82 FR 1647 - General Provisions; Electronic Cigarettes

DEPARTMENT OF THE INTERIOR
National Park Service

Federal Register Volume 82, Issue 4 (January 6, 2017)

Page Range		1647-1651
FR Document		2016-31957
The National Park Service proposes to revise the regulation that defines smoking to include the use of electronic cigarettes and other electronic nicotine delivery systems. The National Park Service also proposes to allow a superintendent to close an area, building, structure, or facility to smoking when necessary to maintain public health and safety.
Federal Register, Volume 82 Issue 4 (Friday, January 6, 2017)
[Federal Register Volume 82, Number 4 (Friday, January 6, 2017)]
[Proposed Rules]
[Pages 1647-1651]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31957]


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DEPARTMENT OF THE INTERIOR

National Park Service

36 CFR Part 1

[NPS-WASO-REGS-17326; GPO Deposit Account 4311H2]
RIN 1024-AE30


General Provisions; Electronic Cigarettes

AGENCY: National Park Service; Interior.

ACTION: Proposed rule.

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SUMMARY: The National Park Service proposes to revise the regulation 
that defines smoking to include the use of electronic cigarettes and 
other electronic nicotine delivery systems. The National Park Service 
also proposes to allow a superintendent to close an area, building, 
structure, or facility to smoking when necessary to maintain public 
health and safety.

DATES: Comments must be received by 11:59 p.m. EST on March 7, 2017.

ADDRESSES: You may submit your comments, identified by Regulation 
Identifier Number (RIN) 1024-AE30, by any of the following methods:
     Electronically: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
     Hard copy: Mail or hand deliver to: A.J. North, 
Regulations Program, National Park Service, 1849 C Street NW., MS-2355, 
Washington, DC 20240.
    Instructions: All submissions received must include the agency name 
and RIN for this rulemaking. We will only accept comments as noted 
above. We will not accept comments via email, fax or by any other 
methods. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided. For 
additional information, see the Public Participation heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Sara Newman, Director, Office of 
Public Health, by telephone 202-513-7225, or email [email protected].

SUPPLEMENTARY INFORMATION: 

Background

General Authority and Jurisdiction

    In the National Park Service Organic Act of 1916, Congress granted 
the National Park Service (NPS) broad

[[Page 1648]]

authority to regulate the use of areas under its jurisdiction to 
``conserve the scenery, natural and historic objects, and wild life in 
[National Park] System units and to provide for the enjoyment of the 
scenery, natural and historic objects, and wild life in such manner and 
by such means as will leave them unimpaired for the enjoyment of future 
generations.'' 54 U.S.C. 100101. The Organic Act authorizes the 
Secretary of the Interior, acting through the NPS, to ``prescribe such 
regulations as the Secretary considers necessary or proper for the use 
and management of [National Park] System units.'' 54 U.S.C. 100751.

NPS Smoking Regulation and Policy

    The NPS protects park resources and visitors by regulating smoking 
within park areas. The regulation governing smoking (36 CFR 2.21) was 
last amended in 1983. This regulation allows the superintendent to 
designate a portion of a park area, or all or a portion of a building, 
structure, or facility as closed to smoking when necessary to protect 
park resources, reduce the risk of fire, or prevent conflicts among 
visitor use activities. The regulation prohibits smoking in an area or 
location so designated and within all caves and caverns. The existing 
definition of ``smoking'' in section 1.4 is limited to combustible 
sources such as a tobacco cigarette; it does not include the use of 
electronic cigarettes and other electronic nicotine delivery systems 
(ENDS). Since 2009, ENDS have emerged as an alternative means of 
nicotine delivery, one that does not require the burning of tobacco. 
Essentially, when a user ``draws'' on an ENDS, a liquid solution 
containing nicotine is heated and vaporized, and inhaled by the user. 
The user then exhales a vapor that mimics the exhalation from a lit 
tobacco cigarette.
    NPS policy with respect to tobacco smoking is found in Director's 
Order #50D (Smoking Policy), originally issued in 2003, and then 
revised and reissued in 2009. The purpose of the Order--in conformity 
with Executive Order 13058 (Protecting Federal Employees and the Public 
From Exposure to Tobacco Smoke in the Federal Workplace)--is to 
``protect employees and park visitors from the health hazards and 
annoyances associated with'' exposure to environmental tobacco smoke, 
commonly known as ``second-hand'' smoke, which is a known human 
carcinogen.
    The Director issued Policy Memorandum 15-03 (Use of Electronic 
Nicotine Delivery Systems) on September 10, 2015. This policy 
establishes NPS guidance on the use of ENDS within all facilities and 
vehicles that are Government owned or leased, and within concessions 
facilities. The purpose of the Policy Memorandum is to afford all NPS 
employees and park visitors the same protections from exposure to 
nicotine and other harmful substances that may be found in ENDS vapor 
that are currently in place for tobacco smoke. Under this policy, use 
of ENDS is now treated as tobacco smoking and all provisions of 
Director's Order #50D apply to ENDS use. With regard to concessions 
facilities, the Policy Memorandum requires that ENDS use be treated the 
same as smoking for purposes of NPS Management Policies (2006).
    Director's Order #50D and Policy Memorandum 15-03 are available 
online on the NPS Office of Policy Web site at http://www.nps.gov/applications/npspolicy/index.cfm by clicking on the drop-down menu and 
selecting ``Smoking'' from the list of policy subjects.

Proposed Revision of NPS Regulations at 36 CFR 1.4 and 2.21

    The NPS proposes to apply its smoking regulations at 36 CFR 2.21 to 
ENDS use the same way they currently apply to tobacco smoking. The 
basis for this regulatory change is stated below and in Policy 
Memorandum 15-03 and will make NPS regulations consistent with NPS 
policy on this subject.
    Non-smokers are exposed to nicotine and other potentially harmful 
components of ENDS vapor at higher than background levels when 
passively exposed to second hand vapor.\1\ The vapor exhaled from an 
ENDS also contains potentially harmful levels of particulate matter in 
addition to nicotine, as well as potentially toxic compounds such as 
carbonyls, metals, and organic volatile compounds.\2\ There has been 
increased attention in the scientific community to explore the level of 
potentially harmful constituents in ENDS vapor.\3\ Despite lower levels 
of nicotine than in second-hand smoke, exhaled ENDS aerosols result in 
similar nicotine uptake levels as measured by blood serum cotinine 
levels in bystanders.\4\ In the case of particulate matter, 
epidemiological studies show adverse effects of particulate matter when 
only slightly elevated above background levels indicating that we 
should strive to achieve the lowest concentrations possible.\5\ The 
Division of Pharmaceutical Analysis of the Food and Drug Administration 
(FDA) analyzed the ingredients in a sample of cartridges from two 
leading brands of ENDS, and found the devices emitted (1) tobacco-
specific nitrosamines (human carcinogens), and (2) diethylene glycol, a 
chemical used in antifreeze that is toxic to humans.\6\ Further 
research is required before it is known whether second hand exposure to 
ENDS vapor will result in negative health outcomes as with tobacco 
smoke.\7\ According to the World Health Organization (WHO), simply 
because ENDS exhaled aerosols contain lower levels of toxicants than 
tobacco smoke it does not mean second hand exposure is acceptable and 
special consideration is needed for sensitive populations like pregnant 
women, developing fetuses, and adolescents.\8\
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    \1\ See ``Cigarettes vs. e-cigarettes: Passive exposure at home 
measured by means of airborne marker and biomarkers'' (http://www.sciencedirect.com/science/article/pii/S0013935114003089). See 
``Secondhand Exposure to Vapors From Electronic Cigarettes'' 
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4565991).
    \2\ See http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_10-en.pdf.
    \3\ See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm.
    \4\ See ``Cigarettes vs. e-cigarettes: Passive exposure at home 
measured by means of airborne marker and biomarkers'' (http://www.sciencedirect.com/science/article/pii/S0013935114003089).
    \5\ See http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_10-en.pdf.
    \6\ See http://www.fda.gov/downloads/drugs/scienceresearch/ucm173250.pdf.
    \7\ See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm.
    \8\ See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm.
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    The Surgeon General's 2014 report The Health Consequences of 
Smoking- 50 Years of Progress (Report) documents the devastating health 
consequences of tobacco smoking and also calls for ``rigorous 
surveillance'' of ENDS in order to weigh their risks and potential 
benefits (e.g., their possible efficacy in reducing use of combustible 
tobacco products).\9\ (Page 761). The Report concludes that, in light 
of the links between tobacco product use and ill health, ``all products 
containing tobacco and nicotine should be assumed to be both harmful 
and addictive.'' (Page 780). In 2016, the Surgeon General issued a 
report entitled ``E-Cigarette Use Among Youth and Young Adults.'' \10\ 
This Report emphasized that ENDS use among youth and young adults is a 
public health concern. The Report concluded that aerosol can contain 
harmful and potentially harmful constituents, including nicotine, which 
can cause addiction and harm the

[[Page 1649]]

developing adolescent brain. The Report stated that the use of products 
containing nicotine, including ENDS, poses dangers to youth, pregnant 
women, and fetuses. In a report released August 26, 2014, the WHO 
called for a ban on the indoor use of ENDS, especially in those spaces 
where smoking is banned.\11\ (See Item #41, page 11.)
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    \9\ See http://www.surgeongeneral.gov/library/reports/50-years-of-progress/.
    \10\ See https://e-cigarettes.surgeongeneral.gov/documents/2016_SGR_Full_Report_non-508.pdf.
    \11\ See http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_10-en.pdf.
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    On May 5, 2016, the FDA finalized a rule (81 FR 28973) extending 
its authority to ENDS under the Family Smoking Prevention and Tobacco 
Control Act (Pub. L. 111-31; 123 Stat. 1776). The rule brings ENDS in 
line with regulations that have governed tobacco products since 2009. 
The rule prohibits the sale of ENDS to minors, requires ENDS to meet 
applicable product standards and receive marketing authorization from 
the FDA, requires the reporting of ingredients, and places health 
warnings on product packages and advertisements. The FDA expressed 
concerns about the increasing use of ENDS, especially among middle and 
high school students, and explained that the rule will ``help protect 
Americans from the dangers of tobacco and nicotine.'' \12\ The FDA 
stated that nicotine is dangerous and highly addictive, even when it 
comes from ENDS use, and that research has clearly demonstrated that 
exposure to nicotine at a young age increases the chance that kids will 
become addicted. In addition to nicotine exposure, the FDA stated there 
are numerous other chemicals present in ENDS that can cause 
disease.\13\
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    \12\ See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm.
    \13\ See http://www.fda.gov/TobaccoProducts/NewsEvents/ucm499383.htm.
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    The General Services Administration (GSA) has advised the managers 
of all GSA-occupied space--which includes space rented by GSA on behalf 
of NPS--that ENDS are subject to the same restrictions imposed on 
smoking tobacco products. The U.S. Fish and Wildlife Service's (FWS) 
policy found at 242 FW 13 goes even further, and prohibits ``vaping''--
another name for ENDS use--in all interior spaces of FWS facilities, 
whether Government owned or leased.\14\ In addition, vaping is also 
prohibited ``in motor vehicles, heavy equipment, aircraft, and most 
watercraft'' owned, leased, or controlled by the FWS. Similarly, on 
August 14, 2014, the U.S. Geological Survey (USGS) banned the use of 
ENDS ``in all interior space, courtyards, atriums, balconies and bus 
stops.'' See, USGS Manual 370.792.3.\15\
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    \14\ See http://www.fws.gov/policy/242fw13.html.
    \15\ See http://www.usgs.gov/usgs-manual/370-600/370-7923.html.
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    In addition to public health risks from the inhalation of vapor, 
ENDS also pose a risk of explosion and fire. A 2014 Federal Emergency 
Management Agency (FEMA) report stated that fires or explosions caused 
by the failure of lithium-ion batteries in ENDS are rare, but 
possible.\16\ Between 2009 and August 2014, 25 incidents of explosion 
and fire involving e-cigarettes were reported in the U.S. Most of the 
incidents occurred while the battery was charging, but serious burn 
injuries were also reported from explosions when the device was in the 
user's mouth. FEMA stated that the shape and construction of e-
cigarettes can make them more likely than other products with lithium-
ion batteries to behave like ``flaming rockets'' when a battery fails. 
FEMA concluded that the number of fires and explosions will likely 
increase as the number of lithium-ion batteries in use continues to 
grow.
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    \16\ See https://www.usfa.fema.gov/downloads/pdf/publications/electronic_cigarettes.pdf.
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    Acting out of an abundance of caution in light of the scientific 
findings and uncertainty to date, and in the interest of equity, the 
purpose of this proposed rule (similar to the purpose of Policy 
Memorandum 15-03) is to afford all NPS employees and park visitors the 
same protections from exposure to nicotine and other harmful substances 
that may be found in ENDS vapor that are currently in place for 
exposure to tobacco smoke.
    The proposed rule would add a new definition to 36 CFR 1.4 that 
defines ``Electronic nicotine delivery system'' as an electronic 
device, such as an electronic cigarette, that a person uses to simulate 
smoking by inhaling vapor from the device. The proposed rule would 
revise the definition of ``Smoking'' in 36 CFR 1.4 to include the 
direct inhalation of vapor from an electronic nicotine delivery system. 
The NPS also proposes to add a new basis for which a superintendent may 
close an area or building, structure, or facility to smoking in 36 CFR 
2.21--when necessary to maintain public health and safety. This 
reflects the health risks associated with smoking tobacco products and 
using ENDS. An existing basis in the regulations for restricting 
tobacco smoking--to reduce the risk of fire--also would apply to the 
use of ENDS for the reasons explained above. After these changes are 
made, the smoking regulation at 2.21 would apply to the smoking of 
tobacco and the use of ENDS, consistent with NPS policy.

Compliance With Other Laws, Executive Orders, and Department Policy 
Regulatory Planning and Review (Executive Orders 12866 and 13563)

    Executive Order 12866 provides that the Office of Information and 
Regulatory Affairs (OIRA) in the Office of Management and Budget will 
review all significant rules. OIRA has determined that this rule is not 
significant.
    Executive Order 13563 reaffirms the principles of Executive Order 
12866 while calling for improvements in the nation's regulatory system 
to promote predictability, to reduce uncertainty, and to use the best, 
most innovative, and least burdensome tools for achieving regulatory 
ends. The executive order directs agencies to consider regulatory 
approaches that reduce burdens and maintain flexibility and freedom of 
choice for the public where these approaches are relevant, feasible, 
and consistent with regulatory objectives. Executive Order 13563 
emphasizes further that regulations must be based on the best available 
science and that the rulemaking process must allow for public 
participation and an open exchange of ideas. We have developed this 
rule in a manner consistent with these requirements.

Regulatory Flexibility Act (RFA)

    This rule will not have a significant economic effect on a 
substantial number of small entities under the RFA (5 U.S.C. 601 et 
seq.). This certification is based on information contained in the 
economic analyses found in the report entitled ``Benefit-Cost and 
Regulatory Flexibility Analyses: Proposed Regulation Revisions for 
Electronic Nicotine Delivery Systems'' which is available online on the 
NPS Office of Policy Web site at http://www.nps.gov/applications/npspolicy/index.cfm by clicking on the drop-down menu and selecting 
``E-cigarettes'' from the list of policy subjects.

Small Business Regulatory Enforcement Fairness Act (SBREFA)

    This rule is not a major rule under 5 U.S.C. 804(2), the SBREFA. 
This rule:
    (a) Does not have an annual effect on the economy of $100 million 
or more.
    (b) Will not cause a major increase in costs or prices for 
consumers, individual industries, Federal, State, or local government 
agencies, or geographic regions.
    (c) Does not have significant adverse effects on competition, 
employment, investment, productivity, innovation, or

[[Page 1650]]

the ability of U.S.-based enterprises to compete with foreign-based 
enterprises.

Unfunded Mandates Reform Act (UMRA)

    This rule does not impose an unfunded mandate on State, local, or 
tribal governments or the private sector of more than $100 million per 
year. The rule does not have a significant or unique effect on State, 
local or tribal governments or the private sector. It addresses public 
use of national park lands, and imposes no requirements on other 
agencies or governments. A statement containing the information 
required by the UMRA (2 U.S.C. 1531 et seq.) is not required.

Takings (Executive Order 12630)

    This rule does not effect a taking of private property or otherwise 
have taking implications under Executive Order 12630. A takings 
implication assessment is not required.

Federalism (Executive Order 13132)

    Under the criteria in section 1 of Executive Order 13132, the rule 
does not have sufficient federalism implications to warrant the 
preparation of a Federalism summary impact statement. This proposed 
rule only affects use of NPS administered lands and waters. It has no 
outside effects on other areas. A Federalism summary impact statement 
is not required.

Civil Justice Reform (Executive Order 12988)

    This rule complies with the requirements of Executive Order 12988. 
This rule:
    (a) Meets the criteria of section 3(a) requiring that all 
regulations be reviewed to eliminate errors and ambiguity and be 
written to minimize litigation; and
    (b) Meets the criteria of section 3(b)(2) requiring that all 
regulations be written in clear language and contain clear legal 
standards.

Consultation With Indian tribes (Executive Order 13175 and Department 
Policy)

    The Department of the Interior strives to strengthen its 
government-to-government relationship with Indian tribes through a 
commitment to consultation with Indian tribes and recognition of their 
right to self-governance and tribal sovereignty. We have evaluated this 
rule under the criteria in Executive Order 13175 and under the 
Department's consultation policy and have determined that tribal 
consultation is not required because the rule will have no substantial 
direct effect on federally recognized Indian tribes.

Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.)

    This rule does not contain information collection requirements, and 
a submission to the Office of Management and Budget under the Paperwork 
Reduction Act is not required. We may not conduct or sponsor and you 
are not required to respond to a collection of information unless it 
displays a currently valid OMB control number.

National Environmental Policy Act of 1969 (NEPA)

    This rule does not constitute a major Federal action significantly 
affecting the quality of the human environment. A detailed statement 
under the NEPA is not required because the rule is covered by a 
categorical exclusion. This rule is excluded from the requirement to 
prepare a detailed statement because it is a regulation of 
administrative, legal, and technical nature (43 CFR 46.210(i)). We have 
also determined that the rule does not involve any of the extraordinary 
circumstances listed in 43 CFR 46.215 that would require further 
analysis under NEPA.

Effects on the Energy Supply (Executive Order 13211)

    This rule is not a significant energy action under the definition 
in Executive Order 13211. A Statement of Energy Effects in not 
required.

Clarity of This Rule

    We are required by Executive Orders 12866 (section 1(b)(12)) and 
12988 (section 3(b)(1)(B)) and by the Presidential Memorandum of June 
1, 1998, to write all rules in plain language. This means that each 
rule we publish must:
    (a) Be logically organized;
    (b) Use the active voice to address readers directly;
    (c) Use clear language rather than jargon;
    (d) Be divided into short sections and sentences; and
    (e) Use lists and tables wherever possible.
    If you feel that we have not met these requirements, send us 
comments by one of the methods listed in the ADDRESSES section. To 
better help us revise the rule, your comments should be as specific as 
possible. For example, you should tell us the numbers of the sections 
or paragraphs that you find unclear, which sections or sentences are 
too long, the sections where you feel lists or tables would be useful, 
etc.
    Drafting Information: The primary authors of this rule are Jay 
Calhoun and Russel J. Wilson, Division of Regulations, Jurisdiction, 
and Special Park Uses, and Michael M. Shelton, Program Analyst, Office 
of Policy, National Park Service, Washington, DC.

Public Participation

    It is the policy of the Department of the Interior, whenever 
practicable, to afford the public an opportunity to participate in the 
rulemaking process. Accordingly, interested persons may submit written 
comments regarding this proposed rule by one of the methods listed in 
the ADDRESSES section. All comments must be received by midnight of the 
close of the comment period. We will not accept comments by fax, email 
or by any other methods. Bulk comments in any format (hard copy or 
electronic) submitted on behalf of others will not be accepted.

Public Availability of Comments

    Before including your address, phone number, email address, or 
other personal identifying information in your comment, you should be 
aware that your entire comment--including your personal identifying 
information--may be made publicly available at any time. While you can 
ask us in your comment to withhold your personal identifying 
information from public review, we cannot guarantee that we will be 
able to do so.

List of Subjects in 36 CFR Part 1

    National parks, Penalties, Reporting and recordkeeping 
requirements, Signs and symbols.

    In consideration of the foregoing, the National Park Service 
proposes to amend 36 CFR part 1 as set forth below:

PART 1--GENERAL PROVISIONS

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

    Authority:  54 U.S.C. 100101, 100751, 320102.

0
2. In Sec.  1.4 amend paragraph (a) by adding, in alphabetical order, 
the term ``Electronic nicotine delivery system'' and revising the term 
``Smoking'' to read as follows:


Sec.  1.4  What terms do I need to know?

    (a) * * *
    Electronic nicotine delivery system means an electronic device, 
such as an electronic cigarette, that a person uses to simulate smoking 
by inhaling vapor from the device.
* * * * *
    Smoking means the carrying of lighted cigarettes, cigars or pipes; 
or the

[[Page 1651]]

intentional and direct inhalation of smoke from these objects; or the 
direct inhalation of vapor from an electronic nicotine delivery system.
* * * * *
0
3. In Sec.  2.21, revise paragraph (a) to read as follows:


Sec.  2.21  Smoking

    (a) The superintendent may designate a portion of a park area, or 
all or a portion of a building, structure or facility as closed to 
smoking when necessary to maintain public health and safety, to protect 
park resources, reduce the risk of fire, or prevent conflicts among 
visitor use activities. Smoking in an area or location so designated is 
prohibited.
* * * * *

    Dated: December 20, 2016.
Michael Bean,
Principal Deputy Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 2016-31957 Filed 1-5-17; 8:45 am]
 BILLING CODE 4312-52-P
Document Created: 2017-01-06 01:30:03
Document Modified: 2017-01-06 01:30:03
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed rule.
Dates		Comments must be received by 11:59 p.m. EST on March 7, 2017.
Contact		Sara Newman, Director, Office of Public Health, by telephone 202-513-7225, or email [email protected]
FR Citation		82 FR 1647
RIN Number		1024-AE30
CFR Associated		National Parks; Penalties; Reporting and Recordkeeping Requirements and Signs and Symbols
82 FR 1647 - General Provisions; Electronic Cigarettes

DEPARTMENT OF THE INTERIORNational Park Service

Federal Register Volume 82, Issue 4 (January 6, 2017)

DEPARTMENT OF THE INTERIOR
National Park Service
