MEMORANDUM
To: 		Docket EPA-HQ-OAR-2023-0072
From: 		U.S. EPA
--------------------------------------------------------------------------------
Subject: 	Proposed Regulatory Approach for Emission Guidelines for Existing Fossil Fuel-fired Stationary Combustion Turbines References
--------------------------------------------------------------------------------

THE FOLLOWING ARE REFERENCES THE U.S. Environmental Protection Agency (EPA) cited in section XI (Proposed Regulatory Approach for Emission Guidelines for Existing Fossil Fuel-fired Stationary Combustion Turbines) of the preamble of the proposed New Source Performance Standards for Greenhouse Gas Emissions from New, Modified, and Reconstructed Fossil Fuel-Fired Electric Generating Units; Emission Guidelines for Greenhouse Gas Emissions from Existing Fossil Fuel-Fired Electric Generating Units; and Repeal of the Affordable Clean Energy Rule.


[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Notices]
[Page 50701]
[FR Doc No: 2012-20612]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Gastrointestinal Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 16, 2012, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Cindy Hong, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), to find
out further information regarding FDA advisory committee information. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss the safety and efficacy of new
drug application (NDA) 203441, with the proposed trade name GATTEX
(teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc,
for the proposed indication of treatment of adult patients with short
bowel syndrome.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
September 28, 2012. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before September 20, 2012.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by September 21, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Cindy Hong at least
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 17, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-20612 Filed 8-21-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36822-36824]
[FR Doc No: 2015-15711]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1837]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic User Fee Payment Request Forms

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Electronic User Fee Payment Request Forms.

DATES: Submit either electronic or written comments on the collection
of information by August 25, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or

provide information to a third party. Section 3506(c)(2)(A) of the PRA
(44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Electronic User Fee Payment Request Forms--Form FDA 3913 and Form FDA
3914 (OMB Control Number (0910-NEW)

    The Government Paperwork Elimination Act (GPEA), Public Law 105-
277, title XVII, was signed into law on October 21, 1998. GPEA requires
Federal Agencies to allow individuals or entities that deal with the
Agencies the option to submit information or transact business with the
Agency electronically, when practicable, and to maintain records
electronically, when practicable. Its goal is to encourage agencies to
incorporate technologically improved respondent reporting as this
process typically lowers the burden on the respondent. GPEA allows FDA
to collect information relating to a user fee payment refund request
and transfer request.
    Form FDA 3913, User Fee Payment Refund Request, is designed to
provide the minimum necessary information for FDA to review and process
a user fee payment refund. The information collected includes the
organization, contact, and payment information. The information is used
to determine the reason for the refund, the refund amount, and who to
contact if there are any questions regarding the refund request. A
submission of the User Fee Payment Refund Request form does not
guarantee that a refund will be issued. FDA estimates an average of
0.40 hours per response, including the time to review instructions,
search existing data sources, gather and maintain the data needed, and
complete and review the collection of information. The estimated hours
are based on past FDA experience with the user fee payment refund
request.
    In fiscal year 2014, approximately 1,741 user fee refunds were
processed for cover sheets and invoices including 27 for Animal Drug
User Fee Act, 5 for Animal Generic Drug User Fee Act, 3 for Biosimilar
Drug User Fee Act, 1 for a Center for Tobacco Products Civil Money
Penalties, 216 for Export Certificate Program, 79 for Freedom of
Information Act requests, 523 for Generic Drug User Fee Amendments, 539
for Medical Device User Fee Amendments, 266 for Mammography inspection
fee, 81 for Prescription Drug User Fee Act, and 1 for a Tobacco product
fee.
    Form FDA 3914, User Fee Payment Transfer Request, is designed to
provide the minimum necessary information for FDA to review and process
a user fee payment transfer request. The information collected includes
payment and organization information. The information is used to
determine the reason for the transfer, how the transfer should be
performed, and who to contact if there are any questions regarding the
transfer request. A submission of the User Fee Payment Transfer Request
form does not guarantee that a transfer will be performed. FDA
estimates an average of 0.25 hours per response, including the time to
review instructions, search existing data sources, gather and maintain
the data needed, and complete and review the collection of information.
FDA estimated hours are based on past FDA experience with the user fee
payment transfer request.
    In fiscal year 2014, approximately 1,291 user fee payment transfers
were processed for cover sheets and invoices including 21 for Animal
Drug User Fee Act, 2 for Animal Generic Drug User Fee Act, 544 for
Generic Drug User Fee Amendments, 627 for Medical Device User Fee
Amendments, and 97 for Prescription Drug User Fee Act.
    Respondents for the electronic request forms include domestic and
foreign firms (including pharmaceutical, medical device, etc.).
Specifically, refund request forms target respondents who submitted a
duplicate payment or overpayment for a user fee cover sheet or invoice.
Respondents may also include firms that withdrew an application or
submission. Transfer request forms target respondents who submitted
payment for a user fee cover sheet or invoice and need that payment to
be re-applied to another cover sheet or invoice (transfer of funds).
    The electronic user fee payment request forms will streamline the
refund and transfer processes, facilitate processing, and improve the
tracking of requests. The burden for this collection of information is
the same for all customers (small and large organizations). The
information being requested or required has been held to the absolute
minimum required for the intended use of the data. Customers will be
able to request a user fee payment refund and transfer online at http://www.fda.gov/forindustry/userfees/default.htm. This electronic
submission is intended to reduce the burden for customers to submit a
user fee payment refund and transfer request.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR Section                               Number of     responses per   Total annual    Average burden per    Total hours
                                                                       respondents     respondent       responses          response
--------------------------------------------------------------------------------------------------------------------------------------------------------
User Fee Payment Refund Request--Form FDA 3913.....................           1,700               1           1,700    0.40 (24 minutes)             680
User Fee Payment Transfer Request--Form FDA 3914...................           1,700               1           1,700    0.25 (15 minutes)             425
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ..............  ..............  ..............  ...................           1,105
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15711 Filed 6-25-15; 8:45 am]
 BILLING CODE 4164-01-P


FHWA Comments on EPA’s PM2.5 Implementation Rule:

[Note:   FHWA may have additional comments on the proposed rule and will
forward them by Monday, Nov. 8, 2004]

Major Comments:

In general, we have major concerns on 5 issues and we would like to
discuss them further with EPA and OMB.

PM2.5 nonattainment designations:  The proposed rule states that EPA’s
plan to finalize the PM2.5 nonattainment designations by Nov. 2004 with
a effective date in early 2005.  However, it did not mention that for
conformity purposes, both for transportation and general conformity,
areas are required to demonstrate conformity one year after the
effective designation date.  That means areas need to start working on
their PM2.5 conformity analyses soon, in order to meet the early 2006
deadline.  However, given that part of the conformity requirements for
PM2.5 are not finalized yet, designations of PM2.5 areas without a final
conformity rule in place will effectively take away the intended grace
period as areas have no idea what analysis is necessary.  If the
conformity rule is finalized during the grace period, areas will have a
much shorter grace period to meet the requirements.  Therefore, we
strongly urge that the designation process coordinated with the
different related rule making to minimize potential impacts on many
areas’ transportation programs and projects.  This is significant
issue and must be addressed.

Hot spot issue:  On page 33, the proposal states, “…we believe that
PM2.5 nonattainment problems generally are not attributable to
“hot-spot” situations caused by a single facility or high traffic
roadway.”  In addition, the footnote on this page states, “Results
of research studies are not conclusive on the existence of PM2.5
hot-spots due to transportation-related sources.”  However, EPA’s
position in the preamble to the supplemental transportation conformity
NPRM for PM-2.5 hot-spots drafted is not consistent with this proposal.
If EPA believes that hot spots are generally not a nonattainment
problem, then the supplemental conformity NPRM should be revised to be
consistent.  We tend to agree with the assessment in the proposal
implementation rule.

Also on Page 135, the proposal states, “A “hot spot analysis” is
also described which may be applied at other, unmonitored locations
where there is concern that concentrations of PM2.5 may be high.”
However, it is not clear how this “hot spot analysis” relates to
attainment demonstrations, or conformity requirements, especially in
light of the early discussions of PM-2.5 as a regional, not localized,
pollutant.  Recommend that this be clarified or the statement deleted.

PM2.5 Precursors:  On page 81, the proposal states, “An additional
consideration is that the majority of potential PM2.5 nonattainment
areas are areas already designated as nonattainment for the 8-hour ozone
standard. Because the ozone areas will be required to address NOx for
ozone control strategy purposes (as well as for the NSR and
transportation conformity programs), the additional burden associated
with including NOx as a precursor under the PM2.5 implementation program
may only apply to 5 areas that are nonattainment for PM2.5 but not for
the 8-hour ozone standard. For PM2.5 areas that are also violating the
8-hour ozone standard, strategies to reduce NOx emissions will help
address both air pollution problems.”

We strongly disagree with the above statement.  Ozone is predominately
formed in the summer.  However, as stated in the proposal itself,
Nitrates are formed primarily in the winter months.  Therefore, there
will be additional burden in all areas.  Air quality modeling will have
to be done for several seasons.  Motor vehicle emissions tests will have
to be done for two seasons.  Emission factor models will have to be run
for two seasons.  These are just examples.  In addition, emissions
factors vary by temperature, and a control strategy that may achieve
certain emissions reductions during one season, may not achieve those
reductions in another season.  Also, the nonattainment boundary for
ozone and PM2.5 may be different and they may have to run different
analysis to be consistent with the nonattainment area boundary.
Therefore, this logic of no “additional burden” is not correct and
should not be used to justify requiring NOx control prior to SIPs.

This is especially bothersome considering that this will add additional
burden to most areas outside of California, since nitrates are, by
statement in the proposal itself, only 6-8% of PM-2.5.  This simply does
not justify requiring that NOx be addressed prior to SIPs anywhere,
except possibly in California.

Finally, an analysis should be done of when the subject areas are
experiencing violations.  Since the proposal states that NOx is
primarily a winter issue, if these areas are only experiencing PM-2.5
violations during the summer, there seems to be little value or
justification in requiring them to comply with the additional burden of
considering NOx prior to SIPs.

This comment applies also to a similar discussion on P. 81.  On page 81,
the proposal states, “An additional consideration is that the majority
of potential PM2.5 nonattainment areas are areas already designated as
nonattainment for the 8-hour ozone standard. Because the ozone areas
will be required to address NOx for ozone control strategy purposes (as
well as for the NSR and transportation conformity programs), the
additional burden associated with including NOx as a precursor under the
PM2.5 implementation program may only apply to 5 areas that are
nonattainment for PM2.5 but not for the 8-hour ozone standard. For PM2.5
areas that are also violating the 8-hour ozone standard, strategies to
reduce NOx emissions will help address both air pollution problems.”
Again, based on the comments presented above, we strongly disagree with
this statement.

Conformity issues –

When both general and transportation conformity should be addressed in
the proposal.  In many parts of the proposal, only transportation
conformity was discussed.

Transportation conformity discussions needs to be updated to reflect the
July 1, 2004 rule and the upcoming rulemaking efforts to address PM2.5
precursors and hot spot analysis.

Page 287.  Recommend that the second paragraph reference the July 1,
2004 transportation conformity rulemaking instead of the 1997
rulemaking, as larger portions of the 1997 rulemaking are no longer
applicable.

Section 4, on page 289 needs to be updated to reflect the July 1, 2004
rulemaking.   PM-2.5 is now addressed in the rule, except for PM-2.5
precursors and hot-spots.  This entire section is out of date, and needs
to be completely revised.

Section 6, on page 290 needs to be updated to reflect the July 1, 2004
rulemaking; in particular the last sentence of this section.

Section 8, on page 292.  The parenthetical at the end of this section
should be updated to reflect the July 1, 2004 rulemaking.

Page 294.  The citation on the last line of the page needs to be updated
to reflect the July 1, 2004 rulemaking.

Page 391 should be updated and revised to reflect MOBILE6.2 as the most
current emissions model outside of California, and EMFAC2002 for
California.

Page 461 should mention EPA’s upcoming guidance on adjusting road dust
inventories to more accurately reflect observed conditions.

 RACM and TCMs:  We are concerned with the many discussions of RACM and
TCMs in the preamble.

On page 174.  A key component of reasonableness is missing.  A measure
is not considered to be RACM if it does not advance the attainment date.
 (See page 217 on RACT; highlight here.) This point has been upheld in
court decisions and should not be lost in the discussion here.  It is
vital that the preamble not imply that emissions reductions that do not
advance the attainment date are RACM.

On page 252, the proposal states, “The demonstration should show that
there are no additional reasonable measures available that would
meaningfully advance the attainment date or contribute to RFP for the
area.”  The term “meaningfully advance” is not all that clear.
Instead, it is recommended that the proposal reiterate here the language
used on page 217 that measures are only RACM if the advance the
attainment date a year.

Starting on page 255, the proposal states, “In the past under other
SIP programs, States may have rejected a single measure under
consideration as RACM because the emission reduction benefits from that
measure alone would not advance the attainment date by one year. The EPA
does not believe this approach is appropriate under section 172. For the
PM2.5 program, our approach is to emphasize the collective evaluation of
RACM measures and whether they will advance the attainment date when
taken together. We believe that the State should not reject an
individual measure unless the State can show that it has evaluated the
collective effect of that measure plus all other available control
measures to determine whether implementing those measures together would
advance the attainment date.”

Why is EPA changing this interpretation?  Is this consistent with the
RACM court decision (Sierra Club v. EPA, 294 F.3d 155 (D.C. Cir. 2002)?
If this is not current policy for ozone and other pollutants, then we
would strongly object to any changes to this definition of RACM.

On page 262, revise to state, “However, under current EPA policy we do
not presume that any or all of these measures are reasonably available
in any areas.”  As written, the proposal still implies that some of
the measures are reasonably available for all areas, and this is not the
case.

On page 263, revise to state, “…we do not believe it is appropriate
to include a presumption that any of these measures should be considered
RACM for any PM2.5 nonattainment area.”  See preceding comment.

On page 263, the proposal states, “PM2.5 monitoring data show that
organic and elemental carbon typically make up a significant percentage
(e.g., 25 percent or more) of the PM2.5 mass in most urban areas, and
analyses have shown that transportation sources are significant emitters
of these PM2.5 components. For this reason, we believe that States
should give serious consideration to TCMs in their RACM analyses.”
We strongly disagree with this conclusion.  This recommendation should
be deleted from the proposal.  It is not needed anyway, as the proposal
already states that all measures must be considered.  There is no reason
to specifically call out TCMs here.  Although transportation sources may
be significant sources of PM2.5 in some areas, we are not sure whether
TCMs are the most cost-effective way to achieve significant emission
reductions.

On page 263, revise to state, “However, experience has shown that
local circumstances vary to such a degree from city to city that it
would not be reasonable to assume that any section 108(f) measures are
reasonably available in any areas.

Page 285 of the proposal states, “Examples of voluntary mobile source
measures include transportation control measures, ozone action plans,
and trip reduction strategies.”  This implies that all TCMs are
voluntary measures, and this is not correct.  Recommend deleting
“transportation control measures from this sentence, and if necessary
replace with a specific example of a voluntary measure.

Page 485. Is this consistent with the RACM court decision (Sierra Club
v. EPA, 294 F.3d 155 (D.C. Cir. 2002)?  If this is not current policy
for ozone and other pollutants, then we would strongly object to any
changes to this definition of RACM that require consideration of
cumulative effects.

Other comments:

 On pages 55-58, the proposal discusses the sources of primary PM bases
on the National Emissions Inventory (NEI).  This is somewhat misleading,
and should focus just on PM-2.5.  For example, the proposal states that
one of the main sources of these particles is re-entrained dust.  It
then states that much of these particles are course rather than fine.
But since this proposal deals with fine particles, it seems out of place
to highlight the sources of PM-10.  This could be confusing to the
reviewer and potential commenter.  Recommend that this section be
revised to focus on PM-2.5 sources.

On page 62, the proposal states, “The main sources of NOx are
combustion of fossil fuel in boilers and onroad mobile sources.”  It
also states that these sources account for 80% of NOx emissions with
each contributing about half.  This does not seem to be correct.  The
2002 and 2003 numbers show that fuel combustion electrical utilities and
highway vehicles only account for 57% of emissions.  Also, as alluded to
elsewhere in the proposal, non-road mobile sources are also a major
source of NOx.  And, over the past decades, while on-road emissions have
decreased significantly, non-road emissions have continued to grow.
Also, according to the NEI, industrial fuel combustion is also a fairly
large source of NOx.  Therefore, this section needs to be updated to
reflect the recently release 2002 or 2003 numbers, and should also list
non-road sources as a major source.

Page 75.  Section 182(f) of the Clean Air Act can also apply to other
sources besides “major stationary sources,” and waive NOx
requirements for ozone.

Page 78. Conformity, both transportation and general conformity take
effect one year after the effective date of designations.

Page 80.  In the first full sentence on the page, shouldn’t this be
“attainment demonstrations SIPs” instead of “nonattainment
SIPs?”

Page 88.  The proposal has left blank the proposed design value for
which areas would be classified as serious under this option.  This is a
vital piece of information that is needed to evaluate this proposal.  In
addition, the proposal should clearly give a basis for this value.

Page 94.  Rural transport nonattainment areas would also be subject to
general conformity.

On page 96, the proposal states that only 1 area may meet the criteria
for a rural transport area.  What is the area?  Since there is only 1
area, it is recommended that the proposal go ahead and identify it,
providing a clearer example of the type of area this section is
referring to.

On page 97, the proposal states, “Under the current schedule,
nonattainment area designations are to be finalized in December 2004.”
 This is inconsistent with earlier in the document.

Page 102-104.  The dates in the example that begins on the bottom of
page 102 should be revised to reflect the actual proposed attainment
dates.  Areas will start with a presumed 2010 attainment date, not 2012.
 The years examined would be 2007, 2008, and 2009, with a 1-year
extension possible to 2011.

Pages 144-146 of the proposal discuss trying to align modeling years.
However, this does not address the issue of seasonal variation.  Even if
you look at ozone, PM-2.5, and regional haze for the same year, each
pollutant or the haze problem, could actually be worse during different
seasons.  How do areas look at this seasonal variation?  Would they need
to look at all three, for two or three different times of the year?  The
proposal seems to imply that one attainment modeling could cover both
ozone and PM-2.5, but depending on the nature of the PM-2.5 problem,
this may not be the case.  This needs to be addressed and clarified.

Page 149.  Would these RFP plans be required to contain motor vehicle
emissions budgets?  It is assumed that they would.  In that case, this
should be highlighted in this section and cross-referenced with the
conformity section.

Page 157.  2010 is proposed as the first RFP milestone year.  Will this
be consistent with the ozone implementation plan attainment dates and
RFP?  It seems that it would be beneficial to have these years aligned.
Also, how does this fit with inventory requirements?  It seems to be
off-cycle.  Periodic inventories will be due in 2005, 2008, 2011, 2014,
etc.  Wouldn’t it be better and conservative of resources, if the RFP
milestone years aligned with the inventory years?

Page 187.  This section discusses using a different geographic area than
the nonattainment area for RFP purposes.  However, if the RFP SIP
establishes a motor vehicle emissions budget, it should only be for the
nonattainment area, as conformity only applies in nonattainment or
maintenances areas.  This issue should be discussed and cross-referenced
with the conformity section.

Page 202 begins a section on what precursors apply to RACT.  However, it
only discusses NOx, VOCs, and ammonia.  What about SO2, which is
mentioned in the first sentence of the section, but not discussed as
whether it applies to RACT.

On page 266, the proposal states, “Programs to expand use of clean
burning fuels (such as biodiesel).”  Can’t biodiesel actually
increase NOx emissions?  If this is the case, it is recommended that the
phrase “such as biodiesel” be deleted.

On page 267, “Reduce dust from paved and unpaved roads” is listed as
an area source.  This should be moved under mobile sources.  Dust from
paved and unpaved roads, if significant, will need to become part of the
on-road motor vehicle emissions budget.  There has been a great deal of
confusion in regards to this issue in the past.  As listed under areas
sources, this may confuse readers.

Section 11, on page 295 needs to be updated to reflect the withdrawal of
the CADC program proposal.

Page 301.  Please see above comments on designations and effective
dates.

On page 318, the proposal states, “We do not believe that this creates
a major regulatory burden because NOx is already a regulated NSR
pollutant. This is because it is a precursor for the ozone NAAQS and an
indicator for the NO2 NAAQS.”  Does this conclusion account for the
fact that ozone is a summer problem, whereas PM-2.5 may be a year-round
pollutant that the PM-2.5 NOx  may be a winter problem?

Page 378 states, “The EPA plans to address these concerns in a future
Tribal NSR rule, which is scheduled for proposal in early 2004.”  This
should be updated.