[Federal Register Volume 76, Number 95 (Tuesday, May 17, 2011)]
[Rules and Regulations]
[Pages 28318-28326]
[FR Doc No: 2011-12095]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 60 and 63

[EPA-HQ-OAR-2002-0051; EPA-HQ-OAR-2007-0877; FRL-9306-7]
RIN 2060-AQ93

National Emission Standards for Hazardous Air Pollutants From the
Portland Cement Manufacturing Industry and Standards of Performance for
Portland Cement Plants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Denial in part and grant in part of petitions to reconsider.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) is denying
in part and granting in part the petitions to reconsider the final
revised National Emission Standards for Hazardous Air Pollutants
emitted by the Portland Cement Industry and the New Source Performance
Standards for Portland Cement Plants issued under sections 112(d) and
111(b) of the Clean Air Act, respectively. The EPA is also denying all
requests that the EPA issue an administrative stay of the National
Emission Standards for Hazardous Air Pollutants and the New Source
Performance Standards.

DATES: This action is effective May 17, 2011.

ADDRESSES: The EPA's docket for this action is Docket ID No. EPA-HQ-
OAR-2002-0051. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (CBI) or other information where disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at
the EPA's Docket Center, Public Reading Room, EPA West Building, Room
3334, 1301 Constitution Avenue, NW., Washington, DC 20004. This Docket
Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the Air Docket is
(202) 566-1742.

FOR FURTHER INFORMATION CONTACT: Mr. Keith Barnett, Office of Air
Quality Planning and Standards; Sector Policies and Programs Division,
Minerals and Manufacturing Group (D243-02); Environmental Protection
Agency; Research Triangle Park, NC 27111; telephone number: (919) 541-
5605; fax number:<PHONE_NUMBER>; e mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On August 6, 2010, the EPA signed a final
rule establishing and amending various air emission limits applicable
to the Portland cement industry. See 75 FR 54970 (Sept. 9, 2010). The
rule establishes National Emission Standards for Hazardous Air
Pollutants (NESHAP) for emissions of mercury, total hydrocarbons (THC),
and particulate matter (PM) from new and existing cement kilns located
at major and area sources, and for emissions of hydrochloric acid (HCl)
from new and existing kilns located at major sources. The rule also
establishes New Source Performance Standards (NSPS) for emissions of
PM, nitrogen oxides, and sulfur dioxide at cement kilns that commence
construction, modification, or reconstruction after June 16, 2008.
    Various entities representing both the regulated industry and the
environmental community have petitioned the EPA for reconsideration of
various standards in these rules, in particular the NESHAP. A number of
industry petitioners also requested that the EPA issue an
administrative stay of the NESHAP and NSPS. For the reasons stated
below, the EPA is denying reconsideration on certain issues raised in
the petitions and is granting reconsideration on a number of other
issues. The EPA is also denying all requests that it issue an
administrative stay.

I. Standard for Reconsideration

    Section 307(d)(7)(B) of the Clean Air Act (CAA) states that: ``Only
an objection to a rule or procedure which was raised with reasonable
specificity during the period for public comment (including any public
hearing) may be raised during judicial review. If the person raising an
objection can demonstrate to the Administrator that it was
impracticable to raise such objection within such time or if the
grounds for such objection arose after the period for public comment
(but within the time specified for judicial review) and if such
objection is of central relevance to the outcome of the rule, the
Administrator shall convene a proceeding for reconsideration of the
rule and provide the same procedural rights as would have been afforded
had the information been available at the time the rule was proposed.
If the Administrator refuses to convene such a proceeding, such person
may seek review of such refusal in the United States court of appeals
for the appropriate circuit (as provided in subsection (b)). Such
reconsideration shall not postpone the effectiveness of the rule. The
effectiveness of the rule may be stayed pending such reconsideration,
however, by the Administrator or the court for a period not to exceed
three months.''
    As to the first procedural criterion for reconsideration, a
petitioner must show why the issue could not have been presented during
the comment period, either because it was impracticable to raise the
issue during that time or because the grounds for the issue arose after
the period for public comment (but within 60 days of publication of the
final action).
    In the EPA's view, an objection is of central relevance to the
outcome of the rule only if it provides substantial support for the
argument that the promulgated regulation should be revised. See, e.g.,
the EPA's Denial of the Petitions to Reconsider the Endangerment and
Cause or Contribute Findings for Greenhouse Gases under Section 202 of
the Clean Air Act, 75 FR 49556, 49561 (Aug. 13, 2010). This
interpretation is appropriate in light of the criteria adopted by
Congress in this and other provisions in section 307(d). Section
307(d)(4)(B)(i) provides that ``[a]ll documents which become available
after the proposed rule has been published and which the Administrator
determines are of central relevance to the rulemaking shall be placed
in the docket as soon as possible after their availability.'' This
provision draws a distinction between comments and other information
submitted during the comment period, and other documents which become
available after publication of the proposed rule. The former are
docketed irrespective of their relevance or merit, while the latter
must be docketed only if a higher hurdle of central relevance to the
rulemaking is met.
    For more extended discussions of the standard for reconsideration
under section 307(d)(7)(B), please see 75 FR 49556, 49560-49563 (August
13, 2010) and 76 FR 4780, 4786-4788 (January 26, 2011).

II. The Petitions for Reconsideration

A. Petition of the Portland Cement Association (PCA)

    1. PCA maintains that after the close of the comment period on the
proposed cement NESHAP, the EPA proposed inter-related rules regulating

Commercial and Industrial Solid Waste Incinerators (CISWI) and
proposing a definition of solid waste for non-hazardous secondary
materials. Petition p. 2. PCA alleges that these proposed rules
``eviscerate the statistical underpinning for the NESHAP rule.''
Petition p. 2. PCA states that under the proposed rule defining non-
hazardous secondary materials that are solid wastes (``solid waste
definition rule''), many cement kilns would have been considered to be
incinerators (i.e., units that combust ``solid waste,'' as that term is
defined by the Administrator under RCRA, see section 129(g)(6)), rather
than cement kilns. PCA further states that under the proposed waste
definition rule, virtually all of the cement kilns comprising the pool
of best performers for each of the cement NESHAP floors would be
incinerators since they burn secondary materials that would have been
defined as solid waste under the proposed solid waste definition rule.
Although acknowledging that the EPA had discussed in the proposed
cement NESHAP how it intended to classify cement kilns that burn
secondary materials (Petition p. 8), PCA maintains that it had no
notice of the potential impact of the CISWI rule and solid waste
definition rule until the EPA proposed a definition of solid waste,
and, in particular, that PCA was unaware of the potential practical
implications of the issue until the EPA proposed a solid waste
definition. Petition pp. 10, 12. Petitioners maintain that the EPA
cannot permissibly classify the same kilns as affected sources under
both rules, and requests that the EPA stay the Portland cement NESHAP
administratively pending reconsideration of the issue.
    2. PCA next maintains that the EPA adopted standards for open
clinker cooler piles in the NESHAP without giving proper notice of what
those standards might be. Petition p. 11.
    3. PCA further requests reconsideration of the standards for
startup and shutdown operations. PCA argues that the final standards
deviated from those proposed, because the EPA had proposed that the
same standards that apply during normal operation also apply during
startup and shutdown operations, whereas the final rule adopts
standards for startup and shutdown that differ from those applicable
during normal operation. Petition p. 14. PCA maintains that it had no
notice of the data on which such standards were based, because the
standards are not based on emissions data. Id. p. 15. The petition
further states that the standards for startup and shutdown were adopted
in disregard of the requirements of section 112(d)(3) of the CAA, again
largely because the standards are not based on emissions data. Id.
    4. In the final rule, the EPA adopted a provision establishing an
affirmative defense to civil penalties for exceedances of emission
standards which result from malfunction events. PCA requests that the
EPA reconsider this affirmative defense provision, which it
characterizes as overly cumbersome, and issued without notice and
adequate opportunity for public comment. Id. at 16.
    5. PCA also requests that the EPA reconsider the standards for PM,
including the new source standard for PM in the NSPS. Id. PCA alleges
that the EPA ``reduce[d] the PM limits * * * dramatically'' between
proposal and final rule, and that the change was based on information
hand-picked by the EPA which information was not known to petitioners.
Id. In a follow-up letter of December 14, 2010, PCA expanded on its
petition to state that the key change between proposal and final rule,
made without proper notice, was to express the PM standard as a 30-day
average and to use a statistical methodology (Upper Prediction Limit,
or UPL) in calculating that limit. December 14 Letter p. 3.
    6. PCA also requested that the EPA reconsider a number of issues of
a more technical nature (many of which pertain to the standards for
open clinker piles). Petition Exhibit 1.

B. Petition of Eagle Materials

    Eagle Materials challenges application of the NESHAP's monitoring
requirements to sources equipped with monovents (vents on the top of a
control device rather than a single stack). Although acknowledging that
this issue was presented during the public comment period, Eagle
Materials maintains that the EPA's disposition of the issue was based
on technical assumptions which are unfounded and unanticipated by Eagle
and other commenters. Eagle Materials also maintains that the EPA
adopted standards for clinker storage piles without providing adequate
notice of what those standards might be.

C. Petitions of Sierra Club, Downwinders at Risk, Friends of Hudson,
Huron Environmental Activist League, Desert Citizens Against Pollution,
Montanans Against Toxic Burning, and the Natural Resources Defense
Council

    A number of environmental groups filed petitions requesting that
the EPA reconsider the provision establishing an affirmative defense to
civil penalties for emission exceedances demonstrated to have occurred
as a result of a malfunction event (as defined). The petitions maintain
that the EPA adopted this provision without adequate notice and
opportunity for public comment.

III. Decision on Issues Raised in the Petitions

A. Issues on Which the EPA Is Denying Reconsideration

1. Relationship Between Portland Cement NESHAP, Solid Waste Definition
and CISWI Rule
    PCA maintains that ``EPA proposed the CISWI/`solid waste'
definition rules after the comment period closed on the NESHAP rule,
foreclosing any real opportunity for PCA to assess and comment on the
impacts of the NESHAP. Indeed, it was not until EPA proposed the
subsequent CISWI/`solid waste' rules that * * * PCA had notice with any
real specificity of the number of cement facilities that may end up
being regulated as CISWI facilities.'' Petition p. 8. The EPA is
denying rehearing on this issue because the petitioners have failed to
demonstrate that it was impracticable to raise their objection during
the public comment period. In addition, the fact that some cement kilns
may have a later change of regulatory classification after the NESHAP
is promulgated is not an issue of central relevance to the outcome of
the NESHAP rule, as required by the statutory standard for
reconsideration. Finally, as discussed below, even if the impacts of
the solid waste rule had been assessed, it would not have made a
significant difference in the final Portland Cement NESHAP.
    a. Was it impractical to raise the objection within the comment
period?
    Section 307(d)(7)(B) requires the EPA to grant reconsideration of
an issue ``[i]f the person raising the objection can demonstrate to the
Administrator that it was impracticable to raise such objection within
[the period for public comment] or if the grounds for such objection
arose after the period for public comment''. PCA could have objected
during the comment period on the proposed Portland Cement NESHAP to
EPA's classification of all Portland cement kilns burning secondary
materials \1\ as cement kilns. In the

proposed Portland Cement NESHAP, the EPA proposed to classify all
cement kilns, including those burning secondary materials, as cement
kilns for the NESHAP rulemaking, and explained why it was doing so. The
EPA discussed the interplay between the cement kiln NESHAP and the
forthcoming rules for incinerators which burn solid waste, noting that
``some Portland cement kilns combust secondary materials as alternative
fuels''. 74 FR at 21138. The EPA then stated that because there was no
regulatory definition of solid waste that would distinguish which of
these alternative fuels burned by cement kilns were wastes and which
were not, the EPA would therefore classify all of the units as cement
kilns. Id. The EPA reasoned that unless and until the Agency adopts a
definition of solid waste classifying the alternative fuels, cement
kilns burning secondary materials as fuels or otherwise using secondary
materials are lawfully classified as cement kilns and rules for cement
kilns therefore would apply to them. Id. The EPA also articulated the
principle of which PCA states it lacked notice: The NESHAP would be
based on the performance of all devices which were cement kilns at the
time of the Portland Cement NESHAP rulemaking. Id. The EPA further
found that combustion of secondary materials as alternative fuels by
cement kilns ``did not have any appreciable effect on the amount of
hazardous air pollutants (HAP) emitted by any source.'' Id. The record
for the proposed rule included an inventory of every material burned by
a large group of cement kilns over a 30-day period, including all of
those comprising the pool of best performers for mercury.\2\
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    \1\ A ``secondary material'' is a material that can potentially
be classified as a solid waste under the Resource Conservation and
Recovery Act when recycled. 50 FR 616 n. 4 (Jan. 4, 1985). Under the
newly adopted regulatory definition of solid waste, secondary
materials encompass ``any material that is not the primary product
of a manufacturing or commercial process, and can include post-
consumer material, off-specification commercial chemical products or
manufacturing chemical intermediates, post-industrial material, and
scrap.'' 40 CFR 241.2.
    \2\ See docket item EPA-HQ-OAR-2002-0051-2043.
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    Neither PCA nor any other commenter objected to any aspect of the
issue of the interplay between the cement kiln NESHAP and the CISWI/
waste definition rules during the comment period.\3\ PCA has
consequently failed to satisfy the requirement of section 307(d)(7)(B)
that it was impractical to raise the issue during the public comment
period or that the grounds for their objection arose after the close of
the comment period.
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    \3\ Two commenters ( 2816 and 2846) noted EPA's
approach. One of these commenters approvingly summarized EPA's
position to classify all cement kilns as cement kilns, based on
their status at the time of the NESHAP. The other commenter simply
summarized EPA's position. Neither of these comments is an objection
putting EPA on notice that a commenter disagreed with EPA's approach
or otherwise raising ``with reasonable specificity'' (section
307(d)(7)(B)) any issue that EPA's approach was objectionable for
legal or policy reasons.
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    Petitioners maintain that ``it was impossible for PCA to provide
informed comments on the interplay between the CISWI/`solid waste'
definition rules and the NESHAP rule'' until the Agency proposed those
rules on April 29, 2010, after the close of the comment period in the
NESHAP. Petition p. 10. Acknowledging that the EPA had already raised
the issue in the proposed cement NESHAP, petitioners maintain that
``[a] generic comment is not adequate to put stakeholders on fair
notice that the CISWI/`solid waste' definition rules could
fundamentally change the scope of the NESHAP source category.'' Id.\4\
But the EPA's discussion at proposal was not generic. It was a
considered discussion stating the approach to classification the EPA
intended to adopt (and did adopt) in the final rule, citing moreover to
the EPA's Advance Notice of Proposed Rulemaking (74 FR 42, January 2,
2009) which had discussed the universe of secondary materials burned by
units including cement kilns, and the considerations the Agency might
use in ultimately classifying these materials by rule as waste or non-
wastes. The administrative record likewise contained item-by-item
accounting--cited to by the EPA when presenting the issue of kiln
classification for public comment--of every secondary material burned
by a large group of cement kilns over an extended period.
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    \4\ Nonetheless, had the final solid waste definition been in
place at the time of the final Portland Cement NESHAP rulemaking,
there would have been only modest change in the scope of the NESHAP
source category and the final standards would have been largely
unaltered. See Table 1 below.
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    PCA appears to be stating that although the EPA had raised the
issue of kiln classification at proposal, the practical implications of
the EPA's approach were not clear until the EPA proposed a solid waste
definition and CISWI standards. But the EPA stated that it would
classify all cement kilns as cement kilns during the NESHAP rulemaking
unless a final definition of solid waste changed their regulatory
status prior to the completion of the section 112 Portland Cement
NESHAP. That issue was unaltered by the EPA issuing a proposed solid
waste definition and proposed CISWI standards. Just like the proposed
cement NESHAP, the final cement NESHAP was based on the performance of
units classified as cement kilns at the time of the cement NESHAP
rulemaking. This included all cement kilns burning alternative fuels.
PCA's objection is no different before the proposed solid waste
definition and CISWI rules than after that proposal. The same issue is
presented now as was presented at proposal: Whether devices which are
classified as cement kilns in the absence of a regulatory waste
definition are properly so classified if they were burning secondary
materials that might ultimately be classified as solid wastes.
Moreover, the type of secondary materials the cement kilns were burning
was well-documented in the NESHAP administrative record (and known to
PCA in any case).\5\ PCA's decision not to comment on the issue because
of perceived lack of practical effect was their choice, not the result
of lack of notice. For this reason, PCA's statement that it could not
gauge the impact of the NESHAP until the proposed waste definition/
CISWI rule appeared (Petition p. 10) misses the point. Those impacts
were going to be the same because the EPA had made clear that it would
continue to classify cement kilns as cement kilns so long as that
remained their legal status. This status remained the same throughout
the rulemaking.
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    \5\ Fuels Use in Portland Cement Kilns, April 25, 2011.
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    b. Are petitioners' objections of central relevance to the outcome
of the rule?
    Section 307(b)(7)(B) also requires that for reconsideration to be
required, objections must be ``of central relevance to the outcome of
the rule.'' The EPA does not believe that is the case here, for reasons
both legal and practical.
    The EPA believes that it validly based the NESHAP on the
performance of devices which were cement kilns at the time of the
rulemaking. See section 112(d)(3)(A) which states that maximum
achievable control technology (MACT) floors for existing sources are to
reflect performance of sources for which the EPA has emissions
information, indicating that standards are to reflect sources' legal
status and performance at the time of the rulemaking.\6\ Later rules

that prospectively establish the classification of certain of the
alternative fuels that these kilns burned does not alter these kilns'
status--cement kilns--at the time of the cement NESHAP rulemaking. This
is all that matters. The solid waste definition rule adopted a half
year after the signature of the Portland Cement NESHAP rule is not
relevant to the cement kilns' classification at the time of the NESHAP
rulemaking.
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    \6\ There is no valid argument that cement kilns burning
alternative fuels were already commercial and solid waste
incinerators at the time of the NESHAP rulemaking. First, all of
these kilns certified that they were cement kilns in compliance with
the 1999 MACT standards for the Portland Cement category (pursuant
to 40 CFR sections 63.1353(b)(5) and 63.9(h)). Second, the status of
these alternative fuels as solid wastes or not solid wastes could
not be determined in the absence of a regulatory definition
addressing the status of those fuels. 74 FR at 21138. Although there
is a statutory definition of solid waste in the Resource
Conservation and Recovery Act (at section 1004 (27)), that
definition does not apply directly to section 129, but must be
implemented by means of an EPA-promulgated regulation. See CAA
section 129(g)(6) (``the ter[m] `solid waste' * * * shall have the
meanin[g] established by the Administrator pursuant to the Solid
Waste Disposal Act''.) Equally important, the status of alternative
fuels cannot be determined from the statutory definition alone (as
illustrated by the different regulatory classifications of different
alternative fuels in the recently-adopted definition of non-
hazardous secondary materials, and the significant changes between
proposal and final rule that EPA made in classifying alternative
fuels).
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    PCA argues, however, that the situation here is controlled by the
DC Circuit's opinion in NRDC v. EPA, 489 F. 3d 1250 (DC Cir. 2007)
(``Boiler MACT''). Petition p. 8. We disagree. In that case, the EPA
had adopted a definition of ``solid waste incineration unit'' which
classified ``commercial or industrial waste'' to include only solid
waste combusted in units which do not recover energy. 489 F. 3d at
1258. The EPA issued MACT standards predicated upon no boilers being
incinerators due to their energy recovery purpose and design. The court
held that the definition was impermissible in that it classified units
burning solid waste as boilers rather than as commercial and industrial
solid waste incineration units and noted that ``[t]he effect of these
definitions is to substantially reduce the number of commercial or
industrial waste combustors subject to section 129's standards''. Id.
The court continued:

    [Since the Court is requiring] EPA to revise the CISWI
Definitions Rule * * *, the Boilers Rule will need to be revised as
well because the universe of boilers subject to its standards will
be far smaller and more homogenous after all CISWI units * * * are
removed from its coverage. Given the likelihood (if not certainty)
that the Boilers Rule will change substantially as a result of our
vacatur of the challenged ``solid waste'' definition, we believe the
Boilers Rule should be vacated in its entirety and remanded for EPA
to repromulgate after revising the CISWI Definitions Rule. 489 F. 3d
at 1261.

    The NESHAP rule at issue in Boiler MACT was thus promulgated when
there was a definition of commercial and industrial wastes (as
incorporated in the definition of solid waste incinerator, 489 F. 3d at
1261), which classified all units as either boilers or incinerators,
albeit improperly. Here, in contrast, there was no regulatory
definition of solid waste that determined (or otherwise addressed) the
status of the alternative fuels burned by cement kilns. Thus, cement
kilns burning alternative fuels or other secondary materials were not
classified as incinerators during the cement NESHAP rulemaking, but as
cement kilns. The cement NESHAP therefore was and is based exclusively
on the performance of cement kilns, as properly classified at the time
of the rulemaking.\7\ PCA states that the EPA cannot promulgate a
NESHAP rule based on calculations that include CISWI units, but the EPA
has not done that. Petition p. 10. All of the cement kilns were cement
kilns during the NESHAP rulemaking.
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    \7\ As noted earlier, all cement kilns certified to EPA that
they were cement kilns in compliance with the applicable section
112(d) standards for cement kilns up to and through the time of the
amendments to the Portland Cement NESHAP.
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    Moreover, although the EPA recognizes that there is case authority
that agencies are compelled to reopen rules when the rules' fundamental
factual basis (or other essential premise) is altered by later
events,\8\ the EPA does not believe that the factual basis of the
NESHAP has changed. The units on which the standard was based were
cement kilns at the time of the NESHAP rulemaking, and, consistent with
section 112(d)(3), the EPA based the NESHAP on that classification.
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    \8\ See Geller v. FCC, 610 F. 2d 973, 979-80 (DC Cir. 1979)
(rules justified as needed to encourage passage of Federal copyright
legislation, without any further justification that the rules were
in the public interest, may have lacked any nexus with the public
interest after passage of the copyright legislation and the Federal
Communications Commission could therefore be compelled to reexamine
the rule); RSR v. EPA, 102 F. 3d 1266, 1270 (DC Cir. 1997) (noting
that in Geller the sole basis for the challenged rule had ``long
since evaporated'' and that agency was compelled to reexamine the
rule in light of the ``abnormal circumstances'' of the case).
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    PCA also states that the EPA committed to reconsider the cement
NESHAP once the CISWI/``solid waste'' definition rules were finalized.
Petition p. 11. This is incorrect. The EPA never committed to reopening
a promulgated rule for the cement source category or any other. In the
preamble to the proposed cement NESHAP, the EPA stated: ``EPA is basing
all determinations as to source classification on the emissions
information now available, as required by section 112(d)(3), and will
necessarily continue to do so until the solid waste definition
discussed above is promulgated.'' 74 FR at 21138; see also 75 FR at
54972 which contains similar language. This statement means no more
than it says: if the EPA had promulgated a final definition of solid
waste that changed the classification of these kilns during the
rulemaking, then the EPA would have based that NESHAP on that new
classification. That did not occur during the Portland Cement NESHAP
rulemaking. The quoted language cannot fairly be read to say that the
EPA would revise standards for source categories properly classified at
the time of the NESHAP based on a post-promulgation definition of solid
waste whether that category be Portland cement kilns, lime kilns, or
any other source category which once burned secondary materials later
defined as solid waste.
    The implications of PCA's position are that all NESHAPs have to be
reopened and amended if units in the source category were burning
secondary material that were classified post-promulgation as solid
wastes by a later rule. Potential examples are lime kilns, chemical
recovery units, as well as cement kilns (including the 1999 dioxin
standard for cement kilns, which was not reopened as part of the 2010
rulemaking amending the NESHAP). The EPA does not accept this position.
All of the NESHAPs are properly based on the units' classification at
the time of the rulemaking.\9\ PCA's position is disruptive to the
rulemaking process and would potentially lead to frequent and
substantial uncertainty for the regulated community and other
stakeholders
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    \9\ For the same reason, EPA cannot be deemed to have
constructively reopened the NESHAP when it issued the solid waste
definition and CISWI rules. Nothing in the later rules changes the
kilns' status as cement kilns at the time of the cement NESHAP
rulemaking.
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    The EPA similarly disagrees with the premise that the Agency cannot
develop standards for any source category which burns materials which
might ultimately be classified as solid waste until developing and
finalizing a solid waste definition rule. This conflicts with the EPA's
obligations under the statute, consent decrees, and settlement
agreements (including the settlement agreement requiring the EPA to
issue the NESHAP for Portland cement by August 2010) to complete
NESHAPs for source categories listed pursuant to section 112(c)(1) by
dates certain. The EPA's obligation in fact is to issue NESHAPs based
on the emissions information before it at the time of the rulemaking
(see section 112(d)(3)(A)), which is what it did here. NESHAPs are thus
necessarily based on the snapshot-in-time assessment of performance
within a source category, which necessarily includes the status of
sources in that category at that moment

in time. To do otherwise makes the process unworkable.
    Moreover, although not necessary to the decision to deny
reconsideration, the EPA has evaluated the practical implications of
the solid waste definition and CISWI standards that it recently
adopted. If the newly-adopted solid waste definition had been
applicable at the time cement kilns conducted the performance testing
used as the basis for the MACT standards and at the time of
promulgation of the final Portland Cement NESHAP, 23 cement kilns (by
the EPA's estimate) out of 146 would have been classified as
incinerators. If these units were removed from the pool of cement
kilns, the floors--with one exception--would have remained either
identical or essentially identical and, since the EPA adopted the
floors as the standards, the standards would likewise have remained
identical or essentially identical. The one floor that would change
appreciably is the floor for THC, which would become significantly more
stringent because the revised data base would reflect cement kilns
experiencing less variability in THC emissions.\10\ Given the minimal
change in the standards, with the exception of the more stringent THC
standard, kilns' compliance strategy would be unaltered.
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    \10\ Nor would EPA alter any of its determinations not to adopt
more stringent beyond-the-floor standards.

   Table 1--Comparison of Floors With and Without Kilns That Could Have Been CISWI Kilns Had the Definition of
                                            Solid Waste Applied \11\
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                                                        Existing source                       New source floor--
                                    Existing source   floor--CISWI kilns  New source floor--      CISWI kilns
            Pollutant              floor--2010 Final     removed from       2010 Final Rule      removed from
                                         Rule              inventory                               inventory
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Mercury.........................  55 lb/MM tons       58 lb/MM tons       21 lb/MM tons       24 lb/MM tons
                                   clinker.            clinker.            clinker.            clinker.
Total Hydrocarbons..............  24 ppmvd..........  15 ppmvd..........  24 ppmvd..........  11 ppmvd.
PM..............................  0.04..............  0.05..............  0.01..............  0.01.
HCl.............................  3 ppmvd...........  3 ppmvd...........  3 ppmvd...........  3 ppmvd.
----------------------------------------------------------------------------------------------------------------

    In this analysis, the EPA finds that none of the cement kilns would
have been potentially CISWI due to the use of secondary material
ingredients (though some kilns would potentially have been CISWI due to
secondary fuels burned). This is because none of these secondary
ingredient materials identified by PCA as being used in cement kilns is
considered to be combusted. A typical dictionary definition of
``combustion'' is ``an act or instance of burning'' or ``a chemical
process (as an oxidation) accompanied by the evolution of light and
heat.'' \12\ Cement kilns typically process ingredients in the cold
regions of the kiln, where ingredients are gradually heated until they
reach the temperature where clinker formation takes place. This is not
a chemical process marked by the evolution of light and heat, and so is
not combustion. Rather, it is analogous to cooking as opposed to
burning.\13\ Cement kiln dust is also used as an ingredient and is
sometimes processed in the hot end of the cement kiln. Due to its
inorganic, essentially inert composition, this material is not
combusted.\14\ Non-hazardous secondary materials used as an ingredient
(as opposed to being combusted) in combustion units are not solid
wastes under newly promulgated definitional rules (to be codified at 40
CFR section 241.3 (b)(3)), assuming the legitimacy criteria in section
241.3 (d) are satisfied.
---------------------------------------------------------------------------

    \11\ In this analysis, nine of the eleven floor kilns for the
final cement NESHAP remain cement kilns. One of the two floor kilns
for THC would be a CISWI, although removing this kiln from the
cement kiln data base would result in a significantly more stringent
THC standard under the NESHAP because this kiln had more associated
variability in its performance than the other kilns ranked closest
to it. For PM, two of six kilns remain classified as cement kilns.
For HCl, two of three floor kilns remain cement kilns, but there are
a whole group of cement kilns that performed identically to the
floor kiln for HCl that was, for purposes of our analysis,
reclassified as a CISWI so there would be no effect on the standard.
75 FR at 54894 (standard based on analytic method detection limit
times a variability factor rather than on the measured values
because those values were so close to the analytic method minimum
detection limit). See the memorandum Revised Floors Without Kilns
That Would Have Been CISWI Kilns Had the Solid Waste Definition
Applied, dated April 25, 2011.
    \12\ Webster's Ninth New Colleg1ate Dictionary. Merriam-Webster
Inc. 1990.
    \13\ See Combustion in a Cement Kiln and Cement Kilns' Use of
Tires as Fuel dated April 25, 2011.
    \14\ Id.
---------------------------------------------------------------------------

    The EPA's analysis also reflects the results of Information
Collection Requests (pursuant to section 114 of the CAA) regarding
cement kilns' use of tires as alternative fuels. Based on these ICR
responses, the EPA finds that most of the responding cement kilns
obtained tires from established tire programs as defined in newly
promulgated part 241, and have reasonably established that the tires
were not discarded and were handled as valuable commodities from the
point of removal through arrival at the cement kiln and therefore would
not have been solid wastes. The EPA does not interpret the
certification required by section 60.2175(w) of the newly-adopted CISWI
rule as requiring ultimate users to know the source of all tires
obtained from an established tire collection program. This is a
practical impossibility. In certifying, users also should not assume
that tires from established programs which participate in occasional
cleanup days were discarded. Rather, it is sufficient that the ultimate
user verify that it is obtaining tires from an established tire
collection program, which program can provide the user with reasonable
assurance that it manages tires carefully from point of collection to
point of burning and which does not receive tires which have been
abandoned in landfills or otherwise.
    There are further practical considerations, which likewise indicate
the relative lack of practical effect of the solid waste definition and
CISWI standards on the NESHAP. First, cement kilns can choose whether
to continue burning solid waste and being classified as incinerators,
or not burn waste and remain classified as cement kilns. Second,
burning alternative fuels (whether classified as solid wastes or not)
does not appreciably affect cement kilns' HAP emissions. 74 FR at
21138; Comments of PCA, Docket EPA-HQ-RCRA-2008-0329 (Aug. 3, 2010) (p.
27) (same). Thus, the measured performance of cement kilns that forms
the basis of the standards in the NESHAP remains technically sound
since that performance would remain the same whether or not kilns burn
``solid waste'' alternative fuels.
    Finally, PCA points out that until there is a solid waste
regulatory definition and a CISWI rule, its members lack the
information to make a rational choice as to which source category to be
subject to--whether or not to continue burning secondary materials and
whether to invest

immediately in the pollution control equipment and operational
practices necessary for most kilns to comply with the Portland Cement
NESHAP. Petition p. 18. The EPA has now adopted both a regulatory solid
waste definition for non-hazardous secondary materials and CISWI
standards, which should provide the basis for kilns to make these
decisions within the necessary investment timeframe.
Conclusion
    The EPA proposed to classify cement kilns burning secondary
materials as cement kilns in the proposed rule, explained why it would
do so, and finalized the NESHAP rule using the approach proposed. No
objections to that approach were raised to the EPA during the
rulemaking. We further reject the position that a solid waste
definition adopted any time after promulgation of a NESHAP compels
reexamination of the NESHAP because it alters the NESHAP's fundamental
premises. The EPA appropriately develops NESHAPs, including the
Portland Cement NESHAP, based on the information available to it at the
time of the rulemaking and it is undisputed that the units in question
here were cement kilns at the time of the final cement NESHAP. The EPA
thus concludes that reconsideration here is neither required nor
appropriate under section 307(d)(7)(B).
2. Standards During Periods of Startup and Shutdown
    PCA maintains that the NESHAP's limits that apply during periods of
startup and shutdown do not meet the requirements of CAA section
112(d)(2) because the standards rest on engineering estimates of
performance rather than on performance data, and that the EPA failed to
provide adequate notice and opportunity for comment. Petition pp. 14-
16. With respect to the startup and shutdown standards, PCA has not
demonstrated that it was unable to raise its objections during the
public comment period. Indeed, it did so. The EPA proposed that the
same standards apply during startup and shutdown conditions as during
normal operating conditions, and solicited any data which might show
that some other standard would be more appropriate. 74 FR at 21162. PCA
commented at length on these proposed standards. PCA Comments, pp. 7-8,
11-13. In response to PCA's own comment that the proposed startup and
shutdown standards should not be normalized to units of production (PCA
Comment of Sept. 4, 2009 at 7-8, EPA-HQ-OAR-2002-0051-2922.1), the EPA
modified the proposed standards so that they are expressed as stack
concentrations. 75 FR at 54991.
    PCA's main contention is that the EPA based the standards for
startup and shutdown on its engineering judgment, so that commenters
have had no opportunity to comment on emissions data supporting those
conclusions. Petition p. 15. PCA is correct that the standards reflect
the EPA's engineering judgment, but the EPA may permissibly rely on
engineering judgment in developing floor standards in a NESHAP. Sierra
Club v. EPA, 167 F.3d 658, 665 (DC Cir. 1999); National Lime, 233 F.3d
at 632; Mossville Environmental Action Now v. EPA, 370 F.3d 1232, 1241-
42 (DC Cir. 2004); see also CAA section 112(d)(3)(A). Furthermore,
neither PCA nor any other commenter provided emissions data for startup
and shutdown operations, despite the EPA's request. 74 FR at 21162.
    Under these circumstances, the EPA believes that the petitioner
both had the opportunity to raise its objections during the public
comment period and did so. Reconsideration is therefore neither
required nor appropriate.
    The EPA, however, is granting reconsideration of one issue related
to standards during startup and shutdown. This is the standard for HCl
during startup and shutdown for kilns equipped with wet scrubbers but
which do not use a continuous emissions monitor (CEM) to measure
compliance. See issue B.4 below.
3. Standards for Particulate Matter
    PCA states that in the final rule ``EPA dramatically deviated from
the range of possible limits that it had proposed for particulate
matter * * * by almost 90 per cent'' for new facilities and by nearly
50 percent for existing facilities. Petition p. 16. PCA further
maintains that this change resulted from ``cherry picked'' data, with
the expanded dataset ``arbitrarily and capriciously biased towards top
performers,'' those with new baghouses. Id. PCA further states that it
was unable to comment on these data because the EPA did not make the
data available until after promulgation of the final rule, and that the
limits may not be achievable for sources that use wet scrubbers for
acid gas control due to loadings of re-entrained particulate. Id. at
17. PCA raises the same issues with respect to the PM limit in the
NSPS, which is identical to the new source standard under the NESHAP.
Id.
    This part of PCA's petition is largely mistaken, and does not
present any grounds requiring the EPA to reconsider the PM standard in
either the NESHAP or the NSPS. Indeed, PCA's public comments suggested
a different PM limit than proposed based largely on the additional
performance data for which they now claim lack of notice. PCA Comments
at p. 86 and App. 1 to those comments. See docket items EPA-HQ-OAR-
2002-0051-2922.1 and 2922.2, September 4, 2009. Much of this
information had already been submitted to the EPA by PCA and individual
PCA members in the parallel NSPS rulemaking as well. See National
Emission Standards for Hazardous Air Pollutants from the Portland
Cement Manufacturing Industry Response to Comments Received on Proposed
Rule (Aug. 6, 2010) (``RTC'') p. 155. See docket item EPA-HQ-OAR-2002-
0051-3464. PCA thus not only had an opportunity to comment on the data
used by the EPA for the final standard, but did so.
    Nor did the EPA ``cherry pick'' among those data. See RTC at pp.
155, and 153-55 demonstrating the opposite: PCA had used the data
selectively in constructing the alternative standard suggested in its
comments, but the EPA's analysis used all of the additional data from
the pool of best performing sources for PM.
    PCA is also mistaken in its claim that it lacked opportunity to
present its objection that the PM standard is based on unrepresentative
performance because it was based on performance of plants with newly-
installed baghouses. Indeed, it raised this issue in its public
comments. PCA Comments at 86; see also RTC at pp. 155-56 indicating
that baghouse performance can improve over time but is characterized by
operating variability both when a baghouse is new and throughout its
operating life. Commenters likewise raised the issue of baghouse
performance decreasing due to re-entrained particulate resulting from
use of wet scrubbers for acid gas control, and the EPA responded by
citing data showing that PM levels from a cement kiln baghouse
decreased after the kiln installed a wet scrubber to control its acid
gas emissions. RTC at p. 158. Since there was ample notice and
opportunity for comment on these issues (and, as just indicated, actual
comment), the EPA is not required to reconsider them.
    In its December 14, 2010, letter, PCA takes a different tack,
stating that the PM standard in the final NESHAP and NSPS is expressed
as a 30-day rolling average rather than as a 1-day average (as at
proposal), and that the EPA used a statistical equation, the Upper
Prediction Limit at the 99th percentile (UPL 99) to construct that
limit. December 14 letter pp. 3-4. The letter

asserts that PCA lacked notice of either issue.
    PCA is correct that the final standard is expressed as a 30-day
standard (met by averaging 30 daily observations per month). 75 FR at
54988.\15\ The EPA stated at proposal that it was considering adopting
a PM standard whereby compliance would be measured with a CEM, and that
CEM-based standards would be expressed as 30-day numbers. The EPA
further had presented the statistical means of converting individual
measurements into 30-day averages by means of the UPL 99 equation. 74
FR at 21157, 21158, 21141-42. PCA's comments criticized use of the UPL
99 equation both generally, and for a PM standard specifically (PCA
Comments pp. 5, 86), and documented their view that the UPL equation
underestimated variability for PM generally and underestimated the
projected 99th percentile of the distribution of PM values (PCA
Comments at App. 2 p. ES-7 and App. 2 p. 5-5). See also the EPA's
responses at 75 FR at 59474-76; Development of the MACT Floors for the
final Portland Cement NESHAP (the EPA, August 6, 2010, docket item EPA-
HQ-OAR-2002-0051-4550) at pp. 2-4, 9-10, 17, explaining why the UPL 99
equation is a reasonable statistical tool for assessing variability,
including variability over a 30-day measuring period.\16\ PCA and
member companies likewise submitted detailed comments questioning the
reliability and suitability of PM CEMs and urged the EPA not to require
their use in measuring the standard. RTC at pp. 163-67. The EPA
consequently does not accept the contention that commenters lacked
notice of these issues and that reconsideration is either required or
appropriate.
---------------------------------------------------------------------------

    \15\ PCA is not correct, however, that the standard became
dramatically more stringent. If expressed as a not-to-exceed limit,
as at proposal, the final existing source standard under the NESHAP
would be approximately 0.07 lb/ton clinker, or only about 12 per
cent more stringent than proposed. This slight increase in
stringency results from corrections to the UPL equation used at
proposal, corrections made in response to comments submitted by PCA.
The additional performance data for PM actually made the standard
less stringent (the net slight increase in stringency resulting, as
noted from the revised UPL equation to the new data set).
Development of the MACT Floors for the Final NESHAP for Portland
cement (EPA, August 6, 2010, Docket  4550) at p. 16.
    \16\ The argument that the UPL equation underestimates
variability of PM control performance because it underestimated
variability for performance of THC is misleading. The UPL equation
measures potential variability based on the within-source variance
and between-source variance of the data set to which it is applied.
74 FR at 21141. The EPA's initial data set for THC was comparatively
sparse, and did not fully reflect the best-performing sources'
within-source variation and between-source variation. The EPA was
able to gather additional performance data between proposal and
comment to expand those data (and to calculate variability directly
from the data; see 75 FR at 54980 n. 22). However, the problem was
not the UPL equation but the data set to which it was applied. It
also should be noted that baghouses controlling PM (the control
device for all of the best performing cement kilns) are relatively
impervious to input loadings, performing relatively constantly
regardless of incoming ash load. 70 FR at 59449 (Oct. 12, 2005); 72
FR at 54879 (Sept. 27, 2007). Baghouse variability thus can be
assessed especially reliably by standard statistical means, such as
the UPL equation. Id.
---------------------------------------------------------------------------

    The EPA, however, is granting reconsideration of two standards
related to PM, the NSPS for PM as applied to modified sources, and the
alternative PM compliance alternative for sources that commingle
certain internal exhaust gas streams. See issues B. 6 and B. 9 below.
4. Monovents
    Petitioner Eagle Materials claims that it lacked notice of the
EPA's basis for requiring use of CEMs for all cement kilns, including
those having monovent exhaust configurations (vents on the top of a
control device rather than a single stack). This issue was presented at
proposal, and the company submitted comments on the issue, as the
petitioner acknowledges. Petition at pp. 3, 5-9. The petitioner
disagrees with the EPA's response (which indicated that a source could
install a separate stack for measurement purposes or seek an
alternative monitoring regime on a site-specific basis pursuant to the
authority at 40 CFR section 63.7 (f), RTC at pp. 75, 120, 145-46, 172-
73), but this does not demonstrate that there was a lack of opportunity
to comment on the issue. The EPA is consequently not granting this
petition.
    Although we are denying the request for reconsideration of the
monitoring provisions for facilities with monovents, we note further
that these types of monitoring issues tend to be very site specific,
and there will likely be individual cases where the national rule will
be impractical. The provisions of section 63.7(f) of the General
Provisions exist for this purpose and we believe that issues related to
monitoring facilities with monovents are best handled on a case-by-case
basis under that rule. These provisions have been used in similar
situations to authorize cost-effective, environmentally appropriate
alternative monitoring and, to our knowledge, have not in and of
themselves required the construction of a single stack.
5. Emissions From Crushers
    Crushers are machines designed to reduce large rocks from a quarry
into gravel-sized feed. See section 63.1341 (definition of
``crusher''). Crushers are typically located at the limestone quarry.
In 2002, the EPA and the PCA entered into a settlement agreement
regarding the 1999 NESHAP for the industry and, as part of that
agreement, agreed to clarify that crushers are not part of the Portland
cement source category. The EPA did so but used convoluted language
\17\ which created unnecessary confusion about collateral issues such
as the regulatory status of other types of equipment such as storage
bins. In the 2005 rule proposing to amend the NESHAP, the EPA proposed
to eliminate the confusing language and simply state that crushers are
not part of the Portland cement source category, and indicated in the
preamble to the 2006 final rule that it intended to finalize this
language. See 70 FR at 72341-42 (Dec. 2, 2005) and 71 FR at 76532 (Dec.
20, 2006). The EPA neglected to include the necessary rule language,
and proposed to add it in this rulemaking. 74 FR at 21163. The final
rule states that ``[c]rushers are not covered by this subpart
regardless of their location.'' Section 63.1340 (c); see also RTC at p.
212 (explaining these actions and citing to earlier regulatory
history).
---------------------------------------------------------------------------

    \17\ Former section 63.1340(c) stated: ``For Portland cement
plants with on-site nonmetallic mineral processing facilities, the
first affected source in the sequence of materials handling
operations subject to this subpart is the raw material storage,
which is just prior to the raw mill. Any equipment of the on-site
nonmetallic mineral processing plant which precedes the raw material
storage is not subject to this subpart. In addition, the primary and
secondary crushers of the on-site nonmetallic mineral processing
plant, regardless of whether they precede the raw material storage,
are not subject to this subpart. Furthermore, the first conveyor
transfer point subject to this subpart is the transfer point
associated with the conveyor transferring material from the raw
material storage to the raw mill.''
---------------------------------------------------------------------------

    PCA asks that the EPA reconsider its decision and restore the
amended regulatory text quoted below. Petition Exhibit 1. The EPA has
provided numerous opportunities to comment on this issue so
reconsideration is clearly not compelled under section 307 (d)(7)(B).
Nor is reconsideration appropriate. The former regulatory text created
confusion about collateral issues and failed to indicate clearly its
ostensible subject--that crushers are not regulated under the Portland
Cement NESHAP. The EPA has amended the rule to make this clear. Doing
so is consistent with the 2001 Settlement Agreement on this point, the
object of which was to make clear that crushers

were not regulated under the NESHAP. In any case, nothing in that
settlement agreement prevents the EPA from amending its regulations if
it is appropriate to do so. The agreement in fact states that
``[n]othing in this Agreement shall be construed to limit or modify the
EPA's discretion to alter, amend, or revise, or to promulgate
regulations that supersede, the regulations identified in section III
of this Agreement.''

B. Issues on Which the EPA Is Granting Reconsideration

1. Standards for Clinker Storage Piles
    PCA and Eagle Materials both maintain that the EPA did not provide
sufficient notice of the standards it might adopt for clinker storage
piles. Although the EPA did give notice that it might adopt standards
for these units (74 FR at 21163), the petitioners are correct that the
Agency did not give sufficient notice of what those standards might be.
The EPA is consequently granting the petition as to this issue. For the
same reason, the EPA is granting the petition as to all of the
miscellaneous issues pertaining to clinker storage piles (issues 1-4 in
Exhibit 1 to PCA's Petition for Reconsideration).
2. Affirmative Defense to Civil Penalties for Exceedances Occurring
During Malfunctions
    Various petitioners representing environmental advocacy groups, as
well as PCA, assert that the EPA adopted in the final rule an
affirmative defense to civil penalties for exceedances of applicable
emission standards during periods of malfunction. Section 63.1344. The
petitioners are correct that there was not a proper opportunity to
comment on this provision at proposal, and the EPA is therefore
granting these petitions as to this issue.
3. Continuously Monitored Parameters for Alternative THC Standard
    Section 63.1343(b)(1) provides two options for meeting a standard
for organic HAP. One is to meet a THC standard of 24 parts per million
by volume dry (ppmvd); the other is to meet a limit of 9 ppmvd of total
organic HAP. If the source elects to meet the total organic HAP
standard, a site specific THC limit is established based on the THC
results during the performance test used to establish compliance with
the total organic HAP limit. Section 63.1348(a)(4)(v).
    PCA has noted that the site specific THC limit can unintentionally
deprive kilns of operating flexibility where kilns have measured total
organic HAP comfortably below the alternative standard. For example, if
a kiln has measured total organic HAP of 3 ppmvd and site specific
levels of THC of 15 ppmvd during the performance test, it would be de
facto subject to a considerably more stringent THC standard than if it
were subject to the main THC standard.
    The EPA believes that the issue of unnecessarily constrained
operating flexibility is worthy of reexamination and therefore is
granting reconsideration of this issue.
4. HCl Limit of Zero During Startup for Sources That Do Not Have a CEM
    The final cement NESHAP provides that existing and new kilns have a
standard of zero for HCl when operating at startup and shutdown and
when compliance is measured by means other than a CEM. Section
63.1343(b) Table 1 note 4. Kilns equipped with wet scrubbers may elect
to comply with the HCl standard by means of performance tests rather
than a CEM, so the practical effect of this provision is that wet-
scrubber equipped kilns electing to comply by means of stack testing
rather than continuous monitoring of HCl with a CEM would be subject to
the emission limit of zero during startup and shutdown. See sections
63.1348(a)(6)(i) and 63.1349(b)(6)(i)(a). PCA indicates in its petition
that the EPA is incorrect in finding that HCl is formed only from
burning normal fuel (75 FR at 54992). PCA maintains that HCl can be
formed by oxidizing chlorides in the raw materials present in the kiln
regardless of the type of fuels used, and so can be present in
emissions during startup and shutdown. PCA urges that the same limit (3
ppmvd) apply during startup as applies to all other kilns during all
operating conditions. Petition Exhibit 1.
    The EPA is granting reconsideration on this issue since PCA's
petition may have technical merit.
5. Allowing Sources With Caustic Scrubbers To Comply With HCl Standard
Using Performance Tests
    As just noted, the final rule allows sources equipped with wet
scrubbers (and tray towers) to comply with the HCl standard by means of
performance tests rather than with continuous monitoring of HCl with a
CEM. (Sources electing to comply by means of stack tests do establish
continuously monitored parameters--liquid flow rate, pressure and pH
(see section 63.1350(m)(5)-(7)). PCA indicates that this compliance
option should not be limited to wet scrubber equipped units, but should
also be available for units equipped with caustic scrubbers, in part
because some sources will be equipped with dry scrubbers (due to water
shortages) and should have the same operating flexibilities as wet
scrubber-equipped kilns.
    The EPA is granting reconsideration to consider the issue of
whether dry scrubber-equipped kilns should have the option of complying
by means of stack tests rather than continuous monitoring.
6. Alternative PM Limit
    Some kilns combine kiln exhaust gas with exhaust gas from other
unit operations, including the clinker cooler. See 75 FR at 54988. The
final cement NESHAP seeks to accommodate these situations by providing
for a site specific PM limit for commingled flows from the kiln and
clinker cooler. Section 63.1343(b)(2). PCA points out, however, that
other flows can be commingled as well. PCA Petition Exhibit 1
(referring to coal mill exhaust and exhaust from an alkali by-pass as
instances of additional flows). Without an allowance for these
additional flows, the site specific PM limit could be stricter than the
EPA intended (since the PM concentration will be divided by a lower
number in the implementing equation), and could penalize the
environmentally beneficial practice of commingling these flows, a
practice resulting in significant energy savings. 75 FR at 54988. The
EPA therefore grants reconsideration on this issue.
7. Monitoring for Mercury and PM During Periods of Startup and Shutdown
    The standards for the four main pollutants regulated by the NESHAP
(mercury, THC/organic HAP, HCl, and PM) are all measured continuously.
This is true of the standards applying during normal operation and
those that apply during startup/shutdown. However, two of the
standards--for mercury and for PM--are normalized to production units
during normal operation and expressed on a concentration basis during
startup/shutdown. See 75 FR at 54991-92.
    PCA suggests in its petition that cement companies would like to
utilize the same monitoring device for both standards, but that this
could pose operational obstacles if sorbent traps are used as the
continuous monitoring device. Petition Exhibit 1. This is because data
from a sorbent trap cannot be readily disaggregated, meaning that a
dedicated trap would be needed to monitor startup and shutdown and a
different sorbent trap used for normal operation. (Data from a CEM can
be disaggregated, so that it is possible to evaluate data from startup/
shutdown

and normal operation from measurements taken by a single PM and mercury
CEM.) PCA questions if this was the EPA's intent.
    The EPA is granting the petition to consider the question of types
of continuous monitoring allowed during startup and shutdown for
mercury and PM.
8. Coal Mills (NESHAP and NSPS)
    In the EPA's recent amendments to the Standards for Performance for
Coal Mills, we exempted coal mills at cement manufacturing facilities
whose only heat source was kiln exhaust. See 74 FR 51952, October 8,
2009. This change was made in response to comment from PCA. PCA argued
that coal mills were similar to inline raw mills. In the case of inline
raw mills, we consider the raw mill to be an integral part of the kiln.
PCA requested the same treatment for coal mills, and the EPA agreed.
However, in the amendments to the Portland Cement NESHAP and NSPS, the
EPA did not address coal mills. This omission was due to the lack of
information on emissions from coal mills. The EPA is granting
reconsideration to reconsider the status of coal mills under the cement
NESHAP.
9. PM Standard for Modified Sources Under the NSPS
    The EPA adopted the level of the new source standard under the
NESHAP as the NSPS for both new and modified kilns. 75 FR at 54996. As
PCA notes in its petition, there need not be functional equivalence
between the NESHAP and NSPS PM limits for modified kilns, and further
comment on the issue is appropriate. Petition p. 17. PCA also notes
that the NSPS for modified kilns could have associated costs which need
to be accounted for pursuant to CAA section 111(a)(1). Since such kilns
would not be subject to the section 112(d) new source standard, any
costs for such modified kilns to control PM to the new source limit
could not be attributed to the section 112(d) new source limit. In
addition, PCA notes that existing Portland cement kilns cannot be
assumed to find ways to avoid triggering the NSPS modification criteria
when making physical or operational changes due to the stringency of
the newly adopted standards for PM.
    The EPA believes that PCA's arguments on this point have merit and
warrant reconsideration of the NSPS standard for PM for modified kilns.

IV. Requests for an Administrative Stay

    PCA also requests that the EPA issue an administrative stay of the
rule pursuant to section 705 of the Administrative Procedure Act (APA),
which authorizes an agency, when it finds that ``justice so requires''
to ``postpone the effective date of action taken by it, pending
judicial review. Petition p. 6. PCA also alludes to the authority in
section 307(d)(7)(B) of the CAA under which the EPA may issue a stay
for up to three months if it grants a petition to reconsider a final
rule.
    First, the effective date of the NESHAP and NSPS--November 8,
2010--has already passed and thus a stay under APA section 705 is not
appropriate. See 76 FR 4780, 4800 (Jan. 26, 2011) (``[p]ostponing an
effective date implies action before the effective date arrives'').
    Section 307(d)(7)(B) of the CAA authorizes the EPA to stay a rule's
effectiveness for three months during reconsideration. Since the EPA is
largely denying the petitions to reconsider and is not granting
reconsideration as to challenges to the principal standards in the
NESHAP or NSPS, an administrative stay is not appropriate under that
authority.
    In reaching these conclusions, the EPA evaluated not only the legal
applicability of the statutory provisions cited in PCA's petition, but
also the merits criteria for granting stays--the likelihood of success
on the merits, possibility of irreparable harm to the petition, harm to
other parties, and the ultimate public interest. As discussed above,
the EPA believes that the NESHAP is validly based on the performance of
cement kilns. The EPA's technical evaluation of kilns' performance is
also sound because burning alternative fuels (whether or not those
fuels are classified as solid waste) does not appreciably effect the
amount of HAP cement kilns emit.
    The EPA also does not believe that the industry is facing the
prospect of irreparable harm. As explained above, the industry's
legitimate concern of having to make critical investment decisions
without knowing the final rules on waste classification and standards
for solid waste incinerators has been rectified by the EPA's issuance
of a final regulatory definition of non-hazardous secondary materials
that are solid waste and CISWI standards. In addition, given the
similarity of many of the emissions limits, the compliance strategy for
either rule would be expected to be similar.
    Moreover, the EPA does not believe that a stay of the rules'
compliance date is in the public interest. The standards in the rule
are projected to result in significant health benefits (thousands of
serious health incidences avoided, including thousands fewer acute
myocardial infarctions) and the rules' monetized benefits are projected
to substantially exceed the rules' social costs. 75 FR at 55027 Table
13 and 55028 (social costs estimated at $926 to 950 million (2005$) and
net monetized benefits are estimated at $6.5 billion to $18 billion
(2005$ and a 7 percent discount rate). Cement kilns' mercury emissions
are among the highest of any emitting source category, and contribute
significantly to the national inventory of airborne mercury. 75 FR at
54979 (cement industry contributes 7.5 tons of mercury emissions per
year to national inventory of 50 tons per year). We note that mercury
is a potent and bioaccumulative neurotoxin that remains in the
environment for an extended period of time. As a result, the additional
mercury that would be emitted as the result of a stay of the rule would
remain in the environment for many years. The NESHAP here for the first
time adopts statutorily-compliant limits to control those emissions.
The EPA does not believe it in the public interest to delay those
controls.

V. Conclusion

    For all of the reasons discussed above, the petitions to reconsider
the final NESHAP and NSPS for Portland cement plants are denied in part
and granted in part. The EPA likewise denies the petitions for an
administrative stay.

    Dated: May 11, 2011.
Lisa P. Jackson,
Administrator.
[FR Doc. 2011-12095 Filed 5-16-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Notices]
[Pages 53493-53494]
[FR Doc No: 2017-24860]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP18-141-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Sec.  4(d) Rate Filing: Non-Conforming--Virginia
Southside II to be effective 12/1/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5001.
    Comments Due: 5 p.m. ET 11/14/17.

    Docket Numbers: RP18-142-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Chesapeake to
Eco-Energy 8948627 to be effective 11/1/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5003.
    Comments Due: 5 p.m. ET 11/14/17.

    Docket Numbers: RP18-143-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Capacity Release
Agreements--11/01/2017 to be effective 11/1/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5071.
    Comments Due: 5 p.m. ET 11/14/17.

    Docket Numbers: RP18-144-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Access South and Adair SW--
NRAs and NC Agreements to be effective 11/7/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5105.
    Comments Due: 5 p.m. ET 11/8/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For

other information, call<PHONE_NUMBER> (toll free). For TTY, call (202)
502-8659.

    Dated: November 3, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-24860 Filed 11-15-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 81015-81016]
[FR Doc No: 2011-33165]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket ID PHMSA-RSPA-2004-19854]

Notice of Public Webinar on Implementation of Distribution
Integrity Management Programs

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of Public Webinar.

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

SUMMARY: Distribution pipeline operators were required to have prepared
and implemented distribution integrity management plans (DIMP) by
August 2, 2011. Federal and state regulators have begun inspecting
those plans and their implementation. This webinar will be the first
opportunity for the regulators to share their findings broadly with the
regulated community. The webinar will also include discussion of
analyses of the initial submissions of data concerning mechanical
fitting failures in distribution pipelines.

DATES: The webinar will be held on January 25, 2012, from 11 a.m. to
12:30 p.m. EST. Refer to the DIMP Web site for additional information:
http://primis.phmsa.dot.gov/dimp/index.htm.

ADDRESSES: Comments: Members of the public may also submit written
comments, either before, during, or after the webinar. Comments should
reference Docket ID PHMSA-RSPA-2004-19854. Comments and questions can
be submitted during the webinar through LiveMeeting. Instructions
describing how to submit questions will be given at the beginning of
the webinar. Comments may be submitted before or after the webinar in
the following ways:
     DIMP Web site: http://primis.phmsa.dot.gov/dimp/comment.htm. This site allows the public to enter questions and
comments about DIMP before or after the webinar. Instructions for
submitting comments are provided on that Web site.
     E-Gov Web Site: http://www.regulations.gov. This site
allows the public to enter comments on any Federal Register notice
issued by any agency. Follow the instructions for submitting comments.
     Fax: 1-(202) 493-2251.
     Mail: Docket Management System, U.S. Department of
Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590.
     Hand Delivery: DOT, Docket Management System, Room W12-
140, on the ground floor of the West Building, 1200 New Jersey Avenue
SE., Washington, DC between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Instructions: Identify the Docket ID at the beginning of your
comments. If you submit your comments by mail, submit two copies. If
you wish to receive confirmation that PHMSA has received your comments,
include a self-addressed stamped postcard. Internet users may submit
comments at http://www.regulations.gov. Note: Comments will be posted
without changes or edits to http://www.regulations.gov including any
personal information provided. Please see the Privacy Act statement
immediately following for additional information.
    Privacy Act Statement: Anyone may search the electronic form of all
comments received for any of our dockets. You may review DOT's complete
Privacy Act Statement in the Federal Register published April 11, 2000
(65 FR 19477).
    Information on Services for Individuals with Disabilities: For
information on facilities or services for individuals with
disabilities, or to request special assistance during the webinar,
please contact Chris McLaren at<PHONE_NUMBER> by January 6, 2012.
    Copies of the presentations will be available on the DIMP Web site
and in the docket PHMSA-2004-19854 at http://www.regulations.gov,
within 30 days following the webinar.

FOR FURTHER INFORMATION CONTACT: Chris McLaren by e-mail at
<EMAIL_ADDRESS>or by phone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Purpose: The DIMP regulation was published December 4, 2009, (74 FR
63906) and became effective on August 2, 2011. This regulation
represents a new approach to assuring the safety and integrity of
distribution pipelines. Previously, regulations presented highly-
prescriptive requirements for which it was relatively easy to
understand what needed to be done to comply. DIMP is much less
prescriptive. It requires pipeline operators to analyze their pipeline
systems, identify threats and risks that may be unique to their
systems, and take appropriate actions to address those threats and
risks. Distribution pipeline operators previously have not been
required to comply with such a performance-based rule.
    A DIMP Implementation Team (Team) was created as a collaboration of
state and Federal regulators to support improvements in the integrity
of the Nation's gas distribution pipeline systems through development
of inspection methods and guidance for the evaluation of an Operator's
DIMP. The Team recognized the challenges posed by the individual
characteristics of each state's oversight program and operating
conditions as well as the evolutionary process that distribution system
operators would go through in building an integrity management culture
from a prescriptive, compliance based culture. Due to the high-level,
risk-based, performance-oriented nature of the regulations contained in
49 CFR 192.1001-192.1015, the Team recognized that operators could
benefit from guidance in implementing their programs. The team
sponsored two webinars to provide operators with information and to
direct operators to resource material. These webinars were conducted on
May 10 and June 8, 2011. This was prior to the August 2, 2011,
effective date of the rule by which time operators were required to
have developed and implemented their DIMP plans.
    The August 2, 2011, deadline has now passed. Distribution pipeline
operators must have implemented their DIMP plans. Initial inspections
of these plans have begun. The material presented at this webinar will
summarize this inspection experience, including the types of concerns
that have been identified and where the initial

inspection experience indicates that operators should devote additional
attention to assure compliance.
    States are implementing the DIMP rule under their individual state
statutory authority in accordance with the applicable certification
under 49 U.S.C. 60105 or agreement under section 60106. State
inspectors will participate in this webinar, but not all states will be
represented. Since regulatory structures differ among states, operators
should contact the state authority regulating their distribution
pipeline system for more information.
    The DIMP rule also required distribution pipeline operators to
report failures of mechanical fittings that result in hazardous leaks.
Such failures have been the cause of a number of serious accidents on
distribution pipelines. Collection of this data is intended to
facilitate better understanding of the causes of fitting failures and
actions that can/should be taken to prevent future failures. Operators
have the option of submitting reports as failures occur or of
submitting all reports for a calendar year by March 15 of the following
year. The new reporting requirement became effective on April 4, 2011.
Operators have submitted many reports to PHMSA. These reports will be
analyzed before the webinar and PHMSA will discuss the results of these
analyses. Operators should note that lessons from mechanical fitting
failure reporting will be preliminary at this time. They will be based
on a limited set of data. The data set is likely to increase
significantly as additional reports are received on or before March 15,
2012. Even then, though, only one year of data will be available, which
may not be sufficient to identify trends. Nevertheless, the initial
analyses will provide some information that will be shared with
stakeholders, and operators will be given a chance to comment on the
mechanical fitting failure reporting process.

Preliminary Webinar Agenda

January 25, 2012, DIMP Implementation Webinar Agenda

 Welcome, Introductions, and Overview.
 Initial DIMP Inspection Findings.
 Results of Initial Analyses of Mechanical Fitting Failure
Reports.
 Question & Answer Session.
 Session Concludes.

    Registration: Members of the public may attend this free webinar.
To help ensure that adequate space is provided, all attendees are
required to register for the webinar at http://opsweb.phmsa.dot.gov/webinars. Upon registration, LiveMeeting information will be
distributed. Due to the limited capacity, we encourage and request that
parties at the same location share a LiveMeeting link. The Webinars
will use the audio feature of LiveMeeting and not a standard phone line
for the voice portion of the Webinars.

    Issued in Washington, DC on December 20, 2011.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2011-33165 Filed 12-23-11; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Notices]
[Pages 63547-63548]
[FR Doc No: 2020-22296]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-14-000]

UGI LNG, Inc; Notice of Request for Extension of Time

    Take notice that on September 21, 2020, and amended on September
24, 2020, UGI LNG, Inc. (UGI) requested that the Federal Energy
Regulatory Commission (Commission) grant an extension of time, until
June 21, 2021, to complete construction of its Temple Truck Rack
Expansion Project (Project) at its Temple liquefied natural gas (LNG)
storage facility located in Ontelaunee Township, Berks County,
Pennsylvania, as authorized in the October 18, 2018 Order Issuing
Certificate (Certificate Order).\1\ Ordering Paragraph B(1) of the
Certificate Order required UGI to complete the construction of the
proposed Project facilities and make them available for service within
one year from of issuance, or by October 18, 2019.\2\
---------------------------------------------------------------------------

    \1\ UGI LNG, Inc., 165 FERC ] 62,040 (Certificate Order) (2018).
    \2\ Id. at ordering para. (B)(1).
---------------------------------------------------------------------------

    UGI states that it submitted its Implementation Plan for the
Project in January 2019, but was unable to request notice to proceed
with project construction activities until late June of 2019, as the
Commission's Division of LNG Facility Review & Inspection required UGI
LNG to submit a significant amount of additional information via phone
calls and in-person meetings before work could begin on the Project.
After submitting its initial request for notice to proceed, UGI
submitted supplemental requests for notices to proceed and supplements
to its Implementation Plan on July 10, August 16, and September 5,
2019. UGI LNG was granted full authorization to proceed with
construction activities on September 18, 2019. In March 2020, UGI
stopped work on the Project due to the Novel Coronavirus Disease
(COVID-19) pandemic.
    UGI states that it intended to request to extend its certificate
authorization prior to October 18, 2019, but failed to do so due to an
internal administrative oversight. UGI now belatedly requests an
additional nine months, or until June 21, 2020, to complete the
authorized construction of the Project facilities and make facilities
available for service.
    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on UGI's request for an
extension of time may do so. No reply comments or answers will be
considered. If you wish to obtain legal status by becoming a party to
the proceedings for this request, you should, on or before the comment
date stated below, file a motion to intervene in accordance with the
requirements of the Commission's Rules of Practice and Procedure (18
CFR 385.214 or 385.211) and the Regulations under the Natural Gas Act
(18 CFR 157.10).\3\
---------------------------------------------------------------------------

    \3\ Only motions to intervene from entities that were party to
the underlying proceeding will be accepted. Algonquin Gas
Transmission, LLC, 170 FERC ] 61,144, at P 39 (2020).
---------------------------------------------------------------------------

    As a matter of practice, the Commission itself generally acts on
requests for extensions of time to complete construction for Natural
Gas Act facilities when such requests are contested before order
issuance. For those extension requests that are contested,\4\ the
Commission will aim to issue an order acting on the request within 45
days.\5\ The Commission will address all arguments relating to whether
the applicant has demonstrated there is good cause to grant the
extension.\6\
---------------------------------------------------------------------------

    \4\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2020).
    \5\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
    \6\ Id. P 40.
---------------------------------------------------------------------------

    The Commission will not consider arguments that re-litigate the
issuance of the April 15th Certificate order, including whether the
Commission properly found the project to be in the public convenience
and necessity and whether the Commission's environmental analysis for
the certificate complied with the National Environmental Policy Act.\7\
At the time a pipeline requests an extension of time, orders on
certificates of public convenience and necessity are final and the
Commission will not re-litigate their issuance.\8\ The OEP Director, or
his or her designee, will act on those extension requests that are
uncontested.
---------------------------------------------------------------------------

    \7\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with NEPA.
    \8\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
---------------------------------------------------------------------------

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning COVID-19, issued by the President on March 13, 2020. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFile'' link at
http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on October 19, 2020.

    Dated: October 2, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-22296 Filed 10-7-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Pages 43768-43770]
[FR Doc No: 2017-19928]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0508]

Registration and Product Listing for Owners and Operators of
Domestic Tobacco Product Establishments; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised guidance for industry entitled ``Registration
and Product Listing for Owners and Operators of Domestic Tobacco
Product Establishments.'' This guidance is intended to assist persons
making tobacco product establishment registration and product listing
submissions to FDA.

DATES: The announcement of the guidance is published in the Federal
Register on September 19, 2017.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:

     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2009-D-0508 for ``Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Matthew Brenner, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised guidance for
industry entitled ``Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments.'' This guidance
is intended to assist persons making tobacco product establishment
registration and product listing submissions to FDA. We are issuing
this guidance consistent with our good guidance practices regulation
(Sec.  10.115 (21 CFR 10.115)). We are implementing this guidance
without prior public comment because we have determined that prior
public participation is not feasible or appropriate given the upcoming
compliance deadline for registration and listing for certain owners and
operators of tobacco product manufacturing establishments. In addition,
the compliance policy for certain product listing labeling submissions
set forth in this revised guidance presents a less burdensome policy
consistent with the public health (Sec.  10.115(g)(2)). Although this
guidance document is immediately in effect, it remains subject to
comment in accordance with FDA's GGP regulation.
    This revised guidance communicates a compliance policy for certain
product listing labeling submissions. Specifically, FDA does not, at
this time, intend to enforce the requirement that owners and operators
of tobacco product establishments submit the labeling for each
individually listed tobacco product if the registrant submits
information that represents the labeling for a selected line of
products. In deciding whether a registrant's submitted information
falls within this compliance policy, FDA may consider whether the
tobacco products' labeling is essentially identical (e.g., the same
formatting, fonts, colors, background text, and images) and whether the
variations are limited to package size, nicotine strength, propylene
glycol/vegetable glycerin ratio, and flavor. Under this compliance
policy, a registrant could submit information that represents the
labeling for a selected line of products, and FDA would not intend to
enforce the requirements in subsections 905(i)(1)(A) and (B) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
387e(1)(A) and (B)) with regard to labeling submissions.
    This revised guidance also updates the compliance date for
registration and listing for persons who owned or operated domestic
manufacturing establishments engaged in the manufacture of newly deemed
products prior to August 8, 2016, and continued to own or operate such
establishment(s) on or after August 8, 2016. Such persons are required
to register and submit product listing information under section 905 of
the FD&C Act by December 31, 2016. However, in a guidance issued in May
2017, FDA announced that it does not intend to enforce these
requirements with respect to newly deemed products provided the
registration and product listing submissions are received by FDA on or
before September 30, 2017.
    The guidance represents the current thinking of FDA on this topic.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. 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 section 905 of the FD&C Act have been
approved under OMB control number 0910-0650.

III. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the guidance at either https://www.regulations.gov or
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19928 Filed 9-18-17; 8:45 am]
 BILLING CODE 4164-01-P


MEMORANDUM

DATE:  7/29/15

FROM:  Ken Mitchell/EPA Region 4

TO:   Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

SUBJECT:  Discussion of the Clean Power Plan at the Tennessee Environmental Conference

SUMMARY:         REGION 4 PROVIDED INFORMATION ON THE CLEAN POWER PLAN to participants at the Tennessee Environmental Conference in Kingsport, TN, on March 17, 2015.  The Clean Power Plan for Existing Power Plants was proposed on June 2, 2014.   ATTENDEES:

EPA Beverly Banister/EPA R4

External Stakeholders Approximately 40 attendees.

ATTACHMENT