[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Rules and Regulations]
[Pages 42507-42510]
[FR Doc No: 2016-15601]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0473]
RIN 165-AA00

Safety Zones; Marine Events Held in the Sector Long Island Sound
Captain of the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing four temporary safety zones
for fireworks displays within the Coast Guard Sector Long Island Sound
(LIS) Captain of the Port (COTP) Zone. This temporary final rule is
necessary to provide for the safety of life on navigable waters during
these events. Entry into, transit through, mooring or anchoring within
these regulated areas is prohibited unless authorized by COTP Sector
Long Island Sound.

DATES: This rule is effective without actual notice from June 30, 2016
through July 7, 2016. For the purposes of enforcement, actual notice
will be used from the date the rule was signed, June 15, 2016, through
June 30, 2016.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2016-0473 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
contact Petty Officer Jay TerVeen, Prevention Department, Coast Guard
Sector Long Island Sound, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
LIS Long Island Sound
NPRM Notice of Proposed Rulemaking
NAD 83 North American Datum 1983

II. Background Information and Regulatory History

    This rulemaking establishes four safety zones for fireworks
displays. Each event and its corresponding regulatory history are
discussed below.
    The Boys and Girls Club of Bellport-Beach Ball 2016 Fireworks
Display is a recurring marine event with regulatory history. A safety
zone was established for this event in 2015 via a temporary final rule
entitled, ``Safety Zones; Marine Events held in the Sector Long Island
Sound Captain of the Port Zone.'' This rulemaking was published on May
18, 2015 in the Federal Register (80 FR 28176).
    The Arts Project Cherry Grove Fireworks Display is a recurring
marine event with regulatory history and is cited in 33 CFR 165.151,
Table 1 to Sec.  165.151, section 6.5. This event has been included in
this rule due to deviation from the cite date.
    The Salute to Veterans Fireworks Display is a recurring marine
event with regulatory history and is cited in 33 CFR 165.151, Table 1
to Sec.  165.151, section 6.4. This event has been included in this
rule due to deviation from the cite date.
    The Clinton Chamber of Commerce Fireworks Display is a recurring
marine event with regulatory history. A safety zone was established for
this event in 2015 via a temporary final rule entitled, ``Safety Zones;
Marine Events held in the Sector Long Island Sound Captain of the Port
Zone.'' This rulemaking was published on August 14, 2015 in the Federal
Register (80 FR 48692).
    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing an NPRM with respect to this rule
because doing so would be impracticable. The event sponsors were late
in submitting the marine event applications. These late submissions did
not give the Coast Guard enough time to publish an NPRM, take public
comments, and issue a final rule before these events take place. For
that reason, issuing an NPRM would be impracticable.
    Under 5 U.S.C. 553(d)(3), and for the same reasons stated in the
preceding paragraph, the Coast Guard finds that good cause exists for
making this rule effective less than 30 days after publication in the
Federal Register.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this temporary rule under authority in
33 U.S.C. 1231. The Captain of the Port (COTP) Long Island Sound has
determined that the safety zones established by this temporary final
rule are necessary to provide for the safety of life on navigable
waterways before, during and after these scheduled events.

IV. Discussion of the Rule

    This rule establishes four safety zones for four fireworks
displays. The location of these safety zones are as follows:

                     Fireworks Displays Safety Zones
------------------------------------------------------------------------

------------------------------------------------------------------------
1 Boys & Girls of Bellport-Beach Ball    Location: All navigable waters
 2016.                                    of Patchogue Bay, Bellport, NY
                                          within 600 feet of the
                                          fireworks barge in approximate
                                          position 40[deg]44'39.19'' N,
                                          072[deg]56'27.72'' W (NAD 83).
2 Arts Project Cherry Grove Fireworks    Location: All navigable waters
 Display.                                 of Great South Bay off Cherry
                                          Grove, Fire Island, NY within
                                          600 feet of the fireworks
                                          barge in approximate position
                                          40[deg]39'49.06'' N,
                                          073[deg]05'27.99'' W (NAD 83).
3 The Salute to Veterans Fireworks       Location: All navigable waters
 Display.                                 of Reynolds Channel off
                                          Hempstead, NY 420 feet of the
                                          land launch in approximate
                                          position 40[deg]35'36.62'' N,
                                          073[deg]35'20.72'' W (NAD 83).
4 Freeport Chamber of Commerce.........  Location: All navigable waters
                                          of Freeport Harbor, Freeport,
                                          NY within 300 feet of the
                                          fireworks barge located in
                                          approximate position
                                          40[deg]37'27.27'' N,
                                          073[deg]34'34.64'' W (NAD 83).
------------------------------------------------------------------------

    This rule prevents vessels from entering, transiting, mooring, or
anchoring within the areas specifically designated as a safety zone and
restricts vessel movement around the locations of the marine events to
reduce the safety risks associated with it during the period of
enforcement unless authorized by the COTP or designated representative.
    The Coast Guard will notify the public and local mariners of these
safety zones through appropriate means, which may include, but are not
limited to, publication in the Federal Register, the Local Notice to
Mariners, and Broadcast Notice to Mariners.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and Executive order and we discuss First
Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive Order12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    The Coast Guard determined that this rulemaking is not a
significant regulatory action for the following reasons: (1) The
enforcement of these safety zones will be relatively short in duration;
(2) persons or vessels desiring to enter these safety zones may do so
with permission from the COTP LIS or a designated representative; (3)
these safety zones are designed in a way to limit impacts on vessel
traffic, permitting vessels to navigate in other portions of the
waterway not designated as a safety zone; and (4) the Coast Guard

will notify the public of the enforcement of this rule via appropriate
means, such as via Local Notice to Mariners and Broadcast Notice to
Mariners to increase public awareness of this safety zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit
these regulated areas may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator. Under section 213(a) of the
Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L.
104-121), we want to assist small entities in understanding this rule.
If the rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please contact the person listed
in the FOR FURTHER INFORMATION CONTACT.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Orders
13132, Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this
action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
temporary rule involves the establishment of four temporary safety
zones. It is categorically excluded from further review under paragraph
34(g) of Figure 2-1 of the Commandant Instruction. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination will be available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; and Department of Homeland Security Delegation
No. 0170.1

0
2. Add Sec.  100.T01-0473 to read as follows:

Sec.  165.T01-0473  Safety Zones; Marine Events held in the Sector Long
Island Sound Captain of the Port Zone.

    (a) Location. This section will be enforced at the locations listed
for each event in Table 1 to Sec.  165.T01-0473.
    (b) Enforcement period. This rule will be enforced on the dates and
times listed for each event in Table 1 to Sec.  165.T01-0473.
    (c) Definitions. The following definitions apply to this section: A
``designated representative'' is any Coast Guard commissioned, warrant
or petty officer of the U.S. Coast Guard who has been designated by the
COTP, Sector Long Island Sound, to act on his or her behalf. The
designated representative may be on an official patrol vessel or may be
on shore and will communicate with vessels via VHF-FM radio or
loudhailer. ``Official patrol vessels'' may consist of any Coast Guard,
Coast Guard Auxiliary, state, or local law enforcement vessels assigned
or approved by the COTP Sector Long Island Sound. In addition, members
of the Coast Guard Auxiliary may be present to inform vessel operators
of this regulation.
    (d) Regulations. (1) The general regulations contained in Sec.
165.23 apply.
    (2) In accordance with the general regulations in Sec.  165.23,
entry into or

movement within these zones are prohibited unless authorized by the
COTP, Long Island Sound.
    (3) Any vessel given permission to deviate from these regulations
must comply with all directions given to them by the COTP Sector Long
Island Sound, or the designated on-scene representative.
    (4) Any vessel given permission to enter or operate in these safety
zones must comply with all directions given to them by the COTP Sector
Long Island Sound, or the designated on-scene representative.
    (5) Upon being hailed by a U.S. Coast Guard vessel by siren, radio,
flashing light or other means, the operator of the vessel shall proceed
as directed.

                     Table 1 to Sec.   165.T01-0473
------------------------------------------------------------------------

------------------------------------------------------------------------
                            Fireworks Events
------------------------------------------------------------------------
1. Boys & Girls of Bellport-Beach Ball    Date: June 18, 2016
 2016.
                                          Rain Date: June 19,
                                          2016
                                          Time: 8:30 p.m. to
                                          10:00 p.m.
                                          Location: All
                                          navigable waters of Patchogue
                                          Bay, Bellport, NY within 600
                                          feet of the fireworks barge in
                                          approximate position
                                          40[deg]44'39.19'' N,
                                          072[deg]56'27.72'' W (NAD 83).
2. Arts Project Cherry Grove Fireworks    Date: June 18, 2016
 Display.
                                          Rain Date: June 19,
                                          2016
                                          Time: 8:50 p.m. to
                                          10:00 p.m.
                                          Location: All
                                          navigable waters of Great
                                          South Bay off Cherry Grove,
                                          Fire Island, NY within 600
                                          feet of the fireworks barge in
                                          approximate position
                                          40[deg]39'49.06'' N,
                                          073[deg]05'27.99'' W (NAD 83).
3. The Salute to Veterans Fireworks       Date: June 25, 2016
 Display.
                                          Rain Date: June 26,
                                          2016
                                          Time: 9:00 p.m. to
                                          10:30 p.m.
                                          Location: All
                                          navigable waters of Reynolds
                                          Channel off Hempstead, NY
                                          within 420 feet of the land
                                          launch in approximate position
                                          40[deg]35'36.62'' N,
                                          073[deg]35'20.72'' W (NAD 83).
4. Freeport Chamber of Commerce........   Date: June 30, 2016
                                          Rain Date: July 7,
                                          2016
                                          Time: 7:45 p.m. to
                                          10:00 p.m.
                                          Location: All
                                          navigable waters of Freeport
                                          Harbor, Freeport, NY within
                                          300 feet of the fireworks
                                          barge located in approximate
                                          position 40[deg]37'27.27'' N,
                                          073[deg]34'34.64'' W (NAD 83).
------------------------------------------------------------------------

    Dated: June 15, 2016.
E.J. Cubanski, III,
Captain, U.S. Coast Guard, Captain of the Port Sector Long Island
Sound.
[FR Doc. 2016-15601 Filed 6-29-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 142 (Wednesday, July 26, 2023)]
[Proposed Rules]
[Pages 48147-48150]
[FR Doc No: 2023-15751]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2021-0752; FRL-9203-01-R10]

Air Plan Approval; WA; Yakima County Outdoor and Agricultural
Burning Rule Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) proposes to approve
into the Washington State Implementation Plan (SIP) the Yakima Regional
Clean Air Agency's (YRCAA) revised outdoor and agricultural burning
rule submitted by the State of Washington (Washington or the State) on
October 14, 2021. The submitted revisions improve stringency, clarity
and enforceability of the rule. The EPA is proposing to approve the SIP
submission as consistent with Clean Air Act (Act or CAA) requirements.

DATES: Comments must be received on or before August 25, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2021-0752, at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from https://www.regulations.gov. The EPA may
publish any comment received to its public docket. Do not
electronically submit any information you consider to be Confidential
Business Information (CBI) or other information the disclosure of which
is restricted by statute. Multimedia submissions (audio, video, etc.)
must be accompanied by a written comment. The written comment is
considered the official comment and should include discussion of all
points you wish to make. The EPA will generally not consider comments
or comment contents located outside of the primary submission (i.e., on
the web, cloud, or other file sharing system). For additional
submission methods, the full EPA public comment policy, information
about CBI or multimedia submissions, and general guidance on making
effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Claudia Vaupel,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, it is intended to refer to the EPA.

I. Background for This Action

    Section 110 of the CAA requires states to develop and submit to the
EPA a SIP to ensure that state air quality meets National Ambient Air
Quality Standards (NAAQS). These ambient standards address six criteria
pollutants: carbon monoxide, nitrogen dioxide, ozone, lead, particulate
matter, and sulfur dioxide. Each federally approved SIP protects air
quality primarily by addressing air pollution at its point of origin
through air pollution regulations and control strategies. The EPA-
approved SIP provisions and control strategies are federally
enforceable. States revise the SIP as needed and submit revisions to
the EPA for review and approval.
    The EPA approved YRCAA's outdoor burning rules into the Washington
SIP in 1998 as part of the Yakima area attainment plan for particulate
matter with an aerodynamic diameter less than or equal to a nominal 10
micrometers (PM10) \1\ On October 14, 2021, Washington
submitted a SIP revision to the EPA that repeals and replaces the 1998
SIP-approved outdoor burning rules for the Yakima area.
---------------------------------------------------------------------------

    \1\ We note that the Yakima area has since been redesignated to
attainment for PM10. (See 70 FR 6591, February 8, 2005).
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II. The State's Submission

    Washington's October 14, 2021, SIP submission significantly revised
the SIP-approved outdoor burning rules for the Yakima area.
Specifically, the SIP revision repeals and replaces the following rules
from Regulation 1 of the Yakima Regional Clean Air Agency, Article 5,
that were federally approved into the Washington SIP in 1998: 5.01
Outdoor Burning; 5.02 Regulations Applicable to All Outdoor Burning;
5.03 Regulations Applicable to All Outdoor Burning within the
Jurisdiction of the Yakima County Clean Air Authority, Local Cities,
Towns, Fire Protection Districts and Conservation Districts; 5.04
Regulations Applicable to Permits Issued by the Yakima County Clean Air
Authority for All Other Outdoor Burning; and 5.05 Additional
Restrictions on Outdoor Burning. The SIP revision replaces the repealed
outdoor burning rules in Regulation 1, Article 5, with Regulation 1,
Article 3, 3.03 Outdoor and Agricultural Burning, that was adopted by
YRCAA on October 8, 2020 and became state effective on November 9,
2020.

III. The EPA's Evaluation

    As mentioned previously, the October 2021 SIP submission replaces
the outdoor burning rules in Regulation 1, Article 5, with outdoor and
agricultural burning rules in Regulation 1, Article 3, Section 3.03.
The revision includes renumbering as well as updates to the rules.

Applicability

    The revised rules continue to apply within YRCAA's jurisdiction.
Section 3.03 of the revised rules applies to burning requiring a permit
and to burning that is exempt from permitting. Section 3.03 also
applies to agricultural burning at agricultural operations and
government operations, and to certain firefighting training fires.
Consistent with the current SIP-approved rules, the revised rules do
not apply to silvicultural burning and contain clarification that
silvicultural burning is regulated by chapter 70A.15.RCW, chapter 332-
24 WAC, and the Department of Natural Resources Washington State Smoke
Management Plan (3.03.B). The revised rules also contain exemptions for
certain fire training fires at enclosed fire training facilities that
meet specific rule requirements. Overall, the scope and applicability
of outdoor burning subject to the revised rules appears at least
equivalent to, if not more stringent than, the current SIP-approved
rules.

General Prohibitions and Requirements for All Burning

    Under the revised rules, residential and land clearing burning is
prohibited

at all times in the 10 urban growth areas (UGAs) in Yakima County
(3.03.C). In contrast, the SIP-approved rules prohibit open burning in
all UGAs and in cities with populations greater than 10,000, but only
when the NAAQS are threatened, and alternative disposal practices are
not reasonably available. Both the SIP-approved rules and the revised
rules prohibit burning during a burn ban, however, to improve
compliance and enforcement of this prohibition, the revised rules
require confirmation of daily burning status (3.03.C.1.b and
3.03.C.2.a). The revised rules improve enforceability by including a
clear requirement to extinguish fires when burning is prohibited.
Specifically, in addition to the requirement that there be no visible
flame, the revised rules add that no visible smoke must come from the
fire and that the material being burned can be handled with bare hands.
The revised rules also shorten the maximum time allowed for larger
fires to be extinguished by 2 hours, from 10 to 8 hours (3.03.C.2.e).
    Furthermore, the revised rules establish that land clearing, storm
and flood debris, and orchard removal burns shall be extinguished
within 8 hours of notification of a burn ban and that all other burns
shall be extinguished within 3 hours of the notification (3.03.C.2.e).
The revised rules also define storm and flood debris burning as
``natural vegetation proposed for burning that was deposited by a storm
or flood from a declared emergency by a governmental authority'' and
establish that storm and flood debris can only be burned within 2 years
of the event or date of the emergency proclamation. (3.03.D.2.c).
    Like the SIP-approved rules, the revised rules require that persons
conduct burning during daylight hours, with limited exceptions. The
revised rules also add specific requirements for the supervision of
fires, location of fires, size of fires, distance requirements from
buildings, fences, other combustible materials, and other fires, and
the requirement to burn on a noncombustible surface (3.03.C.2 and
3.03.D.2). The revised rules continue to list materials that are
prohibited from being burned (3.03.D.1). This list is broader than the
list in the existing SIP-approved rules. In addition to these general
requirements applicable to all burning, the revised rules contain
specific requirements for firefighting training fires and agricultural
burning (3.03.E and 3.03.F). These revisions improve the stringency,
clarity and enforceability of the outdoor burning rules as compared to
the current SIP-approved rules.

Permit Requirements

    As with the SIP-approved rules, burning is not allowed without a
permit, unless exempted (3.03.C.1.e and Table 3.03-1). The revised
rules now require permits for Indian ceremonial fires and for
firefighting training. The revised rules also establish three types of
permits that YRCAA may issue depending on the type of burning,
including individual permits, annual permits, and general rule permits
(3.03.J). The revised rules also allow YRCAA to add specific conditions
to permits as necessary before or after permit issuance (3.03.J.6).
Regarding general permits, the revised rules include several permits
with standard conditions, including for training fires and large
recreational fires. In general, these revisions make the outdoor
burning rules more stringent. The EPA specifically notes that the
permit requirement in the revised rules for ceremonial fires and
firefighting training strengthen the rules.

Permit Limited Exemptions

    The revised rules include specific, narrow exemptions from the
permitting requirements. Importantly, burns exempt from permitting are
still subject to the general restrictions and prohibitions in 3.03.C as
modified by Table 3.03-1. Specific limited exemptions are detailed in
Table 3.03-1. Certain limited exemptions include incidental quantities
of fence rows and windblown vegetation, irrigation or drainage ditches,
and orchard prunings (Table 3.03-1). The revised rules also allow
nonprofit organizations to be granted limited exemptions for large
recreational fires in prohibited areas and for burning outside daylight
hours (Table 3.03-1 and General Rule Permit No. 3.03-5). Overall, these
limited exemptions appear equivalent to or more stringent than the
current SIP-approved rules.

Program Delegation

    The revised rules include provisions for partnering with local,
county, state, and Federal agencies to administer the open burning
program (3.03.I and Table 3.03-2). The revised rules allow for other
entities to administer the permitting program provided the entity meets
certain requirements. The revised rules also allow YRCAA to delegate
authority to issue permits on behalf of YRCAA to other entities. On May
19, 2023, YRCAA submitted a clarification letter to the EPA explaining
that Indian ceremonial fires, residential/tumbleweed, and weed
abatement are the only types of burning with permitting programs
available for delegation pursuant to subsection 3.03.I. YRCAA also
clarified that YRCAA and the Washington Department of Ecology interpret
subsection 3.03.B, subsection 3.03.I and Table 3.03-2 as establishing a
delegation program such that persons conducting outdoor and
agricultural burning subject to Rule 3.03 must comply with Rule 3.03
irrespective of whether program implementation is delegated pursuant to
subsection 3.03.I and Table 3.03-2. Also, YRCAA and the Washington
Department of Ecology acknowledge that once the EPA approves Rule 3.03
and incorporates the rule into 40 CFR part 52, any change to the scope
or stringency of Regulation 1, including through deferral of the
outdoor and agricultural program to another agency, must be submitted
by the State for approval by the EPA in accordance with CAA section 110
and 40 CFR part 51.

Provisions the EPA Is Not Approving

    The revised rules include some provisions that the EPA cannot
approve. These include provisions related to nuisance, asbestos, fees,
and requirements of other agencies. The EPA's authority to approve SIPs
extends to provisions related to attainment and maintenance of the
NAAQS and carrying out other specific requirements of section 110 of
the CAA. Therefore, the EPA is not approving the following provisions
and no further EPA action on these rules is required.
    Nuisance provisions: Rule 3.03.E.2.c., General Rule Permit No.
3.03-1.E.2.b, General Rule Permit No. 3.03-2.E.2.b, General Rule Permit
No. 3.03-3.E.2.b, General Rule Permit No. 3.03-4.E.2.c, and General
Rule Permit No. 3.03-5.E.2.d.
    Asbestos provisions: Rule 3.03.E.3.d, General Rule Permit No. 3.03-
1.E.2.d, General Rule Permit No. 3.03-1.E.2.e.
    Fee provisions: Rule 3.03.K.
    Requirements of other agencies: Rule 3.03.C.2.g, Rule 3.03.E.2a.,
General Rule Permit No. 3.03-1.G, General Rule Permit No. 3.03-2.G,
General Rule Permit No. 3.03-3.G, General Rule Permit No. 3.03-4.G, and
General Rule Permit No. 3.03-5.G.

Conclusion of EPA Analysis

    Based on our review, the EPA is proposing to conclude that the
revised open and agricultural burning rules will not interfere with any
applicable requirement concerning attainment or maintenance of the
NAAQS. The EPA proposes to determine that the revisions result in an
overall strengthening of the requirements for open and agricultural
burning.

IV. Proposed Action

    The EPA is proposing to approve the SIP revisions for outdoor and
agricultural burning submitted by Washington on October 14, 2021,
because they meet Clean Air Act requirements. We are proposing to
approve Regulation 1, Article 3, Section 3.03 into the federally-
approved SIP, except the following rules: 3.03.C.2.g, 3.03.E.2a,
3.03.E.2.c, 3.03.E.3.d, 3.03.K; and the following provisions in General
Rule Permit No.: 3.03-1.E.2.b, 3.03-1.E.2.e, 3.03-1.G, 3.03-2.E.2.b,
3.03-1.E.2.d, 3.03-2.G, 3.03-3.E.2.b, 3.03-3.G, 3.03-4.E.2.c, 3.03-4.G,
3.03-5.E.2.d, and 3.03-5.G. We are also proposing to remove from the
federally-approved SIP the outdated Regulation 1, Article 5 provisions,
Sections 5.01-5.05, that are replaced by Section 3.03.

V. Environmental Justice Considerations

    To provide additional context and information to the public on
potential environmental burdens and susceptible populations in
underserved communities in Yakima County, we conducted a screening-
level analysis using the EPA's environmental justice (EJ) screening and
mapping tool, EJScreen, version 2.1.\2\ We note, however, that this
screening analysis does not serve as a basis for this proposed action.
As detailed in section II of this preamble, the EPA's proposed action
is based on its determination that the SIP revision submitted by
Washington meets Clean Air Act requirements.
---------------------------------------------------------------------------

    \2\ EJScreen provides a nationally consistent dataset and
approach for combining environmental and demographic indicators.
EJScreen is available at https://www.epa.gov/ejscreen/what-ejscreen.
---------------------------------------------------------------------------

    EJScreen includes 12 EJ indexes, each of which combines demographic
factors with a single environmental factor.\3\ EJScreen also includes a
demographic index that combines low income, race and ethnicity data for
an area.\4\ Additionally, there are 7 socioeconomic indicators in
EJScreen: people of color; low income; unemployment rate; limited
English speaking households; less than high school education; low life
expectancy; under age 5; over age 64.\5\ The EPA has determined that
the use of an initial data filter in EJScreen promotes consistency and
provides a pragmatic first step for EPA programs and regions when
interpreting screening results. For early applications of EJScreen, the
EPA has identified the 80th percentile filter as that initial starting
point. For more information on percentiles, please see the EJScreen
technical documentation.\6\
---------------------------------------------------------------------------

    \3\ The 12 EJ indexes in EJScreen are: fine particulate matter
(annual average of fine particulate matter in ambient air); ozone
(summer seasonal ozone averages); diesel particulate matter (diesel
particulate matter level in air); air toxics cancer risk (lifetime
cancer risk of inhalation of air toxics); air toxics respiratory
hazard index; traffic proximity (count of vehicles per day at major
roads divided by distance); lead paint (housing built before 1960,
as index of potential exposure to lead paint); superfund proximity
(count of proposed and listed Superfund national priority list sites
divided by distance); risk management plan facility proximity (count
of risk management plan facilities divided by distance); hazardous
waste proximity (count of waste transfer, storage and disposal
facilities and large quantity generators divided by distance);
underground storage tanks (count of leaking underground storage
tanks and tanks within a buffered block group); wastewater discharge
(risk screening environmental indicators modeled toxic
concentrations at stream segments divided by distance).
    \4\ The demographic index in EJScreen combines the average of
the number of individuals whose household income is less than twice
the poverty level and the number of individuals who list their
racial status as a race other than white alone and/or list their
ethnicity as Hispanic or Latino.
    \5\ The unemployment indicator is based on the number of
individuals who did not have a job at all during the reporting
period made at least one specific active effort to find a job during
the prior 4 weeks and were available for work (unless temporarily
ill). The less than high school education indicator is based on the
number of individuals age 25 and older with less than a high school
degree. The limited English-speaking indicator is based on the
percent of households in which all members age 14 years and over
speak a non-English language and also speak English less than `very
well'. The low life expectancy indicator is based on the average
life expectancy ranked as percentiles. The under age 5 indicator is
based on the percent of individuals under age 5. The over age 64
indicator is based on the percent of individuals over age 64.
    \6\ EJScreen Technical Documentation, available at https://www.epa.gov/sites/default/files/2021-04/documents/ejscreen_technical_document.pdf.
---------------------------------------------------------------------------

    There are 6 EJ indexes in Yakima County that are higher than the
state or national 80th percentile. These are the EJ Index for:
Particulate Matter 2.5 (94th state percentile, 86th U.S. percentile);
ozone (95th state percentile, 70th U.S. percentile); air toxics cancer
risk (91st state percentile, 83rd percentile); air toxics respiratory
health (91st state percentile, 87th percentile U.S.), and risk
management plan facility proximity (92nd state percentile, 82nd
percentile).
    For the demographic index, Yakima County is in the 90th percentile
for the state and in the 75th percentile for the U.S. Additionally,
there are 4 socioeconomic indicators in Yakima County that are higher
than the state or national 80th percentile. These are people of color
(86th state percentile, 71st U.S. percentile); low income (84th state
percentile, 72nd U.S. percentile); limited English speaking households
(84th state percentile, 81st U.S. percentile); less than high school
education (94th state percentile, 87th U.S. percentile).
    This proposed action would approve the revised YRCAA outdoor and
agricultural burning rules submitted by Washington. We expect that this
action and resulting requirements will generally be neutral or
contribute to reduced environmental and health impacts on all
populations in Yakima County, including people of color and low-income
populations. At a minimum, this action would not worsen any existing
air quality and is expected to ensure the area is meeting requirements
to attain and/or maintain air quality standards. Further, there is no
information in the record indicating that this action is expected to
have disproportionately high or adverse human health or environmental
effects on a particular group of people.

VI. Incorporation by Reference

    In this document, the EPA is proposing to include in a final rule,
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the Regulation 1, Article 3, Section 3.03 provisions
described in sections II and III of this preamble. Also, in this
document, the EPA is proposing to remove, in a final EPA rule,
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to remove the
incorporation by reference of the Regulation 1, Article 5, Sections
5.01-5.05, as described in sections II and III of this preamble. The
EPA has made, and will continue to make, these documents generally
available through https://www.regulations.gov and at the EPA Region 10
Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).

VII. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Clean Air Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under

Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR
21879, April 11, 2023);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it approves a state program;
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001); and
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act.
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    YRCAA did not evaluate environmental justice considerations as part
of its SIP submission; the CAA and applicable implementing regulations
neither prohibit nor require such an evaluation. The EPA performed an
environmental justice analysis, as is described above in the section
titled, ``Environmental Justice Considerations.'' The analysis was done
for the purpose of providing additional context and information about
this rulemaking to the public, not as a basis of the action. Due to the
nature of the action being taken here, this action is expected to have
a neutral to positive impact on the air quality of the affected area.
In addition, there is no information in the record upon which this
decision is based inconsistent with the stated goal of E.O. 12898 of
achieving environmental justice for people of color, low-income
populations, and Indigenous peoples.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: July 20, 2023.
Casey Sixkiller,
Regional Administrator, Region 10.
[FR Doc. 2023-15751 Filed 7-25-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 156 (Friday, August 12, 2011)]
[Notices]
[Pages 50226-50230]
[FR Doc No: 2011-20502]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0271]

Harmful and Potentially Harmful Constituents in Tobacco Products
and Tobacco Smoke; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting comments,
including scientific and other information, concerning the harmful and
potentially harmful constituents (HPHCs) in tobacco products and
tobacco smoke. This information will assist the Agency in establishing
a list of HPHCs in tobacco products and tobacco smoke (the HPHC list).

DATES: Submit either electronic or written comments by October 11,
2011.

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

FOR FURTHER INFORMATION CONTACT: Carol Drew, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act amended the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) by, among other
things, adding a new chapter granting FDA important new authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors. Section 904(e) of the FD&C Act (21 U.S.C. 387d(e)), as
added by the Tobacco Control Act, requires FDA to establish, and
periodically revise as appropriate, ``a list of harmful and potentially
harmful constituents, including smoke constituents, to health in each
tobacco product by brand and by quantity in each brand and subbrand.''
Section 904(e) of the FD&C Act also requires that FDA ``publish a
public notice requesting the submission by interested persons of
scientific and other information concerning the harmful and potentially
harmful constituents in tobacco products and tobacco smoke.''
    The Agency has solicited scientific and other information from
interested persons and has developed a list of tobacco product
constituents it currently believes are harmful or potentially harmful
to health. Although the Agency's work to date reflects consideration of
substantial scientific and other information, we believe that
additional information from the public may be beneficial to the Agency
before it establishes the list described in section 904(e) of the FD&C
Act. We are therefore publishing the Agency's

current list as table 1 of this document and requesting public comment
as described in section II of this document. In this section of the
document, we are also providing information about the Agency's guidance
on HPHCs, the criteria that the Agency used to help develop the list,
and reasons the Agency might add or remove constituents.
    On June 10, 2010, FDA announced the availability for public comment
of a draft guidance for industry and FDA staff entitled ``Harmful and
Potentially Harmful Constituents' in Tobacco Products as Used in
Section 904(e) of the Federal Food, Drug, and Cosmetic Act'' (75 FR
32952). FDA announced the availability of the final guidance on January
31, 2011 (76 FR 5387) (available at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation) (HPHC final guidance). This
final guidance represents the Agency's current thinking on the meaning
of the term ``harmful and potentially harmful constituent'' in the
context of implementing section 904(e) of the FD&C Act. It states:
``FDA believes that the phrase 'harmful and potentially harmful
constituent' includes any chemical or chemical compound in a tobacco
product or in tobacco smoke: (a) That is or potentially is inhaled,
ingested, or absorbed into the body; and (b) that causes or has the
potential to cause direct or indirect harm to users or non-users of
tobacco products.''(HPHC final guidance at page 2). The HPHC final
guidance includes examples of constituents that have the potential to
cause direct harm and examples of constituents that have the potential
to cause indirect harm: ``Examples of constituents that have the
'potential to cause direct harm' to users or non-users of tobacco
products include constituents that are toxicants, carcinogens, and
addictive chemicals and chemical compounds. Examples of constituents
that have the 'potential to cause indirect harm' to users or non-users
of tobacco products include constituents that may increase the exposure
to the harmful effects of a tobacco product constituent by: (1)
Potentially facilitating initiation of the use of tobacco products; (2)
potentially impeding cessation of the use of tobacco products; or (3)
potentially increasing the intensity of tobacco product use (e.g.,
frequency of use, amount consumed, depth of inhalation). Another
example of a constituent that has the 'potential to cause indirect
harm' is a constituent that may enhance the harmful effects of a
tobacco product constituent.'' (HPHC final guidance at page 2).
    On May 1, 2010, the Agency established a subcommittee of the
Tobacco Products Scientific Advisory Committee (TPSAC), \1\ the Tobacco
Product Constituents Subcommittee (the subcommittee), and charged the
subcommittee with making preliminary recommendations to TPSAC on HPHCs
in tobacco products and tobacco smoke. The subcommittee held public
meetings on June 8 and 9, 2010, and July 7, 2010. Prior to these
meetings, FDA solicited data, information, and/or views on HPHCs in
tobacco products and tobacco smoke from the public, and at the June
meeting, presentations were made by interested persons.\2\ At these
meetings the subcommittee:
---------------------------------------------------------------------------

    \1\ Information about TPSAC as well as information and
background materials on TPSAC meetings are available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/default.htm.
    \2\ See 75 FR 22147 (April 27, 2010), and 75 FR 33814 (June 15,
2010). Information submitted to the public docket for each of these
meetings is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm222977.htm and http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm222978.htm.
---------------------------------------------------------------------------

     Reviewed example lists of HPHCs developed by other
countries and organizations;
     Identified criteria for selecting carcinogens, toxicants,
and addictive chemicals or chemical compounds in tobacco products and
tobacco smoke;
     Identified chemicals or chemical compounds that met the
identified criteria;
     Confirmed the existence of methods for measuring each
chemical or chemical compound identified; and
     Identified other potentially important information or
criteria for measuring HPHCs in tobacco products or tobacco smoke, such
as smoking machine regimens to be used in measuring HPHCs.
    The subcommittee made preliminary recommendations to TPSAC.
    On August 30, 2010, TPSAC held a public meeting to deliberate on
the recommendations from the subcommittee. Prior to this meeting, FDA
published a notice in the Federal Register soliciting data,
information, and/or views from the public on the issues to be discussed
at this meeting.\3\ FDA asked what criteria TPSAC recommended the
Agency use for determining whether a constituent is a carcinogen,
toxicant, or addictive chemical or chemical compound that should be
included on the HPHC list. As a result of its discussions, TPSAC
recommended to the Agency the following criteria for selecting the HPHC
list:
---------------------------------------------------------------------------

    \3\ See 75 FR 47308 (August 5, 2010). Information submitted by
the public to the docket for this meeting is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm232799.htm.
---------------------------------------------------------------------------

     Constituents identified as known, likely, probably, or
possible human carcinogens by the U.S. Environmental Protection Agency
(EPA);
     Constituents identified as known, probable, or possible
carcinogens by the International Agency for Research on Cancer (IARC)
including IARC Group 1 (carcinogenic to humans), IARC Group 2 (probably
carcinogenic to humans), and IARC Group 2B (possibly carcinogenic to
humans);
     Constituents identified as human carcinogens or reasonably
anticipated to be human carcinogens by the National Toxicology Program
(NTP);
     Constituents identified as potential occupational
carcinogens by the National Institute for Occupational Safety and
Health (NIOSH):
     Constituents identified by EPA or the Agency for Toxic
Substances and Disease Registry (ATSDR) as having adverse respiratory
or cardiac effects;
     Constituents identified by the California Environmental
Protection Agency (CA EPA) as reproductive or developmental toxicants;
     Constituents having, based upon a review of the peer-
reviewed literature, evidence of at least two of the following measures
of abuse liability (addiction):
    [cir] Central nervous system activity;
    [cir] Animal drug discrimination;
    [cir] Conditioned place preference;
    [cir] Animal self-administration;
    [cir] Human self-administration;
    [cir] Drug liking;
    [cir] Signs of withdrawal; and
     Constituents banned in food (for smokeless tobacco
products).
    FDA believes having criteria for use in determining whether a
constituent is harmful or potentially harmful will be beneficial. FDA
carefully evaluated the data, information, and views on HPHCs in
tobacco products provided by TPSAC and the public, in light of the
Agency's own knowledge and expertise, and taking into consideration its
HPHC final guidance. Based on this evaluation, FDA tentatively
concludes that it should use the criteria listed previously in this
document in determining whether a constituent should be included on the
HPHC list. Specifically, FDA has tentatively concluded that it should
consider a constituent meeting these criteria to be harmful or
potentially harmful, such that it should be included on the HPHC list,
unless other scientific information obtained by or submitted to the
Agency shows that the constituent is

not, in fact, harmful or potentially harmful. Applying this approach to
the criteria and the available information, FDA developed table 1 of
this document.
    FDA recognizes that table 1 of this document may not include all
constituents that are ``harmful or potentially harmful.'' For example,
the criteria described previously in this document generally depend on
a chemical or chemical compound being both studied and listed by
another entity, such as constituents identified by EPA or ATSDR as
having adverse respiratory or cardiac effects. The fact that a
constituent has not been so identified by EPA or ATSDR could be because
it has not been adequately studied or has not yet been systematically
reviewed by relevant agencies, rather than because the constituent does
not have adverse respiratory or cardiac effects. Moreover, FDA has only
focused on the five disease outcomes of cancer, cardiovascular disease,
respiratory effects, developmental or reproductive effects, and
addiction. FDA intends to review other disease outcomes to assess
whether additional chemicals or chemical compounds in tobacco products
or tobacco smoke are harmful or potentially harmful constituents that
contribute to the risk of other diseases. Similarly, the criteria FDA
has tentatively selected are limited to those that relate to
carcinogens, toxicants, and addictive chemicals or chemical compounds
in tobacco products and tobacco smoke. We intend to consider whether
additional criteria should be selected to help identify other classes
of harmful or potentially harmful chemicals and chemical compounds for
inclusion on the HPHC list, and whether individual constituents should
be added. Just as these types of new information may lead to additions
to the list, FDA recognizes that it may become aware of new scientific
information about constituents of tobacco products that make it
appropriate to remove one or more of the constituents that appear on
the list. For these reasons, FDA will continue to review scientific
information about tobacco product constituents. FDA intends to do this
both before and after it establishes its list of HPHCs for the purpose
of section 904(e) of the FD&C Act, consistent with the directive in
section 904(e) that the Agency periodically revise the list as
appropriate.

II. Request for Comments and Information

    FDA is soliciting public comment, including scientific and other
information, concerning the HPHCs in tobacco products and tobacco
smoke. We are particularly interested in comments from the public on
the following topics:
     The criteria FDA should use in determining whether a
constituent is harmful or potentially harmful such that it should be
included on the HPHC list;
     Whether any chemicals or chemical compounds not listed in
table 1 of this document should be added because they are harmful or
potentially harmful, including supporting scientific or other
information; and/or
     Whether any of the chemicals or chemical compounds listed
in table 1 of this document should be removed because they are not
harmful or potentially harmful, including supporting scientific or
other information.

III. Submission of Comments

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

 Table 1--List of the Chemicals and Chemical Compounds Identified by FDA
 as Harmful and Potentially Harmful Constituents in Tobacco Products and
                              Tobacco Smoke
------------------------------------------------------------------------
                                   Carcinogen (CA), respiratory toxicant
                                    (RT), cardiovascular toxicant (CT),
           Constituent                 reproductive or developmental
                                       toxicant (RDT), addictive (AD)
------------------------------------------------------------------------
Acetaldehyde.....................  CA, RT, AD
Acetamide........................  CA
Acetone..........................  RT
Acrolein.........................  RT, CT
Acrylamide.......................  CA
Acrylonitrile....................  CA, RT
Aflatoxin B1.....................  CA
4-Aminobiphenyl..................  CA
1-Aminonaphthalene...............  CA
2-Aminonaphthalene...............  CA
Ammonia..........................  RT
Anabasine........................  AD
o-Anisidine......................  CA
Arsenic..........................  CA, CT, RDT
A-[alpha]-C (2-Amino-9H-           CA
 pyrido[2,3-b]indole).
Benz[a]anthracene................  CA, CT
Benz[j]aceanthrylene.............  CA
Benzene..........................  CA, CT, RDT
Benzo[b]fluoranthene.............  CA, CT
Benzo[k]fluoranthene.............  CA, CT
Benzo[b]furan....................  CA
Benzo[a]pyrene...................  CA
Benzo[c]phenanthrene.............  CA
Beryllium........................  CA
1,3-Butadiene....................  CA, RT, RDT
Cadmium..........................  CA, RT, RDT

Caffeic acid.....................  CA
Carbon monoxide..................  RDT
Catechol.........................  CA
Chlorinated dioxins/furans.......  CA, RDT
Chromium.........................  CA, RT, RDT
Chrysene.........................  CA, CT
Cobalt...........................  CA, CT
Coumarin.........................  Banned in food
Cresols (o-, m-, and p-cresol)...  CA, RT
Crotonaldehyde...................  CA
Cyclopenta[c,d]pyrene............  CA
Dibenz[a,h]acridine..............  CA, CT
Dibenz[a,j]acridine..............  CA
Dibenz[a,h]anthracene............  CA
Dibenzo[c,g]carbazole............  CA
Dibenzo[a,e]pyrene...............  CA
Dibenzo[a,h]pyrene...............  CA
Dibenzo[a,i]pyrene...............  CA
Dibenzo[a,l]pyrene...............  CA
2,6-Dimethylaniline..............  CA
Ethyl carbamate (urethane).......  CA, RDT
Ethylbenzene.....................  CA
Ethylene oxide...................  CA, RT, RDT
Formaldehyde.....................  CA, RT
Furan............................  CA
Glu-P-1 (2-Amino-6-                CA
 methyldipyrido[1,2-a:3',2'-
 d]imidazole).
Glu-P-2 (2-Aminodipyrido[1,2-      CA
 a:3',2'-d]imidazole).
Hydrazine........................  CA, RT
Hydrogen cyanide.................  RT, CT
Indeno[1,2,3-cd]pyrene...........  CA
IQ (2-Amino-3-methylimidazo[4,5-   CA
 f]quinoline).
Isoprene.........................  CA
Lead.............................  CA, CT, RDT
MeA-[alpha]-C (2-Amino-3-methyl)-  CA
 9H-pyrido[2,3-b]indole).
Mercury..........................  CA, RDT
Methyl ethyl ketone..............  RT
5-Methylchrysene.................  CA
4-(Methylnitrosamino)-1-(3-        CA
 pyridyl)-1-butanone (NNK).
Naphthalene......................  CA, RT
Nickel...........................  CA, RT
Nicotine.........................  RDT, AD
Nitrobenzene.....................  CA, RT, RDT
Nitromethane.....................  CA
2-Nitropropane...................  CA
N-Nitrosodiethanolamine (NDELA)..  CA
N-Nitrosodiethylamine............  CA
N-Nitrosodimethylamine (NDMA)....  CA
N-Nitrosomethylethylamine........  CA
N-Nitrosomorpholine (NMOR).......  CA
N-Nitrosonornicotine (NNN).......  CA
N-Nitrosopiperidine (NPIP).......  CA
N-Nitrosopyrrolidine (NPYR)......  CA
N-Nitrososarcosine (NSAR)........  CA
Nornicotine......................  AD
Phenol...........................  RT, CT
PhIP (2-Amino-1-methyl-6-          CA
 phenylimidazo[4,5-b]pyridine).
Polonium-210.....................  CA
Propionaldehyde..................  RT, CT
Propylene oxide..................  CA, RT
Quinoline........................  CA
Selenium.........................  RT
Styrene..........................  CA
o-Toluidine......................  CA
Toluene..........................  RT, RDT
Trp-P-1 (3-Amino-1,4-dimethyl-5H-  CA
 pyrido[4,3-b]indole).
Trp-P-2 (1-Methyl-3-amino-5H-      CA
 pyrido[4,3-b]indole ).

Uranium-235......................  CA, RT
Uranium-238......................  CA, RT
Vinyl acetate....................  CA, RT
Vinyl chloride...................  CA
------------------------------------------------------------------------

    Dated: August 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20502 Filed 8-11-11; 8:45 am]
BILLING CODE 4160-01-P