comments as to reliance interests of maintaining the MATS regulation
and reducing regulatory uncertainty by claiming the action did not
affect reliance interests because it did not rescind the MATS
regulation, the 2020 Final Action failed to address the uncertainty
that was created for industry and others by rescinding the appropriate
and necessary finding. Indeed, the EPA further agrees with
environmental commenters who note that the 2020 Final Action
contributed to greater regulatory uncertainty because it led to
challenges to the underlying MATS regulation, which were consolidated
in Westmoreland Mining Holdings LLC v. EPA, No. 20-1160 (D.C. Cir.),
and which created uncertainty for the many stakeholders who cite
reliance interests in favor of keeping the MATS regulation in place.
While such reliance interests are not integral to the EPA's conclusion
to revoke the 2020 Final Action, they nonetheless weigh in favor of
doing so.

D. Comments on the Administrator's Preferred Framework and Conclusion

1. The EPA's Totality-of-the-Circumstances Approach Is Consistent With
Michigan and Shows That Regulation of U.S. EGU HAP Emissions Is
Appropriate and Necessary
    Comment: Commenters stated that the EPA's totality-of-the-
circumstances approach is faithful to the CAA's text and purpose, and
abundant record evidence supports the EPA's determination that
regulation of power plant HAP emissions remains appropriate and
necessary. According to the commenters, the approach is consonant with
the Supreme Court's holding in Michigan that the term ``appropriate''
encompasses all of the advantages and disadvantages of regulation.
Commenters stated that Michigan confirmed that the statute does not
require the EPA to consider costs in a particular way, and it does not
require the EPA to use a formal BCA or attempt to monetize every cost
and benefit. Rather, in the view of commenters, Michigan expressly
recognizes that it is ``up to the Agency (as always, within the limits
of reasonable interpretation) how to account for cost.'' Michigan, 576
U.S. at 759. Commenters asserted that in the proposed totality-of-the-
circumstances approach, the EPA carefully considered and weighed all
statutorily relevant factors to determine whether to regulate HAP from
power plants, including ``account[ing] for cost.''
    Commenters explained that as a first step, consistent with
Congress' focus on public health in CAA section 112(n)(1)(A), the EPA
considered the human health advantages, in particular the direct health
effects, quantified as well as unquantified, of regulating HAP from
power plants. Commenters stated that in amending CAA section 112 in
1990, Congress recognized that some benefits of regulation--such as
reducing ``the public health consequences of substances which express
their toxic potential only after long periods of chronic exposure''--
are not readily captured in monetary terms and ``will not be given
sufficient weight in the regulatory process when they must be balanced
against the present-day costs of pollution control and its other
economic consequences.'' S. Rep. No. 101-228 at 182 (1989), reprinted
in Legis. History of the Clean Air Act Amendments of 1990. Commenters
said that the language and context of CAA section 112's appropriate and
necessary determination indicate that the EPA ought to account for the
many relevant potential benefits of HAP regulation when making the
finding.
    Commenters stated that the EPA appropriately considered the
distribution of the benefits of such regulation and how they affect the
populations most exposed and most vulnerable to the health impacts of
air pollutants, the environmental benefits to society of regulating HAP
emissions from power plants, and the overall volume of emissions of HAP
from power plants. According to the commenters, the EPA then carefully
considered, under several different contextual metrics, the varied
costs of such regulation, including both the direct costs of compliance
as well as the broader costs to society, such as potential increases in
retail electricity prices associated with regulation and potential
reductions in the reliability of electricity service. Finally, the
commenters said, the EPA proposed to conclude that the substantial
benefits of reducing HAP from EGUs, which accrue in particular to the
most vulnerable members of society, are worth the costs, and after
weighing the totality of the circumstances, regulation of HAP from
power plants is appropriate. In the view of commenters, the EPA's
totality-of-the-circumstances approach to the CAA section 112(n)(1)(A)
determination is rationally related to the goals of the statute and is
the best effectuation of Congress' intent.
    Commenters supported the EPA's decision under a totality-of-the-
circumstances approach to prioritize all of the public health benefits
of regulating HAP from power plants, whether capable of quantification
or not, in line with Congress' clear intent (87 FR 7637). According to
the commenters, while Congress did not define the precise methodology
that the EPA is to employ when making an appropriate and necessary
determination in CAA section 112(n)(1)(A), it clearly communicated that
the EPA should focus on the ``hazards to public health . . . as a
result of emissions'' from power plants, explicitly directing the EPA
to conduct a formal study on that issue to inform its determination.
Commenters said that the other studies that Congress authorized the EPA
to conduct in CAA section 112(n) further indicate Congress' intent that
the EPA pay careful attention to the multiple insidious harms of
hazardous air pollution from power plants; Congress directed the EPA to
study and consider: the ``health and environmental effects of such
emissions'' and the amount (``rate and mass'') of those emissions in
CAA section 112(n)(1)(B); and the health risks of even low levels of
mercury to sensitive populations in CAA section 112(n)(1)(C). According
to commenters, section 112 of the CAA also reflects Congress' concern
that HAP emissions may threaten disproportionate risks to those who are
most vulnerable; CAA section 112(f)(2) directs the EPA to consider
residual risk focusing on lifetime cancer risk to the ``individual most
exposed'' as a regulatory trigger.

Commenters noted that other references in CAA section 112 highlight
Congress' concern that the EPA exercise its CAA section 112 authority
to address even small health and environmental risks posed by HAP
(e.g., CAA section 112(b)(3)(D)). Consistent with these congressional
objectives, commenters explained that the EPA's totality-of-the-
circumstances framework properly accounts for the benefits of HAP
regulation that cannot be determined in precise monetary terms but are
no less real than those that can be. The benefits--monetized and
unmonetized--of regulating HAP emissions from power plants are
substantial, according to commenters.
    Commenters stated that the Supreme Court explained that ``
`appropriate' is `the classic broad and all-encompassing term that
naturally and traditionally includes consideration of all the relevant
factors.' '' Michigan, 576 U.S. at 751 (quoting White Stallion Energy
Ctr., LLC, 748 F.3d at 1266 (Kavanaugh, J., dissenting)). Commenters
asserted that it is thus eminently reasonable for the EPA to make the
appropriate and necessary determination by balancing a broad swath of
considerations that Congress has indicated are relevant to CAA section
112's goals, including public health, health impacts on the most
vulnerable and exposed individuals, environmental effects, and costs.
Indeed, courts have routinely blessed agency uses of a totality-of-the-
circumstances approach in analogous statutory contexts. See Catawba
County. v. EPA, 571 F.3d 20, 39 (D.C. Cir. 2009) (holding that agency
may ``adopt a totality-of-the-circumstances test to implement a statute
that confers broad authority''); Chippewa & Flambeau Imp. Co. v. FERC,
325 F.3d 353, 358-59 (D.C. Cir. 2003) (holding that Congress granted
FERC significant discretion ``by enacting [a] `necessary or
appropriate' standard'' and that FERC's ``case-by-case approach'' to
making that determination based on a ``series of relevant factors'' was
reasonable and consistent with the governing statute). Commenters noted
that many states have also adopted similarly wide-ranging analytical
frameworks that account for all relevant factors when enacting their
own regulatory standards to address certain hazardous (and other) air
pollutant emissions from power plants.
    Commenters stated that under the totality-of-the-circumstances
framework, the record evidence available in 2012 alone is more than
sufficient to support a finding that it is appropriate to regulate EGUs
under CAA section 112. Commenters noted that at the time, the EPA
acknowledged substantial quantified and unquantified HAP-reduction
benefits, as well as non-HAP-reduction benefits that the EPA more
completely monetized. According to the commenters, information that has
become available since the 2011 RIA--including much larger estimates of
the health effects of mercury emitted by EGUs, new evidence of the
ecological impacts of mercury, compelling research on the health
effects of toxic metals and metals mixtures, recent research on the
health effects of acid gases, and recent assessments of the science on
the health and environmental effects of PM and ozone--confirms the
finding that it is appropriate to regulate EGUs' HAP emissions under
CAA section 112. Commenters said that the unexpectedly large declines
in these emissions since MATS was promulgated only amplify all these
considerations. Moreover, the need to address the significant and
disproportionate impacts on communities of color and low-income
communities from EGU HAP emissions prior to MATS further supports the
finding of appropriateness, according to the commenters. Commenters
noted that meanwhile, lower natural gas prices, lower costs of
pollution controls, and readily available, inexpensive renewable energy
have all pushed compliance costs far below the EPA's original
projections, which were overestimates even in 2011 based on certain
assumptions about the pollution controls that would be needed to
comply.
    Commenters also stated that the EPA appropriately considered
unquantified benefits and co-benefits as part of the totality-of-the-
circumstances analysis and that doing so is consistent with other case
law, executive guidance, and past EPA practice. Commenters said that
the totality-of-the-circumstances approach recognizes that many
benefits of reducing toxic air pollution exposure cannot be quantified
but that does not mean that these benefits are small, insignificant, or
nonexistent. Commenters stated that to argue that these benefits should
not factor into whether a pollution control measure is appropriate and
necessary because they cannot be quantified runs counter to the law,
statutory text and design, and the Administration's stated EJ
commitments. Indeed, according to the commenters, OMB's Circular A-4
has long cautioned agencies against ignoring unquantifiable benefits,
because the most efficient rule may not have the largest quantified and
monetized estimate. It instead directs agencies to consider values that
are difficult or impossible to quantify, including equity, human
dignity, fairness, and distributive impacts, according to the
commenters.
    Commenters stated that even for benefits where quantification is at
least theoretically possible, the EPA accurately recognized that it can
be extremely difficult and time-consuming to quantitatively estimate
the manifold health and environmental benefits of reducing emissions of
air toxics. Commenters noted that the harms of HAP are often
concentrated, and more studies would be needed to monetize benefits
such as reduced lifetime cancer risk or avoided reproductive harm in
specific communities. Commenters stated that among other reasons, it is
difficult to design population-based epidemiological studies, limited
data exist that monitor ambient air pollutant concentrations and
individual exposure, insufficient economic research exists that would
permit analysts to monetize the health impacts associated with exposure
to air toxics, logistical and ethical barriers make it difficult to
conduct controlled scientific studies on the impacts of HAP exposures,
and the effects of HAP exposures are dispersed less evenly than other
types of impacts that are analyzed epidemiologically. For these and
other reasons, commenters explained, the EPA is unable to quantify, let
alone monetize, anywhere near the full scope of benefits that accrue
from regulation of HAP from power plants, including the prevention of
myriad health effects like cognitive impairment, cancer, and adverse
reproductive effects. Commenters said that these quantification
limitations present complications, but the complications do not mean
the impacts can be ignored. According to the commenters, the EPA is
correct, therefore, to carefully consider potential pathways for
assessing their magnitude and scope, as well as to include robust
qualitative discussion, to ultimately inform the appropriate and
necessary determination. Commenters stated that because important
uncertainties include not just the mechanisms of impact but also the
extent to which specific populations may suffer, it is incumbent on the
EPA to undertake this work to ensure the ensuing HAP protections
achieve sufficient levels of protection--even when those levels cannot
be absolutely quantified. The totality-of-the-circumstances approach
more effectively captures these unquantified or unquantifiable benefits
than one that simply weighs monetized costs against those benefits that
may currently be

quantified, according to the commenters.
    Commenters stated that while the appropriate and necessary finding
is lawful and supported on the basis of direct benefits alone, the EPA
also can and should consider co-benefits of the MATS rule, as was done
here as part of the totality-of-the-circumstances framework. Commenters
noted that the co-benefits of the MATS rule include massive health and
environmental benefits due to reductions in PM and SO2
pollution attributable to the MATS controls. Commenters said that
multiple elements of the CAA's text and structure show that Congress
intended that the EPA take a comprehensive view of regulation's
advantages and disadvantages when evaluating its appropriateness,
including the full scope of its benefits, according to the commenters.
Notably, according to the commenters, CAA section 112(n)(1)(A)'s
direction that the EPA assess how effectively control technologies
targeting other pollutants, under other provisions of the CAA, were
controlling HAP from power plants, demonstrates that Congress did not
intend that the EPA take a blinkered view of benefits when regulating
under CAA section 112. The commenters stated that is especially true
where, as here, doing so would give no weight to reductions in PM and
other pollutants that have led to massive public health benefits.
Commenters noted that in addition, the Supreme Court stated in Michigan
that the EPA has flexibility in how it evaluates costs and benefits
when making the appropriate and necessary finding and specifically
stated that ``an agency may not `entirely fai[l] to consider an
important aspect of the problem' when deciding whether regulation is
appropriate.'' Michigan v. EPA, 576 U.S. 752 (2015) (quoting Motor
Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co.,
463 U.S. 29, 43 (1983)). Commenters said that courts have also agreed
in other contexts that ``considering co-benefits . . . is consistent
with the [Clean Air Act]'s purpose--to reduce the health and
environmental impacts of hazardous air pollutants.'' U.S. Sugar Corp.
v. EPA, 830 F.3d 579, 623-25 (D.C. Cir. 2016) (in a case involving the
HAP program under section 112 of the CAA, affirming the EPA's reliance
on co-benefits, including ``reductions in emissions of other
pollutants,'' to justify more stringent standards for HCl emissions
from boilers, process heaters, and incinerators). The commenters said
that non-HAP benefits that include preventing thousands of
hospitalizations, thousands of heart attacks, and thousands of
premature deaths every year (according to the 2011 RIA) surely count as
an important aspect of the problem.
    Response: For the reasons set forth in section III.D above, and
discussed elsewhere in this preamble and the 2023 RTC Document, the EPA
agrees with commenters that the EPA's preferred totality-of-the-
circumstances approach is consistent with the Supreme Court's decision
in Michigan and reasonably shows that it is appropriate and necessary
to regulate EGU HAP emissions pursuant to CAA section 112. The EPA
further agrees that its preferred approach is well suited to the
appropriate and necessary finding given the wide array of
considerations Congress has indicated are relevant to CAA section 112's
goals, including public health, health impacts on the most vulnerable
and exposed individuals, environmental effects, and costs, and to
properly accounts for the benefits of HAP regulation that cannot be
determined in precise monetary terms. Additionally, the EPA agrees with
commenters that the EPA's preferred totality-of-the-circumstances
approach appropriately considered unquantified benefits as part of the
totality-of-the-circumstances analysis, and that such consideration of
unquantified benefits is consistent with other case law, executive
guidance, and past EPA practice when evaluating public health, equity,
and other relevant considerations. The EPA also agrees with commenters
that non-HAP emission reduction benefits are appropriate to consider
under CAA section 112(n)(1)(A) as explained in section 4.1 of the EPA's
2023 RTC Document.
2. The EPA Failed To Conduct a Weighted Comparison of Costs vs.
Benefits as Required by Michigan
    Comment: Commenters stated that the totality-of-the-circumstances
methodology does not properly consider the important costs related to
regulation, nor does it treat those costs equally with the other
factors that must be considered. Commenters said that the EPA's
proposed approach to cost analysis merely evaluates whether the
industry--or the public at large, since the costs of making a product
are invariably passed on to customers and ratepayers--can afford the
regulation. Commenters stated that in the 2022 Proposal, the EPA
assessed compliance costs based on various metrics (e.g., compliance
costs as percent of power sector sales; compliance expenditures
compared to power sector's annual expenditures; impact on retail price
of electricity; impact on power sector generating capacity) that are
unrelated and not compared to benefits. According to the commenters,
the proper analysis is not whether the industry (or society at large)
can afford the costs of compliance, but whether the costs of compliance
are worth it based on the total benefits derived from regulation. In
the view of commenters, under Michigan, the EPA cannot justify imposing
new requirements on sources simply because it believes that the
industry in question (or the American economy) could afford to foot the
bill of increased regulation. Commenters noted that the utility sector
is a large industry, and the American economy is the largest in the
world. Commenters asserted that the EPA would be hard-pressed to find
the American economy and the utility sector cannot afford the cost of
virtually any regulatory action, especially when such action is viewed
in isolation. That conclusion, however, does not mean the benefits of
the regulation justify its costs, according to the commenters.
Commenters said that in short, a benefit-cost framework requires a
comparison of benefits and costs, not just affordability of the costs.
    Commenters stated that in addition to mischaracterizing the costs
and benefits, the 2022 Proposal also failed to compare the two.
According to the commenters, in Michigan, the Court made clear that
something more than just a general review of all available information
is needed. Commenters said that the Court did not simply ask the EPA to
list or describe both benefits and costs--an analysis is required to
determine whether the benefits justify the costs, and the EPA must
weigh them, one against the other. These commenters averred that
Michigan follows other Supreme Court decisions affirming the principle
that agencies, to act reasonably, must weigh the costs and benefits of
actions (Indus. Union Dep't, AFL-CIO v. API, 448 U.S. 607, 645, 668
(1980); Entergy Corp. v. Riverkeeper, Inc., 556 U.S. 208, 225-26, 232-
33 (2009)). Further, these commenters argued that the comparison of
costs and benefits is necessary for reasonable decision-making to
occur. Commenters asserted that the 2022 Proposal indicates that the
EPA weighed the costs and benefits, but it provides no further
explanation as to how that weighing actually occurred, according to the
commenters. For example, according to the commenters, the EPA did not
explain why and how the non-monetized benefits of the action in
particular outweighed the costs.

Commenters expressed that the 2022 Proposal stated that the EPA
considers all of the advantages of reducing emissions of HAP regardless
of whether those advantages can be quantified or monetized, and the EPA
explained why almost none of those advantages can be monetized.
However, even if benefits cannot be monetized, the EPA must evaluate
and explain whether the specific benefits the EPA identified are worth
the estimated cost, according to the commenters. Instead, commenters
said that the EPA summarily stated that ``[a]fter considering and
weighing all of these facts and circumstances . . . the Administrator
proposes to conclude that the substantial benefits of reducing HAP from
EGUs . . . are worth the costs'' (87 FR 7668). The commenters stated
that other than conclusory statements claiming the asserted benefits
``outweigh'' costs, the EPA nowhere weighed anything at all. According
to the commenters, the EPA is certainly correct that the Supreme Court
in Michigan stopped short of requiring the EPA to conduct a ``formal
cost-benefit analysis'' and deferred to the EPA's judgment on how to
weigh costs and benefits. But the Court's recognition of the difficulty
of the task did not sway its opinion that the EPA must weigh all, and
only, the relevant factors in some reasonable fashion, in the view of
commenters. The commenters said that a single sentence conclusion does
not meet the standard set forth in Michigan.
    Commenters stated that the EPA noted in the 2022 Proposal that
available data and methods currently preclude a full and accurate
quantitative accounting of the impacts of reducing HAP emissions from
EGUs and a monetization of these impacts. Commenters agreed that MATS
may have benefits beyond those that can be reduced to the strictly
economic but stated that the challenge in assessing such benefits is
profound. Therefore, it is most appropriate to rely on monetized
benefits in an analysis of costs versus benefits for a regulation, as
opposed to potential benefits for which value cannot be measured,
according to the commenters. Even considering the EPA's proposed
attempt to monetize the value society places on avoiding potential
effects and the revised cost estimates, commenters stated that the
disparity of costs versus benefits for this regulation is not
compatible with a finding that regulation would be appropriate.
Commenters said that in the absence of compelling and significant
benefits from reductions in HAP from coal- and oil-fired EGUs, the
costs of reducing HAP from these sources must be considered excessive.
    Commenters stated that in the 2022 Proposal, the EPA considered the
potential benefits of ancillary reductions of non-HAP such as
SO2, direct PM2.5, and other PM2.5 and
ozone precursors because they are co-emitted with HAP and the controls
necessary to reduce HAP emissions from EGUs often reduce these
pollutants as well. However, those non-HAP emissions are also regulated
under the Cross State Air Pollution Rule and Ozone Season NAAQS,
according to the commenters. Commenters said that the benefits
associated with such reductions should be considered alternatively and
independently, not in support of a totality-of-the-circumstances
approach under CAA section 112(n)(1)(A). In addition, according to the
commenters, in applying the totality-of-the-circumstances methodology,
the EPA stated that, in considering and weighing advantages to
regulations against costs, the EPA would be ``giving particular
weight'' to the examination of the public health hazards reasonably
anticipated to occur as a result of HAP emissions from EGUs, and ``the
risks posed by those emissions to exposed and vulnerable populations.''
According to the commenters, neither CAA section 112(n)(1)(A) nor the
congressional findings and purposes stated in CAA section 101 justify
giving ``particular weight'' as opposed to weight to the public health
hazards from HAP emissions from EGUs in the calculation of advantages
and disadvantages.
    Other commenters said the EPA should conduct a formal cost-benefit
analysis for the decision to impose regulations and make available to
the public all the information that the EPA relied upon for that
analysis. Commenters expressed that the EPA should also thoroughly
articulate those costs and benefits related to HAP reductions and
identify on the record the precise costs and benefits that can and
cannot be monetized. Commenters stated that the EPA should clearly
identify the basis, consideration, and weight given each variable in
determining whether it is ``appropriate and necessary'' to regulate HAP
emissions from EGUs. Both the ``cost reasonableness'' test put forward
in the 2016 Supplemental Finding and the totality-of-the-circumstances
test in the 2022 Proposal are inadequate, according to the commenters.
    Response: The EPA disagrees with these commenters and, for reasons
set forth in section III.D above, believes that the totality-of-the-
circumstances methodology is fully consistent with the Michigan Court's
``expectation that the Agency should weigh benefits against costs.''
The EPA maintains that its preferred totality-of-the-circumstances
approach, in which the Administrator weighs all of the advantages of
regulation against all of its disadvantages to determine whether
regulation is worth it, is a reasonable interpretation of CAA section
112(n)(1)(A)'s requirement to determine whether it is appropriate and
necessary to regulate EGU HAP emissions under CAA section 112 and is
consistent with the Supreme Court's decision in Michigan v. EPA. The
Supreme Court instructed the EPA to determine a reasonable way to
``pay[ ] attention to the advantages and disadvantages of [our]
decisions,'' Michigan, 576 U.S. at 753, in determining whether it is
appropriate to regulate coal- and oil-fired EGUs under section 112 of
the CAA. The Court held that a formal BCA is not required under the
statute and concluded that the EPA has discretion to decide (within the
limits of reasonable interpretation) how to consider cost. Id. at 759.
    Under CAA section 112(n)(1)(A), Congress directed the EPA to
regulate EGU HAP emissions after considering the results of the ``study
of hazards to public health reasonably anticipated to occur as a result
of emissions'' from such facilities. In CAA sections 112(n)(1)(B) and
(C), Congress directed further studies to examine the health and
environmental effects of EGU mercury emissions, and to examine
threshold levels of mercury concentrations which may be consumed in
fish tissue (including in sensitive populations) without adverse
effects to public health. Accordingly, the EPA finds it is reasonable
to conclude that, in addition to costs, the information from those
studies is important and relevant to a determination of whether HAP
emissions from EGUs should be regulated under CAA section 112. See also
Michigan, 576 U.S. at 753-54 (citing CAA sections 112(n)(1)(B) and (C),
its caption, and the additional studies required under those
subparagraphs as relevant statutory context for the appropriate and
necessary determination).
    The EPA recognized that benefits like those associated with
reduction of HAP can be difficult to monetize, and this incomplete
quantitative characterization of the positive consequences can
underestimate the monetary value of net benefits. This is well-
established in the economic literature. As noted in OMB Circular A-4,
``[w]here all benefits and costs can be expressed as monetary units,
BCA provides decision makers

with a clear indication of the most efficient alternative.'' Circular
A-4 at 2. However, ``[w]hen important benefits and costs cannot be
expressed in monetary units, BCA is less useful, and it can even be
misleading, because the calculation of net benefits in such cases does
not provide a full evaluation of all relevant benefits and costs.''
Circular A-4 at 10.
    Weighing factors and circumstances surrounding potential regulation
is an inherent aspect of agency decision-making, which necessarily
requires tradeoffs and reasonable exercises of discretionary judgment.
See White Stallion, 748 F.3d at 1266 (``All regulations involve
tradeoffs, and . . . Congress has assigned EPA, not the courts, to make
many discretionary calls to protect both our country's environment and
its productive capacity.'') (Kavanaugh J., dissenting). Further, the
D.C. Circuit held in Catawba Cty. v. EPA that ``[a]n agency is free to
adopt a totality-of-the-circumstances test to implement a statute that
confers broad authority, even if that test lacks a definite `threshold'
or `clear line of demarcation to define an open-ended term.' '' 571
F.3d 20, 37 (D.C. Cir. 2009); see also PDK Labs. v. DEA, 438 F.3d 1184,
1194 (D.C. Cir. 2006) (``Agencies routinely employ multifactor
standards when discharging their statutory duties, and we have never
hesitated to uphold their decisions when adequately explained.'').
    Exercising its discretion, and consistent with the statute and with
past court decisions, the EPA determined its preferred totality-of-the-
circumstances approach is particularly well suited to the CAA section
112(n)(1)(A) appropriate and necessary finding in part because the EPA
is unable to quantify or monetize many of the effects associated with
reducing HAP emissions from EGUs. Indeed, the D.C. Circuit has
recognized that ``requiring EPA to wait until it can conclusively
demonstrate that a particular effect is adverse to health before it
acts is inconsistent with both the [Clean Air] Act's precautionary and
preventive orientation and the nature of the Administrator's statutory
responsibilities.'' Lead Industries Ass'n v. EPA, 647 F.2d 1130, 1155
(D.C. Cir. 1980).
    Nor does the EPA agree with commenters that the EPA failed to
compare in a meaningful way the benefits of this action against its
costs, or that the 2022 Proposal did not provide an explanation of how
this weighing actually occurred. The Supreme Court has said that a rule
will be found to be arbitrary and capricious ``if the agency has relied
on factors which Congress has not intended it to consider, entirely
failed to consider an important aspect of the problem, offered an
explanation for its decision that runs counter to the evidence before
the agency, or is so implausible that it could not be ascribed to a
difference in view or the product of agency expertise.'' State Farm,
463 U.S. at 43 (U.S. 1983). Further, an agency is required to give
``some definitional content'' to vague statutory terms by ``defining
the criteria it is applying,'' because a refusal to do so is equivalent
to ``simply saying no without explanation.'' Pearson v. Shalala, 164
F.3d 650, 660 (D.C. Cir. 1999). Here, the EPA has given meaning to its
understanding of the appropriate and necessary determination by laying
out all of the many factors and criteria that it considered based on a
thorough examination of the statute in light of the Michigan decision.
    The Administrator must exercise his judgment in deciding whether
the disadvantages of regulation justify its advantages and the EPA need
not demonstrate that his decision is the same decision that would be
made by another Administrator or a reviewing court. An agency action
need not be the only approach or even the approach that a reviewing
court might find most reasonable. Instead, the test is ``whether the
decision was based on a consideration of the relevant factors and
whether there has been a clear error of judgment.'' Citizens to
Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416 (U.S. 1971);
see also ExxonMobil Gas Mktg. Co. v. FERC, 297 F.3d 1071, 1083-1084
(D.C. Cir. 2002) (``Accordingly, we will uphold the Commission's
application of the test as long as it gives `reasoned consideration to
each of the pertinent factors' and articulates factual conclusions that
are supported by substantial evidence in the record.'' (citation
omitted)). Reasonable people, and different decision-makers, can arrive
at different conclusions under the same statutory provision, but those
conclusions must be reasonable under the statutory structure. The EPA
does not agree with the commenters' positions that HAP emissions from
EGUs do not pose significant hazards to public health and the
environment and that the cost of compliance with MATS is unreasonable.
This factual disagreement with the commenters does not render the EPA's
statutory interpretation of how to consider cost and the
Administrator's weighing of the relevant factors arbitrary. Absent
clear direction from the statute and a demonstration that the
Administrator has made a ``clear error of judgment,'' the EPA's
interpretation and analysis should govern.
    Moreover, contrary to commenters' assertions, the EPA did evaluate
and explain in detail in section III.D above, why the EPA views the
advantages of EGU HAP regulation as outweighing the disadvantages of
doing so. Under the EPA's preferred approach, the EPA considered the
advantages of EGU HAP reductions as informed by types of information
the statute directed the EPA to consider under the studies required by
CAA section 112(n)(1). In particular, the EPA considered the public
health benefits of regulation pursuant to CAA section 112(n)(1)(A), and
the EPA considered the rate and mass of EGU mercury emissions, the
health and environmental effects of such emissions, and the threshold
level of mercury concentrations in fish tissue which may be consumed
(even by sensitive populations) without adverse effects to public
health consistent with the studies required under CAA section
112(n)(1)(B) and (C). The EPA determined that the benefits of
regulating EGU HAP emissions are great and doing so addresses serious
risks to vulnerable populations that remained after implementation of
the ARP and other controls on the power sector under the CAA. The EPA
placed considerable weight on such benefits given the directive to do
so in CAA section 112(n)(1)(A) and Congress' clear purpose in amending
CAA section 112 in 1990. See section II of the 2022 Proposal.
    The EPA also considered compliance costs in a comprehensive manner
by placing such costs in the context of the effect those expenditures
have on the economics of power generation more broadly, the reliability
of electricity, and the cost of electricity to consumers. Similar to
the EPA's evaluation of benefits, the EPA's comprehensive analysis of
disadvantages and costs of regulation is informed by the types of
information the EPA is required to consider under CAA section
112(n)(1). The EPA gave particular consideration to potential adverse
impacts that could be felt by the public via increased electricity
prices and reduced access to a reliable power supply but determined
that EGU HAP regulation would not and has not caused such deleterious
effects to the public. The EPA considered costs based on the record
before the EPA at the time we issued the regulation and made the
threshold determination in 2012, and based on new information, which
suggests cost projections used in the 2016 Supplemental Finding likely

overestimated actual costs of compliance by billions of dollars. While
under both considerations, costs were large in absolute terms, the
EPA's analyses, discussed in detail in sections III.B and III.D above,
found compliance costs are within the range of other expenditures by
the power sector and were commensurate with revenues generated, and
that these expenditures would not and did not have any significant
impacts on electricity prices or reliability.
    After considering and weighing all of the facts and circumstances
associated with advantages and disadvantages of regulating EGU HAP, the
Administrator determined, pursuant to his discretion under the CAA and
prior case law, that regulation is appropriate and necessary under CAA
section 112(n)(1)(A).
    The EPA also disagrees with commenters that its consideration of
costs is confined to whether the power sector can bear the cost of
compliance. These commenters mischaracterize this action. In making the
appropriate and necessary determination, the EPA is not simply
determining it is appropriate to regulate EGU HAP because industry (or
the country in general) can bear the cost of regulation, as some
commenters suggest. Rather, the EPA is making a reasonable decision
within its discretion that regulation is appropriate consistent with
the Supreme Court's direction in Michigan v. EPA and informed by the
studies required by CAA section 112(n)(1), which is founded upon
consideration of whether the cost of regulatory compliance outweighs
the benefits from the reduction in HAP. That inquiry includes
consideration of the disadvantages conferred by expending those
compliance costs and advantages conferred by reducing HAP. So, it is
relevant to the EPA whether expending those compliance costs would
affect the power sector's ability to provide reliable and affordable
electricity. But that does not mean that the EPA has determined that
regulation is appropriate so long as the regulated industry (or the
country in general) can bear the expense regardless of the regulation's
benefits. And the EPA has not made such a determination. Rather, in
this action the EPA carefully weighed all of the advantages and
disadvantages, consistent with Michigan's direction, and the
Administrator determined that the benefits of MATS are worth its costs.
See Michigan v. EPA, 576 U.S. at 755 (``[CAA section 112(n)(1)(A)'s]
broad reference to appropriateness encompasses multiple relevant
factors (which include but are not limited to cost)'').
    As the EPA has noted elsewhere in its response to comments, under
the EPA's preferred totality-of-the-circumstances approach the EPA
found it is appropriate and necessary to regulate HAP emissions from
coal- and oil-fired EGUs under CAA section 112(n)(1)(A) regardless of
non-HAP emission reduction benefits. However, the EPA determined that
if it considers non-HAP emission reduction benefits, such as the
benefits (including reduced mortality) of coincidental reductions in PM
and ozone that flow from the application of controls on HAP, the
balance weighs even more heavily in favor of regulating HAP emissions
from coal- and oil-fired EGUs. Considering non-HAP emission reduction
benefits is consistent with the statute, economic principles, and long-
standing Federal agency practice. For further discussion in support of
the EPA's consideration of non-HAP emission reduction benefits, see
section 4.1 of the 2023 RTC Document.
    The EPA further disagrees with commenters that CAA section
112(n)(1)(A) does not permit the EPA to give ``particular weight'' to
sensitive populations. Congress directed the NIEHS to conduct a study
to determine the threshold level of exposure under which no adverse
effect to human health would be expected to occur, even considering
exposures of sensitive populations, and throughout CAA section 112,
Congress placed special emphasis on regulating HAP from sources to
levels that would be protective of those individuals most exposed to
HAP emissions and most sensitive to those exposures. Because the EPA
was directed by Congress to consider the adverse effects of HAP
emissions on the most sensitive populations, it is reasonable for the
EPA to give particular weight to such considerations.
    Finally, as explained in section III.E above, even assuming that a
formal BCA is required to support the EPA's appropriate and necessary
finding, the EPA has provided such an analysis to independently support
its conclusion.

E. Comments on the Administrator's Benefit-Cost Analysis Approach and
Conclusion

1. Use of Benefit-Cost Analyses in the Appropriate and Necessary
Determination
    Comment: Numerous commenters asserted that the use of the formal
BCA framework was consistent with CAA section 112(n)(1)(A) statutory
directive to the EPA, as interpreted by the court in Michigan v. EPA,
and that the formal BCA approach was a reliable, analytic approach to
tally benefits and costs of regulating EGUs under CAA section 112. Some
commenters asserted that the formal BCA should be the primary driver
for making an appropriate and necessary determination. They stated the
formal BCA discharged the Michigan court's directive that costs were a
``centrally relevant factor'' in making an ``appropriate and
necessary'' decision.
    Response: The EPA agrees that a formal BCA, as represented by the
original MATS 2011 RIA, is a meaningful alternative approach that
further affirms the appropriate and necessary finding. However, given
the challenges associated with quantifying and monetizing the full
suite of adverse effects from EGU HAP emissions on human health and
ecosystems, especially in a way that considers the impacts on the most
susceptible populations, the formal BCA as provided in the original
MATS 2011 RIA should not be the primary approach for determining
whether it is appropriate and necessary to regulate coal- and oil-fired
EGUs under CAA section 112(n)(1)(A). The EPA notes that the Supreme
Court in Michigan specified the EPA was not required to conduct a BCA,
but that it was up to the EPA's reasonable discretion how to account
for costs. 576 U.S. at 759 (``We need not and do not hold that the law
unambiguously required the Agency, when making this preliminary
estimate, to conduct a formal cost-benefit analysis in which each
advantage and disadvantage is assigned a monetary value. It will be up
to the Agency to decide (as always, within the limits of reasonable
interpretation) how to account for cost.''). Rather than relying
primarily on a formal BCA, as described in the 2022 Proposal, the EPA
prefers an approach which is rooted in the Michigan court's direction
to ``pay[ ] attention to the advantages and disadvantages of [our]
decisions.'' 576 U.S. at 753. Hence, the EPA considers all the
advantages of reducing emissions of both HAP and any co-emitted
criteria pollutants, regardless of whether those advantages can be
quantified or fully monetized. The EPA weighs those advantages against
all of the disadvantages of regulation. In following this totality-of-
the-circumstances approach, the EPA found that the advantages of this
final action (both quantified and unquantified) are substantial and far
outweigh the disadvantages.

2. Considering PM2.5 and Other Non-HAP Benefits in the
Context of a CAA Section 112(n) Determination
    Comment: Several commenters stated that, while the BCA approach
offered a framework for weighing the advantages and disadvantages of
regulation consistent with Michigan v. EPA, the EPA's formal BCA
approach utilized in this action suffered from a flaw, as it focused on
factors not relevant to what the EPA must find under CAA section
112(n). In the view of these commenters, since CAA section 112(n) was
focused solely on HAP and was clearly intended to avoid, not rely on,
duplicative regulations, the EPA's formal BCA should not include
consideration of non-HAP EGU benefits such as those that accrue due to
associated reductions in PM2.5 or other non-HAP emissions.
These commenters stated that the definition of ``benefits'' should
exclude: (a) reductions that would occur anyway in absence of the rule
due to non-regulatory drivers or due to other rules; (b) pollutant
reductions below national health-based standards; (c) benefits that
cannot be realized within the U.S. where the EPA's regulatory authority
resides; and (d) benefits from co-emitted non-HAP emissions.
    Response: The EPA disagrees with the commenters' interpretation of
what factors are relevant when comparing the benefits and costs of a
regulation. Consistent with economic theory and best practices, the EPA
Guidelines for Preparing Economic Analyses direct the EPA to account
for all positive consequences of a regulatory action, including those
that are coincident to the policy objective; this is integral to proper
economic analyses determining whether an action yields net benefits to
society. The EPA's Guidelines describe the underlying rationale of a
formal BCA, which is to evaluate the action according to the potential
``Pareto improvement criterion.'' The criterion, which is described in
detail in the Guidelines, requires ``measuring net benefits by summing
all of the welfare changes for all affected groups'' to answer the
question of whether an action increases economic efficiency (p. 1-4,
emphasis added). Consistent with scientific principles underlying BCA,
both OMB Circular A-4 and the EPA's Guidelines for Preparing Economic
Analyses direct the EPA to include all benefits in a BCA. Per Circular
A-4, OMB instructs: ``Your analysis should look beyond the direct
benefits and direct costs of your rulemaking and consider any important
ancillary benefits and countervailing risks. An ancillary benefit is a
favorable impact of the rule that is typically unrelated or secondary
to the statutory purpose of the rulemaking.'' The reductions in
criteria pollutants that are coincident with the MATS control
technologies designed to reduce HAP emissions have known positive
impacts on human health. Thus, quantifying and considering the benefits
from non-HAP like PM2.5 in the MATS BCA is entirely
consistent with economic best practices. The EPA notes this approach is
also entirely consistent with executive guidance on regulatory review,
longstanding EPA practice, and the statute and legislative history of
the MATS rule (see section II.B of the 2022 Proposal).
    In response to the comment that benefits that would occur due to
other rules or non-regulatory drivers should be excluded, we note that
in the MATS BCA, the billions of dollars of benefits attributable to
reductions in premature mortality from improving PM2.5 air
quality are exclusively attributable to the ex-ante projected emissions
reductions for the MATS action and are not attributable to any other
regulation. The EPA continues to assert that the EPA's practice to
quantify health benefits of reducing PM2.5 concentrations
both above and below the levels of the NAAQS is reasonable and well-
supported by scientific evidence. As noted by the EPA Administrator in
the most recent PM NAAQS review,\82\ the available evidence from
epidemiologic, toxicologic and controlled human exposure studies does
not reveal a ``population threshold, below which it can be concluded
with confidence that PM2.5-related effects do not occur. .
.''.
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    \82\ U.S. EPA (2020), Review of the National Ambient Air Quality
Standards for Particulate Matter: Final Action. EPA-HQ-OAR-2015-
0072; FRL-10018-11-OAR. https://www.govinfo.gov/content/pkg/FR-2020-12-18/pdf/2020-27125.pdf.
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V. Summary of Cost, Environmental, and Economic Impacts

    The EPA estimates that there are currently 519 existing EGUs
located at 250 facilities that are subject to the MATS rule. Because
the EPA is not amending the MATS rule, there are no cost,
environmental, or economic impacts as a result of this action. However,
finalizing this affirmative threshold determination provides important
certainty about the future of MATS for regulated industry, states,
other stakeholders, and the public.

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is a significant regulatory action that was submitted
to the OMB for review. Any changes made in response to OMB
recommendations have been documented in the docket. The EPA does not
project any incremental costs or benefits associated with this action
because it does not impose standards or other requirements on affected
sources. However, finalizing this affirmative threshold determination
provides important certainty about the future of MATS for regulated
industry, states, other stakeholders, and the public.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control number 2060-0567. This action does not impose an information
collection burden because the EPA is not making any changes to the
information collection requirements.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. The EPA does
not project any incremental costs or benefits associated with this
action because it does not impose standards or other requirements on
affected sources.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local, or tribal governments or the
private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the National Government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. The Executive order defines tribal implications
as ``actions that have substantial direct effects on one or more Indian
tribes, on the relationship between the Federal Government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes.'' Revocation of the 2020
determination that it is not appropriate and necessary to regulate HAP
emissions from coal- and oil-fired EGUs under CAA section 112 and
affirmation that it remains appropriate and necessary to regulate HAP
emissions from EGUs after considering cost would not have a substantial
direct effect on one or more tribes, change the relationship between
the Federal Government and tribes, or affect the distribution of power
and responsibilities between the Federal Government and Indian tribes
because MATS remains in place. Thus, Executive Order 13175 does not
apply to this action. While this action does not have tribal
implications under Executive Order 13175, the EPA sent a letter to all
federally recognized Indian tribes inviting consultation on this
action. The EPA did not receive any requests from consultation from
Indian tribes.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because this action does not impose new regulatory requirements that
might present a disproportionate risk to children. This action
reaffirms that it is appropriate and necessary to regulate HAP
emissions from U.S. EGUs, but does not impose control requirements,
which were implemented through MATS (77 FR 9304; February 16, 2012).
While this action does not impose or change any standards or other
requirements, it addresses the underpinning for the HAP emission
standards in MATS. The EPA believes the reductions in HAP emissions
achieved under MATS have provided and will continue to provide
significant benefits to children in the form of improved
neurodevelopment and respiratory health and reduced risk of adverse
outcomes. Analyses supporting the 2012 MATS Final Rule estimated
substantial health improvements for children in 2016 in the form of
130,000 fewer asthma attacks, 3,100 fewer emergency room visits due to
asthma, 6,300 fewer cases of acute bronchitis, and approximately
140,000 fewer cases of upper and lower respiratory illness. See 77 FR
9441 (February 16, 2012). Reaffirming the appropriate and necessary
determination assures those benefits will continue to accrue among
children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy. This action is not anticipated to have
impacts on emissions, costs, or energy supply decisions for the
affected electric utility industry as it does not impose standards or
other requirements on affected sources.

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make EJ part of their mission by identifying and addressing, as
appropriate, disproportionately high and adverse human health or
environmental effects of their programs, policies, and activities on
minority populations (people of color and/or indigenous peoples) and
low-income populations.
    The EPA believes that the human health or environmental conditions
that exist prior to this action result in or have the potential to
result in disproportionate and adverse human health or environmental
effects on people of color, low-income populations, and/or indigenous
peoples. As documented in both the NAS Study and Mercury Study, fish
and seafood consumption is the primary route of human exposure to
methylmercury originating from U.S. EGUs, with populations engaged in
subsistence-levels of consumption being of particular concern. As shown
in section III.A.5 of the 2022 Proposal, certain people of color, low-
income populations, and indigenous populations are more likely to
experience elevated exposures, thus higher health risks relative to the
general population due to subsistence fishing. Furthermore,
subpopulations with the higher exposure tend to overlap with those
subpopulations that are particularly vulnerable to small changes in
health risk because of other social determinants of health (e.g., lack
of access to health care and access to strong schooling), thereby
compounding the implications of the implications of mercury exposure.
    The EPA believes that this action is not likely to change existing
disproportionate and adverse effects on people of color, low-income
populations, and/or indigenous peoples because it does not impose
standards or other requirements on affected sources and is limited in
scope to only consider whether it is appropriate and necessary to
regulate HAP emissions from coal- and oil-fired EGUs. While this action
does not impose or modify any standards or other requirements, it
provides the underpinning for the emission standards regulating HAP
from EGUs. The EPA additionally identified and addressed EJ concerns by
reaffirming the appropriate and necessary determination, assuring that
the reduction in risks achieved by MATS continue. Information
supporting this Executive order review is provided in sections III.A.4
and IV.A.3 of this preamble as well as the 2021 Risk TSD. While this
action is limited in scope and does not have tribal implications as
discussed under Executive Order 13175, in addition to a public hearing,
the EPA provided opportunities for meaningful involvement through
actions such as offering consultation on the proposed action to Indian
tribes, providing an overview of the proposed action and opportunity
for tribal input on the February 2022 National Tribal Air Association
Air Policy Update Call, and providing an overview of the proposed
action and opportunity for input on the March 2022 EPA Monthly National
Community Engagement Call.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

Michael S. Regan,
Administrator.
[FR Doc. 2023-03574 Filed 3-3-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 207 (Monday, October 26, 2020)]
[Notices]
[Pages 67755-67756]
[FR Doc No: 2020-23604]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4558-DR; Docket ID FEMA-2020-0001]

California; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of California (FEMA-4558-DR), dated August 22, 2020, and
related determinations.

DATES: This amendment was issued September 30, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice is hereby given that the incident
period for this major disaster is closed effective September 26, 2020,
with the exception

of additional damage resulting from the North Complex Fire.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-23604 Filed 10-23-20; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Notices]
[Pages 44068-44069]
[FR Doc No: 2020-15733]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD20-3-000]

Billing Procedures for Annual Charges for the Costs of Other
Federal Agencies for Administering Part I of the Federal Power Act;
Notice Reporting Costs for Other Federal Agencies' Administrative
Annual Charges for Fiscal Year 2019

    1. The Federal Energy Regulatory Commission (Commission) is
required to determine the reasonableness of costs incurred by other
Federal agencies (OFAs) \1\ in connection with their participation in
the Commission's proceedings under the Federal Power Act (FPA) Part I
\2\ when those agencies seek to include such costs in the
administrative charges licensees must pay to reimburse the United
States for the cost of administering Part I.\3\ The Commission's Order
on Remand and Acting on Appeals of Annual Charge Bills \4\ determined
which costs are eligible to be included in the administrative annual
charges. This order also established a process whereby the Commission
would annually request each OFA to submit cost data, using a form \5\
specifically designed for this purpose. In addition, the order
established requirements for detailed cost accounting reports and other
documented analyses to explain the cost assumptions contained in the
OFAs' submissions.
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    \1\ The OFAs include: The U.S. Department of the Interior
(Bureau of Indian Affairs, Bureau of Land Management, Bureau of
Reclamation, National Park Service, U.S. Fish and Wildlife Service,
Office of the Solicitor, Office of Environmental Policy &
Compliance, Office of Hearings and Appeals, and Office of Policy
Analysis); the U.S. Department of Agriculture (U.S. Forest Service);
the U.S. Department of Commerce (National Marine Fisheries Service);
and the U.S. Army Corps of Engineers.
    \2\ 16 U.S.C. 791a-823d (2018).
    \3\ See id. 803(e)(1) and 42 U.S.C. 7178 (2018).
    \4\ 107 FERC 61,277, order on reh'g, 109 FERC 61,040 (2004).
    \5\ Other Federal Agency Cost Submission Form, available at
https://www.ferc.gov/docs-filing/forms.asp#ofa.
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    2. The Commission has completed its review of the forms and
supporting documentation submitted by the U.S. Department of the
Interior (Interior), the U.S. Department of Agriculture (Agriculture),
and the U.S. Department of Commerce (Commerce) for fiscal year (FY)
2019. This notice reports the costs the Commission included in its
administrative annual charges for FY 2020.

Scope of Eligible Costs

    3. The basis for eligible costs that should be included in the
OFAs' administrative annual charges is prescribed by the Office of
Management and Budget's (OMB) Circular A-25--User Charges and the
Federal Accounting Standards Advisory Board's Statement of Federal
Financial Accounting Standards (SFFAS) Number 4--Managerial Cost
Accounting Concepts and Standards for the Federal Government. Circular
A-25 establishes Federal policy regarding fees assessed for government
services and provides specific information on the scope and type of
activities subject to user charges. SFFAS Number 4 provides a
conceptual framework for federal agencies to determine the full costs
of government goods and services.
    4. Circular A-25 provides for user charges to be assessed against
recipients of special benefits derived from federal activities beyond
those received by the general public.\6\ With regard to licensees, the
special benefit derived from federal activities is the license to
operate a hydropower project. The guidance provides for the assessment
of sufficient user charges to recover the full costs of services
associated with these special benefits.\7\ SFFAS Number 4 defines full
costs as the costs of resources consumed by a specific governmental
unit that contribute directly or indirectly to a provided service.\8\
Thus, pursuant to OMB requirements and authoritative accounting
guidance, the Commission must base its OFA administrative annual charge
on all direct and indirect costs incurred by agencies in administering
Part I of the FPA. The special form the Commission designed for this
purpose, the Other Federal Agency Cost Submission Form, captures the
full range of costs recoverable under the FPA and the referenced
accounting guidance.\9\
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    \6\ OMB Circular A-25 6.
    \7\ OMB Circular A-25 6.a.2.
    \8\ SFFAS Number 4 7.
    \9\ For the past few years, the form has excluded Other Direct
Costs to avoid the possibility of confusion that occurred in earlier
years as to whether costs were being entered twice as Other Direct
Costs and Overhead.
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Commission Review of OFA Cost Submittals

    5. The Commission received cost forms and other supporting
documentation from the Departments of the Interior, Agriculture, and
Commerce. The Commission completed a review of each OFA's cost
submission forms and supporting reports. In its examination of the
OFAs' cost data, the

Commission considered each agency's ability to demonstrate a system or
process which effectively captured, isolated, and reported FPA Part I
costs as required by the Other Federal Agency Cost Submission Form.
    6. The Commission held a Technical Conference on March 26, 2020 to
report its initial findings to licensees and OFAs. Representatives for
several licensees and most of the OFAs attended the conference.
Following the technical conference, a transcript was posted, and
licensees had the opportunity to submit comments to the Commission
regarding its initial review.
    7. Idaho Falls Group (Idaho Falls) filed written comments,\10\
stating its general support of the Commission's analysis but raising a
question regarding U.S. Department of Commerce's National Marine
Fisheries Service (NMFS) individual cost submission. The issue is
addressed in the Appendix to this notice.
---------------------------------------------------------------------------

    \10\ See Letter from Sharon L. White, Van Ness Feldman, to the
Honorable Kimberly D. Bose, FERC, Docket No. AD20-3-000 (filed May
8, 2020).
---------------------------------------------------------------------------

    8. After additional review, full consideration of the comments
presented, and in accordance with the previously cited guidance, the
Commission accepted as reasonable any costs reported via the cost
submission forms that were clearly documented in the OFAs' accompanying
reports and/or analyses. These documented costs will be included in the
administrative annual charges for FY 2020.

Summary of Reported & Accepted Costs for Fiscal Year 2019
[GRAPHIC] [TIFF OMITTED] TN21JY20.002

    9. Figure 1 summarizes the total reported costs incurred by
Interior, Agriculture, and Commerce with respect to their participation
in administering Part I of the FPA. Additionally, Figure 1 summarizes
the reported costs that the Commission determined were clearly
documented and accepted for inclusion in its FY 2020 administrative
annual charges.

Summary Findings of Commission's Costs Review

    10. As presented in Figure 1, the Commission has determined that
$6,121,081 of the $6,180,128 in total reported costs were reasonable
and clearly documented in the OFAs' accompanying reports and/or
analyses. Based on this finding, 1% of the total reported cost was
determined to be unreasonable. The Commission notes the most
significant issue with the documentation provided by the OFAs was the
lack of supporting documentation to substantiate costs reported on the
Other Federal Agency Cost Submission Form.
    11. The cost reports that the Commission determined were clearly
documented and supported could be traced to detailed cost-accounting
reports, which reconciled to data provided from agency financial
systems or other pertinent source documentation. A further breakdown of
these costs is included in the Appendix to this notice, along with an
explanation of how the Commission determined their reasonableness.

Points of Contact

    12. If you have any questions regarding this notice, please contact
Raven Rodriguez at<PHONE_NUMBER>.

    Dated: July 15, 2020.
Kimberly D. Bose,
Secretary.

[FR Doc. 2020-15733 Filed 7-20-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 151 (Friday, August 5, 2011)]
[Notices]
[Pages 47593-47594]
[FR Doc No: 2011-19867]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0541]

Guidance for Small Business Entities on Current Good
Manufacturing Practice for Positron Emission Tomography Drugs;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for small business entities entitled ``PET
Drugs--Current Good Manufacturing Practice (CGMP); Small Entity
Compliance Guide.'' FDA has prepared this guidance in accordance with
the Small Business Regulatory Enforcement Fairness Act. It is intended
to help small businesses better understand FDA's thinking on compliance
with the positron emission tomography drugs (PET) CGMP regulations,
including appropriate resources, procedures, and documentation for PET
drug production facilities.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for

Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Frank Perrella, Center for Drug
Evaluation and Research (HFD-320), Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``PET
Drugs--Current Good Manufacturing Practice (CGMP); Small Entity
Compliance Guide.'' This guidance is intended to help small businesses
better understand and comply with the regulations issued by FDA
concerning CGMP for PET drugs. The guidance addresses resources,
procedures, and documentation for all PET drug production facilities.
In some cases, the guidance provides practical examples of methods or
procedures that PET drug production facilities can use to comply with
the CGMP requirements. FDA has prepared this guidance in accordance
with section 212 of the Small Business Regulatory Enforcement Fairness
Act.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on compliance with CGMP for PET drugs. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 211 have been approved under
OMB control number 0910-0139, and the collections of information in 21
CFR part 212 have been approved under OMB control number 0910-0667.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19867 Filed 8-4-11; 8:45 am]
BILLING CODE 4160-01-P


Deirdre Murphy/RTP/USEPA/US

04/14/2008 04:58 PM

To

Eileen Pritchard/DC/USEPA/US

cc

Tim Benner/DC/USEPA/US@EPA, Connie Bosma/DC/USEPA/US@EPA, James
Brown/RTP/USEPA/US@EPA, Sharon Harper/RTP/USEPA/US@EPA, Charlotte
Bertrand/DC/USEPA/US@EPA, Mike Clark/DC/USEPA/US@EPA, Bridgid
Curry/DC/USEPA/US@EPA, Lesley Schaaff/DC/USEPA/US@EPA, Ken
Munis/DC/USEPA/US@EPA, Maria Doa/DC/USEPA/US@EPA, Angela
Hofmann/DC/USEPA/US@EPA, Joyce Donohue/DC/USEPA/US@EPA, Jerry
Ellis/DC/USEPA/US@EPA, Sandy Evalenko/DC/USEPA/US@EPA, Cathy
Fehrenbacher/DC/USEPA/US@EPA, Brian Heninger/DC/USEPA/US@EPA, Bob
Hetes/RTP/USEPA/US@EPA, Monica Kirk/R10/USEPA/US@EPA, Robert
MacPhail/RTP/USEPA/US@EPA, Onyemaechi Nweke/DC/USEPA/US@EPA, Mary
Ross/RTP/USEPA/US@EPA, Jennifer Seed/DC/USEPA/US@EPA, Brett
Snyder/DC/USEPA/US@EPA, Devon Payne-Sturges/DC/USEPA/US@EPA, Fred
Talcott/DC/USEPA/US@EPA, Aaron Yeow/DC/USEPA/US@EPA, Gerain
Perry/DC/USEPA/US@EPA, Gwen Yoshimura/R7/USEPA/US@EPA, Alice
Todd/R7/USEPA/US@EPA, David Orlin/DC/USEPA/US@EPA, John
Hannon/DC/USEPA/US@EPA, Marion Hoyer/AA/USEPA/US@EPA, Deirdre
Murphy/RTP/USEPA/US@EPA, Zachary Pekar/RTP/USEPA/US@EPA, Karen
Martin/RTP/USEPA/US@EPA, Rosalina Rodriguez/RTP/USEPA/US@EPA, Tricia
Crabtree/RTP/USEPA/US@EPA, Ginger Tennant/RTP/USEPA/US@EPA, Mary
Henigin/DC/USEPA/US@EPA, Alan Rush/DC/USEPA/US@EPA, Nathaniel
Jutras/DC/USEPA/US@EPA, Nicole Owens/DC/USEPA/US@EPA, Wanda
Farrar/DC/USEPA/US@EPA, Tom Eagles/DC/USEPA/US@EPA, Lydia
Wegman/RTP/USEPA/US@EPA, Phil Lorang/RTP/USEPA/US@EPA, Mark
Schmidt/RTP/USEPA/US@EPA, Kevin Cavender/RTP/USEPA/US@EPA, Lewis
Weinstock/RTP/USEPA/US@EPA, Larry Wallace/RTP/USEPA/US@EPA, Kimber
Scavo/RTP/USEPA/US@EPA, Erika Sasser/RTP/USEPA/US@EPA

Subject

Lead NAAQS Review - DRAFT NPR (4/14/08)

Eileen,

Per agreement at today's FAR meeting for the notice of proposed
rulemaking for the Pb NAAQS, I am forwarding a draft package to be
informally shared with OMB.

Deirdre

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

Deirdre L. Murphy, PhD

Health and Environmental Impacts Division

USEPA, OAR, OAQPS

C539-02, RTP, NC  27711

(919)541-0729,  fax=(919)541-0840