[Federal Register Volume 76, Number 102 (Thursday, May 26, 2011)]
[Notices]
[Pages 30724-30725]
[FR Doc No: 2011-13058]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0153]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry and Food and Drug Administration Staff: Food and Drug
Administration and Industry Procedures for Section 513(g) Requests for
Information Under the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by June
27, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Draft Guidance for Industry and FDA Staff: FDA and Industry
Procedures for Section 513(g) Requests for Information Under the
Federal Food, Drug, and Cosmetic Act.'' Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Draft Guidance for Industry and FDA Staff: FDA and Industry Procedures
for Section 513(g) Requests for Information under the Federal Food,
Drug, and Cosmetic Act--(OMB Control Number 0910-NEW)

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain
approval from 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, in the Federal Register of April 29, 2010
(75 FR 22599), FDA published a notice of availability of the draft
guidance document providing a 60-day public comment period on the
proposed collection of information provisions.
    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.
    Title: Draft Guidance for Industry and FDA Staff: FDA and Industry
Procedures for Section 513(g) Requests for Information Under the
Federal Food, Drug, and Cosmetic Act.
    Description: Section 513(g) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360c(g)) provides a means for obtaining
the Agency's views about the classification and regulatory requirements
that may be applicable to your particular device. Section 513(g)
provides that within 60 days of the receipt of a written request of any
person for information respecting the class in which a device has been
classified or the requirements applicable to a device under the FD&C
Act, the Secretary of Health and Human Services shall provide such
person a written statement of the classification (if any) of such
device and the requirements of the FD&C Act applicable to the device.
    Section 513(g) of the FD&C Act provides a means for obtaining FDA's
views about the classification and the regulatory requirements that may
be applicable to a particular device. The purpose of this draft
guidance is to establish procedures for submitting, reviewing, and
responding to requests for information respecting the class in which a
device has been classified or the requirements applicable to a device
under the FD&C Act that are submitted in accordance with section 513(g)
of the FD&C Act. FDA does not review data related to substantial
equivalence or safety and effectiveness in a 513(g) request for
information. FDA's responses to 513(g) requests for information are not
device classification decisions and do not constitute FDA clearance or
approval for marketing. Classification decisions and clearance or
approval for marketing require submissions under different sections of
the FD&C Act. Additionally, the FD&C Act, as amended by the FDA
Amendments Act of 2007 (Pub. L. 110-85), requires FDA to collect user
fees for 513(g) requests for information.
    In the Federal Register of April 29, 2010, FDA published a 60-day
notice requesting public comment on the proposed collection of
information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Average
                                     Number of       Number of     Total annual     burden per
         FD&C Act 513(g)            respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Center for Devices and                       110               1             110              12           1,320
 Radiological Health (CDRH).....
Center for Biologics Evaluation                4               1               4              12              48
 and Research (CBER)............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,368
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents to this collection of information are mostly device
manufacturers; however, anyone may submit a 513(g) request for
information. The total number of annual responses is based on the
average number of 513(g) requests received each year by the Agency. FDA
based its estimates on the number of 513(g) requests for information
received by both CDRH and CBER from 2007 to 2009.

    Dated: May 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13058 Filed 5-25-11; 8:45 am]
BILLING CODE 4160-01-P


Commenter 0169 stated that they do not support EPA's first co-proposal. The commenter stated that using a unit's best historical one year average is unreasonable, illogical, and arbitrary; a unit may have one year where heat rate is optimized based on ambient temperature, water temperature, electricity demand, equipment operation or availability, etc., but it is unreasonable to believe that these same conditions will be sustainable year after year. The commenter stated that recommended using an annualized CO2 emission rate that is based on a 10-year average would account for major and minor outage years, and heat rate degradation that occurs between outages. The commenter stated that it is also unreasonable to presume that any given unit can achieve a 2 percent HRI and that EPA should normalize data to determine what emission rate is possible, but discourages using every theoretical heat rate improvement possible to make this determination.
The commenter stated that the proposal for modified units to not have to meet an emission standard more stringent than the corresponding standard for reconstructed EGUs is so stringent that it would take reconstruction to actually meet it and a modified unit may still not be able to be 2 percent better than its best year due to external factors such as weather, water temperatures, operating duty, and auxiliary load requirements; other factors that affect HRI include dispatch and whether pollution control equipment has been installed in response to regulatory requirements.  The commenter stated that for these reasons, it is not appropriate to require that the best historical emission rate be made 2 percent more stringent than best operating practices recorded since 2002; in other words, best should be defined with reference to current operating conditions, not past conditions that are no longer representative of an EGU's current operations. The commenter recommended a ten consecutive year average to determine the best historical emission rate and if EPA insists on a shorter time period, they recommended that the period of best historical performance should not be determined at the time of modification because unit may have already completed energy efficiency projects in anticipation for compliance with the ESPS. The commenter stated that using the best 10 consecutive year average emission rate without the automatic application of the 2 percent reduction during the years 2002 to the year the modification occurs is potentially more achievable than any one best year's performance.
Commenter 0142 stated that basing a proposed standard upon a historic emission rate is problematic, unfair, and does not appropriately reflect the inherent nature of electric generation. The commenter stated that selection of the baseline year is critical, because CO2 emission rates vary over time and there must be room for a 2 percent reduction in CO2 emissions below that baseline year, given the limited range of technically feasible and economically reasonable optimization methods that are available. The commenter stated that historic variability has little to do with add-on controls, but rather how the unit was dispatched, weather conditions, temperature of cooling water, type and blend of fuel fired, normal wear and tear, degradation of equipment over time, etc. The commenter stated that because the CO2 emission rate varies over time, any applied standard of performance based upon the lowest CO2 emission rate over that time period would be expected to increase, since it was the lowest emission rate selected; there is evidence that factors beyond the control of the unit operators will cause a modified unit's CO2 to creep up over time. The commenter recommended that if the EPA follows this approach, that a three year average from historic emission rates be utilized and that CO2 emission limits remain in effect until the next modification or for a period of five years, whichever comes first.
Commenter 0204 stated that BSER standard should not be the best historical annual emissions rate, since this does not factor in variables that can affect a unit's performance and CO2 emissions, such as load, fuel quality, and temperature; at a minimum, the best three consecutive year average emission rate is more appropriate in order to account for these variables. The commenter stated that EPA should consider allowing an averaging period up to five years, which is the period allowed for evaluating a modification under NSR air permitting requirements and should also accommodate cases where there is insufficient historic operation data to reflect recent physical or operational changes at a source, such as switching from bituminous to sub-bituminous coal or adding on air pollution control equipment. The commenter stated that these types of operational changes would result in a higher net heat rate at the source, and EPA should ensure that the BSER emission limit reflects those higher heat rates.
Commenter 0187 stated that the interval between major outages at coal-fired EGUs is typically three to four years, they support using the unit's best performance based on a three-year average longer (e.g., four-year average); it should not be based on an annual average.
Commenter 0192 stated that if EPA proceeds with a standard of performance based on historical emissions, they urge EPA to base the standard on the facility's emissions over a three-year period rather than a one-year period. The commenter stated that expanding the measurement period to three years will mitigate the risk of basing the standard on a narrow and unrepresentative time frame that reflects unique conditions that are unlikely to occur with regularity. The commenter stated that a three-year period will be more likely to encompass a wide range of operating conditions that more accurately reflects the conditions that a facility will experience in the future after a modification occurs; a longer measurement period will also be more likely to account for the declining performance of heat rate improvements over time and reflect a broader portion of cycle over which routine maintenance activities occur.
The EPA is only finalizing standards for EGUs that conduct modifications resulting in an increase in potential CO2 hourly emissions of more than 10 %. Based on historical trends, we expect few, if any, EGUs to trigger that threshold and become subject to the finals standards. Those that do will do so only after taking actions  -  likely capital intensive actions  -  that trigger the modification provisions. Sources undertaking such capital-intensive projects can take steps to avoid triggering modification, such as measures to avoid increasing their emissions of pollutants  -  or can take measures at the time of the capital-intensive modification project to ensure that the final standard can be achieved. The EPA believes that a final standard of performance based on the units best historical single year adequately captures the expected operational variation and that the resulting standard is achievable via a combination of equipment upgrades and best operating practices  -  or using alternative compliance options such as natural gas co-firing.
Prefer Alternative #1, but period of best historical performance should be years from 2002 to the time when the unit becomes subject to section 111(d).
Commenter 0178 stated that they while they support EPA's first proposed alternative, if EPA finalizes a rule under which units are subject to requirements under both Sections 111(b) and 111(d), EPA should ensure that units are not required to make unreasonable heat rate improvements pursuant to Section 111(b) if they already have made improvements subject to a Section 111(d) plan. The commenter stated that, for example, under the first alternative, the period of best historical performance should be the years from 2002 to the time when the unit becomes subject to the CAA Section 111(d) plan, rather than to the time of the modification. According to the commenter, this would address the concern that sources that make improvements to their CO2 emission rate as a result of a CAA Section 111(d) plan would have lower baseline emissions from which to calculate their required rate. The commenter stated that, further, modified utility boilers and IGCC units that already have become subject to a CAA Section 111(d) plan should not be required to meet the two percent additional emission reduction based on equipment upgrades where the state plan requires heat rate improvements for such sources, or where the source has recently implemented measures to improve its operating efficiency. The commenter stated that in these circumstances, the additional two percent improvement would be unreasonable; this will avoid creating a perverse incentive under which plants would have no reason to invest in heat rate improvements if they anticipate making a future modification that will trigger Section 111(b).
 The EPA is not finalizing standards that are dependent on the timing of the modification.
Heat rates prior to a PCP should not be used in determining best historical CO2 emission rate.
Several commenters (0192, 0239) stated that since 2002, many units have installed pollution control equipment to meet federal air pollution requirements with the result that boiler unit heat rates (e.g. efficiency) are degraded due to the parasitic power load of the pollution control equipment. The commenter stated that this addition of parasitic load makes it challenging for a unit to even meet its best historical CO2 emission rate since 2002. The commenter stated that while pollution control projects (PCPs) are exempt from the definition of modification, other boiler modifications performed after a PCP could cause a unit to become subject to the proposed rule, making it difficult to achieve a pre-PCP heat rate.
 The EPA is only finalizing standards for EGUs that conduct modifications resulting in an increase in potential CO2 hourly emissions of more than 10 %. Based on historical trends, we expect few, if any, EGUs to trigger that threshold and become subject to the finals standards. Those that do will do so only after taking actions  -  likely capital intensive actions  -  that trigger the modification provisions. Sources undertaking such capital-intensive projects can take steps to avoid triggering modification, such as measures to avoid increasing their emissions of pollutants  -  or can take measures at the time of the capital-intensive modification project to ensure that the final standard can be achieved. The EPA believes that a final standard of performance based on the units best historical single year adequately captures the expected operational variation and that the resulting standard is achievable via a combination of equipment upgrades and best operating practices  -  or using alternative compliance options such as natural gas co-firing.
Prefer Alternative #1, but implement in a way that does not penalize investments in heat rate improvements.
Commenter 0260 stated that if EPA finalizes emission standards based on the proposed BSER determination, they support the first proposed alternative, with revisions. The commenter stated that for units that already have made significant heat rate improvements, they do not support an approach under which the time period for best historic performance would be from the year of the first heat rate improvement to the date of the modification as this would penalize units that already have invested in improvements. The commenter stated that the percentage of required emissions reductions from the unit's best demonstrated annual performance should take into account past efficiency improvements. Commenter 0260-14285 provided the following example: equipment upgrades are being conducted at two EGUs to improve heat rates that, when completed, will increase efficiency by approximately four percent overall; because these units already are performing the majority of best work practices that EPA recommends for improving heat rate, significant additional heat rate improvements are not possible; and if the units subsequently made modifications, they would not be able to reduce their emissions by an additional two percent. The commenter stated that EPA also should take into account the fact that, as existing NGCCs are dispatched more frequently pursuant to state Section 111(d) plans, modified and reconstructed coal-fired units will be dispatched less, resulting in the degradation of units' heat rate due to more frequent cycling.
Commenter 0178 stated that they support EPA's first proposed alternative, but it should be implement in a way that does not penalize investments in heat rate improvements. The commenter stated that for units that already have made significant heat rate improvements, they do not support an approach under which the time period for best historic performance would be from the year of the first heat rate improvement to the date of the modification; this would penalize units that already have invested in improvements. The commenter stated that the percentage of required emissions reductions from the unit's best demonstrated annual performance should take into account past efficiency improvements; if a unit subsequently makes modifications, it would not be able to reduce emissions by an additional two percent. The commenter stated that EPA also should take into account the fact that, as existing NGCCs are dispatched more frequently pursuant to state Section 111(d) plans, modified and reconstructed coal fired units will be dispatched less, resulting in the degradation of units' heat rate due to more frequent cycling.
The proposed additional 2% CO2 emission reduction is not being finalized. The EPA is only finalizing standards for EGUs that conduct modifications resulting in an increase in potential CO2 hourly emissions of more than 10 %. Based on historical trends, we expect few, if any, EGUs to trigger that threshold and become subject to the finals standards. Investments in heat rate improvements should not trigger the 10% threshold  -  actually heat rate improvements normally do not result in any increase of potential CO2 hourly emissions as they are actions that result in increased efficiency not in increased fuel-input capacity.
 EGUs that do trigger the modification standards will do so only after taking actions  -  likely capital intensive actions. Sources undertaking such capital-intensive projects can take steps to avoid triggering modification, such as measures to avoid increasing their emissions of pollutants  -  or can take measures at the time of the capital-intensive modification project to ensure that the final standard can be achieved. The EPA believes that a final standard of performance based on the units best historical single year adequately captures the expected operational variation and that the resulting standard is achievable via a combination of equipment upgrades and best operating practices  -  or using alternative compliance options such as natural gas co-firing.
Establish limit based on expected future operations including lower operating loads levels due to greater use of renewables.
Commenter 0162 stated that a modified source's new emission limit will need to be within the realm of what the unit's actual performance capabilities are at the load levels it will be called upon to operate. The commenter stated that the proposed GHG regulations emphasize a significant increase in the quantity of renewable energy being placed on the nation's grid and as more renewable energy is utilized, fossil fuel-fired electric generating units will increasingly be called on at lower load levels. Using the best historic numerical annual emission rate, as proposed, in order to determine the CO2 emission limit will not represent the emission rate that can be achieved by an affected unit; the historic operating data could represent primarily base-load (full-load) operating conditions. The commenter stated that to get a realistic picture of an affected source's CO2 emissions from fossil-fuel fired generating units for the purpose of determining emission limits, the source should be tested at the lower operating load levels required given the amount of expected renewable energy required by the proposed rule.
Commenter 0216 stated that if EPA chooses to adopt a unit-specific emission standard based on the unit's best historical emission rate, EPA should define best historical performance as the best rolling annual average emission rate from 2002 until the date the source undergoes modification, even if this date is after the source became subject to a 111(d) plan. The commenter stated that a standard of performance employing this alternative definition would be contrary to the requirements of 111, because it would not limit a modifying source's emission rate to the lowest rate adequately demonstrated for that source.
The EPA is only finalizing standards for EGUs that conduct modifications resulting in an increase in potential CO2 hourly emissions of more than 10 %. Based on historical trends, we expect few, if any, EGUs to trigger that threshold and become subject to the finals standards. Those that do will do so only after taking actions  -  likely capital intensive actions  -  that trigger the modification provisions. Sources undertaking such capital-intensive projects can take steps to avoid triggering modification, such as measures to avoid increasing their emissions of pollutants  -  or can take measures at the time of the capital-intensive modification project to ensure that the final standard can be achieved. The EPA believes that a final standard of performance based on the units best historical single year adequately captures the expected operational variation and that the resulting standard is achievable via a combination of equipment upgrades and best operating practices  -  or using alternative compliance options such as natural gas co-firing. Regarding the impact of greater renewable energy on operating levels, Section 2.6.5 of Chapter 2 of the `GHG Mitigation Measures' Technical Support Document discusses future capacity factors at coal-fired EGUs.
If total annual unit performance were to be used in attempting to identify a unit's best historical annual CO2 emission rate, CEMS data should not be applied in estimating the heat input.
Commenter 0226 stated that, although they oppose the use of total annual data to determine best year of operation in a particular time-period, if it were to be done in that way, the data should not come from a unit's CEMS. The commenter stated that the regulations in 40 CFR 75 for managing the quality of data from a CEMS allow a certain amount of variation in the CEMS data accuracy, which could lead to significant variation in calculated heat input which would lead to inaccurate heat rate calculations or inaccurate CO2 emission rate data.
Commenter 0226 stated that there have been issues in the past for sources that were attempting to measure heat input through CEMS data. The commenter stated that after installing CEMS as required by the Acid Rain Rule, many utilities noted that the CEMS were recording consistently higher heat input than conventional methods (input/output and output loss). The commenter stated that in the mid 1990's, to better understand the problem, EPRI studied the cause(s) for the high heat input and S02/CO2 emissions measurements. The commenter stated that the report, The Electric Power Research Institute Continuous Emissions Monitoring Heat Rate Discrepancy Project An Update Report- December 1996, indicated that Reference Method 2 had been found to be biased high. The commenter stated that instead of using CEMS data, they suggest that heat rate could be used as a performance indicator and that the total annual heat rate performance could be determined through measured fuel input and measured electricity production.
Chapter 2 of the `GHG Mitigation Measures' Technical Support Document discusses the impact that relative accuracy of CEMS might have on the results (Section 2.5.1) and the impact that changes in flow measurement might have on the results (Section 2.6.6). EPA believes the measurements from CEMS are the most accurate and most reliable measure to assess CO2 emissions rates and heat rates.
Commenter 0215 stated EPA requested comment on whether it should select a year prior to or subsequent to 2002 for purposes of determining the best historical emission rate. Commenter said some of the problems described above that are inherent in EPA's proposed approach might be alleviated to some extent by using the calendar year just before a modification as the baseline year. But this step would not account for the impact of future control retrofits, changes in fuels, changes in duty cycle, and other factors. Moreover, in the absence of any TSD and EPA's emissions database, it is not possible to analyze this issue in any detail. As discussed above, there are innumerable other factors that cause heat rate to deteriorate over time, including operations at lower capacity factors, operating more time at low loads, and normal wear and tear of the hundreds of components that comprise a boiler. Changes in loading order can result from variations in the price of natural gas, the availability or unavailability of other units in a system, and literally whether the sun shines or the wind blows with respect to renewable sources. Similarly, changes in the coal or coal blends burned, especially burning more Powder River Basin than bituminous coal, degrades efficiency. It would be arbitrary for any EPA rule to require that operational changes that occurred before the Agency proposed this rule should dictate the CO2 rate that a modified unit must achieve under the entire range of potential unit operations that affect heat rate. And it would be arbitrary to select any specific heat rate figure as reflective of future potential for improvement for the industry generally, given the numerous site-specific and temporal factors that affect unit heat rate.
The EPA is only finalizing standards for EGUs that conduct modifications resulting in an increase in potential CO2 hourly emissions of more than 10 %. Based on historical trends, we expect few, if any, EGUs to trigger that threshold and become subject to the finals standards. Those that do will do so only after taking actions  -  likely capital intensive actions  -  that trigger the modification provisions. Sources undertaking such capital-intensive projects can take steps to avoid triggering modification, such as measures to avoid increasing their emissions of pollutants  -  or can take measures at the time of the capital-intensive modification project to ensure that the final standard can be achieved. The EPA believes that a final standard of performance based on the units best historical single year adequately captures the expected operational variation and that the resulting standard is achievable via a combination of equipment upgrades and best operating practices  -  or using alternative compliance options such as natural gas co-firing.
6.2.4 Energy Assessment: Similar to NESHAP for Industrial Boilers
Contrary to NSPS and CAA
Commenter 0144 stated that the EPA proposal allowing source specific emissions limits be set based on an energy efficiency audit is contrary to the CAA Section 111(a)(1) and (b)(2); they are not aware of any precedent under the NSPS program for source specific emission limits.
The EPA is not finalizing a standard based on the result of an energy efficiency audit.
Energy efficiency audit in not a standard of performance that reflects BSER for the source category as required under CAA 111(a).
Commenter 0187 stated that section 111(b) of the CAA directs EPA to develop categories of stationary sources and promulgate regulations establishing standards of performance for new sources within such categories. The commenter stated that in establishing such standards, the Agency may distinguish among classes, types, and sizes within categories of new sources; the statute speaks strictly in terms of source categories and subcategories. The commenter stated that nowhere does it authorize development of the kind of source-specific energy efficiency audits EPA proposes; accordingly, the Agency lacks authority to require individual source owners to inspect their affected facilities to identify sources of reduced efficiency and detail ways to improve efficiency to allow the permitting authority to develop a unit-specific emission limit. The commenter stated that an energy efficiency audit is not a standard of performance that reflects application of BSER to the source category as required under the Act.
Commenter 0203 stated that EPA exceeds its authority under the NSPS program by proposing the implementation of source-specific assessments for modified Da (and, should it use the same approach, for KKKK) units. The commenter stated that where appropriate, Congress authorized EPA to establish source-specific emission limitations; examples include BACT determinations for the PSD program, or NOx limits that can under certain circumstances be established in the acid rain program. The commenter stated that nothing in 111(b) authorizes EPA to establish a process whereby performance standards for modifications are to be derived or calculated on a source-specific basis, which could be construed as an attempt to subcategorize each EGU down to the individual unit level. The commenter stated that energy efficiency audits are not performance standards within the meaning of 111 and cannot be used by EPA to bypass the detailed work required to properly establish NSPS for classes of similar sources. The commenter stated that finally, EPA fails to address the requirement that it adopt 111 standards through proper notice and comment. The commenter stated that
Commenter 0203 stated that if EPA is unable to set performance standards for properly subcategorized utility boilers, so that it is infeasible to prescribe or enforce a performance standard, it can set design, equipment, work practice or operational standards for source categories under 111(h); alternatively, it could determine that reconstructed or modified source NSPS are unnecessary, a conclusion arguably admitted as an appropriate outcome in the proposal. The commenter stated that although EPA states that it expects the rule to result in reductions in potential CO2 emissions, the Regulatory Impact Analysis concludes that no significant costs or benefits are anticipated; a rule that provides no benefits exceeds the Agency's authority under the CAA.
Commenter 0146 stated that the proposed provision that allows the section 111(d) implementing authority to determine a unit-specific emission standard that is based on the results of an energy efficiency audit is not lawful. The commenter stated that if EPA wishes to establish a NSPS, it must do so through notice-and-comment rulemaking so that regulated entities learn precisely what standards of performance EPA is proposing and can meaningfully comment; EPA cannot do so by providing for an energy efficiency audit that defers decisions about the numerical emission limit a source may have to meet until a later date. The commenter stated that this approach is arbitrary and capricious. The commenter stated that the NSPS program does not include the authority to establish a procedure by which another entity will determine the standards of performance for individual units on a case-by-case basis. The commenter stated that the proposed alternative contrast with section 111 provisions for prevention of significant deterioration whereby the Agency is authorized to set case-by-case unit-specific limits based on BACT for construction of a major source or major modification of such a source; or under the Act's Title IV Acid Rain Program, whereby section 407(d) authorizes EPA to establish source-specific emission limits for nitrogen oxides (NOx) under certain circumstances. The commenter stated that if EPA believes that it is not feasible to promulgate a standard of performance for the broad and diverse category of Subpart Da units or for subcategories of those units, there are at least two possible solutions: section 111(h) authorizes the Agency to promulgate a design, equipment, work practice, or operational standard, or combination thereof, when it is not feasible to prescribe or enforce a standard of performance; or, EPA could simply withdraw the proposal and determine that promulgating NSPS for modified sources is unnecessary.
Commenter 0211 stated that they do not object to providing additional compliance flexibility to sources subject to section 111 standards; however, EPA cannot transform a CAA program that imposes national standards determined through a notice and comment rulemaking process into a new (and potentially duplicative) CAA permitting program. The commenter stated that a determination of BSER based on individual energy efficient assessments would, by its very nature, be subject to varying state-level determinations and changing standards over time. Such a program does not conform to the CAA statutory directive that BSER reflect the degree of emission limitation achievable and adequately demonstrated after taking into account various factors, including the cost of emission reductions. The commenter stated that while performing a valuable service, an energy efficiency audit, on its face, may not consider or fully weigh the costs of achieving emission reductions, nonair quality health and environmental impacts and energy requirements - all of which are mandatory factors to be considered in section 111(a)(1) standard-setting; also, the fact that this determination would be made at the state or federal level, depending on who the implementing authority is, renders such a process plainly contrary to the statute, which specifies that NSPS for new sources are established and revised only periodically (i.e., within every eight years) by the Administrator. The commenter stated that the fact that EPA seeks comment only with respect to an elective determination by a source to seek such a standard, versus the standard's application to the source by rule, does not cure this defect; under EPA's described alternative, BSER would be determined outside of the statutory process.
Commenter 0173 stated that the options under alternative #2 are illegal and should be withdrawn.
The EPA is not finalizing a standard based on the result of an energy efficiency audit. Comments regarding the establishment of a work practice standard have been addressed in an earlier response.
Contrary to NSPS and CAA - Lack of details on procedures and demonstration of feasibility & fails the notice and comment obligations of CAA.
Commenter 0150 stated that the proposal is too vague with respect to what an energy audit might entail; without any further explanation, use of such a procedure would not be practical. The commenter stated that the lack of detail, moreover, is inadequate to satisfy EPA's notice and comment obligations under the "CAA.
Several commenters (0191, 0249, 0252) stated that the EPA cannot finalize a rule that establishes site-specific emission limit-setting through site-specific audits; under the plain terms of the statute, such emission limits must be set through notice-and-comment rulemaking proceedings.
Several commenters (0153, 0278) stated that the proposed rule does not explain the energy efficiency audit process for determining the applicable CO2 emissions rate limit or put in place any criteria that must be met as the limit is set, nor does EPA provide technical background for these types of audits and their potential effectiveness in improving EGU heat rates. The commenters stated that this is an unprecedented approach to performance standards under section 111 whereby an emissions limit will be determined later.
Commenter 0195 stated that to rely on the results of an energy efficiency audit as the basis for the unit-specific standard is without foundation in section 111, which does not authorize EPA or a state to establish a unit-specific performance standard including one based on the results of an energy efficiency audit. The commenter stated that where Congress intended for EPA to have authority to set unit-specific or case-by-case standards, the statute is very clear. The commenter stated that EPA's references to the energy assessment required in the Boiler MACT is intended to show that EPA has required other sources to perform an energy audit but it is unclear how the one-time energy assessment requirement in the Boiler MACT supports EPA's proposed use of an energy audit to serve as the basis for performance standards for modified EGUs under section 111. The commenter stated that the energy assessment required in the Boiler MACT was not used by EPA in any way to set the MACT standards for the affected boilers; furthermore, the Boiler MACT does not require industrial boilers to implement any of the measures identified in the energy assessment. The commenter stated that what EPA required in the Boiler MACT in terms of a one-time energy assessment does not serve as relevant precedent here for a performance standard for modified EGUs.
Commenter 0195 stated that if EPA could legally use an energy audit to serve as the basis for a performance standard, the proposed elements for the energy audit are so broad and expansive that the proposed elements generate more questions than provide concrete guidance with regard to how such an audit would work in practice. The commenter stated that the proposed elements of the energy audit reach beyond the affected source that would be regulated by section 111; an energy efficiency audit as the basis for a performance standard for an individual EGU is not a standard of performance for a source category or subcategory under section 111(b).
The EPA is not finalizing a standard based on the result of an energy efficiency audit.
EPA's proposed site specific standard and failure to provide for notice and comment are unlawful.
Commenter 0157 stated that the energy efficiency assessment a site-specific, source-specific standard rather than a standard of performance for a category of sources and, therefore, is not a lawful proposal under section 111. The commenter stated that requiring third-party energy efficiency assessors to create ad hoc, source-specific limits is a refusal to articulate a known proposed standard and to take comment on it.
Commenter 0222 stated that EPA does not have the authority to employ energy efficiency audits to set source-specific standards that would be determined at a future date and subject sources to a regulation without an opportunity to provide meaningful comments on that future regulation. The commenter stated that EPA has no authority to subject an existing source covered by a Section 111 (d) plan to an undefined, "unit-specific" standard to be determined at the time of modification.
Commenter 0284stated that EPA cannot evade notice-and-comment rulemaking by employing energy efficiency audits to set source-specific standards in the future; if the Agency wishes to establish an NSPS, it must do so during a notice-and-comment process through which regulated entities can learn precisely what EPA is proposing and can meaningfully comment on that proposal. The commenter stated that Congress has not authorized EPA to establish an energy efficiency audit process with vague and amorphous standards such that a Section 111(d) implementing authority would determine a unit's emission limit.
Commenter 0183 stated that EPA's co-proposal that a unit-specific emission standard (to be determined by the Section 111 (d) implementing authority) be developed based on the result of an in-depth energy study (an energy efficiency audit) is unlawful; the EPA lacks the authority to employ energy efficiency audits to set source-specific standards that would be determined at a future date. The commenter stated that a Section 111 (b) standard must undergo the appropriate rulemaking process including notice-and-comment; to do otherwise leaves sources potentially subject to the regulation without an opportunity to provide meaningful comments on that future regulation.
The EPA is not finalizing a standard based on the result of an energy efficiency audit.
There is no CAA authority for third party audit as basis of standard.
Commenter 0149 stated that subjecting units to a third-party audit to determine what level of additional improvement, if any, is possible is not appropriate. The commenter stated that state agencies should have the discretion to set unit-specific standards that recognize already-achieved efficiency improvements as demonstrated by unit owners and operators, but EPA cannot force states to adopt the conclusions of third-parties with no CAA authority.
Commenter 0249 stated that CAA section 111(b) does not authorize source-specific assessment and standard-setting for modified EGUs; EPA's authority under NSPS is to propose and establish uniform standards for source categories. The commenter stated that Congress has not authorized EPA to establish an energy efficiency audit process with vague and amorphous standards such that a CAA section 111(d) implementing authority would determine a unit's emission limit.
The EPA is not finalizing a standard based on the result of an energy efficiency audit.
Lack of details and lack of support call into question the feasibility of audit approach.
Commenter 0144 stated that the EPA asks for comment on whether there should be a certification system and whether there are organizations that provide certifications of specialists in evaluating energy systems. The commenter stated that given the scope of this proposal, we find it surprising that the EPA would not have performed a cursory investigation as to whether such certification organizations exist, and as a result question whether adequate support for the energy assessment approach has been established.
Commenter 0162 stated that in the proposal the alternative #2 111(b) standard would be based on the source's expected performance after implementation of identified unit-specific energy efficiency improvement opportunities; however, the EPA does not elaborate on what the identified opportunities might be, or whether cost or technical feasibility would be considered.
Commenter 0162 stated that the emission limit for a modified source, as required by the plan, must be feasible for the unit; in addition, the assessment or audit for the modified unit must be feasible for the unit.
The EPA is not finalizing a standard based on the result of an energy efficiency audit.
Energy audit requirements not well defined, and, instead, support work practice standards.
Commenter 0226 stated that the co-proposed Alternative #2 energy improvement audit appears to be a work-standard and is a much more sensible approach to meeting the requirements of Clean Air Act 111 (b) than any of the other proposed standards. The commenter stated that the work standards should be applied in lieu of emission limits to comply with all of section111 with respect to CO2 emissions.
Commenter 0226 suggested that the implementing authority be the State and have authority for approving what should ultimately be a state specific program along with the final results of the standard on any particular unit. The commenter also suggested that any recommendations resulting from the energy audit not be mandatory but should be considered by the State and the respective unit owner/operator in coming to an agreement on how to respond to the audit findings.
Commenter 0239 stated that without well-defined standards and protocols for identifying an emission standard following the completion of an efficiency audit, this method of determining an emission limit is too broad and general to meet the requirements of Section 111(b) for specific performance standards for modified units. The commenter supported instead, work practice or operational standards to be implemented for sources that modify after becoming subject to a Section 111(d) plan.
Commenter 0187 stated that following the alternative #2 energy audit, if the Agency believes additional standards should be implemented at EGUs that have become subject to CAA Section 111(d), then the rule should only require work practice standards, but not energy efficiency projects. The implementing authority has considerable flexibility when developing a compliance plan to meet the requirements of CAA Section 111(d), and this plan may or may not include unit efficiency projects at Subpart Da EGUs. Therefore, if other approaches have been taken to meet CAA Section 111(d) requirements, the EGU should not also then be subject to additional efficiency improvement requirements.
The EPA is not finalizing a standard based on the result of an energy efficiency audit. Comments regarding the establishment of a work practice standard have been addressed in an earlier response.
Alternatives #1 and #2 are unachievable.
Commenter 0209 stated that EPA overestimated available heat rate improvements in co-proposed Alternative #1 by assuming that the opportunities listed in the Sargent & Lundy study are widely available. The commenter stated that they are concerned that EPA considers Alternative #1 to be a good benchmark for Alternative #2, since EPA stated "we anticipate that the audit process that we are considering will result in an emission rate consistent with the highest level of efficiency plus 2 percent (based on equipment upgrades) that we are considering for sources that modify prior to becoming subject to a state plan." (pg 34988). Commenter said because Alternative #1 is unworkable, Alternative #2 should not be presumed to achieve improvements similar to Alternative #1.
The EPA has addressed the achievability of the final standards in previous responses. The EPA is not finalizing a standard based on the result of an energy efficiency audit.
In absence of energy audit expert certification process, EPA should not require one.
Commenter 0242 stated that the EPA is requesting if certification should be required and if so, what the basis of the certification should be and whether any organizations provide this type of certification. The commenter stated that if there currently is no certification process, the EPA should not be promulgating a requirement for such. The commenter stated that to require the assessment be conducted by energy professionals or engineers that have expertise in evaluating energy systems alone should surely be enough specificity without requiring a certification process that does not even currently exist; states would have the ability to determine if a chosen professional is sufficient.
The EPA is not finalizing a standard based on the result of an energy efficiency audit.
Use of previous energy audits.
Commenter 0242 stated that EPA is requesting comment on whether recent energy efficiency audits (e.g., within 3 years of the modification) that meet the requirements of this rule would satisfy the audit requirement or whether facilities that operate under an energy management program compatible to ISO 50001 can be used to satisfy the audit requirement. The commenter stated that any final rule should provide flexibility that recent energy audits, regardless of time, may satisfy the requirements for the energy audit under this proposal upon review by the state. The commenter stated that this flexibility is needed; the state would review the previous audit along with the history of the facility to determine if it is still accurate and appropriate for use under this rule.
Commenter 0169 stated that with regards to the use of previous energy audits, 3 years is too short of a time; a 5 year interval between audits is more realistic. According to the commenter, during a 5 year period some degradation in equipment will occur, but not to a point where the degradation would require replacement; 5 years would allow equipment degradation trending and analysis of cost-benefit to replace, repair or upgrade.
The EPA is not finalizing a standard based on the result of an energy efficiency audit.
Instead of the proposed vaguely defined auditing process, EPA should use PSD programs pre-permitting BACT reviews.
Commenter 0171 stated that the motivation behind energy audit co-proposal is sound, insofar as the ability of a unit to achieve additional heat rate improvements is inherently a unit-specific analysis of which improvements have already been made, among a range of other factors. The commenter stated that, instead of a vaguely-defined auditing process, EPA should use the PSD program's pre-permitting BACT reviews, a process with which state regulators and unit operators have considerable experience. The commenter stated that because the PSD program's modification test requires an increase of mass emissions over minimum thresholds instead of an increase in maximum hourly emissions, many more units trigger PSD requirements than regulation as modified units under section 111. The commenter stated that EGUs that would trigger 111(b) requirements as modified or reconstructed sources are already subject to PSD and must go through a BACT review.
Commenter 0171 stated that section 111 performance standards often establish the BACT floor for a source category and, given that EGU operators are familiar with and subject to the BACT process, EPA could opt to make a determination that standards for modified and reconstructed sources should be the unit-specific BACT process in CAA section 169. The commenter stated that a standard mandating a unit-by-unit review, which units are already familiar with and obligated to undertake, could be a reasonable alternative for setting achievable and workable standards for modified and reconstructed sources.
 The EPA is not finalizing a standard based on the result of an energy efficiency audit.
Purpose of energy audits unclear as states would have to rely on methods other than unit-specific emission rates for modified units to meet their state goals.
Commenter 0142 stated that the proposed rule is unclear about what the energy audit will actually achieve, given EPA's proposal that existing sources subject to section 111(d) remain subject to state plans under section 111(d) after modification or reconstruction. According to the commenter, only four states have final state goals above 1,700 lb CO2/MW, and the EPA acknowledges limited opportunities exist for decreasing CO2 emissions for modified units when the EPA proposes a lower end value of 1,900 lb CO2/MWh. The commenter stated that states would already have to rely upon methods other than a unit-specific emission rate for modified units in order to meet their state goals.
The EPA is not finalizing a standard based on the result of an energy efficiency audit.
Standard that allows states to determine on a case-by-case basis what emission reductions are possible and reasonable after consideration of site specific factors is reasonable alternative.
Commenter 0249 stated that EPA cannot reasonably assume that any specific level of emission reduction can be achieved across the board by EGUs undertaking a modification as the level of additional emission reductions, if any that can be obtained from a source undergoing a modification can only be determined on a case-by-case basis, depending on several factors. The commenter stated that rather than specifying any across-the-board numeric emission reduction goal to be obtained by EGUs undertaking a modification, EPA should instead adopt a standard that allows for a state determination, on a case-by-case basis, of what emission reductions are possible and reasonable after consideration of the factors unique to each unit.
Commenter 0242 stated that they do not feel that meaningful comments can be formed because EPA has introduced so many variables to evaluate as possibilities against the different standards, within the different alternatives, and given the different ranges presented and all compounded by the multitude of changes being considered regarding applicability. The commenter stated that while it is apparent the lower end of the range is not achievable, it may be possible the higher end of the range could be achievable for some types of units; but EPA has not provided enough specificity to provide meaningful comments to determine achievability of the proposed standards of performance. The commenter stated that regardless, they believe that the only option with potential for success is alternative 2, although they believe it has been misapplied in this proposal. The commenter stated that the only portion of alternative 2 that is viable is the setting of an emission limit that would be determined by the implementing authority from the results of an energy efficiency improvement audit; in addition, the commenter is unsure if under this proposal, the energy efficiency audit would be limited to efficiency improvements inside-the-fence or if states would be able to consider outside-the-fence projects that improve efficiency for achieving a specified emissions limitation. The commenter stated that the EPA cannot require an emissions limit be set considering programs like end-use energy efficiency potential under the Section 111(b) source oriented control program.
Commenter 0242 stated that the alternative 2 proposal that an emission limit would be determined by the Section 111(d) implementing authority based on the sources expected performance after implementing unit-specific energy efficiency improvements taking into account what is technically feasible is the exact provision that should be occurring under this plan and under Section 111 (d) and nothing more.
Commenter 0242 stated that regarding the EPA's request for comment on whether a unit that modifies prior to becoming subject to Section 111(d) should also be allowed to meet an emission limit determined from the results of an energy audit and if it should be limited to sources that may have voluntarily, or for any other reason, implemented energy efficiency measures between 2002 and the modification (and if they should be required to provide evidence), the commenter stated that this type of flexibility is what is necessary in order to address issues that will arise as states develop and implement Section 111(d) plans. The commenter stated that the only method that should be used for determining emission limits under this provision and under Section 111(d) itself, is through the state's determination (such as an energy audit) of what is technically and economically feasible at a particular unit given the history of what efficiency improvements have already been completed. The commenter stated that approaches under this plan, of setting a limit and requiring an additional 2 percent, or under Section 111(d) of assuming 6 percent can be achieved on average, based upon inappropriate application of studies and averaging historical rates without any consideration for unit-specific feasibility is wrong, unworkable and can lead to individual facilities in some cases having requirements imposed that are beyond the best system of emission reductions.
Commenter 0256 stated that if EPA is going to implement a rule that presumes that energy efficiency projects can constitute BSER, then the rule needs to allow for a case-by-case assessment. The commenter stated that if a project triggers the NSPS modification or reconstruction provisions, the rule should require an energy assessment, which would be used to determine whether there are any cost-effective energy efficiency improvements that could be implemented. The commenter stated that to allow for a fair process, the EPA should certify that any cost effective energy efficiency improvement that is to be implemented under the modification and reconstruction rule will not be subject to NSR requirements. The commenter stated that the implementation of the energy assessment should not result in numerical limits for the unit; a demonstration that the change is made should suffice to demonstrate compliance with the NSPS.
Commenter 0197 commended the EPA for its realization that existing sources that undergo modification or reconstruction should have a limit determined by technical and economic feasibility from an engineering analysis as this allows the maximum emission reductions to be obtained without exerting undue pressure on the marketplace. The commenter stated that it gives all fuels and technologies the opportunity to compete and ensures that the energy industry is able to pursue economic opportunities and preserve fuel diversity; this, in turn, will ensure that all people will be provided with an affordable and reliable electric system and create a scenario where the environment, consumers, and industry all benefit. The commenter stated that the only additional action that EPA would need to undertake is to remove the obstacle of NSR, which has been cited by both the EPA and the National Energy Technology Laboratories as an impediment to improving the efficiency of fossil fuel-fired EGUs.
Commenter 0165 stated that EPA's BSER is flawed because EPA does not take into account that some of the affected units have already implemented the best operating practices to improve heat rate by 4 percent and equipment upgrades to improve heat rate by 2 percent and will not be available for future modifications. The commenter stated that because each utility boiler and IGGC unit are operating in different ways by different operators, the BSER for modifications should be determined on a case-by-case basis and established by the state, the implementing authority under 111(b), and would be accomplished by requiring the owner or operator of the affected unit to submit an energy assessment or audit of the unit as part of the application to modify or reconstruct the unit and specify a carbon dioxide emission rate. The state can then review the proposal as it would a BACT analysis under the, PSD program and establish the emission rate.
The EPA is not finalizing a standard based on the result of an energy efficiency audit.
EPA should consider using the BACT process to set emission standards for modified and reconstructed units
Commenter 0189 agreed that EPA should consider using the best available control technology (BACT) process for setting emission standards for modified utility boilers, IGCC and natural gas-fired combustion turbines. The BACT process takes into account emission rates that are achievable on a case-by-case basis, which is especially important considering unique limitations when modifying and reconstructing existing units. This is also important considering there is no add-on pollution control feasible to install on EGUs, as is the case for other pollutant.
The EPA is not finalizing a standard based on the result of an energy efficiency audit or any other unit specific analysis such as a BACT determination. The final standards  -  based on the affected unit's best historical performance  -  are achievable on a case-by-case basis.
6.2.5 Subjectivity to 111(d)
Support for being subject to the lower of the 111(d) plan instead of the unit's best performance since 2002
Commenter 0131 stated that, regarding EPA's request for comment on the issue of modified units being subject to the lower of the 111(d) plan or the best performance since 2002 less 2 percent, they support the 111(d) standard. The commenter stated that a single reasonable standard is best and makes the planning and execution of the modification achievable and economically viable.
The EPA is not finalizing this option.
Heat rate improvement potential - an additional 2 percent efficiency improvement may be unachievable for sources that make efficiency improvements as part of a 111(d) state plan. There is simply no record basis for this.
Commenter 0236 stated that there is no record basis for EPA's assumption that all modified sources can achieve a carbon dioxide emission level that is two percent lower than the source's best demonstrated historical performance level from 2002 to the date of the modification. The commenter stated that EPA even admits its concern that as a result of implementation of state plans, the additional 2 percent efficiency improvement may be unachievable for a substantial number of sources that make efficiency improvements as part of a 111(d) plan.
Commenter 0195 stated that under the section 111(d) plan, coal-fired EGUs will be operating at lower capacity factors, which will make further heat rate improvements very difficult to achieve. Commenter added even if modified units were not subject to that rule, the decreased demand for generation from coal-fueled EGUs would have a negative impact on the ability of modified utility boilers to achieve a 2% heat rate improvement.
 The EPA is not finalizing the proposed additional 2% additional emission reduction.
Heat rate improvement potential - EPA is applying existing unit standards (aggregated data for older and newer units) with modified unit standards (unit level rates). This results in standards not shown to be achievable at unit level (not supported in the proposal) as required by 111(a)(1).
Commenter 0226 stated that there isn't a great deal of historical information regarding the CO2 emission rates that are achievable by units undertaking section 111 modifications and reconstructions. The commenter stated that, however, in the GHG Abatement Measures TSD which supports both the 111(d) proposal and this proposal, it is suggested that an industry-wide six percent heat rate improvement is possible for existing sources, which appears to have been arrived at through use of average data to determine the heat rate improvement potential available through O&M practices and equipment upgrades at existing units for the purpose of developing state-specific goals (under the proposed 111(d) guidelines). The commenter stated that, for the proposal, this approach results in applying existing-unit standards (which are in the form of statewide emission rates based on old and newer units) with the modified-unit standards (in the form of individual, unit-level rates), without explaining how the data is equally applicable to both types of units. The commenter stated that these are aggregated data at the state level being applied as standards that must be achieved at the unit-level that haven't been shown to be achievable at the unit-level (not adequately supported in the proposal) as required by section 111(a)(l).
Commenter 0149 stated that based on its assessment in the proposed section 111(d) guidelines (and the related Abatement Measures TSD) that a fleet-wide six percent heat rate improvement is possible for existing sources, EPA concludes that the unit-specific emission limit based on historical best performance (which captures the good O&M practices at the unit) coupled with an additional two percent reduction (which captures minimum opportunities for additional heat rate improvements from equipment and system upgrades) can be achieved at reasonable cost. The commenter stated that EPA cannot rely on this existing source analysis in support of the proposed standards for modified units.
Commenters (0149, 0229) stated that EPA used average data on the heat rate improvement potential available through O&M practices and equipment upgrades at existing units for the purpose of developing state-specific goals, whereas a recently modified unit would be more likely to operate with the most efficient practices.  The commenters stated that EPA, therefore, recognizes that the data used to set the state-specific goals under section 111 would not be suitable for setting achievable unit-level standards;  despite this, EPA attempts to compare the existing source standards (which are in the form of statewide emission rates based on old and newer units) with the modified source standards (which are in the form of individual, unit-level rates), without explaining how the data are equally applicable to both types of units. The commenters stated that further, EPA's prescription of an additional two percent emission reduction has no basis and is not supported by EPA's finding that coal-fired power plants can, on a fleet-wide basis, achieve a six percent heat rate improvement. The commenters stated that EPA has attempted to take aggregated data at the state level and apply it to standards that must be achieved at the unit-level, which has resulted in standards that EPA cannot demonstrate are achievable at the unit-level, as required by CAA section 111(a)(1).
The analyses described in Chapter 2 of the "GHG Mitigation Measures" Technical Support Document for the CPP Final Rule (and available in the Carbon Pollution Standards (111b) rulemaking dockets: EPA-HQ-OAR-2013-0495 and EPA-HQ-OAR-2013-0603) has been updated in response to comments received on this proposed action as well as the proposal, under CAA 111(d), for emission guidelines for existing sources. The analyses in the final document (Chapter 2) indicate that there is significant potential for heat rate improvement from the fleet of coal-fired EGUs, ranging from 4.0 to 6.6 percent nationally if coal-fired EGUs, on average, return to their best past performance between 2002 to 2012. Further, as the EPA has noted in preamble section VI, owners/operators can also consider the use of natural gas co-firing to achieve the final emission limitation for affected modified EGUs.
Reliance on the Sargent & Lundy study does not justify heat rate improvement potential.
Commenter 0157 stated that EPA's assessment of heat rate improvement potential is significantly flawed and that reliance on the Sargent & Lundy study - the report is from 2009 and the data supporting it are even older - is not justified. The commenter stated that the report fails to consider the impact of significantly reduced capacity factors that will result from EPA's 111(d) proposal and that increasing gas output to an average 70 percent capacity factor will reduce coal capacity factors.
 Concerns with the use of the S&L study have been addressed elsewhere in this RTC and in Chapter 2 of the final `GHG Mitigation Measures' Technical Support Document.
Modified source emission standard should consider whether a modification occurs after or before the Section 111 (d) requirements are effective.
Commenter 0169 stated that regarding co-proposed alternative #2, any modified source emission standard should consider whether a modification occurs after or before the Section 111(d) requirements are effective. The commenter stated that as EPA notes, a source which has already undertaken efficiency improvements to meet the highest level of efficiency may not have additional improvements available.
Commenter 0195 stated that EPA has not taken into account efficiency improvements that historically have taken place at utility boilers as they already have an incentive to operate as efficiently as possible, and many of the efficiency improvements envisioned by EPA as available are likely to have already been made by owners and operators. In addition, EPA points out in the preamble that a modifying source is likely part of a section 111(d) plan. Commenter said this would mean that the source already will have implemented extensive efficiency improvements to meet the state goals under the first building block outlined in EPA's section 111(d) proposal.
The final standards are not dependent upon when the modification occurs.
Sources subject to 111(d) guidelines should remain under 111(d) guidelines and not be subject to Section111 (b).
Commenter 0271 stated that the EPA's proposed rule for modified and reconstructed facilities under Section 111(b) would subject the same group of affected sources under Section 111(d) to additional standards above and beyond those required of an existing source and be more stringent than what the EPA determined BSER to be for the same group of affected sources under Section 111(d). The commenter stated that additionally, this proposed rule would require states to achieve emission reductions above and beyond their Section 111(d) defined goal. The commenter stated that based on its definition of BSER and the CO2 goals outlined under Section 111(d), states should not be obligated to seek further reductions from sources subject to 111(d). The commenter stated that affected facilities are likely to have to implement significant modifications to sources in order to meet the Section 111(d) guidelines. The commenter stated that because 111(d) requirements already represent the BSER, they are concerned that it may not be feasible for some facilities to meet an additional 2 percent reduction, and if so, certainly not in a cost effective manner. The commenter recommended that sources subject to Section 111(d) guidelines should remain under 111(d) guidelines, and not be subject to Section 111(b) NSPS.
As previously mentioned, the EPA is finalizing requirements only for steam generating units that conduct modifications resulting in an increase in hourly CO2 emissions (mass per hour) of more than 10 percent as compared to the source's highest hourly emission during the previous five years. With respect to modifications with smaller increases in CO2 emissions (specifically, steam generating units that conduct modifications resulting in an increase in hourly CO2 emissions (mass per hour) of 10 percent or less compared to the source's highest hourly emission during the previous 5 years), the EPA is not finalizing any standard or other requirements, and is withdrawing the June 2014 proposal with respect to these sources (see Section XV below). The effect of the EPA's deferral on setting standards for sources undertaking modifications resulting in smaller increases in CO2 emissions and the withdrawal of the June 2014 proposal with respect to such sources is that such sources will continue to be existing sources and subject to requirements under section 111(d). This is because an existing source does not always become a new source when it modifies. Under the definition of "new source" in section 111(a)(2), an existing source only becomes a new source if it modifies after the publication of proposed or final regulations that will be applicable to it.  Thus, if an existing source modifies at a time that there is no promulgated final standard or pending proposed standard that will be applicable to it as a modified "new" source, that source is not a new source and continues to be an existing source.  Here, because the EPA is not finalizing standards for sources undertaking modifications resulting in smaller increases in CO2 emissions and is withdrawing the proposal with respect to such sources, these sources do not fall within the definition of "new source" in section 111(a)(2) and continue to be an "existing source" as defined in section 111(a)(6).
EPA should ensure units will not be required to make unreasonable HRI under 111(b) if already made under 111(d) and the period of best historical performance should be the years from 2002 to the time when the unit becomes subject to the section 111(d) plan, rather than to the time of the modification.
Commenter 0260 stated that if EPA finalizes a rule under which units are subject to requirements under both Sections 111(b) and 111(d), EPA should ensure that units are not required to make unreasonable heat rate improvements pursuant to Section 111(b) if they already have made improvements subject to a Section 111(d) plan. The commenter stated that under the first alternative, the period of best historical performance should be the years from 2002 to the time when the unit becomes subject to the section 111(d) plan, rather than to the time of the modification. The commenter stated that this would address the concern that sources that make improvements to their CO2 emission rate as a result of a section 111(d) plan would have lower baseline emissions from which to calculate their required rate. The commenter stated that modified units that already have become subject to a CAA Section 111(d) plan should not be required to meet the two percent additional emission reduction based on equipment upgrades where the state plan requires heat rate improvements for such sources, or where the source has recently implemented measures to improve its operating efficiency; in these circumstances, the additional two percent improvement would be unreasonable. The commenter stated that this will avoid creating a perverse incentive under which plants would have no reason to invest in heat rate improvements if they anticipate making a modification that will trigger Section 111(b).
The final standards are not dependent upon when the modification occurs.
Modified sources subject to a 111(d) plan should be evaluated on a case-by-case basis to determine whether or not they should be subject to the 111(d) requirements.
Commenter 0162 stated that modified sources subject to a 111(d) plan should be evaluated on a case-by-case basis to determine whether or not they should be subject to the 111(d) requirements. The commenter stated that, for example, they have already undertaken a project to convert a combustion turbine to a natural gas combined cycle unit at a plant with two coal-fired units that recently transitioned to natural gas. The commenter stated that in general, the EPA recognizes that reductions in CO2 emissions from individual existing EGUs can be achieved by implementing either of two basic approaches: (1) making emission rate improvements at affected EGUs (e.g., by improving heat rates or switching to lower carbon fuels), and/or (2) reducing utilization of GHG-emitting EGUs (e.g., by reducing the overall demand for electricity or by shifting dispatch from higher-GHG-emitting EGUs to lower-GHG-emitting and non-emitting units). The commenter stated that although they has already retired one coal-fired unit and will soon be retiring the second coal-fired unit, they will not be recognized as complying with the regulation until the new unit is further limited by the 111(d) requirements. The commenter stated that the EPA states that this regulation will impact very few sources, but the few that are impacted should not be penalized for modifications that will ultimately reduce overall CO2 emissions.
As previously mentioned, the EPA is finalizing requirements only for steam generating units that conduct modifications resulting in an increase in hourly CO2 emissions (mass per hour) of more than 10 percent as compared to the source's highest hourly emission during the previous five years. With respect to modifications with smaller increases in CO2 emissions (specifically, steam generating units that conduct modifications resulting in an increase in hourly CO2 emissions (mass per hour) of 10 percent or less compared to the source's highest hourly emission during the previous 5 years), the EPA is not finalizing any standard or other requirements, and is withdrawing the June 2014 proposal with respect to these sources (see Section XV below). The effect of the EPA's deferral on setting standards for sources undertaking modifications resulting in smaller increases in CO2 emissions and the withdrawal of the June 2014 proposal with respect to such sources is that such sources will continue to be existing sources and subject to requirements under section 111(d). This is because an existing source does not always become a new source when it modifies. Under the definition of "new source" in section 111(a)(2), an existing source only becomes a new source if it modifies after the publication of proposed or final regulations that will be applicable to it.  Thus, if an existing source modifies at a time that there is no promulgated final standard or pending proposed standard that will be applicable to it as a modified "new" source, that source is not a new source and continues to be an existing source.  Here, because the EPA is not finalizing standards for sources undertaking modifications resulting in smaller increases in CO2 emissions and is withdrawing the proposal with respect to such sources, these sources do not fall within the definition of "new source" in section 111(a)(2) and continue to be an "existing source" as defined in section 111(a)(6).
If EPA requires the 2 percent reduction requirement, it should require that the reduction be off of a unit's heat rate at full load per, calculated pursuant to ASME performance test codes.
Commenter 0193 is concerned with the interplay of the proposed alternatives with the Agency's proposed 111(d) rule, specifically with the relationship between the proposed 2 percent reduction requirement for modified units under Alternative #1 and the proposed Building Block 1 in the CAA Section 111(d) proposal, which assumes for purposes of establishing state emission rates that existing coal-fired EGU can achieve, on average, a 6 percent efficiency improvement. The commenter stated that the Agency acknowledges that units that make efficiency reductions as the result of a 111(d) plan may not reasonably be able to achieve an additional 2 percent reduction following a modification; nor is there support in the record that a limit of 1900 lb CO2/MWh is achievable by existing, large coal-fired boilers, and for these reasons, EPA should not adopt Alternative #1.
Commenter 0193 stated that Alternative #2 is also problematic because units that modify before promulgation of a CAA Section 111(d) plan would be required to improve efficiency by 2 percent. The commenter stated that many existing EGUs have already made the efficiency improvements identified by EPA, and thus an additional 2 percent improvement may not be possible regardless of when the modification occurs; for this reason, EPA should not adopt a standard that requires a 2 percent reduction from a unit's pre-modification baseline emission rate; instead, sources should only be required to achieve reductions that are reasonably achievable. The commenter stated that Alternative #2 also erroneously assumes that existing coal-fired EGU's can achieve a limit of 1900 lb CO2/MWh, and there is no record support for this conclusion.
Commenter 0193 stated that if despite the concerns addressed above EPA nevertheless moves forward with a 2 percent reduction requirement, then at the very least it should modify the requirement to require that the reduction be off of a unit's heat rate at full load, calculated pursuant to applicable American Society of Mechanical Engineers performance test codes, not its actual annual emission rate. The commenter stated that this approach would provide a more objective measure of efficiency improvement than relying on actual annual emission rates, which may be more of a function of dispatch than actual efficiency.
The EPA is not finalizing the proposed 2% additional CO2 emission reduction.
Existing unit reductions are not achievable, it is unrealistic to expect an additional 2% reduction for modified units, and reliance on hypothetical unit is overly simplistic.
Commenter 0263 stated that the proposed standards for affected units are impractical when considered in conjunction with the requirements of 111(d) and EPA should consider allowing affected sources to meet a unit-specific emission limit determined by the implementing authority based on the results of an energy efficiency improvement audit. The commenter stated that the justification provided in this proposal is not sufficient to determine otherwise; however limited the instance of modifications or reconstructions may be, EPA cannot ignore the inability of these units to meet the standards as proposed in this rule. The commenter stated that the EPA intends for existing units to be regulated under the proposed 111(d) state plan and expects that existing units could achieve a six percent emission reduction attributed to energy efficiencies while our evaluation shows that such a blanket reduction in emissions is not achievable for existing units, and it is unrealistic for the EPA to expect that these same units can then further reduce emissions by another two percent should they become modified or reconstructed units.
Commenter 0263 stated that the EPA's reliance on a hypothetical 500 MW coal-fired unit as the basis for assessing the costs and benefits of the proposed rule and emission limits is overly simplistic and results in unrealistic conclusions. The commenter stated that the use of a hypothetical unit does not account for unique variables that would greatly add to the cost of compliance. According to the commenter, in Wyoming, the structure of coal contracts can require a utility to pay for unused fuel, which would negate the savings a utility could realize. The commenter stated that for mine-mouth power plants, the boilers are subject to the fluctuations in the quality of the live feed of coal that cannot be reasonably mitigated through the use of a coal blending; fuel switches or the unexpected need to blend coal could greatly add to the cost of compliance, and these types of factors have been omitted in this proposal.
The EPA is not finalizing the proposed 2% additional CO2 emission reduction.
Should uniform emission standards be available only to sources that modify before becoming subject to an approved 111(d) plan?
Commenter 0242 stated that the EPA is requesting comment on a compliance option of a uniform emissions standard of 1,900 lb CO2/MWh for large units and 2,100 lb CO2/MWh for small units and whether this should be available to only sources that modify before becoming subject to an approved Section 111(d) plan. The commenter stated that if this option is incorporated, they are unsure why the EPA would necessitate it be available only for sources under an "approved" Section 111(d) plan when EPA is proposing "submitted" Section 111(d) plans qualify as being "subject" under alternative 2 above.
The final standards are not dependent upon when the modification occurs.
EPA lacks authority to require modified sources to remain subject to section 111(d) regulation after modification.
Commenter 0173 stated that the proposed requirement for an existing power plant to remain subject to section 111(d) regulation even after that plant undergoes a modification and triggers the CO2 NSPS for modified power plants is contrary to section 111(a)(2) definitions of   "new source"  and "existing source." The commenter stated that the definitions of "new source" and "existing source" are mutually exclusive. The commenter stated that the definition of "new source" addresses the precise question of whether an existing source that undergoes a modification can still be considered an existing source: under section 111(a)(2), any existing source that undergoes a modification after the publication of a NSPS proposal for such sources becomes a "new source;" and, under section 111(a)(6), such a source cannot also be an existing source because that section defines an existing source as any source "other than a new source." The commenter stated that, consequently, under the statute, a stationary source cannot be regulated under section 111 as both a "new" source and an "existing" source; a source commencing construction prior to issuance of the relevant NSPS proposal for that source is an existing source unless (and until) it undergoes modification, at which point it becomes a "new source" and can no longer be an "existing source" under the very terms of the definition of "existing source."
Commenter 0173 stated that, furthermore, section 111(d) clearly prohibits application of section 111(d) performance standards to new sources. The commenter stated that under section 111(d), plans established by the states apply only to existing sources and because the term "existing source" means any stationary source "other than a new source," standards under section 111(d) may only apply to stationary sources "other than" new sources. The commenter stated that consequently, because modified sources are clearly "new sources" under section 111, section 111(d) performance standards cannot apply to them and EPA's interpretation to the contrary is thus contradicted by the clear terms of the statute.
Commenter 0173 stated that if, for the sake of argument, the statute were ambiguous on the question of whether EPA may continue to regulate modified sources under section 111(d), EPA's interpretation is not entitled to deference by the courts. The commenter stated that it is a well-established rule of construction that a statute's failure to prohibit a federal agency from regulating a certain entity does not mean that the agency may regulate that entity. The commenter stated that as the D.C. Circuit has reiterated, "if we were to presume a delegation of power from the absence of an express withholding of such power, agencies would enjoy virtually limitless hegemony". The commenter stated that to suggest that an agency may claim an administrative power "any time a statute does not expressly negate the existence of a claimed administrative power...is both flatly unfaithful to the principles of administrative law...and refuted by precedent." According to the commenter, the EPA is not entitled to deference on the question of whether it may regulate sources that are modified after becoming subject to a state or federal plan under section 111(d). The commenter stated that, in sum, section 111 is clear that performance standards under section 111(d) apply exclusively to existing sources, and that modified sources cannot also be "existing sources" and EPA's interpretation is directly contradicted by the statute.
EPA is not finalizing an interpretation under which existing sources continue to be subject to requirements under section 111(d) after they become subject to requirements under section 111(b).  This issue has been addressed in Chapter 2 (Legal Issues) of this RTC.