Use of Electronic Cigarettes on Aircraft

Federal Register, Volume 81 Issue 43 (Friday, March 4, 2016)

Federal Register Volume 81, Number 43 (Friday, March 4, 2016)

Rules and Regulations

Pages 11415-11428

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2016-04799

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

14 CFR Part 252

Docket No. DOT-OST-2011-0044

RIN 2105-AE06

Use of Electronic Cigarettes on Aircraft

AGENCY: Office of the Secretary (OST), Department of Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The Department of Transportation is issuing a final rule to extend the smoking ban in DOT's regulation to include all charter (i.e., nonscheduled) flights where a flight attendant is a required crewmember. The revised regulation would comport with 49 U.S.C. 41706, which was revised in 2012, to ban smoking on charter flights where a flight attendant is a required crewmember. This final rule also explicitly bans the use of electronic cigarettes (``e-cigarettes'') on all flights where smoking is banned. The Department interprets the existing regulation to prohibit e-cigarette use, but is codifying this interpretation.

DATES: The rule is effective April 4, 2016.

FOR FURTHER INFORMATION CONTACT: Robert M. Gorman, Senior Trial Attorney, or Blane A. Workie, Assistant General Counsel, Office of the Assistant General Counsel for Aviation Enforcement and Proceedings, U.S. Department of Transportation, 1200 New Jersey Ave. SE., Washington, DC 20590, 202-366-9342, 202-366-7152 (fax), robert.gorman@dot.gov or blane.workie@dot.gov (email).

SUPPLEMENTARY INFORMATION:

Background

The Wendell H. Ford Aviation Investment and Reform Act for the 21st Century (Pub. L. 106-181) was signed into law on April 5, 2000. Section 708 of this statute, ``Prohibitions Against Smoking on Scheduled Flights'' (codified as 49 U.S.C. 41706), banned passengers from smoking on all flights in scheduled passenger interstate and intrastate air transportation, and directed the Secretary of Transportation to prohibit smoking in foreign air transportation (with an exception process for foreign carriers). Shortly thereafter, the Department of Transportation (``DOT,'' or ``the Department'') amended its rule on smoking aboard aircraft, 14 CFR part 252, to implement section 41706. Under part 252, the smoking of tobacco products is banned on all scheduled passenger flights of air carriers, and on all scheduled passenger flight segments of foreign air carriers between points in the United States and between the United States and foreign points. Under part 252, foreign governments may request and obtain a waiver from DOT provided that an alternative smoking prohibition resulting from bilateral negotiations is in effect. Further, part 252 was amended to permit carriers operating single-entity charters to allow smoking throughout the aircraft, but also required a no-smoking section for each class of service (e.g., first class) on other charter flights where smoking is not banned.

Throughout this preamble, we use the terms ``air carrier'' and ``foreign air carrier'' as defined in 49 U.S.C. 40102, in which an ``air carrier'' is a citizen of the United States undertaking to provide air transportation, and a ``foreign air carrier'' is a person, not a citizen of the United States, undertaking to provide foreign air transportation.

The Notice of Proposed Rulemaking

Electronic Cigarettes and Other Nicotine Delivery Systems

On September 15, 2011, the Department published a notice of proposed rulemaking (NPRM) in which it proposed to amend its existing smoking rule (part 252) to explicitly ban the use of e-cigarettes on all flights covered by that rule (i.e., all flights of U.S. air carriers in scheduled passenger interstate, intrastate and foreign air transportation and all scheduled flight segments of foreign air carriers in, to, or from the United States).\1\ E-cigarettes typically contain a cartridge or chamber, which contain an atomizer or heating element, a battery and a liquid solution. Most often e-cigarettes contain liquid nicotine but they may contain other chemicals. When a user inhales, the heating element aerosolizes the liquid solution. This produces an aerosol,\2\ which requires an inhalation and exhalation similar to smoking cigarettes. In addition to nicotine, e-cigarette aerosol can contain heavy metals, ultrafine particulates that can be inhaled deep into the lungs, and cancer-causing agents like acrolein. Secondhand

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aerosol that is exhaled by users may reduce air quality and is potentially harmful to health. Sometimes e-cigarettes are designed to look like traditional cigarettes, but at times they are also made to look like cigars, pipes, and even everyday products such as pens.

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\1\ Smoking of Electronic Cigarettes on Aircraft, Department of Transportation, Office of the Secretary, 14 CFR part 252, Docket No. DOT-OST-2011-0044, RIN 2105-AE06, 76 FR 57008 (Sept. 15. 2011).

\2\ Our NPRM and many commenters referred to the exhaled product of e-cigarettes as a ``vapor.'' It is more accurate to refer to the product as an aerosol. See Grana et al., E-Cigarettes: A Scientific Review, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4018182/. Products that create both vapors and aerosols are included in the Department's definition of ``smoking.''

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The increased promotion and availability of e-cigarettes raised the issue of whether the statutory ban on smoking on scheduled passenger flights in section 41706 and the existing regulatory prohibition on the smoking of tobacco products in part 252 applied to e-cigarettes. In the NPRM, we explained that the Department views the existing statutory and regulatory framework to be sufficiently broad to include the use of e-

cigarettes; however, the purpose of the proposal was to clarify and codify this position. In addition to relying on section 41706 as our statutory authority for the rule, we also relied on 49 U.S.C. 41702, which requires air carriers to provide safe and adequate interstate air transportation. Another Federal statute, 49 U.S.C. 41712, which prohibits airlines from engaging in unfair or deceptive practices or unfair methods of competition in air transportation or the sale of air transportation, provides additional support for the e-cigarette rule. (See ``Authority to Regulate E-Cigarettes under 49 U.S.C. 41712,'' below).

The NPRM stated our position that the reasons supporting the statutory and regulatory ban on smoking also apply to a ban on e-

cigarettes: Improving air quality within the aircraft, reducing the risk of adverse health effects on passengers and crewmembers, and enhancing aviation safety and passenger comfort. We also discussed Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. Dec. 7, 2010), in which the court held that the Food and Drug Administration (FDA) could not regulate ``customarily marketed'' electronic cigarettes as drugs or devices under the Federal Food, Drug, and Cosmetic Act (FDCA), but that the FDA could regulate the e-

cigarettes at issue as tobacco products under the FDCA as amended by the Family Smoking Prevention and Tobacco Act of 2009 (Tobacco Control Act).

The FDA has express authority under the Tobacco Control Act to regulate only the following tobacco products at this time: cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Tobacco Control Act permits the FDA to extend its tobacco products authority to other types of tobacco products by issuing regulations. On April 25, 2014, the FDA issued a proposed rule to extend FDA's tobacco product authorities to include e-cigarettes and other types of tobacco products.\3\

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\3\ Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, Department of Health and Human Services, Food and Drug Administration, 14 CFR parts 1100, 1140, and 1143, Docket No. FDA-

2014-N-0189, RIN 0910-AG38, 79 FR 23142 (April 25, 2014).

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Similarly, in our NPRM, we proposed to amend DOT's smoking rule so it clearly covers e-cigarettes by including a definition of smoking. For purposes of this rule, we proposed to define smoking as: ``the smoking of tobacco products or use of electronic cigarettes and similar products designed to deliver nicotine or other substances to a user in the form of a vapor,'' with an exemption for ``the use of a device such as a nebulizer that delivers a medically beneficial substance to a user in the form of a vapor.''

In the NPRM, the Department sought comment on: (1) Whether the definition of ``smoking'' in the proposed rule text was so broad that it might unintentionally include otherwise permissible medical devices that produce a vapor; (2) concerns over, and benefits of, the proposal to clarify the prohibition in part 252 to explicitly cover e-

cigarettes; and (3) any other information or data relevant to the Department's decision.

Charter (Nonscheduled) Passenger Flights

In addition, the NPRM also stated the Department's intent to consider whether to extend the ban on smoking, including e-cigarettes, to charter flights with aircraft that have a seating capacity of 19 or more passenger seats--i.e., those flights that generally require a flight attendant.\4\ The Department proposed banning smoking on charter flights with 19 or more passenger seats, citing public health concerns for flight attendants who may be subject to secondhand smoke on board such charter flights. Thus, the Department sought comment on the benefits and drawbacks of extending the smoking ban to charter flights that have a seating capacity of 19 or more passenger seats.

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\4\ Generally, pursuant to FAA regulations, a flight attendant is a required crewmember for Part 121, 125, and 135 operations where the aircraft has a seating capacity of more than nineteen. See 14 CFR 121.391, 125.269, 135.107. A flight attendant is also a required crewmember for Part 121 operations with airplanes that have a maximum payload capacity of more than 7,500 pounds and a seating capacity of more than nine. 14 CFR 121.269(a)(1).

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A ban on smoking on charter flights where a flight attendant is a required crewmember was enacted into law on February 14, 2012, in the FAA Modernization and Reform Act of 2012, Public Law 112-95. Section 401 of the Act amended section 41706, the existing smoking statute, by broadening the smoking prohibition to include aircraft in nonscheduled passenger interstate, intrastate and foreign air transportation, if a flight attendant is a required crewmember on the aircraft (as determined by the Federal Aviation Administration or a foreign government).

Discussion of Comments

Overview

In response to the NPRM, the Department received over 1000 comments, the majority of which were in response to the e-cigarette issue. A majority of the comments received on the NPRM were from individuals. In addition, the Department received comments from the following entities: U.S. carrier and foreign carrier associations, members of Congress, pilot associations, flight attendant associations, consumer organizations, advocacy and special interest organizations, local governments, and medical associations.

The Department has carefully reviewed and considered the comments received. The commenters' positions are summarized below.

Definition of ``Smoking''

In the NPRM, we asked whether the definition of ``Smoking'' in the proposed rule text is too broad in that it may unintentionally include otherwise permissible medical devices that produce a vapor. We proposed the following definition:

Smoking means the smoking of tobacco products or use of electronic cigarettes and similar products designed to deliver nicotine or other substances to a user in the form of a vapor. It does not include the use of a device such as a nebulizer that delivers a medically beneficial substance to a user in the form of a vapor.

The Air Transport Association of America (now Airlines for America (A4A)), International Air Transport Association (IATA), Regional Airline Association (RAA), and Air Carrier Association of America (ACAA) filed a joint comment stating their view that the proposed definition was adequate as written, and that it would not unintentionally include otherwise permissible medical devices. Also, the American Thoracic Society suggested that the Department consider explicitly stating in its definition that FDA-approved medical devices, such as

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nebulizers, metered dose inhalers, ventilators, supplemental oxygen and other respiratory assistive devices meeting Federal Aviation Administration (FAA) requirements, are not covered by the definition of smoking.

With respect to comments received from individuals, there was a concern raised by some that the definition could include all inhalers, asthma inhalers, or permissible nicotine replacement products. Some suggested that ``medically beneficial'' is too broad because in some cases, nicotine may be medically beneficial. Therefore, the commenters suggest changing the language to ``medically necessary substances,'' ``FDA-approved devices,'' or ``prescription drugs.'' One commenter stated that the definition is circular because it uses ``smoking'' in the definition of ``smoking.'' In addition, some commenters suggested it would be clearer to add the word ``harmful'' before ``vapor.''

Finally, one commenter suggested the following definition as an alternative to the proposed rule text: ``any inhalation or exhalation of a tobacco product, electronic cigarette, or similar products that emits a smoke, mist, vapor, etc., with the exception of medical devices such as nebulizers.''

DOT Response

Based on the comments received, we have decided to edit our proposed definition of smoking to read as follows:

Smoking means the use of a tobacco product, electronic cigarettes whether or not they are a tobacco product, or similar products that produce a smoke, mist, vapor, or aerosol, with the exception of products (other than electronic cigarettes) which meet the definition of a medical device in section 201(h) of the Federal Food, Drug and Cosmetic Act, such as nebulizers.

We feel this change more succinctly addresses our targeted prohibition and makes clear that products which meet the definition of a medical device (other than electronic cigarettes) in section 201(h) of the Federal Food, Drug and Cosmetic Act, such as nebulizers, are exempt. The use of electronic cigarettes would fall within the smoking ban even if electronic cigarettes were to meet the definition of a medical device.

Coverage of E-Cigarettes

In the NPRM, we explained that we interpret the existing part 252 to ban the use of e-cigarettes on all flights and that we were seeking to codify this interpretation. We solicited comments about the potential benefits or harm of this proposal.

In their joint comment, A4A, IATA, RAA, and ACAA stated their support for the proposed ban, arguing that e-cigarettes should be treated the same as other tobacco products. These organizations voiced concern over the ingredients in e-cigarettes, which could possibly cause airway irritation for users and others nearby. They also named design flaws, inadequate labeling, quality control, and health issues as concerns. Further, the commenters stated, ``in fact, all carriers already prohibit e-cigarette use in the cabin for the same reasons the Department provided.''

The Air Line Pilots Association (ALPA) stated its belief that the proposed rule would prevent degradation of the air quality onboard aircraft, and asserted that the health risks for human use need to be more thoroughly understood for both users and non-users who are subjected to ``secondhand smoke.'' ALPA also noted the possibility of passenger and crewmember confusion in differentiating e-cigarettes from tobacco cigarettes, as the two products can be difficult to distinguish from each other.

The Association of Flight Attendants (AFA) reported that it has received occasional reports of in-flight passenger use of the devices and some confusion among travelers regarding airline policies. AFA stated its support for treating the devices the same as traditional cigarettes. AFA believes that DOT is appropriately applying a precautionary principle because the toxicity of e-cigarettes is not well understood. In addition, the Association of Professional Flight Attendants, representing flight attendants for American Airlines, submitted a comment stating that American Airlines currently bans e-

cigarettes, but nonetheless still urged DOT to promulgate a final rule to create consistency across the industry. The Association further noted that the science behind the effects that e-cigarettes may have on third parties is, at best, inconclusive, and that they adamantly advocate for a healthy environment for all flight attendants.

The Independent Pilots Association, the bargaining unit for the pilots of United Parcel Service, stated its support for the rule on safety grounds (based on the inherent dangers of using lithium battery powered e-cigarettes onboard aircraft). However, it also expressed the view that DOT has created a double standard of safety regulations by carving out less safe standards for cargo aircraft operations, and urged that the rule be applied to all aircraft.

We received comments from a number of medical associations, each voicing their support for the proposed ban. The American Academy of Pediatrics (AAP) commented that it was unaware of any data which would suggest that it is safe for children as passengers in aircraft to be in close proximity to exhaled ``vapors'' from e-cigarettes. Further, the AAP noted that FDA data demonstrate that e-cigarette vapor includes known toxicants, carcinogens, and irritants of the respiratory tract. The American Thoracic Society (ATS) commented that while e-cigarette manufacturers claim that the devices are a reduced-risk product, there is little evidence to support this claim, and that the limited research on these products has found significant variation between manufacturers' attestations and the actual dose of nicotine delivered by the products. ATS further stated that it is not aware of any studies that suggest exhaled e-cigarette vapors are risk-free and that the use of these devices in the confined space of an airline cabin should be viewed with extreme caution. The California Medical Association (CMA) stated its support for the prohibition of the use of any nicotine delivery devices not approved by the FDA in places where smoking is already prohibited by law. CMA also noted that several local and State governments have banned e-cigarettes in indoor public spaces and workplaces. The Oncology Nursing Society expressed its support for the ban, citing evidence for the presence of toxic chemicals in e-cigarette aerosol.

The Department also received a letter of support for the proposed rule signed by seven members of the U.S. Senate.\5\ The Senators urged a strong final rule, and stated that the devices raise significant public health concerns. They also expressed concern with respect to the manufacturing and quality control of e-cigarettes. In sum, the Senators stated that the proposed rule recognizes the rights of airline passengers to a safe travel environment and promotes public health.

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\5\ Letter from Senators Barbara Boxer, Richard J. Durbin, Tom Harkin, Richard Blumenthal, Jack Reed, and Edward J. Markey to Secretary Anthony Foxx (June 10, 2014) (available in the public docket).

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In addition, we received two comments from local governments. The New York City Department of Health and Mental Hygiene (DOHMH) submitted a comment stating its concern that e-cigarettes are not FDA-approved and may contain chemicals that could harm users or those around them, especially in confined spaces such as

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aircraft. DOHMH noted that the proposed rule would make enforcement of the existing smoking ban easier, as e-cigarettes can be difficult to distinguish from traditional cigarettes. Seattle and King County, Washington, which passed a regulation prohibiting the use of e-

cigarette devices in places where smoking is prohibited by law, commented that a precautionary approach is warranted as the products are relatively new to the market and research has not conclusively identified the components of the vapor that are exhaled.

We received several comments from other advocacy organizations. The American Cancer Society, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Legacy submitted a joint comment in support of the proposed rule, stating that in the context of smoking prohibitions on aircraft, e-cigarettes should be considered the same as traditional cigarettes. The organizations commented that the health consequences of e-cigarette use are unknown, and therefore restrictions on their use inside aircraft are appropriate until it can be shown with a high degree of certainty that they pose no harm to non-users. The organizations also argued that allowing the use of e-cigarettes on aircraft would create significant confusion for passengers and enforcement challenges for airline personnel, citing an incident on a Southwest Airlines flight on July 13, 2011, where a man was arrested for pelting a flight attendant with peanuts and pretzels after being asked to put away his e-cigarette upon attempting to smoke the device. The organizations also argued that DOT's proposed rule is consistent with the decision in Sottera. Finally, the organizations argued that prohibiting e-cigarette use on aircraft promotes the health goal of reducing the use of tobacco products through the promotion of non-smoking environments.

Americans for Nonsmokers' Rights (ANR) submitted a comment in support of the proposed rule, stating its belief that e-cigarettes should be prohibited in all places where the smoking of tobacco products is prohibited. ANR stated that its primary reason for supporting the ban is that the devices' components raise significant health concerns. ANR also asserted that e-cigarettes can undermine and cause confusion over compliance with smoke-free rules when used on airplanes. Finally, ANR noted that there are at least 25 municipalities that define ``smoking'' to include the use of e-cigarettes and prohibit their use in workplaces and public places. Arizonans for Nonsmokers' Rights expressed the view that e-cigarettes posed respiratory hazards to non-users, and that permitting e-cigarettes aboard aircraft may infringe on the rights of individuals with respiratory disabilities.

The Kentucky Center for Smoke-free Policy submitted a comment strongly in support of the proposed ban, stating that although there is a need for rigorous scientific study of e-cigarettes, it is known that the vapor emitted from the devices contains several volatile organic compounds (e.g., acetone, styrene, and ethyl alcohol acetaldehyde) that can cause negative health effects. The Kentucky Center also commented that the use of e-cigarettes on aircraft may lead people to believe that smoking is permitted, and may undermine smoke-free policies. The Tobacco Free Coalition of Pinellas County (FL) expressed similar health concerns.

FlyersRights.org, a non-profit airline passenger rights advocacy organization, conducted a survey of its members to gauge public opinion on the proposed rule. The survey garnered 987 responses, and those who responded voted overwhelmingly (81.4%) in favor of the NPRM. Support was generally based on the grounds of public health or cabin comfort. Those opposing the ban were almost evenly divided in their reasoning, with some doubting that the e-cigarettes pose any risk, others believing that current research is insufficient to support the regulation, and still others objecting generally to the proposed ban.

The following organizations submitted comments in opposition to the proposed rule. Smokin' Vapor LLC submitted a comment in opposition stating that e-cigarettes do not burn any matter, and that their ingredients (water, flavorings, nicotine--when chosen--and propylene glycol) are safe, and even beneficial to users in some instances. The National Vapers Club submitted a comment stating that e-cigarettes do not produce smoke and therefore do not create the byproducts of combustion. National Vapers stated that banning e-cigarettes is akin to banning the use of Nicotrol inhalers. The organization added that e-

cigarettes have not been shown to cause any harm to bystanders; until such harm is proven, the club believes that the ban is unfounded. National Vapers also asserted that it is the responsibility of airlines to explain the use of e-cigarettes to those who are uncomfortable with them, and to alleviate the concerns of those who are not familiar with the products. In addition, Smokers Fighting Discrimination, Inc., submitted a comment in opposition to the proposed ban, stating that e-

cigarettes emit water vapor, but not smoke.

Smokefree Pennsylvania submitted a comment that outlined several reasons for its opposition to the proposed ban. The organization challenged the Department's statutory authority to promulgate the rule under 49 U.S.C. 41706. The organization reasoned that the statute does not authorize the ban of e-cigarettes because vapor does not involve combustion, and thus is vastly different from tobacco smoke. Smokefree Pennsylvania stated that the Department falsely alleged that using an e-cigarette is the same as smoking. The organization also challenged the Department's statutory authority under 49 U.S.C. 41702, stating that there is no evidence that e-cigarettes have harmed anyone or that they pose any health or safety risks to users or non-users. The organization alleged that the NPRM deceives the public into believing that e-cigarettes emit smoke and pose health risks to users and non-

users similar to those posed by cigarette smoke. Furthermore, it argued that none of the studies cited by the Department had found any hazardous levels of chemicals in e-cigarettes. The organization also asserted that the proposal is unenforceable, as e-cigarette consumers can use the products discreetly without anyone noticing because the vapor that is emitted is not visible. As evidence of this assertion, the organization stated that there have been no citations issued for violating indoor e-cigarette usage bans in New Jersey, Seattle, or other jurisdictions where e-cigarettes have been banned. Finally, the organization noted that violators of the Department's proposed rule would face a $3,300 fine, which the organization claimed is excessive and may violate the 8th Amendment's prohibition against cruel and unusual punishment.

The Consumer Advocates for Smoke-Free Alternatives Association (CASAA) and the Competitive Enterprise Institute (CEI) submitted a comment urging the Department to withdraw its proposed ban, and cited reasons for its opposition similar to those offered by Smokefree Pennsylvania. CASAA and CEI challenged the Department's statutory authority, arguing that the statutory ban on in-flight smoking, 49 U.S.C. 41706, does not extend to smoke-free products such as e-

cigarettes. Also, these organizations argued that the Department's reliance on 49 U.S.C Sec. 41702 is misplaced, as there is no research indicating that e-cigarette vapor, with or without nicotine, is harmful to users or bystanders. The organizations cited a Health New Zealand report where e-cigarette mist

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was tested for over 50 cigarette smoke toxicants, and no such toxicants were found. CASAA and CEI additionally argued that the Department has failed to perform a cost-benefit analysis and has not demonstrated that the ban would produce any benefits; the American Aviation Institute echoed this view. Lastly, CASAA and CEI stated that the possible civil penalty of $3,300 for violating part 252 is not justified, as e-

cigarettes would not impair cabin air quality or cause damage to aircraft seats or carpeting.

We now turn to comments received from the public. By the end of the comment period on November 15, 2011, the Department received approximately 700 total comments; approximately 500 of those were from individuals opposed to the proposed ban. (Many of the comments received in opposition to the proposed rule were identical.) The purported lack of DOT jurisdictional authority to create the proposed rule and lack of research, data, evidence, or proof to support the rule were common themes. Many felt that the Department was overstepping its statutory authority, and argued that e-cigarettes are not smoked, but ``vaped'' (producing water vapor), and as such do not fall within the smoking statute, section 41706. Also, many felt that the Department failed to justify the proposed ban under section 41702 because it did not provide any evidence that e-cigarettes are harmful to bystanders. Some individuals asserted that there have not been any reported health issues with respect to the devices and stated that lack of evidence cannot be the basis for a rule. Many argued that the proposed rule was an example of unnecessary government regulation, and that the better approach would be to allow the industry to devise its own rules for the products. It was also argued that the proposed regulation would be unenforceable because users can easily hide their use of e-cigarettes. Finally, some argued that the civil penalty associated with a violation of the proposed rule is excessive and illegal under the 8th Amendment.

Supporters of the rule generally viewed the Department as having the appropriate authority and stated that the unknown risk and potential harmful effects justified the ban. Many voiced concern over the air quality aboard aircraft, stating that the rights and public health concerns of passengers who are not e-cigarette users should be protected, as these people do not have the option of leaving the space. Supporters also raised the point that potentially vulnerable passengers, such as children, the elderly, and people with asthma should be protected from the effects of e-cigarette vapor. Another reason cited in support of the rule was the elimination of potential passenger and crew confusion; supporters argued that a ban on both traditional cigarettes and e-cigarettes would make enforcement of the smoking regulation easier for crewmembers, because e-cigarettes resemble traditional cigarettes. It was also stated that this proposed rule would create only minimal inconvenience for smokers and ``vapers,'' as the existing smoking ban on aircraft has been in place since 2000.

In more recent years, the Department has noted a substantial increase in individual comments supporting the ban. Of the approximately 350 additional individual comments received after the close of the comment period, approximately 60 opposed the ban while approximately 290 supported it. Most commenters supporting the ban cited health concerns, and expressed the view that e-cigarette aerosol was either already demonstrated to be harmful, or should be banned unless it is proven to be safe. A number of individuals expressed impatience at the Department's slow progress in implementing the ban.

We note that several commenters, both organizations and individuals, cited safety reasons as additional grounds for supporting the proposed ban (e.g., potential fire concerns and hazards associated with the lithium batteries that power the devices).

DOT Response

After fully considering the comments received, the Department has decided to amend its existing smoking rule to explicitly ban the use of e-cigarettes on all flights in passenger interstate, intrastate and foreign air transportation where other forms of smoking are banned. We are primarily concerned with the potential adverse health effects of secondhand exposure to aerosols generated by e-cigarettes, particularly in the unique environment of an aircraft cabin. We further believe that the ban on the use of e-cigarettes fulfills the statutory mandates of sections 41706, 41702, and 41712. We do not address in this rulemaking any safety-related issues that may exist with regard to the use of e-

cigarettes aboard aircraft. The Pipeline and Hazardous Materials Safety Administration (PHMSA) regulates hazardous materials safety \6\ and the FAA regulates smoking aboard aircraft under its safety mandate. See 14 CFR 121.317, 129.29, 135.127.

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\6\ With respect to the Independent Pilots Association's comment that DOT should expand the ban on e-cigarettes to include cargo flights, we note that the Association's concern appears to be largely on the safety hazards of transporting lithium batteries. On August 6, 2014, PHMSA issued a final rule addressing this issue. See 79 FR 46011 (August 6, 2014); PHMSA-2009-0095 (HM-224F).

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Authority To Regulate E-Cigarettes Under 49 U.S.C. 41706

We begin with section 41706, the statutory smoking ban. With respect to domestic air transportation, section 41706(a) provides that ``an individual may not smoke in an aircraft in scheduled passenger interstate or intrastate air transportation; or in an aircraft in nonscheduled passenger interstate or intrastate air transportation if a flight attendant is a required crewmember on the aircraft.'' Similarly, with respect to foreign air transportation, section 41706(b) provides that ``the Secretary of Transportation shall require all air carriers and foreign air carriers to prohibit smoking in an aircraft in scheduled passenger foreign air transportation; and in an aircraft in nonscheduled passenger foreign air transportation, if a flight attendant is a required crewmember on the aircraft.''

While section 41706 does not define `smoking,'' nothing in the text of section 41706 suggests that the definition of ``smoking'' should be limited to the combustion of traditional tobacco products. Instead, Congress vested broad authority in the Department to implement the statutory smoking ban. Specifically, section 41706(d) states that ``the Secretary shall provide such regulations as are necessary to carry out this section.'' We interpret section 41706 as a whole as vesting the Department with the authority to define the term ``smoking,'' and to refine that definition as necessary to effectuate the purpose of the statute while adapting to new technologies and passenger behavior. Like section 41706, the Department's regulation in 14 CFR part 252 did not contain a definition of ``smoking'' prior to the issuance of this final rule. However, the Department has previously taken the position that the prohibition against smoking in 49 U.S.C. 41706 and 14 CFR part 252 should be read to ban the use of electronic cigarettes on U.S. air carrier and foreign air carrier flights in scheduled intrastate, interstate and foreign air transportation, a position that was noted in connection with a June 17, 2010 hearing before the Senate Committee on Commerce, Science and Transportation. This final rule formalizes the Department's interpretation by defining smoking to explicitly include the use of e-cigarettes.

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Some commenters contend that section 41706 cannot be relied upon to reach this result because it prohibits smoking, and e-cigarettes are ``vaped'' and produce a vapor. Although e-cigarettes typically do not undergo combustion, they do produce an aerosol of chemicals and require an inhalation and exhalation action similar to that which is required when smoking traditional cigarettes. E-cigarettes are generally designed to look like and be used in the same manner as conventional cigarettes. Further, the purpose behind the statutory ban on smoking aboard aircraft in section 41706 and the regulatory ban on smoking tobacco products in part 252 were to improve cabin air quality, reduce the risk of adverse health effects on passengers and crewmembers, and enhance passenger comfort. The in-cabin dynamics of e-cigarette use are similar enough to traditional smoking to necessitate including e-

cigarette use within the definition of ``smoking.'' Like traditional smoking, e-cigarette use introduces a cloud of chemicals into the air that may be harmful to passengers who are confined in a narrow area within the aircraft cabin without the ability to avoid those chemicals.

A recent study published in the journal Nicotine & Tobacco Research found that e-cigarettes are a source of secondhand exposure to nicotine but not to combustion toxicants.\7\ The conclusions of the study were that using e-cigarettes in indoor environments may involuntarily expose non-users to nicotine, and that more research is needed to evaluate the health consequences of secondhand exposure to nicotine, especially among vulnerable populations such as children, pregnant women, and people with cardiovascular conditions. More recent research has determined that persistent residual nicotine on indoor surfaces from e-

cigarettes can lead to third hand exposure through the skin, inhalation, and ingestion long after the air itself has cleared.\8\

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\7\ Jan Czogala et al., Secondhand Exposure to Vapors From Electronic Cigarettes, 16 Nicotine & Tobacco Research 655 (2014), doi: 10.1093/ntr/ntt203.

\8\ ML Goniewicz & L Lee, Electronic Cigarettes Are a Source of Thirdhand Exposure to Nicotine, Nicotine Tob Res. 2014 Aug 30. pii:ntu152. Epub ahead of print; see also WG Kuschner et al., Electronic Cigarettes and Thirdhand Tobacco Smoke: Two Emerging Health Care Challenges for the Primary Care Provider, 4 Int J Gen Med. 115 (2011), doi: 10.2147/IJGM.S16908.

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Additionally, we find it significant that the three medical associations that submitted comments cited the unknown health risks of exposure to e-cigarette aerosol in a confined space as a reason for concern. Also citing public health concerns were the American Cancer Society, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Legacy. In addition, each comment received from the airline industry voiced strong support for the rule, based on the unknown ingredients in the devices and their possible health consequences.

While the specific hazards of e-cigarette aerosol have not yet been fully identified, the Department does not believe that it would be appropriate to exempt e-cigarettes from the ban for now, pending a more definitive catalog of those hazards. Since the NPRM was issued, research continues to undermine claims that the use of e-cigarettes would have no adverse health implications on users or others who are nearby. Research has detected toxic chemicals such as formaldehyde and acetaldehyde in the aerosol from certain e-cigarettes.\9\ The aerosol was also found to contain acrolein, which can cause irritation to the nasal cavity and damage to the lining of the lungs, and may contribute to cardiovascular disease in cigarette smokers.\10\ Another study identified 22 chemical elements in e-cigarette aerosol, including lead, nickel, and chromium, among others that can cause adverse health effects in the respiratory and nervous systems.\11\

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\9\ Goniewicz, M. L., J. Knysak, M. Gawron, et al., Levels of Selected Carcinogens and Toxicants in Vapour From Electronic Cigarettes, 23 Tobacco Control 133 (2013), doi: 10.1136/

tobaccocontrol-2012-050859.

\10\ Goniewicz, M. L., J. Knysak, M. Gawron, et al., Levels of Selected Carcinogens and Toxicants in Vapour From Electronic Cigarettes, 23 Tobacco Control 133 (2013), doi: 10.1136/

tobaccocontrol-2012-050859.

\11\ Williams, M., A. Villarreal, K. Bozhilov, et al., Metal and Silicate Particles Including Nanoparticles Are Present in Electronic Cigarette Cartomizer Fluid and Aerosol, 8 Public Library of Science One e57987 (2013), doi: 10.1371/journal.pone.0057987.

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Some studies have found that lower levels of toxicants are observed in e-cigarette aerosols than in combusted tobacco smoke.\12\ However, research on near real-use conditions of e-cigarettes has found increased indoor air levels of polycyclic aromatic hydrocarbons; 1,2-

propanediol; 1,2,3-propanetriol; glycerine; nicotine; fine particles; ultrafine particles; particle number concentrations; and aluminum, all of which raise health concerns.\13\ We recognize that the aerosol that is exhaled by users of some e-cigarettes and similar electronic apparatus may not pose as much harm as smoke emitted from combusted tobacco products. However, given that studies do indicate that both nicotine and other toxicants are found in the exhaled aerosol, limiting exposures must be considered. Because the potential for harm to consumers from second hand aerosol is even greater in the closed environment of an aircraft, we believe a precautionary approach is warranted. In sum, releasing an aerosol that may contain harmful substances or respiratory irritants in a confined space, especially when those who are at a higher risk are present, is contrary to the statutory ban on smoking aboard aircraft.

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\12\ Goniewicz, M., et al., ``Levels of Selected Carcinogens and Toxicants in Vapour from Electronic Cigarettes,'' Tobacco Control, 23(2):133-139, 2014.

\13\ Schober, W., et al., Use of Electronic Cigarettes (E-

Cigarettes) Impairs Indoor Air Quality and Increases FeNO Levels of E-Cigarette Consumers, 217 Int J Hyg Environ Health 628 (2014), doi: 10.1016/j.ijheh.2013.11.003; Schripp T., D. Markewitz, E. Uhde, and T. Salthammer, Does E-Cigarette Consumption Cause Passive Vaping?, 23 Indoor Air 25 (2013), doi: 10.1111/j.1600-0668.2012.00792.x.

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Authority To Regulate E-Cigarettes Under 49 U.S.C. 41702

We also find an independent source of authority for this rulemaking in section 41702, which mandates safe and adequate interstate air transportation. The Department's predecessor, the Civil Aeronautics Board (CAB), relied upon section 404(a) of the Federal Aviation Act of 1958 (subsequently re-codified as 41702), requiring air carriers ``to provide safe and adequate service, equipment and facilities,'' as authority to adopt its first regulation restricting smoking on air carrier flights (ER-800, 38 FR 12207, May 10, 1973). At that time, CAB issued a ``smoking rule'' under its economic regulations titled, ``Part 252--Provision of Designated `No Smoking' Areas Aboard Aircraft Operated by Certificated Air Carriers,'' which mandated designated ``no smoking'' areas on commercial flights. See 38 FR 12207 (May 10, 1973). The rule predated a Congressional ban on smoking on scheduled flights. In the preamble to the 1973 rule, the CAB cited a joint study by the FAA and the then Department of Health, Education, and Welfare that concluded that the low levels of contaminants in tobacco smoke did not represent a health hazard to nonsmoking passengers on aircraft; however, the study found that a significant portion of the nonsmokers stated that they were bothered by tobacco smoke. The CAB stated, ``unlike persons in public buildings, nonsmoking passengers on aircraft may be assigned to a seat next to, or otherwise in close proximity to, persons who smoke and cannot escape this

Page 11421

environment until the end of the flight.'' The principal basis for the 1973 smoking rule was passenger discomfort issues. Just as the CAB relied on the ``adequate'' prong of the predecessor to section 41702 to adopt a smoking ban in 1973, the Department believes that it has the authority today to ban the use of e-cigarettes under section 41702 to ensure ``adequate'' service by reducing a similar kind of passenger discomfort. In our view, passenger discomfort arises from at least two aspects of e-cigarette aerosol exposure. First, the non-user passenger may feel the direct effects of inhaling the aerosol, which, as noted above, has been shown to contain respiratory irritants. More broadly, passengers may reasonably be concerned that they are inhaling unknown quantities of harmful chemicals, and that they will not be able to avoid the exposure for the duration of the flight.

Authority To Regulate E-Cigarettes Under 49 U.S.C. 41712

In addition to the Department's authority under sections 41716 and 41702, the Department has the authority and responsibility to protect consumers from unfair or deceptive practices in air transportation under 49 U.S.C. 41712. Using this authority, the Department has found practices to be ``unfair'' if they are harmful to passengers but could not be reasonably avoided by them. For example, the Department relied upon section 41712 and its ``unfair'' practice component when promulgating the ``Tarmac Delay Rule,'' \14\ in which the Department addressed problems consumers face when aircraft sit for hours on the airport tarmac. In doing so, the Department considered the harm to the consumer and the fact that the harm was unavoidable. The Department concluded that regulatory action was necessary and that a three-hour time limit is the maximum time after which passengers must be permitted to deplane from domestic flights given the cramped, close conditions in aircraft and the inability of passengers to avoid lengthy tarmac delays. Here, as with the tarmac delay rule, the Department believes that the practice of allowing use of e-cigarettes onboard aircraft would be potentially harmful to passengers and there is no way for the passenger to reasonably avoid the harm. The harms include the potential for decreased cabin air quality, confusion about whether the passenger is being exposed to traditional cigarette smoke, and possible health risks arising from exposure to the chemicals contained in e-cigarette aerosol. These harms are unavoidable because passengers who do not wish to be exposed to e-cigarette aerosol cannot escape this environment until the end of the flight.

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\14\ See 74 FR 68983 (December 30, 2009) and 76 FR 23110 (April 25, 2011).

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In sum, we are amending our existing smoking regulation to explicitly ban the use of e-cigarettes because we view the ban to be consistent with the statutory mandates of sections 41706, 41702 and 41712. We do not believe that it is appropriate, as some commenters have suggested, to allow the airline industry to adopt its own standards with respect to the inclusion of electronic cigarettes within the prohibition on smoking. We recognize that the industry has generally banned the use of electronic cigarettes on flights, either as a matter of preference or in recognition of the Department's well-

publicized enforcement policy. On the other hand, we believe that without a clear, uniform regulation, some carriers may feel free to adopt policies that allow the use of e-cigarettes onboard aircraft. In light of the potential health hazards posed to flight attendants and fellow passengers, as well as the potential diminution in air cabin quality posed by the use of electronic cigarettes in an aircraft cabin, we do not believe that a free-market approach is appropriate or desirable.

An additional benefit of this rule is that it eliminates passenger or crewmember confusion with regard to the permissibility of e-

cigarettes by creating an explicit ban. In our notice, we stated that through Congressional correspondence, anecdotal evidence, and online sources, including blogs, we were made aware that some passengers have attempted to use e-cigarettes onboard aircraft. The Association of Flight Attendants also stated in comments submitted to the Department that it receives occasional reports of in-flight passenger use and confusion among travelers regarding airline policies. In the absence of regulation, e-cigarette users may believe that an airline's policy banning e-cigarettes is merely a preference, and that they may continue to use such devices because they are not prohibited by federal law. This rule would eliminate any such arguments with respect to the use of e-cigarettes, and provide flight crew with the clear message that e-

cigarettes are placed firmly on the same footing as traditional tobacco products. The traveling public would also have the benefit of knowing with certainty that e-cigarettes are prohibited onboard aircraft, Moreover, to the extent that carriers may be inclined to permit e-

cigarettes on the ground that the Department's enforcement policy is not consistent with the regulatory text, this rule would preclude that option.

Charter (Non-Scheduled) Flights

Section 401 of the FAA Modernization and Reform Act of 2012 prohibited smoking on domestic nonscheduled (charter) passenger flights that require a flight attendant, and directed the Department to prohibit smoking on nonscheduled (charter) passenger flights in foreign air transportation that require a flight attendant. In the NPRM in this proceeding, we sought comment on the issue of banning smoking on most charter flights. We received few comments on this issue; however, those that did comment overwhelmingly supported the proposal. The Association of Flight Attendants (AFA) stated its support for the ban, claiming that it would be beneficial to the occupational health of flight attendants and the health of the traveling public. AFA stated that there is virtually universal agreement that exposure to environmental tobacco smoke is harmful to health, and requested that DOT acknowledge these findings and expand the smoking ban to all charter operations.

The Association of Professional Flight Attendants, representing American Airlines flight attendants, stated its support of the ban to create consistency across the industry and argued that no flight attendant should be subjected to cigarette smoke on an airplane, given what is known about secondhand smoke.

The American Cancer Society, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Legacy stated that the health effects of secondhand smoke are well established in scientific literature. The organizations argued that charter flight staff should not be exposed at their workplace to secondhand smoke, which has been shown to increase risk of heart disease, stroke, and cancer. These organizations expressed their concern that charter flight passengers are potentially exposed to secondhand smoke for extended periods of time in a confined space. The organizations argued that there is no safe level of exposure to secondhand smoke, regardless of the type of plane or flight one takes, and that the current regulations do not effectively protect public health. We received a few comments from the public on this issue, with most stating their support for the proposal and some suggesting extending the ban to all flights.

Page 11422

DOT Response

We are amending the rule text of part 252 to implement section 401 of the FAA Modernization and Reform Act. Section 401 requires U.S. and foreign air carriers to ban smoking in nonscheduled passenger interstate, intrastate, and foreign air transportation where a flight attendant is a required crewmember. The amendment to part 252 is necessary to harmonize the Departmental regulation with the new statutory requirement.\15\ The 2011 NPRM sought comment on banning smoking on charter flights that use aircraft with 19 or more passenger seats. In view of the statutory smoking ban in section 401 that was signed into law in 2012, this final rule conforms part 252 to the requirement in the statute. Consequently, this new rule bans smoking on all nonscheduled passenger air transportation where a flight attendant is a required crewmember of the aircraft.

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\15\ For the reasons discussed in the prior section, this ban will include the use of e-cigarettes.

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The rule also continues a ban on smoking on nonscheduled passenger air transportation where a flight attendant is not a required crewmember of the aircraft, except for single entity charters and on-

demand services of air taxi operators. Under the existing sections 252.2 and 252.13, U.S. carriers are required to ban smoking on all flights (scheduled and charter) that use aircraft with 30 or fewer passenger seats except for the on-demand services of air taxi operators. Section 252.19 of the existing rule permits smoking on single-entity charter flights of U.S. air carriers. In other words, under the existing rule, smoking is allowed on single-entity charter flights and on-demand services of air taxi operators regardless of aircraft size. For U.S. carriers, smoking is prohibited on all other charter flights that use aircraft with 30 or fewer passenger seats.

If an aircraft has more than 30 seats, under section 252.7 of the existing rule the air carrier operating the charter flight (other than single-entity charters or on-demand services of air taxi operators) must establish a non-smoking section for each class of service. As an organizational matter, we are eliminating this section as it is no longer needed because section 401 bans smoking on charter flights where a flight attendant is a required crewmember. All charter flights covered under section 252.7 would require a flight attendant as that section only applies to aircraft with more than 30 seats.

The only change that is not directly required by the statute is eliminating the requirement in the existing rule for carriers to give notice to each passenger on a single-entity charter of the smoking procedures for that flight. It would be of limited usefulness to have such a requirement where smoking on single-entity charters would not be banned by this rule (i.e., on aircraft where a flight attendant is not a required crewmember, which essentially means aircraft with 19 seats or less).

Regulatory Analysis and Notices

  1. Executive Order 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review) and DOT Regulatory Policies and Procedures

This final rule has been determined to be significant under Executive Order 12866 and the Department of Transportation's Regulatory Policies and Procedures. It has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866 (Regulatory Planning and Review) and Executive Order 13563 (Improving Regulation and Regulatory Review) and is consistent with the requirements in both orders.

The Final Regulatory Evaluation, included in this section, qualitatively evaluates the benefits and costs of the final rule. Both benefits and costs are expected to be very small because the final rule only represents a modest change, if any, to existing industry practice. Nonetheless, the Department believes that the rule is necessary for the reasons noted below. As discussed below, DOT was unable to find any airline that explicitly states that it allows smoking of any type or includes accommodating smokers in its business plan, including e-

cigarettes and their users, and as such, would be affected by this rule. In fact, the overwhelming majority of passenger seats are on scheduled flights where smoking traditional cigarettes is already banned. Moreover and again as discussed below, commercial airlines have interpreted the existing DOT smoking ban to cover e-cigarettes and do not allow their use. Due to the inability to identify any specific airlines that would have to change their policies in response to the final rule, it was not possible to quantify benefits or costs. However, DOT does not rule out the possibility that a few airlines may at times provide services that could be affected by the rule, and therefore provides a qualitative analysis of potential benefits and costs for those situations.

The Final Regulatory Evaluation

Introduction

In April 2000, the Wendell H. Ford Aviation Investment and Reform Act for the 21st Century (Pub. L. 106-181) was signed into law. Section 708 of the Act amended 49 U.S.C. 41706 to impose a ban on smoking on all scheduled passenger interstate, intrastate, and foreign air transportation. DOT subsequently incorporated this ban in its rule on smoking on commercial airline flights. Because of confusion as to whether the use of e-cigarettes was allowed on aircraft, in September 2011, DOT issued a NPRM (see 79 FR 57008), which proposed to amend 14 CFR part 252 to explicitly include the use of e-cigarettes in the smoking ban. Specifically, the NPRM proposed to define smoking as, ``the smoking of tobacco products or use of electronic cigarettes and similar products designed to deliver nicotine or other substances to a user in the form of vapor.'' The NPRM also considered whether to extend the smoking ban (including e-cigarettes) to nonscheduled passenger flights or air carriers and foreign air carriers between points in the United States and between the United States and any foreign point with aircraft that have a designed seating capacity of 19 or more passenger seats.

In February 2012, the FAA Modernization and Reform Act of 2012 (Pub. L. 112-95) (the Act) was signed into law. Section 401 of the Act amended 49 U.S.C. 41706 to extend the smoking prohibition to aircraft in nonscheduled passenger interstate, intrastate, and foreign air transportation, offered by both U.S. and foreign carriers, if a flight attendant is a required crewmember.

This final rule primarily makes two regulatory changes. First, it amends the existing smoking ban in 14 CFR part 252 to explicitly ban the use of e-cigarettes whenever smoking is banned by revising the definition of smoking to cover the use of e-cigarettes. Second, the rule amends 14 CFR part 252 to implement section 401 of the FAA Modernization and Reform Act and extends the smoking ban to flights in nonscheduled interstate, intrastate, and foreign passenger air transportation where a flight attendant is required.

Current Industry Practice/Regulatory Baseline

In 2014, there were a total of 104 U.S. carriers and 151 foreign air carriers providing service in the United States. About 75 percent of these carriers provided scheduled service and the remaining 25 percent provided only

Page 11423

charter service. However, the overwhelming majority of air passenger service is provided by the 75 percent of scheduled service carriers; in 2014, roughly 99 percent of U.S. passenger enplanements were associated with scheduled flights.\16\ Table A.1 provides an overview of the carriers providing service in the United States in 2014.

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\16\ Source: Bureau of Transportation Statistics, T-100 Market and Segment (http://www.rita.dot.gov/bts/data_and_statistics/by_mode/airline_and_airports/airline_passengers.html).

Table A.1--Carriers Operating in the U.S. Market by Size and Type of Service

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Seats on

largest Total carriers Charter only Scheduled

aircraft service

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U.S. Carriers................................... >60 41 13 28

30-60 15 2 13

60 123 12 111

30-60 2 0 2

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