Results of Preliminary Review of Comments Received on the ANPR for
Greenhouse Gases (73FR44354, July 30, 2008) for Comments Addressing
Whether CO2 is Currently a Pollutant “Subject to Regulation” under
the CAA

The following table and attachment presents the results of EC/R’s
preliminary search of available comments on the ANPR for Greenhouse
Gases Under the Clean Air Act (as submitted to Docket No.
EPA-HQ-OAR-2008-0318) concerning whether the greenhouse gas CO2 is
currently “subject to regulation” under the Clean Air Act.  Note
that the assessment of the subject docket items was confined to
documents that were uploaded to the docket (in both draft and final
form) as of December 11, 2008.  Utilizing Adobe® software, key search
words were used to identify comments, and several of the significant
comment letters were reviewed individually that were determined not to
be searchable under Adobe.  Note that not all documents were reviewed
individually and that Air Docket has reported that many documents (100s)
have not yet been reviewed and uploaded to the relevant docket as of
December 11, 2008 (public comment period ended at the end of November).
Therefore, it is highly likely that additional relevant comments, not
identified in preliminary search, will be identified in later searches.

	As shown in the table and attached comment excepts, several commenters
addressed the “subject to regulation” question directly, several
commenters provided comments that indicate a presumption that CO2 is not
currently a regulated pollutant under the CAA, and some commenters
referred to the Deseret case without specific argument.  All of these
comment types have been included in the table and attachments that
follow.AttachmentDocket ID No.	Commenter	Major Thrust of Comment
Relevant to “Subject to Regulation” Issue

@1221.1	Chamber of Commerce of the U.S.	Comments suggest CO2 is not
currently subject to regulation.

@1273	Food Industry Environmental Council	We believe that EPA can
exercise its discretion to define “regulated NSR pollutant” further
to include only those GHGs that are specifically regulated at a Section
111 source, and only to the extent the GHGs are emitted from regulated
source categories.

@1423	Council of Industrial Boiler Owners	Even while CO2 is not
regulated, permitting decisions are being delayed and others are being
challenged based on CO2 (e.g., Deseret case)

@1440.1	New York Attorney General’s Office	In light of the recent
ruling the the EPA EAB, EPA can no longer take the position that past
agency interpretations constrain its ability to interpret the phrase
“subject to regulation”  (Deseret case)

@DRAFT-2173	Center for Biological Diversity on EPA’s CAA	EPA currently
asserts that CO2 is not currently “subject to regulation.”  This
position is incorrect. (refers to Deseret and other cases)

@DRAFT-2257	American Public Power Association	APPA agrees with EPA that
CO2 does not become a “regulated pollutant: under NSR and Title V
until the pollutant is “tied to a control technology.”  Refers to
Deseret and urges Congress to amend the Act to clarify that CO2 is not
regulated under the NSR program.

@DRAFT-2271	Climate Solutions	EPA should implement a moratorium on the
construction of new coal-fired power plants without proven controls to
reduce and sequester GHG emissions.  Refers to Deseret.

@DRAFT-2285.1	UARG	EPA believes – and UARG agrees – that PSD does
not currently apply to GHGs.

@DRAFT-2371	Clean Air Implementation Project	PSD permits have not been
required to contain a BACT emissions limit for GHGs because GHGs (and
CO2 in particular) have not been subject to any provisions of the Act or
EPA regulations that require actual control of emissions.  EPA properly
interprets “subject to regulation” to apply only to pollutants
subject to actual controls on emissions.  Refers to Deseret.

@DRAFT-2401.1	Californians for Renewable Energy (CARE)	Refers to Deseret
and other cases, and Part 75 requirements-Section 821 of the Public Law
as support that CO2 is “subject to regulation” under the CAA.  EAB
determined that the administrative record of the permitting decision did
not support the EPA’s position that it did not have the authority to
impose CO2 BACT limits because of its historical interpretation.

@DRAFT-2404	National Tribal Air Association	EPA should halt the approval
and construction of proposed coal-fired power plants until the Agency
establishes a BACT standard specific to GHG emissions.  Refers to
Deseret.

@DRAFT 2538.1	LA Department of Water and Power – footnote.	While EAB
did not specifically rule on whether CO2 limits must be included in the
Deseret PSD Permit, the opinion requires the Region to reconsider
whether to impose CO2 BACT limits on the unit and to develop an adequate
record for its decision.

@DRAFT-2559.1	Environmental Defense Fund	The ANPR sets forth the same
incorrect position about the meaning of the phrase “subject to
regulation” under the Act that the OAR has taken in Desert Rock and
other permit proceedings before the EAB.  The EPA should reverse the
incorrect position that OAR has taken in Deseret and Desert Rock (and
repeated in the ANPR).  EPA should make clear that applicants for PSD
permits must use BACT to limit their CO2 emissions.

Comments Identified in Preliminary Search of Docket EPA-HQ-OAR-2008-0318
Relevant to Whether CO2 is Currently a Regulated Pollutant under the
CAAATTACHMENT A – Comment Excerpts Relevant to Issue of Whether CO2
is Currently “Subject to Regulation” (bolding added to emphasize
relevance)

Comment #1221.1, Chamber of Commerce of the U.S.

At page 14:

3. Prevention of Signficant Deterioration (PSD)

a. Mandatory Trigger

PSD is triggered the moment CO2 becomes a “regulated pollutant”
under the

CAA.  It happens instantaneously—sooner, even, than a NAAQS orNSPS.14
 Under

the CAA, should CO2 be deemed regulated under the Act—even if the
regulation is

for vehicles or fuels and is specifically not directed at stationary
sources—no new or

existing “ major” stationary source of CO2can be built or modified
(if the modification increases net emissions) without first obtaining a
PSD permit. Like Nonattainment NSR, “major sources” are defined as
either a source in one of 28 listed categories (mostly industrial
manufacturers and energy producers) that emits at least 100 tons per
year (tpy) of an air pollutant, or an other source with the potential to
emit 250 tpy of an air pollutant.

14 The U.S. Chamber does not believe an endangerment finding alone would
trigger PSD. However, because so

many provisions in the CAA are tied to endangerment, the moment
regulation occurs through one of those

programs, PSD applies.

At page 23:

EPA argues it can circumvent the PSD program through several regulatory

options, such as: subjective interpretation of potential to emit;
general permits;

streamlined BACT; phase-in of applicability of PSD; and raising the
threshold for

exposure to the PSD program. Environmental groups play along, too: on
September

23, 2008, David Bookbinder, Chief Climate Counsel for the Sierra Club
(and a

Petitioner in Massachusetts) told the Senate Environment and Public
Works Committee

that even if PSD were triggered, he did not expect that his organization
or others

would seek to enforce PSD program requirements on anything but the
largest

emitters. However, EPA has never, under any circumstances, attempted to
use any of

the aforementioned methods to limit applicability of PSD. Although
convenient, it is

hard to imagine that the judges who wrote Massachusetts and North
Carolina would

tolerate EPA’s attempts to re-interpret the text of the CAA. At that
point, the only

thing standing in the way of widespread application of PSD is the word
of Mr.

Bookbinder that PSD would not exploited—a statement that should be
viewed with

informed skepticism, given that Sierra Club, NRDC and others are arguing
in several

pieces of active litigation, as well as a challenge to Delaware’s SIP,
that greenhouse

gases are already regulated under the CAA and PSD already applies.

In the past year alone, environmental groups have actively pursued the
trigger and enforcement of PSD for greenhouse gases in the following
cases:  In re: Deseret Power (before EPA’s Environmental Appeals Board
(“EAB”), PSD Appeal No. 07-03);  In re: Sevier Power Company Power
Plant (case before the Utah Air Quality Board, No. DAQE-AN 2529001 -

04, decided January 9, 2008); In re: ConocoPhillips (case before the
EAB, PSD Appeal No. 07-02); Desert Rock Energy and Dine Power Authority
v.EPA ( case filed in S.D. Tex, No. 08-0872); Environmental Defense Fund
v. North Carolina Dept. of Env. & Nat. Res. (case before the NC Office
of Administrative Hearings, No. filed March 27, 2008); and In re:
Christian County Generation, LLC ( case before the EAB, PSD Appeal No.
07-01, decided January 28, 2008).  On November 14, 2008—the day after
the EAB remanded the Deseret Power case back to EPA Region 8 for a
determination of whether PSD has been triggered and CO2 BACT is
required—Mr. Bookbinder’s organization, the Sierra Club, ran a
front-page story on its website championing the decision, with a
statement that “ all new and proposed coal plants nationwide must go
back and address their carbon dioxide emissions.”

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

1273, Food Industry Environmental Council

At page 11:

(2) EPA has discretion to include only GHG emissions from Section 111
sources in the preconstruction permit program

If no climate change legislation is forthcoming, we suggest that EPA
decline to impose a preconstruction permit program on small sources
using one of the following two methods.  First, the federal
preconstruction permitting program regulates only sources that emit a
“pollutant subject to regulation.”  EPA takes the position that the
phrase “pollutant subject to regulation” is inherently ambiguous,
and is therefore subject to EPA interpretation.  And at least one
adjudicative body has agreed with EPA.  EPA’s most recent formal
definition of the phrase states that a “regulated NSR pollutant”
includes, among other things, “[a]ny pollutant that is 30 See 42
U.S.C. § 7475(a)(4).  31 See In re Deseret Power Electric Cooperative,
PSD App. No. 07-03, slip op. at 28–29, (Envt’l App. Bd. Nov. 13,
2008).  32 See id. at 29) subject to any standard promulgated under
section 111 of the Act.”  At first glance, this definition would
appear to cover all GHGs if any GHG sources are regulated under a
Section 111 standard.  However, we believe that EPA can exercise its
discretion to define “regulated NSR pollutant” further to include
only those GHGs that are specifically regulated at a Section 111 source,
and only to the extent the GHGs are emitted from regulated source
categories.  For example, if EPA promulgated a GHG standard of
performance for coal-fired boilers, the “regulated NSR pollutant”
would only be GHGs emitted at the coal-fired boilers covered by the
standard, and not GHGs emitted by other sources not subject to the
standard.  In this way, EPA and others could focus their permitting and
enforcement resources on the largest and most significant sources of
GHGs, without inefficiently (and largely ineffectively) requiring
smaller sources to comply with the burdensome preconstruction permit
requirements.  Second, even if the definition of “regulated NSR
pollutant” were not modified, EPA has in the past exercised its
discretion to not impose preconstruction permitting requirements at
facilities emitting more than de minimis amounts of a regulated NSR
pollutant.  For example, in a 1998 guidance document that still informs
the permitting of new sources, EPA concluded that CFCs—though
technically listed as a regulated NSR pollutant—did not have to be
included in a source’s NSR analysis.  Similarly, EPA could declare 33
67 Fed. Reg. 80,186, 80,240 (2002).  Instead of amending the PSD
regulations—and as outlined below, the Title V regulations—EPA could
state as it promulgated each new source performance standard that only
those pollutants emitted by sources subject to the standard of
performance are defined as a “regulated pollutant.”  This approach
would leave intact EPA’s current approach to non-GHG regulated
pollutants.  If EPA lists GHGs as a criteria pollutant, its discretion
to exempt GHGs from regulation as a “regulated NSR pollutant” is
severely constrained.  This is another reason why we urge EPA not to
list GHGs as a criteria pollutant.  See Letter from John S. Seitz to
Kevin Tubbs (Mar. 19, 1998), available at   HYPERLINK
"http://www.epa.gov/Region7/programs/artd/air/nsr/nsrmemos/rfrigrnt.pdf"
 www.epa.gov/Region7/programs/artd/air/nsr/nsrmemos/rfrigrnt.pdf . that
GHGs need not be regulated in practice as a part of a source’s
preconstruction review.  In summary, we believe that EPA has sufficient
discretion to exclude GHGs from regulation under the new source review
program through either a refined definition of “regulated NSR
pollutant” or by simply not regulating GHGs in permitting practice.

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

1423, Council of Industrial Boiler Owners

At pages 6 and 7:

Already, even while CO2 is not regulated, permitting decisions are being
delayed and others are being challenged based on CO2.  Most recently,
the Environmental Appeals Board (EAB) remanded a permit for the Deseret
Power Electric Cooperative to EPA Region 8, directing it to reconsider
whether it should set a best available control technology (BACT) for CO2
and to develop a record for that decision.  Under the CAA, should CO2 be
regulated under the Act—even if the regulation is for vehicles or
fuels and is specifically not directed at stationary sources—no new or
existing “major” stationary source of CO2 can be built or modified
(if the modification increases net emissions) without first obtaining a
PSD permit. Given that the CAA specifies thresholds for PSD and Title V
permitting and given that emissions of CO2 are orders of magnitude
higher than those of conventional pollutants, and given that there is no
add-on control available for reducing CO2 emissions, the consequences of
PSD and Title V applicability for CO2 emissions would be devastating to
U.S. industry.  While EPA has analyzed the numbers of sources that would
exceed CAA thresholds and trigger PSD and Title V permitting for CO2,
EPA has not considered the even greater number of sources that trigger
modification provisions under PSD for CO2.  In order for businesses to
compete globally, they must continually improve products, quality,
efficiency, reliability and other factors.  Industry continually
improves operations with minor changes to conventional pollutants.
However, should EPA proceed down the path (either willingly or be forced
to unwillingly by litigation) to make GHG a regulated pollutant under
the Act, the current low thresholds of PSD applied to CO2 would trigger
an untold number of PSD modifications.  As a result, continual
improvement options for U.S. businesses would be severely constrained
and U.S. industry would simply not be able to compete effectively in the
global economy.

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

1440.1, New York Attorney General’s Office

At pages 11 and 12:

1. “Subject to Regulation”

Under the CAA, a PSD permit must include a BACT emission limitation for
air pollutants that are “subject to regulation” under the Act. 42
U.S.C. § 7475(a)(4); see 40 C.F.R. § 52.21(b)(50)(iv) (BACT required
for “any pollutant that is otherwise subject to regulation under the
Act.”).  The statute defines BACT as “an emissions limitation . . .
based on the maximum degree of reduction for each pollutant subject to
regulation under the Act” that the Administrator determines is
achievable “on a case-by-case basis, taking into account energy,
environmental, and economic impacts and other costs.” 42 U.S.C. §
7479(3); see 40 C.F.R. § 52.21(b)(12). Given the language of the
statute and the regulations, pollution controls that meet the BACT
standard are required not only for criteria pollutants such as nitrogen
oxides and sulfur dioxide, but for “any pollutant that is otherwise
subject to regulation under the Act.”  In light of a recent ruling by
the EPA Environmental Appeals Board, EPA can no longer take the position
that past agency interpretations constrain its ability to interpret the
phrase “subject to regulation” to include GHG emissions.  In re
Deseret Power Electric Coop., PSD Permit Appeal No. 07-03 (EPA EAB, Nov.
13, 2008).  In the Deseret case, EPA Region 8 had issued a PSD permit
for a new coal-fired generating unit without requiring the facility
owner to implement BACT for CO2.  The EAB granted the Sierra Club’s
petition for review, rejecting EPA Region 8’s argument that it lacked
the authority to require a BACT limit for GHG emissions.  Specifically,
the EAB found unpersuasive EPA Region 8’s contention that previous
agency interpretations only authorized BACT where there was a regulation
in place requiring the control of the pollutant in question.  The EAB
remanded the PSD permit to Region 8, meaning that EPA must either
include a BACT emission limitation for GHG emissions from the unit or
provide a legally sound rationale for not including such limitation.
Deseret, EAB Slip Op. at 63-64.  In response to the EAB remand in the
Deseret case, EPA should conclude that CO2 and other recognized GHG
emissions are “subject to regulation under the Act.”  Given the
Supreme Court’s decision last year in Massachusetts v. EPA, there is
no question that EPA possesses the authority to regulate CO2 emissions
under the Act.

Based on the plain language of the statute, the Court held that the
Act’s definition of “air pollutant” “embraces all airborne
compounds of whatever stripe,” including CO2.  127 S.Ct. at 1460.
Although the phrase “subject to regulation under the Act” is not
defined in the statute, that just means that EPA should give the phrase
its ordinary meaning.  See American Fed’n of Gov’t Employees v.
Glickman, 215 F.3d 7, 10 (D.C. Cir. 2000) (lack of a statutory
definition does not render a term ambiguous, but instead means it should
be given its ordinary meaning).  GHG emissions are “subject to
regulation under the Act” because not only does the Agency possess the
authority to regulate CO2, there can be no serious dispute that CO2
emissions from power plants and other major sources “may reasonably be
anticipated to endanger public health or welfare.”  As discussed
elsewhere in these comments, the scientific evidence regarding the pace
and harmful effects of global warming caused by CO2 and other greenhouse
gases is extraordinarily compelling.  In addition, harm from global
warming is already occurring, or is imminent. Massachusetts, 127 S.Ct.
at 1455  (“The harms associated with climate change are serious and
well-recognized.”).  Interpreting the term “subject to” regulation
in this fashion is further compelled by consideration of the purposes of
the PSD program.  For example, Section 160(1) states that one of the
program’s goals is “to protect the public health and welfare from
any actual or potential adverse effect which in the Administrator’s
judgment may reasonably be anticipated to occur from air pollution,”
i.e., to protect against anticipated threats to air quality, not waiting
until those threats become realized. 42 U.S.C. 7470(1).  Similarly,
Section 160(5) provides that another goal of the program is “to assure
that any decision to permit increased air pollution in any area . . . is
made only after careful evaluation of all the consequences of such a
decision and after adequate procedural opportunities for informed public
participation in the decision-making process.”  Id., 7470(5).  In
light of the overwhelming scientific evidence that GHGs harm public
health and welfare, and the fact that major stationary sources such as
power plants can be expected to operate for 50 or more years –
generating enormous amounts of greenhouse gases – it is imperative
that EPA require controls for CO2 emissions in PSD permits.  In the
Deseret decision, the EAB recognized that this individual
permit-by-permit approach may be cumbersome and that a national approach
to regulation of GHG emissions under the PSD program is preferable.
Slip. Op. at 64.  EPA should heed the advice of the EAB by moving
forward expeditiously with a rulemaking to implement PSD permitting for
major emitting facilities.  At the same time, EPA should announce that
it will not grant or approve of any PSD permits for major stationary
sources that fail to include a BACT emission limitation for GHG
emissions.

The definition of “major emitting facility” applies to several
listed categories of sources, including power plants, that emit or have
the potential to emit one hundred tons per year or more of “any air
pollutant” and “any other source with the potential to emit two
hundred fifty tons per year or more of any air pollutant.” 42 U.S.C.
§ 7479(1).  Contrary to EPA’s statement in the ANPR that a major
emitting facility is one that emits or has the potential to emit 250
tons per year of a “regulated NSR pollutant,” 73 Fed. Reg. at
44,498, the plain language of this statute is even broader than the
definition of BACT because it covers “any air pollutant,” not just
an air pollutant that is “subject to regulation under the Act.”  See
Order Requesting Further Briefing at 4, Deseret, PSD Appeal No. 07-03
(EPA EAB, June 16, 2008) (noting the difference in statutory language in
these definitions).

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

DRAFT-2173, Center for Biological Diversity on EPA’s CAA.

At file pages 22 and 23:

EPA currently asserts that CO2 is not currently “subject to
regulation” under the CAA.  This position is incorrect.  As the
petitioners in the Deseret case have explained, Part 75 of Title 40 of
the Code of Federal Regulations, which requires monitoring and reporting
of carbon dioxide emissions, renders carbon dioxide “subject to
regulation” under the Act.

The EPA’s position has already been overturned both by the EPA’s
Environmental Appeals Board104 and a Georgia state trial court.  In In
Re Deseret Power Electric Cooperative, the Sierra Club, supported by the
Center for Biological Diversity, challenged the EPA’s decision to
exclude CO2 from its BACT limits in approving a PSD permit for the
Bonanza coal plant.  The EAB rejected the EPA’s rationale for the
exclusion and remanded the permit to the EPA for reconsideration.  In
Friends of the Chattahoochee v. Couch, the Georgia Superior court
similarly overturned EPA’s issuance of a PSD permit for a 1200 MW
coal-fired power plant in Early County, Georgia.  The Court held that
CO2 is a pollutant “subject to regulation” under the Act, and
therefore EPA’s failure to set a BACT emission limit was unlawful.

The EPA’s position that GHGs are not “subject to regulation” under
the Act cannot stand, even in the current absence of an endangerment
finding under Section 202 or other sections discussed herein.  Moreover,
as EPA notes in the ANPR, as soon as the EPA takes any one of the
required additional steps outlined here, there can be no question that
New Source Review will apply to GHG-emitting major sources.  The agency,
therefore, should save precious time and resources and avoid further
legal battles by immediately regulating GHGs under the PSD program.
Doing so would allow EPA to quickly and effectively regulate GHGs from
the largest emitters like coal-fired plants that contribute extensively
to climate change and would avoid locking in unnecessarily high
emissions.  We note that doing so would also give additional certainty
to the regulated community.  While it is uncontroversial that EPA should
prioritize the largest pollution sources first, one of the reasons that
the NSR program will be such an effective tool for reducing GHG
emissions is that it applies to a wide array of sources that will emit
in excess of the applicable statutory thresholds of 250 or 100 tons per
year.  As the EPA notes, it is generally more effective and less
expensive to engineer and install controls at the time a source or major
modification is being designed and built as opposed to retrofitting
controls independently at an existing facility.  Instead of appreciating
this aspect of the act as the enormous opportunity that it is, the EPA
and the commenting agency heads instead have vastly exaggerated
procedural and administrative issues associated with an increase in
permitting.

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

DRAFT – 2257, American Public Power Association

At pages 37 and 38:

E. NSR Should Not Apply to GHGs.

APPA agrees with EPA that CO2 does not become a “regulated
pollutant” under NSR and Title V until the pollutant is “tied to a
control technology.” See, 73 Fed. Reg. at 43504.  We discussed above
that we agree that the NSR program creates considerable legal and
economic risk to regulated industry and currently unregulated
facilities, businesses, residences, and public and private institutions
including schools and churches, etc.  Moreover, EPA attempts to amend
the current NSR regulations to redefine “a pollutant subject to
regulation under the [PSD program]” as suggested by EPA’s
Environmental Appeals Board in the Deseret PSD Permit Appeal decision do
not resolve the uncertainty and risk for sources in the next several
years, because both those EPA regulations and individual permit
decisions by states and EPA regions will continue to be challenged by
permit opponents and state and federal courts will likely continue to
issue conflicting decisions on this issue.  For these reasons, APPA
calls on the Agency to urge Congress immediately to amend the Act to
clarify that CO2 is not regulated under the NSR program.  The
“Environmental Appeals Board (EAB)” in In Re Deseret Power Electric
Cooperative PSD Permit No. PSD-OU-0002-04.00, PSD Appeal No. 07-03 (Slip
Opinion, November 13, 2008), directs EPA Region 8, the permitting
authority to “(R)econsider whether or not to impose a CO2 BACT limit
in light of the Agency’s discretion to interpret, consistent with the
CAA, what constitutes a “pollutant subject to regulation under the
Act.”  In addition, EAB urges the Region to “consider whether
interested persons, as well as the Agency, would be better served by the
Agency addressing the interpretation of the phrase in the context of an
action of nationwide scope, rather than through this specific permit
proceeding.“  (Slip Opinion at 63-64)

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

DRAFT-2271, Climate Solutions

At pages 3 and 4:

B. EPA Needs to Act Promptly to Reduce GHG Emissions Under the Act

The Clean Air Act is clear: EPA must immediately issue the endangerment
finding, and act to reduce GHG emissions.  Specifically, EPA must
address new motor vehicle emissions and be ready to phase in a range of
stationary and mobile source controls well suited for implementation
under the Act.  These include a range of actions outlined in the ANPR,
such as adopting increased standards for mobile sources (the specific
subject of the Supreme Court’s decision) and actions to address major
emissions sources including Best Available Control Technology (BACT),
and New Source Performance Standards.  Indeed, EPA has the opportunity
to fast-track appropriate controls on mobile sources.  EPA should
immediately grant a waiver of preemption for automobile regulations to
allow the Northwest states of Washington and Oregon to implement
enhanced standards for vehicle efficiency, joining California and
fourteen other states.  The 2005 Washington Clean Cars Act required all
vehicles powered by gasoline and diesel fuels to match California’s
strict emissions management beginning with Model Year 2009.  Oregon
followed suit in 2007, passing clean car legislation.  EPA blocked these
efforts by failing to grant the required waiver under the Clean Air Act,
despite overwhelming precedent and factual evidence that the waiver
would reduce emissions and save energy and money in the affected states.
EPA should immediately reverse this decision, grant the waiver, and
begin working on national standards to reduce vehicle emissions.
Another step that EPA should take immediately is to implement a
moratorium on the construction of new coal-fired power plants without
proven controls to reduce and sequester GHG emissions. As demonstrated
by the recent decision of the Environmental Appeals Board (EAB)
remanding the permit for the Bonanza power plant in Utah, EPA must
evaluate CO2 when determining what constitutes Best Available Control
Technology for new facilities.  In re: Deseret Power Electric
Cooperative, PSD Permit No. PSD-OU-0002-04.00 (Nov. 13, 2008).  EPA
needs to immediately apply this reasoning to all coal-fired power plants
throughout the country, avoiding the potential for lock-in of the most
polluting technologies while we move toward cleaner sources of energy.
The Clean Air Act is a ready tool for lowering U.S. GHG emissions in the
short term.  While significant climate legislation is likely to be
debated in the next Congress, it may take several years to fully
implement GHG reduction measures under new legislation.  Climate
scientists agree that immediate action is needed to slow and reverse the
growth of GHGs in order to avoid the most dangerous effects of climate
disruption.  Failing to act now, using existing legal authorities, would
be perilous and costly.  Furthermore, the Supreme Court gave EPA a clear
mandate to use existing tools to address dangerous air pollutants rather
than waiting for new legislation. Once EPA makes the required
endangerment finding, it must act to address GHGs using the full range
of tools outlined in the ANPR.  As such, the Clean Air Act is ready to
be EPA’s interim framework for immediate GHG stabilization.
Implementing the program now will provide important lessons in crafting
a broader Congressional climate plan later, and jump-start the
regulatory infrastructure of transitioning to a low-carbon economy.

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

DRAFT-2285.1, UARG

At page 124:

E. Implications for the PSD Program from Possible Regulation of GHGs
Under

the CAA

At the present time, EPA believes -- and UARG agrees -- that PSD does
not currently apply to GHGs.31 Id. at 44497/3.  If EPA decided to
propose and promulgate a rule establishing limits on emissions of GHGs
from mobile sources or stationary sources, PSD permits would need to
contain an emissions limit for those GHGs that reflects BACT. BACT is
“defined as the maximum achievable degree of emissions reduction for a
given pollutant (determined by the permitting authority on a
case-by-case basis), taking into account energy, environmental, and
economic impacts.”  Id.  ..

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

DRAFT-2371, Clean Air Implementation Project

At pages 13 and 14:

1 . GHGs Are Not Currently "Regulated Air Pollutants."

The PSD program applies to each air pollutant (other than a HAP) that is
"subject to regulation under the Act" within the meaning of sections
165(a)(4) and 169(3) of the Act and EPA's regulations.  As EPA points
out in the ANPR, it has historically interpreted the phrase "subject to
regulation under the Act" to describe air pollutants that require actual
control of emissions of that pollutant.  PSD permits have not been
required to contain a BACT emissions limit for GHGs because GHGs (and
C02 in particular) have not been subject to any provisions of the Act or
EPA regulations that require actual control of emissions.  EPA properly
interprets "subject to regulation" to apply only to pollutants subject
to actual controls on emissions.  It is clear that Congress did not
intend to regulate GHGs under the PSD program.  Although section 211(o)
of the Act now targets GHG emissions, Congress made clear that neither
it nor implementing regulations are to affect the regulatory status of
GHGs under the Act.  In the absence of statutory or regulatory
requirements to control GHG emissions under the Act, a stationary source
need not take into account those emissions when determining its major
source status or whether a major modification occurs when a change is
made at the source.  While Congress has required that GHGs be subject to
monitoring and reporting requirements under section 821 of the Act, EPA
has appropriately not interpreted BACT to apply to air pollutants that
are only subject to such requirements.  BACT should not apply to
pollutants unless a determination has been made by EPA or Congress that
such pollutants should in fact be controlled.  The intent of section 821
was clearly to gather information in anticipation of potential
regulation, rather than to trigger regulation itself.  If the gathering
of information alone is enough to make a pollutant subject to
regulation, this would lead to the nonsensical result that the simple
act of trying to determine whether regulation was appropriate or the
best scope for regulation would lead to premature controls before the
extent of the problem is even known.

Further, the Massachusetts decision did not make GHGs "subject to
regulation" under PSD.  As EPA has pointed out, not all air pollutants
are subject to regulation within the meaning of sections 165(a)(4) and
169(3).  The Court was clear that EPA would have to make an

endangerment finding before GHGs could be regulated under section 202.
See Massachusetts v.EPA, 127 S .Ct. 1438, 1462 (2007)  ("If EPA makes a
finding of endangerment, the Clean Air Act requires the agency to
regulate emissions of the deleterious pollutant from new motor
vehicles.") (emphasis added).  EPA's Environmental Appeals Board (EAB)
recently ruled in the Deseret Electric Cooperative permit appeal that it
found no express statements in the administrative record to support
EPA's position that the phrase "subject to regulation" only applies to
pollutants subject to controls on emissions.  It ruled, however, that
the phrase is ambiguous and open to reasonable Agency interpretation and
remanded the permit decision for EPA to develop an administrative record
either supporting its interpretation or finding that C02 should be
treated as a regulated air pollutant.  Recognizing that the issue had
broad implications, the EAB recommended that EPA consider addressing the
question in an action of "nationwide scope."

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

DRAFT-2401.1, Californians for Renewable Energy (CARE)

At file pages 6 through 10:

The CAA requires the proponent of any new major stationary sources of
air pollution such as a fossil fuel fired power plant to obtain a
construction permit before commencing construction. 42 U.S.C § 7411.
Carbon Dioxide, CO2, and Nitrous Oxide, N2O, are components of the
emissions expected from the combustion turbines (“CTs”).  The EPA
website recognizes the climate change impacts of these emissions and yet
they were not included as pollutants.  The United States Supreme Court
issued a decision over a year ago noting that the EPA has regulatory
authority to control these emissions and yet they are not even mentioned
in the permit.  The United States Supreme Court issued a landmark
decision on the subject of greenhouse gases and global warming in the
case of Massachusetts v. EPA, 549 U.S. 1438, 1455 (April 2, 2007),
affirming that “[t]he harms associated with climate change are serious
and well recognized."  The Court argued that “greenhouse gases fit
well within the Clean Air Act’s capacious definition of ‘air
pollutant’” (Massachusetts, at 1462).  On Nov. 13, 2008, the US
Environmental Protection Agency's (EPA) Environmental Appeals Board (EAB
or the Board) issued an order that denied review in part and remanded in
part a challenge to the Agency's issuance of a Prevention of Significant
Deterioration (PSD) permit to Deseret Power Electric Cooperative for
construction of a new electric generating unit in Utah (In re Deseret
Power Electric Cooperative, PSD Appeal No. 07-03 (Nov. 13, 2008)).

Although the Board rejected the grounds upon which the Agency declined
to include a Best Available Control Technology (BACT) limit on carbon
dioxide (CO2) in the PSD permit, it also rejected the petitioner's claim
that the Clean Air Act (CAA) requires a PSD permit to include such BACT
limits.  In remanding the PSD permit to the EPA, the board suggested the
EPA consider addressing the issue not in the context of this (and other)
individual permitting decisions, but on a national basis.  Deseret
sought a PSD permit for a new waste-coal-fired electric generating unit
at its existing facility near Bonanza, Utah.  The EPA issued a draft
permit in 2006; the Utah Chapter of the Sierra Club participated in the
permitting process, and submitted comments to the EPA suggesting that if
the Supreme Court were to rule in Massachusetts v. EPA that the Agency
did have the authority to regulate CO2 under the CAA, the agency might
be required to include BACT limits on CO2 emissions in the PSD permit.
The EPA (Region 8) granted Deseret's permit application on Aug. 30, 2007
(after the Massachusetts v. EPA Supreme Court decision), and declined to
include BACT limits for CO2.  The Sierra Club sought review of the
Agency's permitting decision before the EAB, and raised two issues: (1)
whether the EPA impermissibly failed to consider alternatives to the
proposed power plant; and (2) whether the EPA was required to impose
BACT limits for CO2 because CO2 is a "pollutant subject to regulation
under [the Clean Air Act]."  In its Petition for Review, the Sierra Club
took the position that Sections 165(a)(4) and 169(3)--which require a
PSD permit contain BACT limits for "each pollutant subject to regulation
under this Act"--dictate the EPA must impose a BACT CO2 limit because
CO2 is a pollutant subject to regulation.  The Sierra Club argued that
the plain language of the statute precluded the EPA from interpreting
the language to exclude CO2.  In support of its position, the Sierra
Club cited the Massachusetts v. EPA decision, as well as the 40 CFR Part
75 regulations which impose monitoring and reporting requirements for
CO2 (arguing that such requirements render CO2 "subject to regulation").
 The Agency argued that the decision in Massachusetts v. EPA did not
require the EPA to set CO2 emission limits, and that it had historically
interpreted the phrase "subject to regulation" to mean only pollutants
that were subject to requirements that actually controlled emissions of
the pollutant at issue.  Because the Part 75 regulations cited by the
Sierra Club only required monitoring and reporting of CO2 emissions, and
not control of CO2 emissions, the EPA argued it was constrained by its
historical interpretation, which prevented the EPA from changing its
interpretation.  The Agency cited several sources as evidence of this
interpretation, including a 1978 Federal Register preamble, a 2002
rulemaking, and two internal Agency memos from Lydia Wegman and Jonathan
Cannon from 1993 and 1998, respectively.  The EPA also argued that even
if the Part 75 requirements were deemed to subject CO2 to regulation,
the source of the Part 75 requirements--Section 821 of the Public Law,
added in 1990 as part of the bill that amended the CAA--is not a part of
the CAA in the context of pollutants that are subject to regulation
"under this Act."

The EAB evaluated each of the components of the Sierra Club's argument
that the plain meaning of "regulation" necessarily required that the
Board ignore the Agency's interpretation of that term, ultimately
rejecting the premise that the statutory language negates the EPA's
authority to interpret "subject to regulation" in the same manner as the
EPA.  The Board found "no evidence of a Congressional intent to compel
EPA to apply BACT to pollutants that are subject only to monitoring and
reporting requirements."  Slip op. at 63.  The Board found the statutory
language was broad enough to support several different meanings of the
phrase in the context of PSD permitting, thus leaving the door open to
agency discretion in interpreting whether CO2 is "subject to
regulation."  The Board analyzed the documents relied upon by the EPA in
its argument that it was precluded from imposing BACT limits on CO2 by
its own historical interpretations of the phrase "subject to
regulation."  In the absence of any document "expressly stating" that
"subject to regulation" means subject to a provision that requires
actual control of emission, the EAB determined the administrative record
of the permitting decision did not support the EPA's position that it
did not have the authority to impose a CO2 BACT limit because of its
historical interpretation.  The Board reviewed the documents cited by
the EPA and concluded that the series of Agency statements were "at
best, weak authorities upon which to anchor the region's conclusion" and
not "sufficiently clear and consistent articulations of an agency
interpretation" to prohibit the Agency from taking the position
advocated by the petitioners.

The EAB also rejected the Agency's argument that Section 821 was not
part of the CAA, noting that while Section 821 "is not a model of
drafting clarity," it contains language that both supports and subverts
the EPA's position.  Pointing to differing interpretations offered by
the EPA in various contexts and proceedings regarding the specific issue
of Section 821 and its relationship to the CAA, the Board concluded it
could not accept the EPA's interpretation in the context of this appeal,
noting that it was unsure what degree of deference a reviewing court
would give to the Agency, where it had publicly indicated it was not
sure where Section 821 fit into the CAA structure.  The Board remanded
the permit to the EPA Region 8 to "reconsider whether or not to impose a
CO2 BACT limit in light of the agency's discretion to interpret,
consistent with the CAA, what constitutes a 'pollutant subject to
regulation under this Act.'"  Slip op. at 63.  The Board also noted,
however, that it was cognizant of the national scope of this issue, and
asked the EPA whether all parties would be "better served by the agency
addressing the interpretation of the phrase 'subject to regulation under
this Act' in the context of an action of nationwide scope."  Id.

The Board clearly favors this approach, suggesting that (a) the Agency
should specifically evaluate and address whether the historical
interpretations offered by the Agency in fact mandate that the issue be
addressed in the broader context of a nationwide action; and (b) it may
be more efficient to tackle the issue at the national level rather than
seeking to develop the requisite factual record supporting the Agency's
position in not only this permitting process (which requires reopening
the public comment period), but in subsequent permitting proceedings as
well.  The Board's decision does not finally resolve the issue of
whether CO2 BACT limits must or should be included in PSD permits, a
result which does little to reduce the uncertainties that project
proponents will continue to face. By leaving the key question to Agency
discretion, the Board ensures that the debate over this issue will
continue.  The Board does provide some guidance for the Agency--if the
decision is made not to include CO2 BACT limits, the basis for that
decision must be supported by specific evidence developed for and
included in the administrative record, and not simply by general
references to broad Agency statements of policy.  Further, the Board
expressed a clear desire that the Agency consider addressing the issue
at the national level, presumably as part of the broader ongoing
discussion regarding the regulation of greenhouse gas emissions under
existing CAA authority.

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

DRAFT-2404, National Tribal Air Association

At pages 2 and 3:

A. Best Regulatory Options

As for other steps, the NTAA recommends that EPA take three specific
ones.  First, the EPA should halt the approval and construction of
proposed coal-fired power plants until the Agency establishes a best
achievable control technology standard specific to GHG emissions.  A
recent EPA Environmental Appeals Board decision helped moved the Agency
in such a direction, now requiring that the EPA or jurisdictions with
delegated authority under the CAA to conduct a carbon dioxide BACT
analysis for all future coal-fired power plants permitted under the
Act’s Prevention of Significant Deterioration (PSD) program (see In Re
Deseret Power Electric Cooperative, EPA, EAB, PSD Appeal No. 07-03,
11/13/08).  Second, the EPA should begin the process of proposing new
source performance standards (NSPS) under section 111 of the CAA for
GHGs emitted by coal-fired power plants, petroleum refineries, and
cement kilns.  Under this section, the Agency can use a pick-and-choose
approach as to which source categories to establish standards; it can be
selective in picking those categories with the greatest contribution of
GHG emissions with the Agency prescribing a rational emissions
threshold.  Some things that the EPA should consider for regulating GHGs
under this section are the magnitude of GHG emissions from a source
category; the potency of the particular GHGs emitted; whether the
emissions are continuous, seasonal or intermittent; the availability of
information regarding the category’s GHG emissions, and whether
regulating GHG emissions from the source category would be beneficial.
Third, the EPA should begin a rulemaking on low-carbon fuels by
utilizing the Agency’s authority under section 211 of the CAA.  None
of these regulatory actions, however, should preempt the work being
conducted by such groups as the Regional Greenhouse Gas Initiative and
Western Climate Initiative which are already accomplishing much in
moving toward significant GHG emission reductions in the respective
regions that they serve.

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

DRAFT-2538.1, LA Department of Water and Power, page 8 footnote,
non-searchable file.

At page 8:

Finally, the issue of whether BACT emissions limits for CO2 should be
imposed has been raised in several recent legal challenges regarding
whether New Source Review permitting requirements apply to new
coal-fired power plants, including one pending legal challenge in which
the EPA’s EAB remanded a NSR permit for failure to include a permit
limit for CO2 based on BACT.  In re: Deseret Power Electric Cooperative.
 While the EAB did not specifically rule on whether CO2 limits must be
included in the Deseret PSD permit, the opinion requires the Region to
reconsider whether to impose CO2 BACT limits on the unit and to develop
an adequate record for its decision.

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

DRAFT-2559.1, Environmental Defense Fund (EDF)

At pages 18 and 19:

In the ANPRM, the EPA sets forth the same incorrect position about the
meaning of the phrase “subject to regulation” under the Act that the
Office of Air and Regulation has taken in Desert Rock and other permit
proceedings before the EAB.  Since the Agency issued the ANPRM, the
Environmental Appeals Board has decisively rejected the reasoning behind
that position, in a permit proceeding about a proposed coal-fired plant
in Utah.  In Re: Deseret Power Electric Coop., PSD App. No 07-03, slip
op. (EAB Nov. 13, 2008) (remanding to EPA for further consideration).
The EPA should reverse the incorrect position that OAR has taken in
Deseret and Desert Rock (and repeated in the ANPRM), and to satisfy
judicial requirements when an agency takes a new course provide a
careful explanation of why it is correcting that position.  Since the
EAB has rejected the reasoning behind the position taken by OAR to date,
the Agency should properly interpret the phrase “subject to regulation
under the Act” to encompass carbon dioxide and other appropriate
pollutants.  In doing so, the EPA should make clear that applicants for
PSD permits must use Best Available Control Technology to limit their
carbon dioxide emissions.

Draft.- 12/12/2008	Do Not Cite or Quote	December 12, 2008

A-  PAGE   \* MERGEFORMAT  13

Draft.- 12/12/2008 - Do Not Cite or Quote


[Federal Register: March 31, 2010 (Volume 75, Number 61)]
[Rules and Regulations]
[Page 16001-16002]
[DOCID:fr31mr10-5]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2003-N-0446] (formerly Docket No. 2003N-0324)

New Animal Drugs; Removal of Obsolete and Redundant Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is removing portions of
a regulation that required sponsors to submit data regarding the
subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide
drugs administered in animal feed as these regulations have been
determined to be obsolete or redundant. The portions of the regulation
being removed are provisions listing certain feed use combinations for
oxytetracycline and neomycin in the tables contained in that
regulation. This rule does not finalize the provisions of the proposed
rule regarding removing the remainder of the regulation.

DATES: This rule is effective April 30, 2010.

FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for
Veterinary Medicine (HFV-50), 7519 Standish Pl., Rockville, MD 20855,
240-276-9090, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 8, 2003 (68 FR 47272), FDA
published a notice of proposed rulemaking to remove 21 CFR 558.15
Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals
(Sec.  558.15 (21 CFR 558.15)) on the grounds that these regulations
were obsolete or redundant. The proposed rule explained the nature and
purpose of Sec.  558.15, and noted that most of the products and use
combinations subject to the listings in that section had approvals that
were already codified in part 558, subpart B (21 CFR part 558, subpart
B).
    In the same issue of the Federal Register as the proposed rule,
FDA's Center for Veterinary Medicine (CVM) published a Notice of
Opportunity for Hearing (NOOH), which announced CVM's findings of
effectiveness for nine products and use combinations that were listed
in Sec.  558.15, but which were subject to the Drug Efficacy Study
Implementation (DESI) program (68 FR 47332). CVM proposed to withdraw
the new animal drug applications (NADAs) for those nine products and
use combinations lacking substantial evidence of effectiveness,
following an opportunity to supplement the NADAs with labeling
conforming to the relevant findings of effectiveness. For applications
proposed to be withdrawn, the agency provided an opportunity for
hearing.
    FDA received hearing requests regarding two products owned by
Pennfield Oil Co. (Pennfield). One is a bacitracin methylene
disalicylate (BMD) Type A medicated article, NADA 141-137, that is
listed in the table in Sec.  558.15(g)(1). This listing is under
Fermenta Animal Health Co., which is a predecessor in interest to
Pennfield. The other is a two-way, fixed-combination Type A medicated
article containing oxytetracycline and neomycin sulfate, NADA 138-939,
that is listed in the table in Sec.  558.15(g)(2).
    The agency received only one set of comments on the 2003 proposed
rule, from Pennfield. The comment objected to the removal of Sec.
558.15 until the issues in the NOOH are addressed. It argued that the
BMD listing in Sec.  558.15 provides evidence of Pennfield's approval,
and that removal of that section, without updating the BMD listing in
part 558, subpart B, would result in a lack of recognition in the
regulations of the approval that Pennfield currently has.
    In 2006, FDA finalized portions of the 2003 proposed rule. In that
final rule (71 FR 16219, March 31, 2006), FDA removed from the tables
in Sec.  558.15(g) products and use combinations that were not
approved, and products and use combinations whose approval was
reflected in part 558, subpart B. FDA retained only the listings for
NADA 141-137 and NADA 138-939 in those tables. In addition, FDA
retained Sec.  558.15(a) through (f). FDA stated it intended to
finalize the proposed rule to remove all of Sec.  558.15 once, as part
of the DESI program, either the approvals for NADA 141-137 and NADA
138-939 have been withdrawn or part 558, subpart B has been amended to
reflect their approvals.
    Subsequently, Pennfield filed a supplement to NADA 138-939 for its
fixed-combination oxytetracycline/neomycin Type A medicated articles.
The supplemental NADA, which provided labeling conforming to the
relevant findings of effectiveness announced in the NOOH, was approved
on July 2, 2009, and the regulations were amended in Sec.  558.455 of
subpart B to reflect that approval (74 FR 40723, August 13, 2009).

    This oxytetracycline/neomycin use combination is listed in the
table in Sec.  558.15(g)(2) and is the only use combination listed in
this provision. Because this use combination's approval is now
reflected in Sec.  558.455, FDA is removing Sec.  558.15(g)(2) as
obsolete or redundant. As in the 2006 final rule, FDA is retaining the
sole listing in the table in Sec.  558.15(g)(1) for NADA 141-137 as
well as Sec.  558.15(a) through (f), and intends to continue to
finalize the proposed rule to remove all of Sec.  558.15.

II. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-602), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
    FDA proposed the removal of Sec.  558.15 on August 8, 2003, because
it was obsolete or redundant. The original purpose of Sec.  558.15,
requiring the submission of the results of studies on the long-term
administration of then-marketed antimicrobial drugs in animal feed on
the occurrence of multiple drug-resistant bacteria associated with
these animals, was obsolete as FDA had a new strategy and concept for
assessing the safety of antimicrobial new animal drugs, including
subtherapeutic use of antimicrobials in animal feed, with regard to
their microbiological effects on bacteria of human health concern. This
final rule would delete the only animal drug use combination listed in
Sec.  558.15(g)(2) which is redundant because its approved conditions
of use are now listed in Sec.  558.455.

A. Benefits

    Only one set of comments on the proposal was received by FDA.
Because these comments did not question the benefits as described in
the proposed rule, we retain the benefits for the final rule. This
final rule is expected to provide greater clarity in the regulations
for new animal drugs for use in animal feeds by deleting obsolete
provisions in Sec.  558.15. We do not expect this final rule to result
in any direct human or animal health benefit. Rather, this final rule
would remove regulations that are no longer necessary.

B. Compliance Costs

    We do not expect the final rule that revokes Sec.  558.15(g)(2) to
have a substantive effect on any approved new animal drugs, or to cause
any approved new animal drug to lose its marketing ability or
experience a loss of sales.

C. Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. FDA has determined that this final rule does not
impose compliance costs on the sponsors of any products that are
currently marketed. Further, it does not cause any drugs that are
currently marketed to lose their marketing ability. We therefore
certify that this final rule would not have a significant economic
effect on a substantial number of small entities.

D. Unfunded Mandates Reform Act

    Section 202(a) of the Unfunded Mandates Reform Act requires that
agencies prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

IV. Paperwork Reduction Act of 1995

    FDA concludes that this rule does not have information collection
requirements.

List of Subjects in 21 CFR Part 558

     Animal drugs, Animal feeds.

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

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.15  [Amended]

0
2. In Sec.  558.15, remove and reserve paragraph (g)(2).

    Dated: March 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7108 Filed 3-30-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: August 31, 2010 (Volume 75, Number 168)]
[Notices]
[Page 53287-53289]
[DOCID:fr31au10-48]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 2

August 24, 2010.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2336-000.
    Applicants: DeGreeff DP, LLC.
    Description: DeGreeff DP, LLC submits tariff filing per 35.12:
DeGreeffpa, DP, LLC Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5065.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2337-000.
    Applicants: CL Power Sales Eight, L.L.C.
    Description: CL Power Sales Eight, L.L.C. submits tariff filing per
35.12: CL Power Sales Eight, L.L.C. Baseline Filing to be effective 8/
25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5066.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2338-000.
    Applicants: CP Power Sales Nineteen, L.L.C.
    Description: CP Power Sales Nineteen, L.L.C. submits tariff filing
per 35.12: CP Power Sales Nineteen, L.L.C. Baseline Filing to be
effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5067.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2339-000.
    Applicants: CP Power Sales Seventeen, L.L.C.
    Description: CP Power Sales Seventeen, L.L.C. submits tariff filing
per 35.12: CP Power Sales Seventeen, L.L.C. Baseline Filing to be
effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5068.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2340-000.
    Applicants: CP Power Sales Twenty, L.L.C.
    Description: CP Power Sales Twenty, L.L.C. submits tariff filing
per 35.12: CP Power Sales Twenty, L.L.C. Baseline Filing to be
effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5069.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2341-000.
    Applicants: Edison Mission Marketing & Trading, Inc.
    Description: Edison Mission Marketing & Trading, Inc. submits
tariff filing per 35.12: Edison Mission Marketing & Trading, Inc.
Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5070.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2342-000.
    Applicants: Edison Mission Solutions, LLC.
    Description: Edison Mission Solutions, LLC submits tariff filing
per 35.12: Edison Mission Solutions, LLC Baseline Filing to be
effective 8[sol]25[sol]2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5071.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2343-000.
    Applicants: J.P. Morgan Commodities Canada Corporation.
    Description: J.P. Morgan Commodities Canada Corporation submits
tariff filing per 35.12: Baseline eTariff Filing Pursuant to Order No.
714 to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5072.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2344-000.
    Applicants: EME Homer City Generation, L.P.
    Description: EME Homer City Generation, L.P. submits tariff filing
per 35.12: EME Homer City Generation. L.P. Baseline Filing to be
effective 8[sol]25[sol]2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5073.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2345-000.
    Applicants: Domtar Maine, LLC.
    Description: Domtar Maine, LLC submits tariff filing per 35.12:
Application for MBR Authority and Request for Waivers and Blanket
Authorization to be effective 9/23/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5074.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2346-000.
    Applicants: Forward WindPower LLC.
    Description: Forward WindPower LLC submits tariff filing per 35.12:
Forward Wind Power LLC Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5075.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2347-000.
    Applicants: Groen Wind, LLC.
    Description: Groen Wind, LLC submits tariff filing per 35.12: Groen
Wind, LLC Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5079.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2348-000.
    Applicants: High Lonesome Mesa, LLC.
    Description: High Lonesome Mesa, LLC submits tariff filing per
35.12: High Lonesome Mesa, LLC Baseline Filing to be effective 8/25/
2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5082.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2349-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator submits tariff
filing per 35.13(a)(2)(iii: LGIA--NYSEG and

Standard Binghamton--8/24/10 to be effective 8/24/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5085.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2350-000.
    Applicants: Hillcrest Wind, LLC.
    Description: Hillcrest Wind, LLC submits tariff filing per 35.12:
Hillcrest Wind, LLC Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5089.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2351-000.
    Applicants: Jeffers Winder 20, LLC.
    Description: Jeffers Winder 20, LLC submits tariff filing per
35.12: Jeffers Wind 20, LLC Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5098.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2352-000.
    Applicants: Larswind, LLC.
    Description: Larswind, LLC submits its Baseline FERC Electric
Tariff pursuant to Order No 714, to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5099.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2353-000.
    Applicants: Lookout WindPower LLC.
    Description: Lookout WindPower LLC submits tariff filing per 35.12:
Lookout WindPower LLC Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5100.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2354-000.
    Applicants: Midway-Sunset Cogeneration Company.
    Description: Midway-Sunset Cogeneration Company submits tariff
filing per 35.12: Midway Sunset Cogeneration Company to be effective 8/
25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5101.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2355-000.
    Applicants: Midwest Generation LLC.
    Description: Midwest Generation LLC submits tariff filing per
35.12: Midwest Generation, LLC Baseline Filing to be effective 8/25/
2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5102.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2356-000.
    Applicants: Sierra Wind, LLC.
    Description: Sierra Wind, LLC submits tariff filing per 35.12:
Sierra Wind, LLC Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5106.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2357-000.
    Applicants: Sleeping Bear, LLC.
    Description: Sleeping Bear, LLC submits tariff filing per 35.12:
Sleeping Bear, LLC Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5107.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2358-000.
    Applicants: Storm Lake Power Partners I LLC.
    Description: Storm Lake Power Partners I LLC submits tariff filing
per 35.12: Storm Lake Power Partners I, LLC Baseline Filing to be
effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5108.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2359-000.
    Applicants: Sunrise Power Company, LLC.
    Description: Sunrise Power Company, LLC submits tariff filing per
35.12: Sunrise Power Company, LLC Baseline Filing to be effective 8/25/
2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5109.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2360-000.
    Applicants: TAIR Windfarm, LLC.
    Description: TAIR Windfarm, LLC submits tariff filing per 35.12:
TAIR Windfarm, LLC Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5110.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2361-000.
    Applicants: Wildorado Wind, LLC.
    Description: Wildorado Wind, LLC submits its Baseline Filing of
FERC Electric Tariff, pursuant to Order No 714, to be effective 8/25/
2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5111.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2362-000.
    Applicants: Coalinga Cogeneration Company.
    Description: Coalinga Cogeneration Company submits its Baseline
Filing of FERC Electric Tariff, pursuant to Order No 714, to be
effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5112.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2363-000.
    Applicants: Kern River Cogeneration Company.
    Description: Kern River Cogeneration Company submits tariff filing
per 35.12: Kern River Cogeneration Company Baseline Filing to be
effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5113.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2364-000.
    Applicants: Mid-Set Cogeneration Company.
    Description: Mid-Set Cogeneration Company submits tariff filing per
35.12: Mid-Set Cogeneration Company Baseline Filing to be effective 8/
25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5114.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2365-000.
    Applicants: Salinas River Cogeneration Company.
    Description: Salinas River Cogeneration Company submits tariff
filing per 35.12: Salinas River Cogeneration Company Baseline Filing to
be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5115.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2366-000.
    Applicants: Sargent Canyon Cogeneration Company.
    Description: Sargent Canyon Cogeneration Company submits tariff
filing per 35.12: Sargent Canyon Cogeneration Company to be effective
8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5116.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2367-000.
    Applicants: Sycamore Cogeneration Company.
    Description: Sycamore Cogeneration Company submits tariff filing
per 35.12: Sycamore Cogeneration Company Baseline Filing to be
effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5117.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2368-000.

    Applicants: Laredo Ridge Wind, LLC.
    Description: Laredo Ridge Wind, LLC submits tariff filing per
35.12: Laredo Ridge Wind Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5118.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2369-000.
    Applicants: Taloga Wind, LLC.
    Description: Taloga Wind, LLC submits tariff filing per 35.12:
Taloga Wind Baseline Filing to be effective 8/25/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5119.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-21656 Filed 8-30-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Proposed Rules]
[Pages 26030-26031]
[FR Doc No: 2019-11757]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0800; FRL-9994-50-Region 4]

Air Plan Approval; KY; Jefferson County Existing and New VOC
Storage Vessels Rule Changes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Jefferson County portion of the Kentucky State
Implementation Plan (SIP), submitted by the Commonwealth of Kentucky,
through the Energy and Environment Cabinet (Cabinet), through a letter
dated March 15, 2018. The revisions were submitted by the Cabinet on
behalf of the Louisville Metro Air Pollution Control District
(District, also referred to herein as Jefferson County) and make minor
ministerial amendments to applicability dates and standards for both
existing and new storage vessels for volatile organic compounds (VOC).
EPA is proposing to approve the changes because they are consistent
with the Clean Air Act (CAA or Act).

DATES: Comments must be received on or before July 5, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2018-0800 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Evan Adams of the Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-9009. Mr. Adams can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What action is EPA proposing?

    Through a letter dated March 15, 2018, KDAQ submitted SIP revisions
to EPA for approval that include changes to Jefferson County
Regulations 6.13 and 7.12.\1\ EPA is proposing to approve the changes
to Jefferson County Regulation 6.13, Standards of Performance for
Existing Storage Vessels for Volatile Organic Compounds, and Regulation
7.12, Standards of Performance for New Storage Vessels for Volatile
Organic Compounds. The SIP revisions update the current SIP-approved
versions of Regulation 6.13 (Version 6) and Regulation 7.12 (Version 6)
to Version 7 of each. The changes that are being proposed for approval
in this rulemaking, and EPA's rationale for proposing approval, are
described in more detail below.
---------------------------------------------------------------------------

    \1\ EPA notes that the Agency received these SIP revisions on
March 23, 2018, along with other revisions to the Jefferson County
portion of the Kentucky SIP. EPA will be considering action for
these other SIP revisions in a separate rulemaking.
---------------------------------------------------------------------------

II. EPA's Analysis of the State Submittal

    The changes to Jefferson County Air Quality Regulations 6.13 and
7.12 are administrative in nature and will better align the two
regulations, reconciling their respective applicability based on the
date of a facility's construction, modification, or reconstruction. In
the current SIP-approved versions, the regulations' applicability
overlaps by approximately four years, with Regulation 6.13 covering
facilities built or permitted before September 1, 1976, and Regulation
7.12 covering facilities built or modified on or after April 19, 1972.
Jefferson County has changed the date for Regulation 6.13, Standards of
Performance for Existing Storage Vessels for Volatile Organic
Compounds, so that it applies to VOC storage vessels that commenced
construction, modification, or reconstruction on or before April 19,
1972. The applicability date remains the same in Regulation 7.12,
Standards of Performance for New Storage Vessels for Volatile Organic
Compounds, but now applies to VOC storage vessels that commenced not
only construction or

modification but also reconstruction after April 19, 1972.
    Furthermore, the true vapor pressure standards of 78 millimeters of
mercury (mm Hg) (1.5 pounds per square inch absolute (psia)), which are
already outlined in Section 3, Standard for Volatile Organic Compounds
of both Regulation 6.13 and 7.12, have been added to Section 1,
Applicability, for both regulations.

III. Why is EPA proposing this action?

    The March 15, 2018, SIP revisions that are the subject of this
proposed rulemaking address the four-year overlap between the
applicability dates of standards for existing and new VOC storage
vessels. The SIP revision changes the date in Regulation 6.13 for
existing vessels and aligns it with the date in Regulation 7.12 for new
vessels. By adding the true vapor pressure value of 78 mm Hg (1.5 psia)
to the Applicability section of Regulation 6.13 and 7.12, the District
is clarifying that Regulations 6.13 and 7.12 apply to VOC storage tanks
with respect to which the true vapor pressure of the VOC as stored is
equal to or greater than 78 mm Hg (1.5 psia). EPA notes the full
regulations, including monitoring requirements, apply as described
therein. The regulations will continue to apply to sources with a true
vapor pressure of 1.5 psia, as established in Section 3, Standard for
Volatile Organic Compounds, and a capacity of 250 gallons. As the
District has indicated, the monitoring requirements in Sections 5.1 and
5.2 will also continue to apply to sources that, in addition to other
features described in Section 5.1, store a liquid having a true vapor
pressure greater than 1.0 psia.\2\ EPA views these changes as
administrative in nature and does not believe that they will result in
a change in emissions.
---------------------------------------------------------------------------

    \2\ See the Supplemental Letter dated April 3, 2019, located in
the docket.
---------------------------------------------------------------------------

IV. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference changes to the Louisville Metro Air Pollution Control
District portion of the Kentucky SIP at Regulation 6.13, Standards of
Performance for Existing Storage Vessels for Volatile Organic
Compounds, Version 7, and Regulation 7.12, Standards of Performance for
New Storage Vessels for Volatile Organic Compounds, Version 7, both
state effective January 17, 2018. EPA has made, and will continue to
make, these materials generally available through www.regulations.gov
and at the EPA Region 4 office (please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).

V. Proposed Action

    EPA is proposing to approve the aforementioned changes to the
Jefferson County portion of the Kentucky SIP because the changes are
consistent with section 110 of the CAA and will not interfere with the
NAAQS or any other applicable requirement of the Act. The changes are
administrative in nature and clarify the regulations' applicability.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
proposes to approve state law as meeting Federal requirements and does
not impose additional requirements beyond those imposed by state law.
For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: May 17, 2019.
Mary S. Walker,
Acting Regional Administrator, Region 4.
[FR Doc. 2019-11757 Filed 6-4-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 1, 2009 (Volume 74, Number 103)]
[Notices]
[Page 26248-26249]
[DOCID:fr01jn09-51]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0464] (formerly Docket No. 2005N-0403)

Guidance for Industry on Providing Regulatory Submissions in
Electronic Format--Drug Establishment Registration and Drug Listing;
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Providing Regulatory
Submissions in Electronic Format--Drug Establishment Registration and
Drug Listing.'' This guidance document is designed to assist industry
(e.g., manufacturers, repackers, and relabelers) with the electronic
submission of drug establishment registration and drug listing
information. Specifically, the document provides guidance to industry
on the types of information to include for purposes of drug
establishment registration and drug listing and on how to prepare and
submit the information in an electronic format that FDA can process,
review, and archive.

DATES:  Submit written or electronic comments on agency guidances at
any time. As of June 1, 2009, FDA will only accept electronic
submissions of drug establishment registration and drug

listing information, unless a waiver is granted.

ADDRESSES:  Submit written requests for single copies of this guidance
to the Office of Critical Path Programs (HF-18), Office of the
Commissioner, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one self-addressed adhesive label to assist
that office in processing your requests. The guidance may also be
obtained by mail by calling the Office of Critical Path Programs at
301-827-1512. Submit written comments on the guidance to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  Lonnie Smith, Office of Critical Path
Programs (HF-18), Office of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Requirements for drug establishment registration and drug listing
are set forth in section 510 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360) and section 351 of the Public Health
Service Act (the PHS Act) (42 U.S.C. 262) and 21 CFR part 207.
Fundamental to FDA's mission to protect the public health is the
collection of this information, which is used for important activities
such as postmarket surveillance for serious adverse drug reactions,
inspection of drug manufacturing and processing facilities, and
monitoring of drug products imported into the United States.
Comprehensive, accurate, and up-to-date information is critical to
conducting these activities with efficiency and effectiveness.
    Changes in the act, resulting from the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Public Law 110-85), require that drug
establishment registration and drug listing information be submitted
electronically, unless a waiver is granted. Before FDAAA was enacted,
section 510(p) of the act expressly provided that drug establishment
registration information must be submitted electronically, based on a
finding that electronic receipt was feasible, and section 510(j) of the
act stipulated that drug listing information must be submitted in the
form and manner prescribed by FDA. Section 224 of FDAAA, which amends
section 510(p) of the act, now expressly requires drug listing to be
submitted by electronic means in addition to requiring electronic drug
establishment registration.
    Drug establishment registration and drug listing information have,
until now, been submitted using a paper-based format, i.e., Form FDA
2656 (Registration of Drug Establishment/Labeler Code Assignment), Form
FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered
Establishments' Report of Private Label Distributors). Moving from a
paper-based format to an electronic system will improve the timeliness
and accuracy of the submissions.
    This guidance is designed to assist manufacturers, repackers, and
relabelers with electronic submissions of drug establishment
registrations and drug listing information. The guidance and
accompanying technical documents explain (among other things):
     The statutory requirement to submit electronically drug
establishment registration and drug listing information;
     How to create a Structured Product Labeling (SPL) file for
submitting drug establishment registration and drug listing information
to FDA through the Electronic Submissions Gateway (ESG) using defined
code sets and codes, i.e., a language recognized by the computer
system; and
     That FDA intends to no longer accept drug establishment
registration and drug listing information in paper format, unless a
waiver is granted.
FDA encourages manufacturers, repackers, and relabelers to establish a
gateway account as soon as possible so that they will be prepared to
electronically submit drug establishment registration and drug listing
information by June 1, 2009.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on providing regulatory submissions in
electronic format for drug establishment registration and drug listing
information. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection(s) of information in this guidance was approved under OMB
control number 0910-0045.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/
guidelines.htm, http://www.fda.gov/cvm/guidance/guidance.html, and
http://www.regulations.gov.

    Dated: May 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12743 Filed 5-28-09; 4:15 pm]

BILLING CODE 4160-01-S