[Federal Register: October 4, 2006 (Volume 71, Number 192)]
[Rules and Regulations]
[Page 58525-58533]
[DOCID:fr04oc06-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 302 and 355

[EPA-HQ-SFUND-2003-0022; FRL-8227-7]
RIN 2050-AF02

Administrative Reporting Exemption for Certain Air Releases of
NOX (NO and NO2)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency is issuing a final rule
that will reduce reporting burdens under the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980, as
amended, and the Emergency Planning and Community Right-to-Know Act,
also known as Title III of the Superfund Amendments and Reauthorization
Act.
    In this rule, EPA broadens the existing reporting exemptions for
releases that are the result of combustion of less than 1,000 pounds of
nitrogen oxide and less than 1,000 pounds of nitrogen dioxide to the
air in 24 hours. These may also include emissions from detonation or
processes that include both combustion and non-combustion operations,
such as nitric acid production. This administrative reporting exemption
is protective of human health and the environment and consistent with
the Agency's goal to reduce unnecessary reports given that the levels
for which the Clean Air Act regulates nitrogen oxides are considerably
higher than 10 pounds. In addition, the Agency believes that the
information gained through submission of the reports for those exempted
releases would not contribute significantly to the data that are
already available through the permitting process to the government and
the public.

DATES: This final rule is effective on November 3, 2006.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-SFUND-2003-0022. 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., CBI or other information
whose 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 Superfund Docket, EPA/DC,

EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The
Public Reading Room 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
Superfund Docket is<PHONE_NUMBER>.

    Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to visit the Public Reading Room to
view documents. Consult EPA's Federal Register notice at 71 FR 38147
(July 5, 2006) or the EPA Web site at http://www.epa.gov/epahome/dockets.htm
 for current information on docket status, locations and

telephone numbers.

FOR FURTHER INFORMATION CONTACT: Lynn Beasley, Regulation and Policy
Development Division, Office of Emergency Management, Office of Solid
Waste and Emergency Response (5104A), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
(202) 564-1965; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

A. Does This Action Apply to Me?

------------------------------------------------------------------------
        Type of entity               Examples of affected entities
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Industry.....................  Application of this rule should result in
                                a reduction to your reporting burden--
                                persons in charge of vessels or
                                facilities that may release nitrogen
                                oxide (NO) or nitrogen dioxide (NO2) or
                                both (NOX) to the air that is the result
                                of combustion and combustion-related
                                activities.
State, Local, or Tribal        State and Tribal Emergency Response
 Governments.                   Commissions, and Local Emergency
                                Planning Committees.
Federal Government...........  National Response Center and any Federal
                                agency that may release NOX.
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    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by this action. Other types of entities
not listed in the table could also be regulated. To determine whether
your facility is regulated by this action, you should carefully examine
the criteria in section I.C of this final rule preamble and the
applicability criteria in Sec.  302.6 of title 40 of the Code of
Federal Regulations. If you have questions regarding the applicability
of this action to a particular entity, consult the person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.

B. Outline of This Preamble

    The contents of this preamble are listed in the following outline:
I. Introduction
    A. What is the Statutory Authority for this Rulemaking?
    B. What is the Background For this Rulemaking?
    C. Which NO and NO2 Releases Are Administratively
Exempt From the Reporting Requirements?
    D. What Are the Changes From the Proposed Rule?
II. Response to Comments
    A. Support for Proposed Reporting Exemptions
    B. Support for Expanding Continuous Release Reporting in
Addition to Proposed Exemption
    1. Simplify Continuous Release Initial Release Notification
    2. Clarify Continuous Release Reporting Requirements
    C. Support to Increase Level of the Exemption
    1. Support a Number Larger than 1,000 Pounds
    2. Increase RQ for Combustion-Related Exemption to 5,000 Pounds
    3. Raise or Eliminate the 1,000 Pound Reporting Threshold for
all Combustion-Related Releases
    D. Request That the Administrative Reporting Exemption Not
Include the Qualifier ``Accidents and Malfunctions''
    1. Accidents and Malfunctions

    2. Also Include in Exemptions--Start-ups, Shut-downs, and Up-
sets
    3. Clarify that Flares are Control Devices--Not Considered
Accidents and Malfunctions
    E. Requests That the Administrative Reporting Exemption Include
Combustion and Non-Combustion Processes
    F. Interpretation of CERCLA Provisions
    1. Proposed Exemption only Applies to Emissions Not Considered
Federally Permitted
    2. Clarify that NOX Represents NO and NO2
Interchangeably
    G. Issues Related to Rulemaking Procedure
III. Regulatory Analysis
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution or Use
    I. National Technology Transfer and Advancement Act of 1995
    J. Congressional Review Act

I. Introduction

A. What Is the Statutory Authority for This Rulemaking?

    The Comprehensive Environmental Response, Compensation, and
Liability Act of 1980 (CERCLA), 42 U.S.C. 9601 et seq., as amended by
the Superfund Amendments and Reauthorization Act of 1986, gives the
Federal government broad authority to respond to releases or threats of
releases of hazardous substances from vessels and facilities. The term
``hazardous substance'' is defined in section 101(14) of CERCLA
primarily by reference to other Federal environmental statutes.\1\
Section 102 of CERCLA gives the U.S. Environmental Protection Agency
(EPA) authority to designate additional hazardous substances. Currently
there are 764 CERCLA hazardous substances,\2\ exclusive of
Radionuclides, F-, K-, and Unlisted Characteristic Hazardous Wastes.
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    \1\ Other Federal environmental statutes include: Federal Water
Pollution Control Act (sections 1321(b)(2)(A), 1317(a)), Solid Waste
Disposal Act (section 6921), Clean Air Act (section 7412), and Toxic
Substances Control Act (section 2606).
    \2\ This total includes the P- and U-listed wastes under
Subtitle C of the hazardous waste regulations.
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    Under CERCLA section 103(a), the person in charge of a vessel or
facility from which a CERCLA hazardous substance has been released in a
quantity that equals or exceeds its reportable quantity (RQ) must
immediately notify the National Response Center (NRC) of the release. A
release is reportable if an RQ or more is released within a 24-hour
period (see 40 CFR 302.6). This reporting requirement, among other
things, serves as a trigger for informing the Federal government of a
release so that Federal personnel can evaluate the need for a Federal
removal or remedial action and undertake any necessary action in a
timely fashion.
    On March 19, 1998, the Agency issued a final rule (see 63 FR 13459)
that broadened the existing reporting exemptions for releases of
naturally occurring radionuclides. The Agency relied on CERCLA sections
102(a), 103, and 115 (the general rulemaking authority under CERCLA) as
authority to issue regulations governing section 103 reporting
requirements, as well as administrative reporting exemptions. These
exemptions were granted for releases of hazardous substances that pose
little or no risk or to which a Federal response is infeasible or
inappropriate (see 63 FR 13461).
    In addition to the reporting requirements established pursuant to
CERCLA section 103, section 304 of the Emergency Planning and Community
Right-to-Know Act of 1986 (EPCRA), 42 U.S.C. 11001 et seq., requires
the owner or operator of certain facilities to immediately report
releases of CERCLA hazardous substances or any extremely hazardous
substances \3\ to State and local authorities (see 40 CFR 355.40).
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    \3\ Extremely hazardous substances are those listed in Appendix
A and B of 40 CFR part 355. EPCRA section 11002(a)(2) required the
Agency to publish a list of extremely hazardous substances that is
the same list as the list of substances published in November 1985
by EPA in Appendix A of the ``Chemical Emergency Preparedness
Program Interim Guidance.''
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    This rule that applies to CERCLA section 103 notification
requirements also applies to EPCRA section 304 notification
requirements. In part, EPCRA's reporting requirement is designed to
effectuate a statutory purpose of informing communities and the public
generally about releases from nearby facilities. Notification is to be
given to the community emergency coordinator for each Local Emergency
Planning Committee (LEPC) for any area likely to be affected by the
release, and the State Emergency Response Commission (SERC) of any
State likely to be affected by the release. Through this notification,
State and local officials can assess whether a response to the release
is appropriate, regardless of whether the Federal government intends to
respond. EPCRA section 304 notification requirements apply only to
releases that have the potential for off-site exposure and that are
from facilities that produce, use, or store a ``hazardous chemical,''
as defined by regulations promulgated under the Occupational Safety and
Health Act of 1970 (29 CFR 1910.1200(c)) and by section 311 of EPCRA.

B. What Is the Background for This Rulemaking?

    On December 21, 1999, EPA published interim guidance on the
Federally permitted release exemption to section 103 of CERCLA and
section 304 of EPCRA (see 64 FR 71614). The interim guidance discussed
EPA's interpretation of the Federally permitted release exemption as it
applies to some air emissions and solicited public comment. The public
comment period closed, after several extensions, on April 10, 2000. The
Agency received many comments on the interim guidance, including
specific questions regarding EPA's interpretation of the Federally
permitted release exemption as it applies to NOX releases.
NOX releases to air are somewhat unique in that, in most
cases, Federally enforceable permits (including State issued through
delegated programs) are not issued to facilities that release
NOX below a certain threshold. NOX emissions from
these sources are minimal and may not pose a hazard to health or the
environment. In its final Guidance on the CERCLA Section 101(10)(H)
Federally Permitted Release Definition for Certain Air Emissions (67 FR
18899, April 17, 2002), EPA responded to the concern that many small
facilities do not have Federally enforceable permits by stating in that
Federal Register notice that it recognized, ``that certain uncontrolled
air emissions of nitrogen oxide (NO) and nitrogen dioxide
(NO2) equal to or greater than the ten pound RQ may rarely
require a government response.'' (See 67 FR 18904.) When the Agency
published that final Guidance, it also extended and expanded an on-
going enforcement discretion (Appendix B to that Notice) policy \4\
with regard to owners, operators or persons in charge of facilities or
vessels for failure to report air releases of NO and NO2
that would otherwise trigger a reporting obligation under CERCLA
section 103 and EPCRA section 304, unless such releases are the result
of an accident or malfunction. (See 67 FR 18904.)
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    \4\ The enforcement discretion policy was initially announced in
a memorandum to EPA Regional Counsels and Division Directors for
EPCRA section 304/CERCLA section 103 from Steven A. Herman,
Assistant Administrator, Office of Enforcement and Compliance
Assurance, dated February 15, 2000.

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    Since the publication of the Guidance, there has been significant
interest and inquiry by industry for the Agency to address the
reporting obligations for NOX releases to air under CERCLA
and EPCRA. Most recently, the Office of Management and Budget (OMB)
asked the public for their suggested reforms to rules, guidance
documents, or paperwork requirements that would reduce unnecessary
costs, increase effectiveness, reduce uncertainty, and increase
flexibility. In OMB's report to Congress on the costs and benefits to
Federal regulation (the ``Thompson Report''), one of the nominated
reforms meriting priority consideration by EPA was to grant some form
of reporting relief for certain releases of NOX to air. As a
result, on October 4, 2005, EPA published a proposed rule (see 70 FR
57813) that provided notice of, and requested comments, including any
relevant data, on a proposed new administrative reporting exemption
from certain notification requirements under CERCLA and EPCRA. The
Agency also sought public comment on human health risk assessment data
or other relevant data that related to the proposal. The proposed
administrative reporting exemption pertained to releases of less than
1,000 pounds of nitrogen oxide and nitrogen dioxide (or collectively
referred to as ``NOX'' for the proposed rule) to the air in
24 hours that is the result of combustion activities, unless such
release is the result of an accident or malfunction. The proposed rule
included a requirement that notifications must still be made for
accidents or malfunctions that result in the releases of NOX
at the final RQ of 10 pounds or more per 24 hours. The Agency also
sought comment on two other options to address the high frequency of
release notifications. Those options involved more efficient use of
Continuous Release reporting and a complete exemption from the
notification requirements under CERCLA and EPCRA.
    Twenty-seven comment letters, totaling more than 150 pages, were
received on the proposed rule. Of the 27 comment letters, 14 were
received from trade organizations, five from power corporations, five
from chemical companies, two from organizations representing chemical
companies, and one from a not-for-profit organization. This final rule
was developed following careful consideration of all issues and
concerns raised in public comments. Upon the effective date of this
final rule, the Agency is withdrawing the existing enforcement
discretion policy, described above, for failure to report air releases
of NO and NO2 that would otherwise trigger a reporting
obligation under CERCLA section 103 and EPCRA section 304.

C. Which NO and NO2 Releases Are Administratively Exempt
From the Reporting Requirements?

    In this final rule, releases of NO to the air that are the result
of combustion and combustion-related activities that are less than
1,000 pounds per 24 hours, and releases of NO2 to the air
that are the result of combustion and combustion-related activities
that are less than 1,000 pounds per 24 hours, are administratively
exempt from the reporting requirements of CERCLA and EPCRA, established
in 40 CFR 302.6 and 40 CFR 355.40, respectively. Some examples of
combustion-related activities that are intended to be included in this
exemption are emissions from blasting or detonation at construction or
mining sites and those NOX emissions from nitric acid
plants.
    The existing RQ for both NO and NO2 is 10 pounds in any
24 hour period. This RQ is easily met by those facilities that release
NOX \5\ to the air. This is especially true when the
facility processes include combustion and combustion-related
activities. For example, an 80 million BTU/hr natural gas boiler will
exceed the RQ for NOX after 2.5 hours of operation. A 120
million BTU/hr coal boiler will exceed the RQ for NO2 in
less than 3 hours of operation and the RQ for NO in less than 2 hours
of operation. Small engines also trigger the 10 pound threshold--an 18
horsepower engine running 24 hours will exceed the RQ for
NOX and a 100 horsepower engine will exceed the RQ for
NOX in five hours. Even turning on bakery ovens could
trigger the RQ for NOX when turned on for daily
operations.\6\
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    \5\ For shorthand purposes only, we use the convention
NOX to refer to both NO and NO2 either
collectively or as individual hazardous substances. However, where
regulatory clarity is needed, we will specifically refer to each
hazardous substance.
    \6\ These examples were submitted to the Agency during the
comment period for the Guidance on the CERCLA Section 101(10)(H)
Federally Permitted Release Definition for Certain Air Emissions
(see 67 FR 18899, April 17, 2002) discussed further in the
Background section of this preamble. A sample of the letters
received related to NOX and its 10 pound RQ are provided
in the Docket for today's final rule (SFUND-2003-0022). All of the
letters received pursuant to the Guidance can be found in that
Docket (GE-G-1999-029).
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    The exemptions apply only to CERCLA section 103 and EPCRA section
304 reporting requirements and do not apply to the related response and
liability provisions. EPA is promulgating the administrative reporting
exemption at 1,000 pounds for 24-hours, based on our review of the
comments, for three principal reasons. First, the 1,000 pound level
represents a 100-fold increase from the regulatory RQ of 10-pounds.
This level was one of three (100, 1000, and 5000 pounds) levels
suggested by two organizations representing regulated industries \7\ as
a level for the Agency to raise the RQ for NO and NO2.
Second, the Agency sought public comment on human health risk
assessment data or other relevant data that related to its proposed
rule, including an alternative for a complete exemption from the
notification requirements under CERCLA and EPCRA. Although the Agency
received considerable comment, including two specific examples
generated from a USEPA screening model that support the desire to (1)
raise the administrative exemption to 5,000 pounds or higher or (2)
completely exempt NO and NO2 from CERCLA and EPCRA reporting
requirements, the Agency did not receive risk assessment data that
would support a different level for the administrative reporting
exemption. The Agency also did not receive any human health risk
assessment data that would oppose the administrative reporting
exemption at the proposed level. Third, EPA believes that a CERCLA
response to the release otherwise reportable would be very unlikely and
possibly infeasible or inappropriate, because (1) the releases are
generally at levels below those that are regulated under the Clean Air
Act (CAA), and (2) the Agency has generally not responded to such
releases. As a result, the administrative reporting exemptions are
intended to allow EPA to focus its resources on the more serious
releases and to protect public health and welfare and the environment
more effectively and efficiently. At the same time, the exemptions will
significantly eliminate unnecessary reporting burdens on persons-in-
charge of facilities and vessels that release NOX during
combustion and combustion-related activities.
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    \7\ The organizations were the National Association of
Manufacturers (NAM) and the American Chemistry Council (ACC). The
ACC also provided comment to the proposed rule.
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D. What Are the Changes From the Proposed Rule?

    In response to comments, EPA has made one change and clarified a
few of the provisions included in the October 4, 2005, proposed rule.
Specifically, EPA decided to remove the qualifier to the exemption for
releases that are the ``result of accidents and malfunctions.'' As
discussed in more detail in Sections

II. D.1-3 of this preamble, information submitted by public commenters
and assembled by the Agency in response to comments are sufficient to
support a finding that the qualifier adds unnecessary confusion that
may lead to additional burden and unnecessary reporting. This final
rule includes a better explanation as to what is covered under
combustion, and clarifies that combustion-related activities (where
they cannot be realistically separated) are included within the
administrative reporting exemption and that NOX represents
NO and NO2 interchangeably. See Section II.E. and Section
II.F.2, respectively.

II. Response to Comments

    EPA's full response to public comments related to this rule are
contained in ``Responses to Comments on the October 4, 2005 Notice of
Proposed Rulemaking on Administrative Reporting Exemptions for Certain
Air Releases of NOX (NO and NO2 )'' (Responses to
Comments), which is available for inspection at the location described
in ADDRESSES, above. The following sections provide a summary of the
major public comments and EPA's responses.

A. Support for Proposed Reporting Exemptions

    All of the 27 comment letters submitted on the October 4, 2005
proposed rule supported to some extent the Agency's effort to reduce
reporting burden for releases of NO and NO2
(NOX). Of those, 10 specifically supported the proposed
administrative reporting exemption at 1,000 pounds.

B. Support for Expanding Continuous Release Reporting in Addition to
Proposed Exemption

    Seven commenters supported this alternative that would expand
continuous release reporting to require that NOX release
notifications be covered under the continuous release reporting scheme.
However, those who supported this alternative generally believed that
it should be in addition to rather than instead of the administrative
reporting exemption. On the other hand, four commenters opposed this
alternative primarily because it would be in lieu of the proposed
exemption, and would not afford practicable relief.
1. Simplify Continuous Release Initial Release Notification
    While commenters both supported and opposed the use of the
continuous release reporting mechanism, they all expressed the same
concern--that is, the Agency would promulgate the continuous release
reporting mechanism in place of the administrative reporting exemption.
In this final rule, both the administrative reporting exemption and the
continuous release reporting mechanism, as discussed below, can be used
to reduce burden.
    For those commenters who expressed support for simplifying the
continuous release initial release notifications, they argued that EPA
must broaden its concepts of ``continuous'' and ``stable in quantity
and rate'' so as to encompass startup and shutdown operations. EPA
believes that in certain instances startup and shutdown operations may
meet the definitions of continuous and stable in quantity and rate. The
definition of continuous under 40 CFR 302.8 says that, ``a continuous
release is a release that occurs without interruption or abatement or
that is routine, anticipated, and intermittent and incidental to normal
operations or treatment processes.'' The definition of stable in
quantity and rate under 40 CFR 302.8 says that, ``a release that is
stable in quantity and rate is a release that is predictable and
regular in amount and rate of emission.'' The regulation puts the
burden on the person in charge of a facility or vessel to establish a
sound basis for qualifying the release for continuous release reporting
(see 40 CFR 302.8(d)) and allows that establishment to be made using
release data, engineering estimates, knowledge of operating procedures,
best professional judgment, or reporting to the NRC for a period
sufficient to establish the continuity and stability of the release.
Therefore, we believe that the existing rules already provide, in
certain instances, for the use of continuous release reporting. To the
extent that EPA believes it appropriate to broaden the definition of
``continuous'' and ``stable in quantity and rate,'' we believe such
revision should apply more broadly to all hazardous substances and
extremely hazardous substances and would require further rulemaking.
2. Clarify Continuous Release Reporting Requirements
    One of the commenters requested that EPA clarify that the exemption
also applies to continuous release reporting requirements. The Agency
agrees that the administrative reporting exemption for releases of NO
and NO2 would also apply to continuous releases.

C. Support To Increase Level of the Exemption

    Eighteen commenters supported this alternative to increase the
level of the exemption. In general, five of those commenters supported
some number larger than 1,000 pounds, ten commenters supported
increasing the combustion-related exemption to 5,000 pounds, and three
commenters supported eliminating the 1,000 pound reporting threshold
altogether for all combustion-related releases.
1. Support a Number Larger than 1,000 Pounds
    Some of the commenters who supported a number larger than 1,000
pounds also proposed another level. One commenter suggested increasing
the exemption to a 1,500 pound level arguing that those releases would
also be below the 250 tons per year (TPY) that EPA cites in the NPRM.
EPA has adopted the RQ levels of 1, 10, 100, 1000, and 5000 pounds
originally established pursuant to CWA section 311 (see 40 CFR Part
117). The Agency adopted the CWA five-level system primarily because
(1) it has been successfully used pursuant to the CWA, (2) the
regulated community is already familiar with these five levels, and (3)
it provides a relatively high degree of discrimination among the
potential hazards posed by different CERCLA hazardous substances. ( See
50 FR 13456, 13465, April 4, 1985.) Therefore, the Agency has decided
not to promulgate an administrative reporting exemption level that is
inconsistent with its long-established RQ levels.
    One commenter suggested that EPA identify additional sources of
NOX emissions to further reduce the notification burden. At
this time, EPA is not considering extending the administrative
reporting exemption to specific sources. However, EPA wishes to clarify
that the release of NOX during the activity of explosive
detonation associated with blasting of hard rock in quarries is, for
the purposes of this final rule, a release of NOX that is
the result of combustion and thus, eligible for the administrative
reporting exemption promulgated today.
2. Increase RQ for Combustion-Related Exemption to 5,000 Pounds
    One of the commenters who supported increasing the combustion-
related exemption to 5,000 pounds also believes that EPA should change
the basic reportable quantity from 10 pounds. EPA disagrees. Changing
the basic reportable quantity (RQ) from 10 pounds to a ``reasonable''
figure, which the commenter considers to be 5,000 pounds, would be
contrary to EPA's long established principle of maintaining one RQ that
applies to all media. The RQ for NO and NO2 was adjusted in
the final rule published

April 4, 1985. (See 50 FR 13456.) The RQ for both hazardous substances
was adjusted from their statutory RQ to the current 10 pound RQ for
each.
3. Raise or Eliminate the 1,000 Pound Reporting Threshold for all
Combustion-Related Releases
    Three commenters expressly supported eliminating the 1,000 pound
reporting threshold for all combustion-related releases. While the
Agency acknowledges the commenters' position, we did not receive
adequate information (for example, human health and ecological risk
assessment) to support extending the administrative reporting exemption
beyond the proposed 1,000 pound level.
    One commenter \8\ used a USEPA air dispersion model to illustrate
the impact of an incremental 5,000 pounds of emissions from actual
boiler and gas turbine operations to support the position that the
administrative reporting exemption should be raised to 5,000 pounds.
The commenter provided two examples of NO2 emissions (NO
quickly reacts to NO2 after release from a combustion stack)
and the resulting hourly concentrations (micrograms/meter 3)
that illustrate concentration levels that are much less than the
California acute reference exposure level (REL) for NO2.\9\
EPA does not consider the risk information addressing these two
examples to be sufficient for the requested human health and ecological
risk assessments because, (1) commenters were informed in the proposed
rule where to obtain guidance on conducting human health and ecological
risk assessments,\10\ including addressing all current complete site-
specific exposure pathways for all affected media, future land use
potential, potential exposure pathways, and toxicity information and
(2) the example emission scenarios are too narrow given the broader
potential release scenarios that this administrative reporting
exemption is seeking to include. In addition, releases of
NOX to the environment cause a wide variety of health and
environmental impacts that is not addressed by the California REL. For
example, ground-level ozone is formed when NOX and volatile
organic compounds (VOCs) react in the presence of sunlight; acid rain
is formed when NOX and sulfur dioxide react with other
substances in the air to form acids; and NOX reacts readily
with common organic compounds to form a wide variety of toxic products.
Therefore, the Agency believes that the information provided, while
informative, is not sufficient to further increase the administrative
reporting exemption.
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    \8\ This commenter's position was endorsed and supported by
reference in several other comment letters.
    \9\ The NO2 REL of 470 micrograms per cubic meter is
a one-hour risk-based number based on respiratory/asthma problems.
    \10\ See, 70 FR 57819, October 4, 2005. Guidance can be found
at: http://www.epa.gov/oswer/riskassessment/superfund_toxicity.htm.

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D. Request That the Administrative Reporting Exemption Not Include the
Qualifier ``Accidents and Malfunctions''

    Twenty-five commenters requested that the administrative reporting
exemption not include the qualifier for ``accidents and malfunctions.''
Of those 25 commenters, 16 commented specifically on accidents and
malfunctions, three commenters requested that EPA also include start-
ups, shut-downs, and up-sets, and five sought clarification that flares
are control devices and therefore not considered the result of
accidents and malfunctions.
1. Accidents and Malfunctions
    The Agency received considerable support for either extending the
administrative reporting exemption to releases resulting from accidents
and malfunctions or limiting the scope of the administrative reporting
exemption to combustion devices (eliminating the need to identify
accidents and malfunctions), or both. Several commenters were correct
in pointing out that no NOX releases from combustion
devices--including many related to accidents and malfunctions-has
required any Federal response. In fact, the NOX release
notifications that have required response actions have only been in the
category of releases not related to combustion devices, such as in
situations where NOX was released incidental to the actual
reason for the response (i.e., fires and explosions). Some commenters
argued that the ``accidents and malfunctions'' qualifier would result
in minimal burden reduction, if not an increase in burden. The
historical data that the Agency used to predict future releases is
populated with release information that was not covered by the
enforcement discretion in place since February 15, 2000, essentially
releases that were due to ``accidents and malfunctions.'' If the
administrative reporting exemption retains the ``accident and
malfunction'' qualifier, then the Agency could receive notification of
releases at 1,000 pounds and above that were not reported due to the
enforcement discretion in addition to the notifications anticipated
based on the historical notification data. This would be inconsistent
with the intent of the rulemaking to offer burden reduction.
    CERCLA section 103 and EPCRA section 304 notification requirements
require the person in charge of the facility or vessel that released
the hazardous substance to make the notification to Federal, State, and
local authorities. Neither statute nor their implementing regulations
differentiate the cause of the release (i.e., whether the release was
the result of an accident or malfunction). EPA agrees with the
commenters that to require a separate assessment as to whether the
release was the result of an accident or malfunction, particularly with
respect to releases that result from combustion, may be overly
burdensome and not consistent with the intention of either statute, nor
the Agency's goal of reducing burden. If a response is not necessary
for a release of NOX from a facility due to normal
operations, that assessment should apply even if an accident or
malfunction somehow generated the release. EPA also agrees that,
particularly with respect to certain combustion activities, it may be a
challenge, if not impossible, to determine whether the combustion
activities were caused by an accident or malfunction. Thus, protective,
over-reporting could result.
    A few of the commenters pointed out that EPA has not defined the
terms, ``accident'' and ``malfunction'' and insist that EPA will need
to ensure that any interpretation of what is considered within an
``accident'' or ``malfunction'' event is consistent with
interpretations in other EPA programs (e.g., air permitting). EPA
agrees that inconsistency with other EPA programs has the potential to
create unnecessary confusion. Therefore, the definition and
interpretation of those terms should remain within the EPA programs
where they have a direct regulatory application. The Agency is also not
providing a definition of ``excess emissions'' because it is no longer
necessary without the ``accident and malfunction'' qualifier.
    Therefore, EPA will not include the qualifier, ``unless such
release is the result of an accident or malfunction'' to the
administrative reporting exemption for releases of NO or
NO2, or both, to air that are the result of combustion or
combustion-related activities.
2. Also Include in Exemptions--Start-ups, Shut-downs, and Up-sets
    Three commenters requested that the Agency expand the exemption to
include additional emissions from combustion sources, such as start-
ups,

shut-downs, and upsets. For the reasons described in Section II.D.1
above, EPA will not include the qualifier, ``unless such release is the
result of an accident or malfunction'' to the administrative reporting
exemption for releases of NO or NO2, or both, to air that
are the result of combustion or combustion-related activities. To the
extent that start-up, shut-down, and up-sets are part of a combustion
or combustion-related activity, they are eligible for the
administrative reporting exemption, provided such releases are below
the 1,000 pound level per 24-hours.
3. Clarify That Flares Are Control Devices--Not Considered Accidents
and Malfunctions
    Five commenters requested that the Agency clarify that flares are
control devices and not considered the result of an accident or
malfunction. For the reasons described in Section II.D.1 above, EPA
will not include the qualifier, ``unless such release is the result of
an accident or malfunction'' to the administrative reporting exemption
for releases of NO or NO2, or both, to air that are the
result of combustion or combustion-related activities. To the extent
that flaring is combustion or a combustion-related activity, it is
considered within this administrative reporting exemption, provided
such releases are below the 1,000 pound level per 24-hours.

E. Requests That the Administrative Reporting Exemption Include
Combustion and Non-Combustion Processes

    The Agency received three requests to expand the exemption to
include combustion processes that also include non-combustion
activities and non-combustion processes. One of those comments
specifically identified NOX emissions from nitric acid
plants during the production of fertilizer. The commenter described the
process of NOX emissions from nitric acid plants. The
process begins with mixing ammonia with air that is combusted across a
platinum/rhodium catalyst creating a hot NOX gas, primarily
NO. The hot NOX gas is cooled through a series of heat
exchangers and most of the NO reacts with the excess oxygen to form
NO2. The NOX gas is then introduced into an
absorber, where it interacts with a weak nitric acid solution and fresh
water, resulting in a series of over 38 chemical reactions. Generally,
NO2 is absorbed into the aqueous phase and nitric acid is
formed. As a result, however, NO and a much smaller fraction of the
NO2 are released back into the gas phase. Since NO is
produced in each reaction that makes nitric acid, extra air is
introduced into the absorber to convert the NO back to NO2.
The NO2 is reabsorbed and the cycle repeats itself. Since NO
does not appreciably absorb into the aqueous phase, some NO ultimately
exits the top of the column. A smaller fraction of NO2 also
exits the column due to the kinetics and equilibrium of the reactions.
The gas exiting the absorption column is called tail gas. At this
point, most of the gas is again NO. The tail gas is heated and directed
through an air pollution control device to control NOX
emissions to the atmosphere. The hot, pressurized tail gas is then sent
through an expander to generate power for the air compressor, and
finally exits out the stack.
    The NO and NO2, or NOX released from nitric
acid plants is originally formed as a product of NH3
combustion. However, nitric acid plants also produce NOX
from N2O4 in an aqueous reaction. Because it is
impossible to determine which NOX emissions result from
combustion as opposed to non-combustion processes, all NOX
emissions from nitric acid plants qualify for this NO and
NO2 administrative reporting exemption because all NO and
NO2 released from nitric acid plants originates from
combustion activities.
    Similarly, where nitric acid is used in the Adipic Acid
manufacturing process, there may be releases of NOX from
control devices in an upstream process. To the extent that those
control devices are functioning properly and operate as combustion
devices, the resulting NO and NO2 emissions would be covered
under this administrative reporting exemption.
    Releases of NO and NO2 from storage tanks are not
intended to be administratively exempt from CERCLA and EPCRA
notification requirements because there is a higher likelihood that
there would be a response to such a release scenario.

F. Interpretation of CERCLA Provisions

    Nine commenters provided comment on the interpretation of certain
CERCLA provisions.
1. Proposed Exemption Only Applies to Emissions Not Considered
Federally Permitted
    One commenter requested that EPA clarify that Federally permitted
releases are already exempt from reporting under CERCLA section
101(10)(H) and that the 1,000 pound limit applies only to emissions
that are not considered Federally permitted releases. We agree with the
commenter that the administrative reporting exemption described in this
rule applies to those releases that are not otherwise covered by CERCLA
or EPCRA exemptions, including those covered by Federal permits defined
under CERCLA section 101(10)(H).
2. Clarify that NOX Represents NO and NO2
Interchangeably
    One commenter recommended that EPA clarify in the rule that the
terms NO and NO2 are interchangeable with the term
NOX. Nitrogen oxide (NO) is a CERCLA hazardous substance
with an RQ of 10 pounds per 24 hours. Nitrogen dioxide (NO2)
is also a CERCLA hazardous substance with an RQ of 10 pounds per 24
hours. During combustion and combustion-related activities, NO will
quickly form NO2. The term NOX was used in the
proposed rule and this final rule as short-hand for NO and
NO2. For the purpose of reporting, and the administrative
reporting exemption, NO and NO2 are and continue to be
treated as individual hazardous substances. This final rule clarifies
that point.

G. Issues Related to Rulemaking Procedure

    One commenter requested that EPA conform the preamble to the rules
actually proposed to make clear that the administrative reporting
exemption affords a 1,000 pound exemption to nitrogen oxide and another
1,000 pound exemption to nitrogen dioxide. The commenter is correct
that the administrative reporting exemption affords a 1,000 pound
exemption to nitrogen oxide and another 1,000 pound exemption to
nitrogen dioxide. The preamble to this final rule has clarified this
point.

III. Regulatory Analysis

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993),
this action is a ``significant regulatory action.'' It has been
determined that this rule is a ``significant regulatory action''
because it raises novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order. Accordingly, EPA submitted this action to the
Office of Management and Budget (OMB) for review under EPA 12866 and
any changes made in response to OMB recommendations have been
documented in the docket for this action. OMB had no comments on this
action.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
This rule represents a reduction in the burden for both industry and
the government by administratively exempting the notification
requirements for releases of less than 1,000 pounds of NO to the air in
24-hours and less than 1,000 pounds of NO2 to the air in 24-
hours that are the result of combustion and combustion-related
activities. However, the Office of Management and Budget (OMB) has
previously approved the information collection requirements contained
in the existing regulations 40 CFR 302 and 40 CFR 355 under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
has assigned OMB control number 2050-0046, EPA ICR number 1049.10 and
OMB control number 2050-0086, EPA ICR number 1445.06. A copy of the OMB
approved Information Collection Requests (ICRs) may be obtained from
Susan Auby, Collection Strategies Division; U.S. Environmental
Protection Agency (2822T); 1200 Pennsylvania Ave., NW., Washington, DC
20460 or by calling<PHONE_NUMBER>.
    The proposed rule estimated that the annual reporting and
recordkeeping burdens associated with the information collected for the
episodic release of oil and all hazardous substances (1049.10) to be
reduced by approximately 5,449 hours. This represented a reduction in
the likely number of respondents from 24,082 to 22,753 a reduction of
1,329 reportable releases. For the purpose of this burden analysis,
each reportable episodic release equals one respondent. With respect to
the information collected for the continuous release reporting
regulation (1445.06) for all hazardous substances, the Agency estimated
a reduction of 869 hours, a reduction in the likely number of
respondents from 3,145 to 3,009, a reduction of 136 respondents. These
estimates remain the same for this final rule.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations is in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedures Act or any other statute, unless the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise that is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of this final rule on small
entities, I hereby certify that this action will not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities.'' 5 U.S.C. 603
and 604. Thus, an agency may certify that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves regulatory burden, or otherwise has a positive
economic effect on small entities subject to the rule.
    This rulemaking will relieve regulatory burden because we propose
to eliminate the reporting requirement for certain releases of
NOX to the air. We expect the net reporting and
recordkeeping burden associated with reporting releases of
NOX under CERCLA section 103 and EPCRA section 304 to
decrease. This reduction in burden will be realized mostly by small
businesses because larger businesses usually operate under Federal
permits and therefore qualify for the ``Federally permitted release''
exemption for reporting under CERCLA. 40 CFR 302.6. We have therefore
concluded that this final rule will relieve regulatory burden for all
affected small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective, or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted.
    Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments, it must have developed under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
    This rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, local, or tribal
governments or the private sector. The rule imposes no enforceable duty
on any State, local or

tribal governments or the private sector; promulgation of this rule
will result in a burden reduction in the receipt of notifications of
the release of NOX. EPA has determined that this rule does
not include a Federal mandate that may result in expenditures of $100
million or more for State, local, or tribal governments, in the
aggregate, or the private sector in any one year. This is because this
final rule imposes no enforceable duty on any State, local, or tribal
governments. EPA also has determined that this rule contains no
regulatory requirements that might significantly or uniquely affect
small governments. In addition, as discussed above, the private sector
is not expected to incur costs exceeding $100 million. Thus, this final
rule is not subject to the requirements of Sections 202 and 205 of
UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have Federalism implications.''
``Policies that have Federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This final rule does not have Federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. There are no State and local
government bodies that incur direct compliance costs by this
rulemaking. Thus, Executive Order 13132 does not apply to this rule.
    In the spirit of Executive Order 13132 and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicited comment on the proposed rule
from State and local officials. No States or local governments
commented on the proposed rule.

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

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This final rule does not have
tribal implications, as specified in Executive Order 13175. This rule
does not significantly or uniquely affect the communities of Indian
tribal governments, nor would it impose substantial direct compliance
costs on them. Thus, Executive Order 13175 does not apply to this rule.

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

    The Executive Order 13045, entitled ``Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997) applies to any rule that: (1) Is determined ``economically
significant'' as defined under Executive Order 12866, and (2) concerns
an environmental health or safety risk that EPA has reason to believe
may have a disproportionate effect on children. If the regulatory
action meets both criteria, the Agency must evaluate the environmental
health or safety effects of the planned rule on children, and explain
why the planned regulation is preferable to other potentially effective
and reasonably feasible alternatives considered by the Agency.
    EPA has determined that the final rule is not subject to Executive
Order 13045 because it is not an ``economically significant'' rule as
defined by Executive Order 12866. EPA also expects the rule does not
have a disproportionate effect on children's health.

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

    This final rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act of 1995

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
    This final rulemaking does not involve technical standards.
Therefore, EPA is not considering the use of any voluntary consensus
standards

J. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, that includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective 30 days after it is published in
the Federal Register.

List of Subjects

40 CFR Part 302

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous wastes, Intergovernmental relations,
Natural resources, Reporting and recordkeeping requirements, Superfund,
Water pollution control, Water supply.

40 CFR Part 355

    Air pollution control, Chemicals, Disaster assistance, Hazardous
substances, Hazardous waste, Intergovernmental relations, Natural
resources, Penalties, Reporting and recordkeeping requirements,
Superfund, Water pollution control, Water supply.

    Dated: September 28, 2006.
Stephen L. Johnson,
Administrator.

0
For the reasons set out in the preamble, title 40, chapter I of the
Code of Federal Regulations is amended as follows:

PART 302--DESIGNATION, REPORTABLE QUANTITIES, AND NOTIFICATION

0
1. The authority citation for part 302 continues to read as follows:

    Authority: 42 U.S.C. 9602, 9603, 9604; 33 U.S.C. 1321 and 1361.

0
2. Section 302.6 is amended by adding paragraph (e) to read as follows:

Sec.  302.6  Notification requirements.

* * * * *
    (e) The following releases are exempt from the notification
requirements of this section:
    (1) Releases in amounts less than 1,000 pounds per 24 hours of
nitrogen oxide to the air which are the result of combustion and
combustion-related activities.
    (2) Releases in amounts less than 1,000 pounds per 24 hours of
nitrogen dioxide to the air which are the result of combustion and
combustion-related activities.

PART 355--EMERGENCY PLANNING AND NOTIFICATION

0
3. The authority citation for part 355 continues to read as follows:

    Authority: 42 U.S.C. 11002, 11004, and 11048.

0
4. Section 355.40 is amended by adding paragraph (a)(2)(vii) to read as
follows:

Sec.  355.40  Emergency release notification.

    (a) * * *
    (1) * * *
    (2) * * *
    (vii) Any release in amounts less than 1,000 pounds per 24 hours
of:
    (A) Nitrogen oxide (NO) to the air that is the result of combustion
and combustion-related activities.
    (B) Nitrogen dioxide (NO2) to the air that is the result
of combustion and combustion-related activities.
* * * * *

[FR Doc. E6-16379 Filed 10-3-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Rules and Regulations]
[Page 70679]
[FR Doc No: 2015-28848]

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

Food and Drug Administration

21 CFR Part 25

[Docket No. FDA-2013-N-1282]

National Environmental Policy Act; Environmental Assessments for
Tobacco Products; Categorical Exclusions; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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

SUMMARY: The Food and Drug Administration (FDA or we) is correcting the
preamble to a final rule that appeared in the Federal Register of
September 24, 2015. This final rule provided FDA with categorical
exclusions from the requirement to prepare environmental assessments
for certain actions regarding the marketing of tobacco products under
the Family Smoking Prevention and Tobacco Control Act (Tobacco Control
Act). The final rule also included amendments to certain environmental
impact regulations to include tobacco products, where appropriate, in
light of its authority under the Tobacco Control Act.
    The document published with technical errors in reference numbers
cited in the document. This document corrects those errors. We are
placing a corrected copy of the rule in the docket.

DATES: Effective on November 16, 2015.

FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, Bldg.
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
877-287-1373<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is correcting the preamble to the
September 24, 2015 (80 FR 57531), final rule entitled, ``National
Environmental Policy Act; Environmental Assessments for Tobacco
Products; Categorical Exclusions.'' The document published with three
technical errors in reference numbers cited in the document. This
document corrects those errors. We are correcting reference 2 and
adding new reference 3. We are also placing a corrected copy of the
rule in the docket.
    In FR Doc. 2015-24219, appearing on page 57531 in the Federal
Register of Thursday, September 24, 2015 (80 FR 57531), FDA is making
the following corrections:
    1. On page 57533, in the second column, under the Response for
Comment 1, add ``(Ref. 3)'' at the end of the second sentence.
    2. On page 57535, in the first column, under section IX, ``2.
Statement of RADM David Ashley, Ph.D. and Hoshing Chang, Ph.D., `Impact
of Tobacco Products on the Environment.' '' is corrected to read ``2.
`Final Regulatory Impact Analysis,' Food and Drug Administration,
available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.'
    3. On page 57535, in the first column, under section IX, add ``3.
Statement of RADM David Ashley, Ph.D. and Hoshing Chang, Ph.D., `Impact
of Tobacco Products on the Environment.'

    Dated: November 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28848 Filed 11-13-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 50 (Thursday, March 16, 2017)]
[Notices]
[Page 14002]
[FR Doc No: 2017-05247]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-N-2016-4198]

Public Meeting on Patient-Focused Drug Development for
Sarcopenia; Request for Comments; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Public Meeting on Patient-Focused Drug Development for
Sarcopenia'' that appeared in the Federal Register of December 14, 2016
(81 FR 90361). The document announced a public meeting and an
opportunity for public comment on Patient-Focused Drug Development for
Sarcopenia. The location of the meeting has changed and this document
provides the updated meeting location.

FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>    In the Federal Register of Wednesday, December 14, 2016, in FR Doc.
2016-29998, the following correction is made:
    1. On page 90361, in the second column, in the first sentence of
the ADDRESSES section, ``FDA White Oak Campus, 10903 New Hampshire
Ave., Bldg. 31 Conference Center, the Great Room, (Rm. 1503), Silver
Spring, MD 20993-0002.'' is corrected to read ``Tommy Douglas
Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903.''

    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05247 Filed 3-15-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Notices]
[Pages 48735-48738]
[FR Doc No: 2020-17561]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89498; File No. SR-CboeEDGX-2020-036]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating To Introduce a New Data Product To Be Known As Intraday Open-
Close Data

August 6, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 29, 2020, Cboe EDGX Exchange, Inc. (the ``Exchange'' or ``
``EDGX'' '') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Exchange
filed the proposal as a ``non-controversial'' proposed rule change
pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-
4(f)(6)

thereunder.\4\ The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe EDGX Exchange, Inc. (the ``Exchange'' or ``EDGX'') is filing
with the Securities and Exchange Commission (``Commission'') a proposed
rule change to introduce a new data product to be known as Intraday
Open-Close Data. The text of the proposed rule change is provided in
Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/edgx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to introduce a new data product on EDGX to be
known as Intraday Open-Close Data, which will be available for purchase
to EDGX Members (``Members'') and non-Members.\5\ Cboe LiveVol, LLC
(``LiveVol''), a wholly owned subsidiary of the Exchange's parent
company, Cboe Global Markets, Inc., will make the Intraday Open-Close
Data available for purchase to Members and non-Members on the LiveVol
DataShop website.\6\ The Exchange also proposes to amend Exchange Rule
21.15(b) to provide that the Open-Close Data product will be available
on an end-of-day basis and intraday basis.
---------------------------------------------------------------------------

    \5\ The Exchange intends to submit a separate rule filing to
establish fees for Intraday Open-Close Data.
    \6\ See https://datashop.cboe.com/.
---------------------------------------------------------------------------

    Currently, the Exchange offers Open-Close Data, which is an end-of-
day volume summary of trading activity on the Exchange at the option
level by origin (customer, professional customer, broker-dealer, and
market maker), side of the market (buy or sell), price, and transaction
type (opening or closing). The customer and professional customer
volume is further broken down into trade size buckets (less than 100
contracts, 100-199 contracts, greater than 199 contracts). The Open-
Close Data is proprietary EDGX trade data and does not include trade
data from any other exchange. It is also a historical data product and
not a real-time data feed.
    Now, the Exchange is proposing to offer an additional product, the
Intraday Open-Close Data. The Intraday Open-Close Data will provide
similar information to that of Open-Close Data, but will be produced
and updated every 10 minutes during the trading day. Data is captured
in ``snapshots'' taken every 10 minutes throughout the trading day and
is available to subscribers within five minutes of the conclusion of
each 10 minute period. For example, subscribers to the intraday product
will receive the first calculation of intraday data by approximately
9:45 a.m. ET, which represents data captured from 9:30 a.m. to 9:40
a.m. Subscribers will receive the next update by 9:55 a.m.,
representing the data previously provided aggregated with data captured
through 9:50 a.m., and so forth. Each update will represent combined
data captured from the current ``snapshot'' and all previous
``snapshots'' and thus will provide open-close data on an aggregate
basis. The Intraday Open-Close Data will provide a volume summary of
trading activity on the Exchange at the option level by origin
(customer, professional customer, broker-dealer, and market maker),
side of the market (buy or sell), and transaction type (opening or
closing). The customer and professional customer volume will be further
broken down into trade size buckets (less than 100 contracts, 100-199
contracts, greater than 199 contracts). The Intraday Open-Close Data is
proprietary EDGX trade data and does not include trade data from any
other exchange. In contrast to the existing Open-Close Data product,
the Intraday Open-Close Data will not provide execution price.\7\
---------------------------------------------------------------------------

    \7\ Price information is not included in Intraday Open-Close
Data because it cannot be provided within the time parameters
necessary to generate the file.
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    A description of each market data product offered by the Exchange
is described in Exchange Rule 21.15(b). The Exchange proposes to amend
Rule 21.15(b)(5) to provide that Open-Close Data will be offered on an
end-of-day and intraday basis.
    The Exchange will establish a monthly subscriber fee for Intraday
Open-Close Data by way of a separate proposed rule change, which the
Exchange will submit in connection with the launch of the Intraday
Open-Close market data product.
    The Exchange anticipates a wide variety of market participants to
purchase Intraday Open-Close Data, including, but not limited to,
individual customers, buy-side investors, and investment banks. The
Exchange believes the proposed Open-Close Data product may also provide
helpful trading information regarding investor sentiment that may allow
market participants to make better trading decisions throughout the day
and may be used to create and test trading models and analytical
strategies and provides comprehensive insight into trading on EDGX. For
example, intraday open data may allow a market participant to identify
new interest or possible risk throughout the trading day, while
intraday closing data may allow a market participant to identify fading
interests in a security. The proposal is a completely voluntary
product, in that the Exchange is not required by any rule or regulation
to make this data available and that potential subscribers may purchase
it only if they voluntarily choose to do so. The Exchange notes that
other exchanges offer a similar data product.\8\
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    \8\ See Securities Exchange Act Release No. 62887 (September 10,
2010), 75 FR 57092 (September 17, 2010) (SR-Phlx-2010-121); See also
Securities Exchange Act Release No. 65587 (October 18, 2011), 76 FR
65765 (October 24, 2011) (SR-NASDAQ-2011-144).
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\9\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\10\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and to protect investors and the public
interest, and that it is not designed to permit unfair

discrimination among customers, brokers, or dealers.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In adopting Regulation NMS, the Commission granted self-regulatory
organizations (``SROs'') and broker-dealers increased authority and
flexibility to offer new and unique market data to the public. It was
believed that this authority would expand the amount of data available
to consumers, and also spur innovation and competition for the
provision of market data. The Exchange believes that the proposed
Intraday Open-Close Data would further broaden the availability of U.S.
option market data to investors consistent with the principles of
Regulation NMS. The proposal also promotes increased transparency
through the dissemination of Intraday Open-Close Data. The proposed
rule change would benefit investors by providing access to the Intraday
Open-Close Data, which may promote better informed trading throughout
the trading day. Moreover, other exchanges offer a similar data
product.\11\
---------------------------------------------------------------------------

    \11\ See supra note 8.
---------------------------------------------------------------------------

    In adopting Regulation NMS, the Commission granted self-regulatory
organizations (``SROs'') and broker-dealers increased authority and
flexibility to offer new and unique market data to the public. It was
believed that this authority would expand the amount of data available
to consumers, and also spur innovation and competition for the
provision of market data. The Exchange believes that the proposed
Intraday Open-Close Data would further broaden the availability of U.S.
option market data to investors consistent with the principles of
Regulation NMS. The proposal also promotes increased transparency
through the dissemination of Intraday Open-Close Data. The proposed
rule change would benefit investors by providing access to the Intraday
Open-Close Data, which as noted above, may promote better informed
trading. Particularly, information regarding opening and closing
activity across different option series may indicate investor
sentiment, which can be helpful trading information. Subscribers to the
data may be able to enhance their ability to analyze option trade and
volume data on an intraday basis, and create and test trading models
and analytical strategies. The Exchange believes Intraday Open-Close
Data provides a valuable tool that subscribers can use to gain
comprehensive insight into the trading activity in a particular series,
but also emphasizes such data is not necessary for trading.
    Moreover, other exchanges also off a substantially identical data
product.\12\ Specifically, NASDAQ OMX PHLX (``PHLX'') and the NASDAQ
Stock Market LLC (``NASDAQ'') offer the PHLX Options Trade Outline
(``PHOTO'') and NASDAQ Options Trade Outline (``NOTO''), respectively.
PHOTO and NOTO provide substantially the same information as that
included in the proposed Intraday Open-Close Data product. Further,
like the proposed product, the data is provided to subscribers
cumulatively every 10 minutes and is available to subscribers within
five minutes of the conclusion of each 10 minute period.
---------------------------------------------------------------------------

    \12\ Id.
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. Rather, the
Exchange believes that the proposal will promote competition by
permitting the Exchange to offer a data product similar to those
offered by other competitor options exchanges.\13\ The Exchange is
proposing to introduce Intraday Open-Close Data in order to keep pace
with changes in the industry and evolving customer needs, and believes
this proposed rule change would contribute to robust competition among
national securities exchanges. As noted, at least two other U.S.
options exchanges offer a market data product that is similar to the
Intraday Open-Close Data.\14\ As a result, the Exchange believes this
proposed rule change permits fair competition among national securities
exchanges. Therefore, the Exchange does not believe the proposed rule
change will result in any burden on competition that is not necessary
or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \13\ Id.
    \14\ Id.
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to Section 19(b)(3)(A) of the Act \15\ and Rule 19b-4(f)(6)
\16\ thereunder.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay.\17\ The Commission finds that waiving the 30-day operative delay
is consistent with the protection of investors and the public interest.
Specifically, waiver of the operative delay will allow the Exchange to
offer to investors without delay an optional historical data product
that is substantially similar to products offered by other options
exchanges. The proposal therefore does not present any novel issues
and, accordingly, the Commission designates the proposal operative upon
filing.\18\
---------------------------------------------------------------------------

    \17\ 17 CFR 240.19b-4(f)(6)(iii).
    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule change's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CboeEDGX-2020-036 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-CboeEDGX-2020-036. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-CboeEDGX-2020-036 and should
be submitted on or before September 2, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-17561 Filed 8-11-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 9, 2008 (Volume 73, Number 132)]
[Notices]
[Page 39327-39328]
[DOCID:fr09jy08-84]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1773-DR]

Missouri; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster for the
State of Missouri (FEMA-1773-DR), dated June 25, 2008, and related
determinations.

EFFECTIVE DATE: June 30, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated June 30, 2008, the President amended the cost-sharing
arrangements concerning Federal funds provided under the authority of
the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121-5206 (Stafford Act), in a letter to R. David Paulison,
Administrator, Federal Emergency Management Agency, Department of
Homeland Security, as follows:

    I have determined that the damage in certain areas of the State
of Missouri resulting from severe storms and flooding beginning on
June 1, 2008, and continuing, is of sufficient severity and
magnitude that special cost sharing arrangements are warranted
regarding Federal funds provided under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. Sec. Sec.
5121-5206 (the Stafford Act).
    Therefore, I amend my declaration of June 25, 2008, to authorize
Federal funds for emergency protective measures, including direct
Federal assistance, at 90 percent Federal funding of total eligible
costs. This adjustment is effective until the respective date at
which the National Oceanic and Atmospheric Administration's National
Weather Service River Forecast Center reports that the rivers in the
State of Missouri, which have experienced historical flooding, fall
below flood stage.
    This adjustment cost sharing applies only to Public Assistance
costs and direct Federal assistance eligible for such adjustments
under applicable law. The Robert T. Stafford Disaster Relief and
Emergency Assistance Act specifically prohibits a similar adjustment
for funds provided for Other Needs Assistance (Section 408), and the
Hazard Mitigation Grant Program (Section 404). These funds will
continue to be reimbursed at 75 percent of total eligible costs.
    This cost share is effective as of the date of the President's
major disaster declaration.

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

R. David Paulison,
Administrator, Federal Emergency Management Agency.
 [FR Doc. E8-15540 Filed 7-8-08; 8:45 am]

BILLING CODE 9110-10-P