our response to the comments on the definition of
“actual emissions,” as set forth above.

ii. again, “NSR pollutant” is too narrow and should be changed as
commented above.

EPA refers here to our response to the comments on the definition of
“NSR pollutant,” as set forth above.

iii. subparagraph (SSS)(3)(f)(ii) is new and does not make sense. The
phrase “federally enforceable” should be reinstated and the phrase
“as a practical matter” should be deleted.

EPA approves Ohio’s use of the term “as a practical matter”
because in the case National Mining Ass’n v. United States
Environmental Protection Agency, 59 F.3d 1351 (D.C. Cir. 1995), the
court rejected an EPA requirement that potential to emit be based on
federally enforceable terms.  Instead limitations need only be
enforceable as a practical matter.

i. Paragraphs (CCCC) through (KKKK), definitions pertaining to
“PALs.”

i. OEC’s comments to the “Plantwide Applicability Limit” rule,
3745-31-32, are incorporated herein.

EPA refers here to our response to the comments on the “Plantwide
Applicability Limit” rule, as set forth below.

ii. because (CCCC)(1) refers to “emissions units,” OEC understands
that “PAL allowable emissions” can not be calculated from air
contaminant sources that do not meet the definition of “emissions
unit.”  If this understanding is incorrect, then EPA needs to explain.

This is EPA’s understanding.  Ohio’s definition of “PAL allowable
emissions” is consistent with the definition of “allowable
emissions” in 51.165(f)(2) and 51.166(w)(2).  Therefore, consistent
with the federal program, Ohio’s rules allow only air contaminant
sources which meet the definition of “emissions unit” to be included
in the PAL.

iii. because (DDDD) refers to a “PAL permit,” OEC understands that
air contaminant sources that do not constitute “emissions units”
cannot be covered in a PAL permit. If this understanding is incorrect,
then EPA needs to explain. Also, the word “generally” should be
clarified; what would be an instance when the “PAL effective date”
would NOT be the effective date of the PAL permit?

EPA responds that Ohio’s definition of “PAL effective date” is
consistent with the federal definition in 51.165(f)(2) and 51.166(w)(2).
 Therefore, consistent with the federal program, Ohio’s rules allow
only air contaminant sources which meet the definition of “emissions
unit” to be included in the PAL.  The use of the term “generally”
is also consistent with the federal definition, therefore, the
definition is to be applied consistently with the federal program.

iv. because (FFFF) refers to “major emissions unit,” OEC understands
that air contaminant sources that are regulated ONLY under state law
cannot be a “PAL unit” or cannot be part of the “PAL permit.” If
this understanding is incorrect, then EPA needs to explain.

EPA responds that Ohio’s definition of “PAL major emissions unit”
is consistent with the federal definition in 51.165(f)(2) and
51.166(w)(2).  Therefore, consistent with the federal program, Ohio’s
rules allow only air contaminant sources which meet the definition of
“emissions unit” to be included in the PAL.

v. because (HHHH) refers to “PAL permit” and includes the phrase
“major stationary source,” OEC understands that minor sources cannot
and do not qualify for a “PAL.” If this understanding is incorrect,
then EPA needs to explain.

EPA responds that Ohio’s definition of “PAL permit” is consistent
with the federal definition in 51.165(f)(2) and 51.166(w)(2).
Therefore, consistent with the federal program, Ohio’s rules provide
for PAL permits at major stationary sources.

vi. because (JJJJ) refers to “emissions unit,” OEC understands that
“small emissions unit” cannot include any air contaminant source
that does not emit any “NSR pollutant.” If this understanding is
incorrect, then OEPA needs to explain.

EPA responds that OAC 3745-31-01(JJJJ) defines “PAL significant
emission unit” which has no mention of “small emissions unit.”
OAC 3745-31-01(KKKK) defines “PAL small emissions unit.”  Both
definitions are consistent with the federal program.  “PAL small
emissions units” are defined as emission units which emit the PAL
pollutant below the significance level.  The PAL pollutant is defined in
OAC 3745-31-01(IIII) as the pollutant for which a PAL is established at
a major stationary source.  Therefore the Ohio definition is consistent
with the federal program.

j. Paragraph (PPPP), definition of “PM10.”

i. This is a new definition that was not previously addressed before the
proposed rule. Ohio EPA has not indicated what impact adding this
definition to the NSR program would have, thus causing more uncertainty
to the program.

EPA responds that this PM10 definition is based on the federal
definition found in 40 CFR 50.6. PM10 has been a regulated pollutant in
the federal program and Ohio’s program for well over a decade.  Since
the Ohio definition is consistent with the federal definition, and PM10
has been regulated under the NSR program, the addition of this
definition is approvable and does not provide uncertainty to the
program.

k. Paragraph (QQQQ), definition of “PM10 emissions.”

i. This is a new definition that was not previously addressed before the
proposed rule. Ohio EPA has not indicated what impact adding this
definition to the NSR program would have, thus causing more uncertainty
to the program.

EPA responds that this PM10 definition is based on the federal
definition found in 40 CFR 50.6. PM10 emissions have been regulated
under the federal program and Ohio’s program for well over a decade.
Since the Ohio definition is consistent with the federal definition, and
PM10 emissions have been regulated under the NSR program, the addition
of this definition is approvable and does not provide uncertainty to the
program.

1. Paragraph (RRRR), definition of “Pollution Control Project.”

i. OEC’s comments to the “Pollution Control Project” rule,
3745-31- 31, are incorporated herein.

EPA refers to our responses to comments regarding the Pollution Control
Project rule below.

ii. because (RRRR) refers to “at an existing emissions unit,” OEC
understands that air contaminant sources that do not emit any “NSR
pollutant” cannot qualify for a pollution control project. If this
understanding is incorrect, then EPA needs to explain.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of the definition for “Pollution Control
Project”.  Furthermore, on June 2, 2008, OEPA removed this definition
from its rules.  The action became effective on June 30, 2008.  EPA is
not approving this definition into the SIP.

iii. EPA needs to clarify whether the phrase “with a more effective
unit” refers only to “emissions units” that emit only a “NSR
pollutant” or whether a “more effective unit” includes any air
contaminant source.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of the definition for “Pollution Control
Project”.  Furthermore, on June 2, 2008, OEPA removed this definition
from its rules.  The action became effective on June 30, 2008.  EPA is
not approving this definition into the SIP.

m. Paragraph (XXXX), definition of “Prevention of Significant
Deterioration

(PSD) Permit.”

i. This is a new definition that was not previously addressed before the
proposed rule. Ohio EPA has not indicated what impact adding this
definition to the NSR program would have, thus causing more uncertainty
to the program. Moreover, addition of this rule would require Ohio EPA
to issue a PSD permit to an entity that received a PSD permit from
another state, even if that other state had worse air quality than Ohio,
thereby hindering Ohio’s efforts to timely comply with the NAAQS.

EPA responds that this state definition is based on the federal
definition. PSD permits have been issued under the federal program and
Ohio’s program for well over 2 decades.  Since the definition is
consistent with the federal definition and PSD permits have been issued
by OEPA for many years, the addition of this definition is approvable
and does not provide uncertainty to the program.

n. Paragraph (ZZZZ), definition of “Projected Actual Emission.”

i. again, the phrase “a regulated NSR pollutant” is too narrow and
should be deleted because it excludes many types of emissions from
regulation.

EPA responds that OEPA’s definition of “projected actual
emission,” including the phrase “a regulated NSR pollutant” is
consistent with the federal definitions at 40 CFR 51.165 and 51.166,
therefore, this definition approvable.

ii. the phrase “in any one of the 5 years (12-month period)” should
be replaced with “for the two year period.” A five year “look
ahead” is not representative of actual emissions. Moreover, a two year
look ahead provides just as much “certainty” as does a 5-year look
ahead.

EPA responds that OEPA’s definition of “projected actual
emission,” including the phrase “in any one of the 5 years (12-month
period),” is consistent with the federal definitions at 40 CFR 51.165
and 51.166 as written, therefore, no changes are necessary for approval.

iii. the phrase that reads “following the date the unit resumes
regular operation after the NSR project” should be replaced with
“after a physical change or change in the method of operation of a
unit.” The proposed rule would allow additional emissions into the
atmosphere without being accounted for, i.e., emissions from the date of
startup to the date of “regular operation,” and would thus be
detrimental to human health and the environment.  In addition, the
proposed rule fails to define “regular operation,” thus allowing
additional emissions into the atmosphere to the detriment of human
health and the environment.  The sooner the “projected-actual”
calculation is begun, the lesser the adverse impact the construction
will have on human health and the environment.

EPA responds that OEPA’s definition of “projected actual
emission,” including the phrase “following the date the unit resumes
regular operation after the NSR project,” is consistent with the
federal definitions at 40 CFR 51.165 and 51.166 as written, therefore,
no changes are necessary for approval.

iv. the language that begins with “or in any one of the 10 years”
and the language that constitutes the remainder of the sentence should
be deleted in its entirety because it makes no sense. As written, a
source could increase its potential to emit without being subject to New
Source Review.  This is clearly contrary to the existing definition of
“modification” as contained in both the Clean Air Act and the Ohio
Administrative Code. For example, any source that increases its
potential to emit would, as a matter of law, be increasing its
“allowable” emissions, and under current Ohio law any such increase
that is a result of a physical change or change in the method of
operation of a source constitutes a “modification” and must be
preceded by the issuance of a Permit to Install.  The proposed rule,
however, would compare those increased emissions to a “baseline” to
determine whether “significant” threshold levels are exceeded, and
if not then New Source Review is unnecessary.  Thus, the proposed rule
provides for an anomaly, i.e., a source may increase its allowable
emissions yet not be subject to New Source Review. Consequently, the
proposed rule creates an absurd result and should not be approved by
EPA.  If EPA ultimately decides to approve the rule, it would be
impossible for the Ohio Attorney General to certify that Ohio’s Permit
to Install program is “more stringent” than the federal New Source
Review program.

EPA responds that OEPA’s definition of “projected actual
emission,” including the language referenced in your comment, is
consistent with the federal definitions at 40 CFR 51.165 and 51.166 as
written, therefore, Ohio’s rule is as stringent as the federal program
in this respect.

v. the language in (ZZZZ)(1) that states “before beginning actual
construction” should be changed to read “before commencement of
actual construction” in order to be consistent with current Ohio law.

EPA responds that OEPA’s definition of “projected actual
emission,” including the phrase “before beginning actual
construction,” is consistent with the federal definitions at 40 CFR
51.165 and 51.166, as written, therefore, no changes are necessary for
approval.

vi. section (1)(b) should be deleted in its entirety. There is no way to
determine a maximum annual rate of emissions associated with startups,
shutdowns and malfunctions. Moreover, implicit in the definition of
“projected actual emissions” is that such emissions should be
“representative” of the source’s “normal” operation, and
emissions associated with startups, shutdowns and malfunctions are not
at all representative of normal operations.  In addition, including
emissions from startups, shutdowns and malfunctions in a projected
actual emissions determination results in an artificial projection.
Moreover, emissions from startups and shutdowns are not included in a
source’s “actual” emissions or purposes of determining compliance
with the source’s allowable emission limit so they should not be
included in determining any projected actual emission level for the
source.  Finally, the proposed rule as written would allow a source to
include as part of its projected actual” calculation all “actual”
emissions that exceed its “allowable” emissions, creating an absurd
result, i.e., including non-complying emissions in a “projected
actual” calculation.

EPA responds that OEPA’s definition of “projected actual
emission,” including section (1)(b), is consistent with the federal
definitions at 40 CFR 51.165 and 51.166 as written, therefore, no
changes are necessary for approval.

o. Paragraph (DDDDD), definition of “Regulated NSR pollutant.”

i. the definition should be rejected in its entirety.  The proposed
definition exempts from New Source Review the installation in a
non-attainment area of a new source that has the potential to emit over
100 tons per year of mercury.  This is an absurd result.

EPA responds that OEPA’s definition of “projected actual emission”
is consistent with the federal definitions at 40 CFR 51.165 and 51.166
as written, therefore, no changes are necessary for approval.

p. Paragraph (EEEEE), definition of “replacement unit.”

i. because the definition refers to “emissions unit,” OEC
understands that air contaminant sources that do not emit an “NSR
pollutant” cannot qualify as a replacement unit.  If this
understanding is incorrect, then EPA needs to explain.

EPA shares this understanding.  A “replacement unit” is an emissions
unit that meets the criteria in OAC 3745-31-01(EEEEE) and emits at least
one regulated NSR pollutant.

2. OAC 3745-31-01(E), (J), (M), (X), (JJ), (QQ), (DDD), (EEE), (XXX),

(HHHHH), and (XXXXX).

a. OEC objects to the inclusion of these definitions in 31-01 because
they have not been addressed by the interested parties and they have
nothing to do with the December 2002 federal regulations that were
adopted by EPA.  Although Ohio EPA alleges these definitions are
necessary because OAC 3745-31-03 (exemptions to NSR) has been modified,
Ohio EPA has not demonstrated that these new definitions are required at
this time and has not provided any explanation why they are required at
the present.

EPA finds no reason not to approve these definitions.  OEPA submitted
the relevant changes to OAC 3745-31-03 to EPA for approval into its
state implementation plan (SIP) on April 24, 2006.  Once these
exemptions to Ohio’s NSR program are acted on, interested parties will
be able to comment on the exemptions for which these definitions would
apply.

3. OAC 3745-31-10, Air Stationary Source Obligations

a. OEC objects to the inclusion of this rule because it has not been
addressed by the interested parties and it has nothing to do with the
federal regulations that were adopted by EPA. Although Ohio EPA alleges
this rule is necessary because of recent changes to its non-attainment
designations by EPA, Ohio EPA has not demonstrated that this rule is
required at this time and has not provided any explanation why it is
required at the present.

EPA responds that OAC 3745-31-10 is consistent with the federal
definitions at by 40 C.F.R. 51.165(a)(6) and 51.166(r), therefore, the
rule is approvable.

b. Paragraph (C).

i. because this rule refers to “emissions units,” only those
projects undertaken at air contaminant sources that do not emit a “NSR
pollutant” are exempt from the requirements of paragraph (C).

EPA shares this understanding.  Therefore, consistent with the federal
program, Ohio’s rules allow only air contaminant sources which meet
the definition of “emissions unit” would be exempt from the
requirements of paragraph (C).

4. OAC 3745-31-13, Attainment Provisions

a. OEC objects to the inclusion of this rule because it has not been
addressed by the interested parties and it has nothing to do with the
federal regulations that were adopted by EPA.  Although Ohio EPA alleges
this rule is necessary because of recent changes to its nonattainment
designations by EPA, Ohio EPA has not demonstrated that this rule is
required at this time and has not provided any explanation why it is
required at the present.

EPA responds that these changes to OAC 3745-31-13 update the rule to be
consistent with the terminology of the federal program and the CAA.
These changes are approvable.

b. Paragraph (H), exemptions to ambient monitoring.

i. since mercury, beryllium and vinyl chloride are now deleted from the
ambient monitoring requirements of the proposed rule, OEC understands
that these pollutants are now regulated under the final “Interstate
Air Quality Rule” and final “Mercury Emissions from Power Plants”
rules.  If this understanding is incorrect, then EPA needs to explain.

EPA responds that Section 112(b)(6) of the CAA prohibits the regulation
of these compounds under this federal program.

5. OAC 3745-31-21, Nonattainment Provisions

a. OEC objects to the inclusion of this rule because it has not been
addressed by the interested parties and it has nothing to do with the
federal regulations that were adopted by EPA. Although Ohio EPA alleges
this rule is necessary because of recent changes to its nonattainment
designations by EPA, Ohio EPA has not demonstrated that this rule is
required at this time and has not provided any explanation why it is
required at the present.

EPA responds that Ohio’s changes to these rules are to update the rule
to be consistent with the terminology of the federal program and the
CAA.  These changes are necessary.

b. Paragraph (B), applicability of nonattainment provisions.

i. all of the nonattainment provisions contained in rules 31-21 through
31-27 should apply to all air pollutants, not to just “NSR
pollutants.”

EPA responds that Ohio’s rules do not define “air pollutants.”
The definition of “regulated NSR pollutant” was added to be
consistent with the federal program.  Ohio’s choice to change “air
pollutant” to “regulated NSR pollutant” makes its rules more
consistent with the federal program and is approvable.

6. OAC 3745-31-22, Nonattainment Provisions

a. OEC objects to the inclusion of this rule because it has not been
addressed by the interested parties and it has nothing to do with the
federal regulations that were adopted by EPA.  Although Ohio EPA alleges
this rule is necessary because of recent changes to its nonattainment
designations by EPA, Ohio EPA has not demonstrated that this rule is
required at this time and has not provided any explanation why it is
required at the present.

EPA responds that several of the changes made do not change the meaning
of the provisions.  They were intended to update the rule language to
make it consistent with a general regulatory format.

In a November 15, 2005 letter, OEPA withdrew its request for approval of
OAC 3745-31-22(A)(3)(e) and (f).  Furthermore, on June 2, 2008, OEPA
removed this language from its rules.  The action became effective on
June 30, 2008.  EPA is not approving these sections into the SIP.  The
language of OAC 3745-31-22(A)(3)(g) is still required by 40 C.F.R.
51.165, therefore, Ohio’s rules are consistent with the federal
program.

7. OAC 3745-31-24, Nonattainment Provisions

a. OEC objects to the inclusion of this rule because it has not been
addressed by the interested parties and it has nothing to do with the
federal regulations that were adopted by EPA. Although Ohio EPA alleges
this rule is necessary because of recent changes to its nonattainment
designations by EPA, Ohio EPA has not demonstrated that this rule is
required at this time and has not provided any explanation why it is
required at the present.

EPA responds that the language of OAC 3745-31-24 is consistent with the
federal definitions at 40 C.F.R. 51.165, therefore, Ohio’s rules are
consistent with the federal program.

b. Paragraph (B)(1). There is a typographical error in the phrase that
should read “the actual emissions of sources located within . . . .”

EPA responds that the language of OAC 3745-31-24(B)(1) does read as
described in the comment, therefore there is no typographical error.

8. OAC 3745-31-26, Nonattainment Provisions

a. OEC objects to the inclusion of this rule because it was not
submitted for public comments by interested parties and it has nothing
to do with the federal regulations that were adopted by EPA.  Although
Ohio EPA alleges this rule is necessary because of recent changes to its
nonattainment designations by EPA, Ohio EPA has not demonstrated that
this rule is required at this time and has not provided any explanation
why it is required at the present.  Moreover, there is no basis in the
Clean Air Act for a nonattainment area to be designated “Basic” nor
for a VOC offset ratio to be greater than 1.0 to 1.0 without specifying
how much greater.

EPA responds that the November 29, 2005 final 8-hour ozone rule, and the
CAA, require this offset ratio for subpart I nonattainment areas.
Although the federal 8-hour ozone rule does redesignate areas in Ohio as
“basic” nonattainment areas, Ohio’s NSR rules that we are
approving do not refer to the “basic” designation, therefore OEC’s
comment about the legalities of “basic” nonattainment areas is not
relevant to this rulemaking.

9. OAC 3745-31-30, Clean Unit

a. the language in (A)(1) that reads “within the past 10 years”
should be  changed to read “within the past 5 years.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-30.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-30 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

b. the word “project” in section (A)(2)(a) and those sections
following should be defined. Does this encompass “any physical change
in or change in the method of operation of” a source?

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-30.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-30 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

c. the last sentence in (A)(2)(b) that reads “the emissions unit
remains a Clean Unit” should be changed to read “the emissions unit
remains a Clean Unit for that project.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-30.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-30 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

d. the language in (A)(2)(c) that reads “then the emissions unit
looses its designation as a Clean Unit upon issuance of the necessary
permit revisions (unless the quit requalifies as a Clean Unit pursuant
to paragraph (A)(3)(c) of this section)” should be deleted in its
entirety and should be replaced with the following “then actual
construction on the project is prohibited.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-30.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-30 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

e. the language in (A)(2)(e) that reads “In addition, the requirements
of * * *do not apply to emissions units that qualify for Clean Unit
status under * * *” should be deleted. The clean unit’s allowable
emission limit will be already established by the PSD permit and any
off-sets that may have been allowed will already have been accounted
for.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-30.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-30 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

f. the beginning language in (A)(3) that reads “An emissions unit
automatically qualifies as a Clean Unit when the unit meets the criteria
in paragraphs * * * of this rule” should be deleted because it is
inconsistent with the definition in 3745-31- 01(Y).

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-30.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-30 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

g. the language in (A)(3)(b) that reads “through the use of an air
pollution control technology” should be changed to read “through the
use of an installed air pollution control technology approved by the
director.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-30.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-30 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

h. the language in (A)(4)(a) that reads “the emissions unit’s air
pollution control technology” should be changed to read “the
emissions unit’s approved air pollution control technology.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-30.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-30 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

i. the language in (A)(5)(a) and (b) should be consistent with section
(A)(2)(c).

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-30.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-30 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

j. the sentence in (A)(8) that begins with “However, if the Clean Unit
reduces emissions below the level that qualified the unit as a Clean
Unit, * * * should be deleted in its entirety because this language
allows what the rest of this and the other proposed regulations
prohibit, i.e., emissions reductions created by a Clean Unit shall not
be used for calculating offsets or credits.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-30.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-30 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

k. the language in (A)(8) that reads “For purposes of generating
offsets, the reductions must also be federally enforceable” should be
changed to read “For purposes of generating offsets, emissions that
are reduced below the level that qualified the unit as a Clean Unit must
also be federally enforceable.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-30.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-30 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

10. OAC 3745-31-31, Pollution Control Project

a. does EPA intend for “pollution prevention projects” to be
included within the definition of “pollution control projects”? Ohio
EPA has an “office of pollution prevention” that encourages
pollution prevention (P2) projects, and Ohio EPA has a policy of
encouraging P2 projects, either through a voluntary program initiated by
the regulated community, through findings and orders, or through
enforcement orders negotiated with the attorney general’s office. If
P2 projects are to be included in the scope of this rule then the
definition of PCP needs to be changed and “prevention” needs to be
added to this portion of the rule.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

b. anytime the word “project” is used, it should be changed to read
“any operation, activity or project.” This is necessary to be
consistent with the definition of “air contaminant source,” which is
defined in OAC chapter 3745-31 as an “operation or activity.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

c. the OEC recommends that the federal list of “approved” PCPs for
which a permit application is not necessary should not be adopted by
EPA. Any attempt to further relax the standards of the clean air act
through federal administrative fiat should be rejected.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

d. the language in (B)(1) which reads “the owner or operator must
submit a permit application and obtain approval” should be changed to
read “the owner or operator must submit a modified permit application
and receive a modified permit.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

e. the word “outweigh” in (B)(2)(a) should be defined, or some
concrete, objective criteria developed before an “environmental
benefit” is determined.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

f. the following language in (B)(2)(a) should be deleted: “A statement
that a technology from a PCP of this section is being used shall be
presumed to satisfy this requirement.” The entity seeking the PCP
exclusion should be required to perform the requisite analysis to
demonstrate the “environmentally beneficial” aspect of the PCP.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

g. an additional criteria should be included in paragraph (B)(2)(b),
such as “emissions increases from the project will not cause a
violation of any applicable law.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

h. under section (B)(3)(a), the description of the project should
include the costs and the timetable.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

i. the language in (B)(3)(c) that reads “should be sufficient”
should be changed to read “shall be those specified.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

j. the language in (B)(3)(d) that reads “in such a way as to
minimize” should be changed to read “in such a way as to minimize or
prevent.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

k. the language in (B)(3)(e) that reads “an air quality impact
analysis is not required for any pollutant that will not experience a
significant emissions increase as a result of the project” should be
deleted. If this language is not deleted, then “significant” should
be defined in a manner consistent with OAC chapter 3745-31.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

l. the language in (B)(4) that reads “may begin actual construction of
the project immediately after notice is sent to the director” should
be changed to read “may begin actual construction of the project no
sooner than 30 days after notice is sent to the reviewing authority.”
This change allows the director to determine if additional information
on the PCP is necessary, as contemplated by the remainder of section
(B)(4), and prevents a situation where the entity rushes to begin actual
construction only to find later that its project does not qualify as a
PCP.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

m. the language in (B)(4) that reads “shall respond to any requests by
the director for additional information” should be changed to read
“shall, within 10 days, provide any additional information requested
by the director.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

n. the language in (B)(6)(a) that reads “in such a way as to
minimize” should be changed to read “in such a way as to minimize or
prevent.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

o. the language in (B)(6)(b) that reads “must maintain copies on
site” should be changed to read “must maintain copies on site for a
minimum of three years.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

p. the language in (B)(6)(d) that reads “unless the emissions unit
further reduces emissions” should be changed to read “unless the
emissions unit demonstrates that further emissions reductions will be
achieved.”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

q. The sentence in (B)(6)(d) that begins with “The owner or operator
may generate a credit for the difference” should be deleted in its
entirety because this language allows what the rest of this and the
other proposed regulations prohibit, i.e., emissions reductions created
by a PCP shall not be used for calculating offsets or credits.

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

r. the language in (B)(6)(d) that reads “For purposes of generating
offsets, the reductions must also be federally enforceable” should be
changed to read “For purposes of generating offsets, the further
emissions reductions that are demonstrated after the emissions unit
qualifies for the PCP exclusion must also be federally enforceable”

EPA responds that in a November 15, 2005 letter, the OEPA withdrew its
request for approval of OAC 3745-31-31.  Furthermore, on June 2, 2008,
OEPA removed this OAC 3745-31-31 from its rules.  The action became
effective on June 30, 2008.  EPA is not approving this section into the
SIP.

11. OAC 3745-31-32, PALs

a. OEC does not see any benefit to this rule, thus, it should be
deleted. The concept of a PAL has been embodied by Ohio EPA in various
permits it has already issued. This practice should continue through
permitting rather than through a rule that is too lengthy and cumbersome
to be of any value, to either industry, Ohio EPA, human health or the
environment.

EPA responds that the language of OAC 3745-31-32 is required by 40
C.F.R. 51.165 therefore, Ohio’s rules are consistent with the federal
program.

b. because the PAL rule uses the definition of baseline actual
emissions, it is possible to have a baseline that allows increased
emissions which results in an exemption from NSR. Thus, an increase in
actual emission should result in the installation of modern air
pollution controls, rather than a reward in the form of being exempted
from NSR.

See the response to comments on the definition of “baseline actual
emissions” above.

c. baselines set at levels within the past 10 years could exceed the
emissions in ozone maintenance inventories, and a PAL that is set at a
level exceeding the facility level in the maintenance inventory would
require a SIP revision with equal reductions required from some other
source in the inventory. Such baselines would also allow increases in
areas that are nonattainment for the 8-hr standard, where the current
inventory is obviously not low enough.

EPA responds that the language of OAC 3745-31-32 is consistent with the
federal definitions at 40 C.F.R. 51.165 therefore, Ohio’s rule is
consistent with the federal program.

d. under the federal PAL, new units could be installed without controls,
another unreasonable proposal for nonattainment areas. Ohio EPA should
go on record as stating that they are going to retain their minor NSR
rule and requirement for BAT on all new units.

EPA responds that the language of OAC 3745-31-32 is consistent with the
federal definitions at 40 C.F.R. 51.165, therefore, Ohio’s rules are
consistent with the federal program.

e. an area where the PAL rule could be useful is an extension of the
“Clean Unit” concept to a “Clean Facility.” Facilities that have
BACT on all significant units would be accorded flexible operation under
the BACT level cap. The idea of "partial PALs", where a group of sources
(production line, boiler house, group of printing presses, etc) with
BACT installed would be allowed flexible operation, seems workable.

This comment would be more appropriately directed to the federal rule.
However, since Ohio’s rule is consistent with the federal rule, it is
approvable.

 PAGE

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[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63582-63584]
[FR Doc No: 2023-20007]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5966]

Breakthrough Devices Program; Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Breakthrough Devices
Program.'' This final guidance describes policies that FDA intends to
use to implement a section of the Federal Food, Drug, and Cosmetic Act
(FD&C Act). This guidance updates the previous version of the guidance,
of the same title, issued on December 18, 2018, and describes how the
Breakthrough Devices Program may also be applicable to certain devices
that benefit populations impacted by health and/or healthcare
disparities. Consistent with our obligations under the SUPPORT for
Patients and Communities Act (SUPPORT Act), the Breakthrough Devices
Program may be available for certain non-addictive medical products to
treat pain or addiction.

DATES: The announcement of the guidance is published in the Federal
Register on September 15, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-5966 for ``Breakthrough Devices Program.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a

single hard copy of the guidance document entitled ``Breakthrough
Devices Program'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Ouided Rouabhi, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G221, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Anne Taylor, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance entitled
``Breakthrough Devices Program.'' The document describes policies that
FDA intends to use to implement section 515B of the FD&C Act (21 U.S.C.
360e-3), as created by section 3051 of the 21st Century Cures Act
(Cures Act) (Pub. L. 114-255), amended by section 901 of the FDA
Reauthorization Act of 2017 (Pub. L. 115-52), and amended by section
3001 of the SUPPORT for Patients and Communities Act (Pub. L. 115-271)
(the ``Breakthrough Devices Program''). The Breakthrough Devices
Program is a voluntary program for certain medical devices and device-
led combination products that provide for more effective treatment or
diagnosis of life-threatening or irreversibly debilitating diseases or
conditions. It is available for devices and device-led combination
products that are subject to review under a premarket approval
application (PMA), premarket notification (510(k)), or De Novo
classification request (``De Novo request'').
    The Breakthrough Devices Program may also be applicable to certain
devices that benefit populations impacted by health and/or healthcare
disparities, thereby promoting and advancing health equity. In
addition, consistent with our obligations under section 3001 of the
SUPPORT Act, the Breakthrough Devices Program may be available for
certain non-addictive medical products to treat pain or addiction
(section 515B of the FD&C Act). The considerations set forth in the
guidance document apply to FDA's review of devices as non-addictive
methods to treat pain or addiction. This program is intended to help
patients have more timely access to designated medical devices,
including those that provide for more effective treatment or diagnosis
of life-threatening or irreversibly debilitating diseases or conditions
in populations impacted by health and/or healthcare disparities, by
expediting their development, assessment, and review, while preserving
the statutory standards for PMAs, 510(k) clearance, and De Novo
marketing authorization, consistent with the Agency's mission to
protect and promote public health.
    This guidance finalizes the draft guidance entitled ``Select
Updates for the Breakthrough Devices Program Guidance: Reducing
Disparities in Health and Healthcare.'' A notice of availability of the
draft guidance appeared in the Federal Register of October 21, 2022 (87
FR 64057). FDA considered comments received and revised the guidance as
appropriate in response to comments, including further clarifying FDA's
intent to consider technologies and device features that may help to
address health and/or healthcare disparities and promote health equity
by providing for more effective treatment or diagnosis in various
populations that exhibit health and healthcare disparities. FDA did not
substantively change the sections of the existing Breakthrough Devices
Program guidance that were not affected by the select update.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the ``Breakthrough Devices Program.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Breakthrough Guidance Program'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00001833 and complete title to
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
812............................  Investigational Device        0910-0078
                                  Exemption.
860, subpart D.................  De Novo classification        0910-0844
                                  process.
``Requests for Feedback and      Q-submissions..........       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
822............................  Postmarket Surveillance       0910-0449
                                  of Medical Devices.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
------------------------------------------------------------------------

    Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20007 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52925-52926]
[FR Doc No: 2016-18914]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32208; 812-14661]

TrimTabs ETF Trust, et al.; Notice of Application

August 4, 2016.

AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (the ``Act'') for an exemption from
sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1
under the Act, under sections 6(c) and 17(b) of the Act for an
exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under
section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and
12(d)(1)(B) of the Act. The requested order would permit (a) actively-
managed series of certain open-end management investment companies
(``Funds'') to issue shares redeemable in large aggregations only
(``Creation Units''); (b) secondary market transactions in Fund shares
to occur at negotiated market prices rather than at net asset value
(``NAV''); (c) certain Funds to pay redemption proceeds, under certain
circumstances, more than seven days after the tender of shares for
redemption; (d) certain affiliated persons of a Fund to deposit
securities into, and receive securities from, the Fund in connection
with the purchase and redemption of Creation Units; (e) certain
registered management investment companies and unit investment trusts
outside of the same group of investment companies as the Funds (``Funds
of Funds'') to acquire shares of the Funds; and (f) certain Funds
(``Feeder Funds'') to create and redeem Creation Units in-kind in a
master-feeder structure.

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Applicants: TrimTabs ETF Trust (the ``Trust''), a Delaware statutory
trust that is registered under the Act as an open-end management
investment company with multiple series, TrimTabs Asset Management, LLC
(the ``Initial Adviser''), a Delaware limited liability company
registered as an investment adviser under the Investment Advisers Act
of 1940, and Foreside Fund Services, LLC (the ``Distributor''), a
Delaware limited liability company and broker-dealer registered under
the Securities Exchange Act of 1934 (``Exchange Act'').

Filing Dates: The application was filed on June 8, 2016, and amended on
July 1, 2016.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on August 29, 2016, and should be accompanied by proof of
service on applicants, in the form of an affidavit, or for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street
NE., Washington, DC 20549-1090; Applicants: The Trust and the Initial
Adviser, 1345 Avenue of the Americas, Fl. 2, New York, NY 10105; the
Initial Distributor, 3 Canal Plaza, Suite 100, Portland, ME 04101.

FOR FURTHER INFORMATION CONTACT: Hae-Sung Lee, Attorney-Adviser, at
(202) 551-7345, or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

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

Summary of the Application

    1. Applicants request an order that would allow Funds to operate as
actively-managed exchange traded funds (``ETFs'').\1\ Fund shares will
be purchased and redeemed at their NAV in Creation Units only. All
orders to purchase Creation Units and all redemption requests will be
placed by or through an ``Authorized Participant'', which will have
signed a participant agreement with the Distributor. Shares will be
listed and traded individually on a national securities exchange, where
share prices will be based on the current bid/offer market. Certain
Funds may operate as Feeder Funds in a master-feeder structure. Any
order granting the requested relief would be subject to the terms and
conditions stated in the application.
---------------------------------------------------------------------------

    \1\ Applicants request that the order apply to an initial series
and any future series of the Trust offering exchange-traded Shares,
as well as other existing or future open-end management companies or
existing or future series thereof offering exchange-traded Shares
(and their respective existing or future Master Funds, as defined
below) that may utilize active management investment strategies
(collectively, ``Future Funds''). Any Future Fund will (a) be
advised by the Initial Adviser or an entity controlling, controlled
by, or under common control with the Initial Adviser (each, an
``Adviser''), and (b) comply with the terms and conditions of the
application.
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    2. Each Fund will consist of a portfolio of securities and other
assets and investment positions (``Portfolio Holdings''). Each Fund
will disclose on its Web site the identities and quantities of the
Portfolio Holdings that will form

the basis for the Fund's calculation of NAV at the end of the day.
    3. Shares will be purchased and redeemed in Creation Units and
generally on an in-kind basis. Except where the purchase or redemption
will include cash under the limited circumstances specified in the
application, purchasers will be required to purchase Creation Units by
depositing specified instruments (``Deposit Instruments''), and
shareholders redeeming their shares will receive specified instruments
(``Redemption Instruments''). The Deposit Instruments and the
Redemption Instruments will each correspond pro rata to the positions
in the Fund's portfolio (including cash positions) except as specified
in the application.
    4. Because shares will not be individually redeemable, applicants
request an exemption from section 5(a)(1) and section 2(a)(32) of the
Act that would permit the Funds to register as open-end management
investment companies and issue shares that are redeemable in Creation
Units only.
    5. Applicants also request an exemption from section 22(d) of the
Act and rule 22c-1 under the Act as secondary market trading in shares
will take place at negotiated prices, not at a current offering price
described in a Fund's prospectus, and not at a price based on NAV.
Applicants state that (a) secondary market trading in shares does not
involve a Fund as a party and will not result in dilution of an
investment in shares, and (b) to the extent different prices exist
during a given trading day, or from day to day, such variances occur as
a result of third-party market forces, such as supply and demand.
Therefore, applicants assert that secondary market transactions in
shares will not lead to discrimination or preferential treatment among
purchasers. Finally, applicants represent that share market prices will
be disciplined by arbitrage opportunities, which should prevent shares
from trading at a material discount or premium from NAV.
    6. With respect to Funds that hold non-U.S. Portfolio Holdings and
that effect creations and redemptions of Creation Units in kind,
applicants request relief from the requirement imposed by section 22(e)
in order to allow such Funds to pay redemption proceeds within fifteen
calendar days following the tender of Creation Units for redemption.
Applicants assert that the requested relief would not be inconsistent
with the spirit and intent of section 22(e) to prevent unreasonable,
undisclosed or unforeseen delays in the actual payment of redemption
proceeds.
    7. Applicants request an exemption to permit Funds of Funds to
acquire Fund shares beyond the limits of section 12(d)(1)(A) of the
Act; and the Funds, and any principal underwriter for the Funds, and/or
any broker or dealer registered under the Exchange Act, to sell shares
to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act.
The application's terms and conditions are designed to, among other
things, help prevent any potential (i) undue influence over a Fund
through control or voting power, or in connection with certain
services, transactions, and underwritings, (ii) excessive layering of
fees, and (iii) overly complex fund structures, which are the concerns
underlying the limits in sections 12(d)(1)(A) and (B) of the Act.
    8. Applicants request an exemption from sections 17(a)(1) and
17(a)(2) of the Act to permit persons that are Affiliated Persons, or
Second Tier Affiliates, of the Funds, solely by virtue of certain
ownership interests, to effectuate purchases and redemptions in-kind.
The deposit procedures for in-kind purchases of Creation Units and the
redemption procedures for in-kind redemptions of Creation Units will be
the same for all purchases and redemptions and Deposit Instruments and
Redemption Instruments will be valued in the same manner as those
Portfolio Holdings currently held by the Funds. Applicants also seek
relief from the prohibitions on affiliated transactions in section
17(a) to permit a Fund to sell its shares to and redeem its shares from
a Fund of Funds, and to engage in the accompanying in-kind transactions
with the Fund of Funds.\2\ The purchase of Creation Units by a Fund of
Funds directly from a Fund will be accomplished in accordance with the
policies of the Fund of Funds and will be based on the NAVs of the
Funds.
---------------------------------------------------------------------------

    \2\ The requested relief would apply to direct sales of shares
in Creation Units by a Fund to a Fund of Funds and redemptions of
those shares. Applicants, moreover, are not seeking relief from
section 17(a) for, and the requested relief will not apply to,
transactions where a Fund could be deemed an Affiliated Person, or a
Second-Tier Affiliate, of a Fund of Funds because an Adviser or an
entity controlling, controlled by or under common control with an
Adviser provides investment advisory services to that Fund of Funds.
---------------------------------------------------------------------------

    9. Applicants also request relief to permit a Feeder Fund to
acquire shares of another registered investment company managed by the
Adviser having substantially the same investment objectives as the
Feeder Fund (``Master Fund'') beyond the limitations in section
12(d)(1)(A) and permit the Master Fund, and any principal underwriter
for the Master Fund, to sell shares of the Master Fund to the Feeder
Fund beyond the limitations in section 12(d)(1)(B).
    10. Section 6(c) of the Act permits the Commission to exempt any
persons or transactions from any provision of the Act if such exemption
is necessary or appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act. Section 12(d)(1)(J) of the Act
provides that the Commission may exempt any person, security, or
transaction, or any class or classes of persons, securities, or
transactions, from any provision of section 12(d)(1) if the exemption
is consistent with the public interest and the protection of investors.
Section 17(b) of the Act authorizes the Commission to grant an order
permitting a transaction otherwise prohibited by section 17(a) if it
finds that (a) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (b) the proposed transaction is consistent with the policies
of each registered investment company involved; and (c) the proposed
transaction is consistent with the general purposes of the Act.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-18914 Filed 8-9-16; 8:45 am]
 BILLING CODE 8011-01-P