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information, you can contact the DEPARTMENT OF TRANSPORTATION passenger flights of air carriers, and on Airspace Policy Group, Federal Aviation all scheduled passenger flight segments Administration, 800 Independence Office of the Secretary of foreign air carriers between points in Avenue SW., Washington, DC 20591; the United States and between the telephone: (202) 267–8783. The Order is 14 CFR Part 252 United States and foreign points. Under also available for inspection at the [Docket No. DOT–OST–2011–0044] part 252, foreign governments may National Archives and Records request and obtain a waiver from DOT RIN 2105–AE06 Administration (NARA). For provided that an alternative information on the availability of FAA prohibition resulting from bilateral Use of Electronic on Aircraft negotiations is in effect. Further, part Order 7400.9Z at NARA, call (202) 741– 252 was amended to permit carriers 6030, or go to http://www.archives.gov/ AGENCY: Office of the Secretary (OST), operating single-entity charters to allow federal_register/code_of_federal- Department of Transportation (DOT). _ ACTION: Final rule. smoking throughout the aircraft, but regulations/ibr locations.html. also required a no-smoking section for FOR FURTHER INFORMATION CONTACT: SUMMARY: The Department of each class of service (e.g., first class) on Jason Stahl, Airspace Policy Group, Transportation is issuing a final rule to other charter flights where smoking is Office of Airspace Services, Federal extend the smoking ban in DOT’s not banned. Aviation Administration, 800 regulation to include all charter (i.e., Throughout this preamble, we use the Independence Avenue SW., nonscheduled) flights where a flight terms ‘‘air carrier’’ and ‘‘foreign air carrier’’ as defined in 49 U.S.C. 40102, Washington, DC 20591; telephone: (202) attendant is a required crewmember. in which an ‘‘air carrier’’ is a citizen of 267–8783. The revised regulation would comport with 49 U.S.C. 41706, which was the United States undertaking to SUPPLEMENTARY INFORMATION: revised in 2012, to ban smoking on provide air transportation, and a charter flights where a flight attendant ‘‘foreign air carrier’’ is a person, not a Background is a required crewmember. This final citizen of the United States, undertaking A final rule was published in the rule also explicitly bans the use of to provide foreign air transportation. Federal Register on January 14, 2016 electronic cigarettes (‘‘e-cigarettes’’) on The Notice of Proposed Rulemaking (81 FR 1877), FR Doc. 2015–33095, that all flights where smoking is banned. The Department interprets the existing Electronic Cigarettes and Other reversed the order of points listed in the Delivery Systems legal description of RNAV Route Q–35 regulation to prohibit e- use, as published in FAA Order 7400.9, but is codifying this interpretation. On September 15, 2011, the Airspace Designations and Reporting DATES: The rule is effective April 4, Department published a notice of Points. Subsequent to publication, the 2016. proposed rulemaking (NPRM) in which it proposed to amend its existing FAA found that the FAA docket number FOR FURTHER INFORMATION CONTACT: smoking rule (part 252) to explicitly ban for this document was inadvertently Robert M. Gorman, Senior Trial Attorney, or Blane A. Workie, Assistant the use of e-cigarettes on all flights mistyped. This action corrects the FAA covered by that rule (i.e., all flights of docket number. General Counsel, Office of the Assistant General Counsel for Aviation U.S. air carriers in scheduled passenger Correction to Final Rule Enforcement and Proceedings, U.S. interstate, intrastate and foreign air Department of Transportation, 1200 transportation and all scheduled flight Accordingly, pursuant to the segments of foreign air carriers in, to, or Ave. SE., Washington, DC 1 authority delegated to me, in the 20590, 202–366–9342, 202–366–7152 from the United States). E-cigarettes Federal Register of January 14, 2016 (81 (fax), [email protected] or typically contain a cartridge or chamber, FR 1877), the docket number, as [email protected] (email). which contain an atomizer or heating element, a battery and a liquid solution. published in the Federal Register on SUPPLEMENTARY INFORMATION: January 14, 2016 (81 FR 1877), FR Doc. Most often e-cigarettes contain liquid 2015–33095, amending the legal Background nicotine but they may contain other description of RNAV Route Q–35, is The Wendell H. Ford Aviation chemicals. When a user inhales, the corrected as follows: heating element aerosolizes the liquid Investment and Reform Act for the 21st 2 Century (Pub. L. 106–181) was signed solution. This produces an aerosol, § 71.1 [Amended] which requires an inhalation and into law on April 5, 2000. Section 708 exhalation similar to smoking cigarettes. of this statute, ‘‘Prohibitions Against ■ On page 1877, column 1, line 4, In addition to nicotine, e-cigarette Smoking on Scheduled Flights’’ Remove ‘‘Docket No. FAA–2013–6001’’ aerosol can contain heavy metals, (codified as 49 U.S.C. 41706), banned and add in its place ‘‘Docket No. FAA– ultrafine particulates that can be inhaled passengers from smoking on all flights 2015–6001. deep into the lungs, and -causing in scheduled passenger interstate and agents like acrolein. Secondhand Issued in Washington, DC, on February 25, intrastate air transportation, and 2016. directed the Secretary of Transportation 1 Smoking of Electronic Cigarettes on Aircraft, Kenneth Ready, to prohibit smoking in foreign air Department of Transportation, Office of the Acting Manager, Airspace Policy Group. transportation (with an exception Secretary, 14 CFR part 252, [Docket No. DOT–OST– 2011–0044], RIN 2105–AE06, 76 FR 57008 (Sept. [FR Doc. 2016–04739 Filed 3–3–16; 8:45 am] process for foreign carriers). Shortly thereafter, the Department of 15. 2011). BILLING CODE 4910–13–P 2 Our NPRM and many commenters referred to Transportation (‘‘DOT,’’ or ‘‘the the exhaled product of e-cigarettes as a ‘‘vapor.’’ It Department’’) amended its rule on is more accurate to refer to the product as an smoking aboard aircraft, 14 CFR part aerosol. See Grana et al., E-Cigarettes: A Scientific 252, to implement section 41706. Under Review, http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC4018182/. Products that create both vapors and part 252, the smoking of tobacco aerosols are included in the Department’s definition products is banned on all scheduled of ‘‘smoking.’’

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aerosol that is exhaled by users may product authorities to include e- crewmember was enacted into law on reduce air quality and is potentially cigarettes and other types of tobacco February 14, 2012, in the FAA harmful to health. Sometimes e- products.3 Modernization and Reform Act of 2012, cigarettes are designed to look like Similarly, in our NPRM, we proposed Public Law 112–95. Section 401 of the traditional cigarettes, but at times they to amend DOT’s smoking rule so it Act amended section 41706, the existing are also made to look like cigars, pipes, clearly covers e-cigarettes by including smoking statute, by broadening the and even everyday products such as a definition of smoking. For purposes of smoking prohibition to include aircraft pens. this rule, we proposed to define in nonscheduled passenger interstate, The increased promotion and smoking as: ‘‘the smoking of tobacco intrastate and foreign air transportation, availability of e-cigarettes raised the products or use of electronic cigarettes if a flight attendant is a required issue of whether the statutory ban on and similar products designed to deliver crewmember on the aircraft (as smoking on scheduled passenger flights nicotine or other substances to a user in determined by the Federal Aviation in section 41706 and the existing the form of a vapor,’’ with an exemption Administration or a foreign regulatory prohibition on the smoking of for ‘‘the use of a device such as a government). tobacco products in part 252 applied to nebulizer that delivers a medically Discussion of Comments e-cigarettes. In the NPRM, we explained beneficial substance to a user in the that the Department views the existing form of a vapor.’’ Overview statutory and regulatory framework to In the NPRM, the Department sought In response to the NPRM, the be sufficiently broad to include the use comment on: (1) Whether the definition of e-cigarettes; however, the purpose of Department received over 1000 of ‘‘smoking’’ in the proposed rule text comments, the majority of which were the proposal was to clarify and codify was so broad that it might this position. In addition to relying on in response to the e-cigarette issue. A unintentionally include otherwise majority of the comments received on section 41706 as our statutory authority permissible medical devices that for the rule, we also relied on 49 U.S.C. the NPRM were from individuals. In produce a vapor; (2) concerns over, and addition, the Department received 41702, which requires air carriers to benefits of, the proposal to clarify the provide safe and adequate interstate air comments from the following entities: prohibition in part 252 to explicitly U.S. carrier and foreign carrier transportation. Another Federal statute, cover e-cigarettes; and (3) any other 49 U.S.C. 41712, which prohibits associations, members of Congress, pilot information or data relevant to the associations, flight attendant airlines from engaging in unfair or Department’s decision. deceptive practices or unfair methods of associations, consumer organizations, competition in air transportation or the Charter (Nonscheduled) Passenger advocacy and special interest sale of air transportation, provides Flights organizations, local governments, and additional support for the e-cigarette In addition, the NPRM also stated the medical associations. rule. (See ‘‘Authority to Regulate E- Department’s intent to consider whether The Department has carefully Cigarettes under 49 U.S.C. 41712,’’ to extend the ban on smoking, including reviewed and considered the comments below). e-cigarettes, to charter flights with received. The commenters’ positions are The NPRM stated our position that aircraft that have a seating capacity of summarized below. the reasons supporting the statutory and 19 or more passenger seats—i.e., those Definition of ‘‘Smoking’’ regulatory ban on smoking also apply to flights that generally require a flight In the NPRM, we asked whether the a ban on e-cigarettes: Improving air attendant.4 The Department proposed quality within the aircraft, reducing the definition of ‘‘Smoking’’ in the proposed banning smoking on charter flights with rule text is too broad in that it may risk of adverse health effects on 19 or more passenger seats, citing public passengers and crewmembers, and unintentionally include otherwise health concerns for flight attendants permissible medical devices that enhancing aviation safety and passenger who may be subject to secondhand comfort. We also discussed Sottera, Inc. produce a vapor. We proposed the on board such charter flights. following definition: v. Food & Drug Administration, 627 Thus, the Department sought comment F.3d 891 (D.C. Cir. Dec. 7, 2010), in on the benefits and drawbacks of Smoking means the smoking of tobacco which the court held that the Food and extending the smoking ban to charter products or use of electronic cigarettes and Drug Administration (FDA) could not flights that have a seating capacity of 19 similar products designed to deliver nicotine or other substances to a user in the form of regulate ‘‘customarily marketed’’ or more passenger seats. electronic cigarettes as drugs or devices a vapor. It does not include the use of a A ban on smoking on charter flights device such as a nebulizer that delivers a under the Federal Food, Drug, and where a flight attendant is a required Cosmetic Act (FDCA), but that the FDA medically beneficial substance to a user in the form of a vapor. could regulate the e-cigarettes at issue as 3 Deeming Tobacco Products to be Subject to the tobacco products under the FDCA as Federal Food, Drug, and Cosmetic Act, as Amended The Air Transport Association of amended by the Family Smoking by the Family Smoking Prevention and Tobacco America (now Airlines for America Prevention and Tobacco Act of 2009 Control Act; Regulations on the Sale and (A4A)), International Air Transport ( Act). Distribution of Tobacco Products and Required Association (IATA), Warning Statements for Tobacco Products, The FDA has express authority under Department of Health and Human Services, Food Association (RAA), and Air Carrier the Tobacco Control Act to regulate only and Drug Administration, 14 CFR parts 1100, 1140, Association of America (ACAA) filed a the following tobacco products at this and 1143, [Docket No. FDA–2014–N–0189], RIN joint comment stating their view that time: cigarettes, cigarette tobacco, roll- 0910–AG38, 79 FR 23142 (April 25, 2014). the proposed definition was adequate as 4 Generally, pursuant to FAA regulations, a flight your-own tobacco, and smokeless attendant is a required crewmember for Part 121, written, and that it would not tobacco. The Tobacco Control Act 125, and 135 operations where the aircraft has a unintentionally include otherwise permits the FDA to extend its tobacco seating capacity of more than nineteen. See 14 CFR permissible medical devices. Also, the products authority to other types of 121.391, 125.269, 135.107. A flight attendant is also American Thoracic Society suggested a required crewmember for Part 121 operations with tobacco products by issuing regulations. airplanes that have a maximum payload capacity of that the Department consider explicitly On April 25, 2014, the FDA issued a more than 7,500 pounds and a seating capacity of stating in its definition that FDA- proposed rule to extend FDA’s tobacco more than nine. 14 CFR 121.269(a)(1). approved medical devices, such as

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nebulizers, metered dose inhalers, In their joint comment, A4A, IATA, We received comments from a ventilators, supplemental oxygen and RAA, and ACAA stated their support for number of medical associations, each other respiratory assistive devices the proposed ban, arguing that e- voicing their support for the proposed meeting Federal Aviation cigarettes should be treated the same as ban. The American Academy of Administration (FAA) requirements, are other tobacco products. These Pediatrics (AAP) commented that it was not covered by the definition of organizations voiced concern over the unaware of any data which would smoking. ingredients in e-cigarettes, which could suggest that it is safe for children as With respect to comments received possibly cause airway irritation for users passengers in aircraft to be in close from individuals, there was a concern and others nearby. They also named proximity to exhaled ‘‘vapors’’ from e- raised by some that the definition could design flaws, inadequate labeling, cigarettes. Further, the AAP noted that include all inhalers, inhalers, or quality control, and health issues as FDA data demonstrate that e-cigarette permissible nicotine replacement concerns. Further, the commenters vapor includes known toxicants, products. Some suggested that stated, ‘‘in fact, all carriers already , and irritants of the ‘‘medically beneficial’’ is too broad prohibit e-cigarette use in the cabin for respiratory tract. The American because in some cases, nicotine may be the same reasons the Department Thoracic Society (ATS) commented that medically beneficial. Therefore, the provided.’’ while e-cigarette manufacturers claim commenters suggest changing the The Air Line Pilots Association that the devices are a reduced-risk language to ‘‘medically necessary (ALPA) stated its belief that the product, there is little evidence to substances,’’ ‘‘FDA-approved devices,’’ proposed rule would prevent support this claim, and that the limited or ‘‘prescription drugs.’’ One commenter degradation of the air quality onboard research on these products has found stated that the definition is circular aircraft, and asserted that the health significant variation between because it uses ‘‘smoking’’ in the risks for human use need to be more manufacturers’ attestations and the definition of ‘‘smoking.’’ In addition, thoroughly understood for both users actual dose of nicotine delivered by the some commenters suggested it would be and non-users who are subjected to products. ATS further stated that it is clearer to add the word ‘‘harmful’’ ‘‘secondhand smoke.’’ ALPA also noted not aware of any studies that suggest before ‘‘vapor.’’ the possibility of passenger and exhaled e-cigarette vapors are risk-free and that the use of these devices in the Finally, one commenter suggested the crewmember confusion in confined space of an airline cabin following definition as an alternative to differentiating e-cigarettes from tobacco should be viewed with extreme caution. the proposed rule text: ‘‘any inhalation cigarettes, as the two products can be The California Medical Association or exhalation of a tobacco product, difficult to distinguish from each other. (CMA) stated its support for the , or similar products The Association of Flight Attendants prohibition of the use of any nicotine that emits a smoke, mist, vapor, etc., (AFA) reported that it has received delivery devices not approved by the with the exception of medical devices occasional reports of in-flight passenger FDA in places where smoking is already such as nebulizers.’’ use of the devices and some confusion prohibited by law. CMA also noted that among travelers regarding airline several local and State governments DOT Response policies. AFA stated its support for have banned e-cigarettes in indoor treating the devices the same as Based on the comments received, we public spaces and workplaces. The traditional cigarettes. AFA believes that have decided to edit our proposed Oncology Nursing Society expressed its DOT is appropriately applying a definition of smoking to read as follows: support for the ban, citing evidence for precautionary principle because the Smoking means the use of a tobacco the presence of toxic chemicals in e- product, electronic cigarettes whether or not toxicity of e-cigarettes is not well cigarette aerosol. they are a tobacco product, or similar understood. In addition, the Association The Department also received a letter products that produce a smoke, mist, vapor, of Professional Flight Attendants, of support for the proposed rule signed or aerosol, with the exception of products representing flight attendants for by seven members of the U.S. Senate.5 (other than electronic cigarettes) which meet , submitted a the definition of a medical device in section The Senators urged a strong final rule, comment stating that American Airlines and stated that the devices raise 201(h) of the Federal Food, Drug and currently bans e-cigarettes, but Cosmetic Act, such as nebulizers. significant public health concerns. They nonetheless still urged DOT to also expressed concern with respect to We feel this change more succinctly promulgate a final rule to create the manufacturing and quality control of addresses our targeted prohibition and consistency across the industry. The e-cigarettes. In sum, the Senators stated makes clear that products which meet Association further noted that the that the proposed rule recognizes the the definition of a medical device (other science behind the effects that e- rights of airline passengers to a safe than electronic cigarettes) in section cigarettes may have on third parties is, travel environment and promotes public 201(h) of the Federal Food, Drug and at best, inconclusive, and that they health. Cosmetic Act, such as nebulizers, are adamantly advocate for a healthy In addition, we received two exempt. The use of electronic cigarettes environment for all flight attendants. comments from local governments. The would fall within the smoking ban even The Independent Pilots Association, New York City Department of Health if electronic cigarettes were to meet the the bargaining unit for the pilots of and Mental Hygiene (DOHMH) definition of a medical device. United Parcel Service, stated its support submitted a comment stating its concern for the rule on safety grounds (based on Coverage of E-Cigarettes that e-cigarettes are not FDA-approved the inherent dangers of using lithium and may contain chemicals that could In the NPRM, we explained that we battery powered e-cigarettes onboard harm users or those around them, interpret the existing part 252 to ban the aircraft). However, it also expressed the especially in confined spaces such as use of e-cigarettes on all flights and that view that DOT has created a double we were seeking to codify this standard of safety regulations by carving 5 Letter from Senators Barbara Boxer, Richard J. interpretation. We solicited comments out less safe standards for cargo aircraft Durbin, Tom Harkin, Richard Blumenthal, Jack Reed, and Edward J. Markey to Secretary Anthony about the potential benefits or harm of operations, and urged that the rule be Foxx (June 10, 2014) (available in the public this proposal. applied to all aircraft. docket).

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aircraft. DOHMH noted that the Arizonans for Nonsmokers’ Rights ban, stating that e-cigarettes emit water proposed rule would make enforcement expressed the view that e-cigarettes vapor, but not smoke. of the existing smoking ban easier, as e- posed respiratory hazards to non-users, Smokefree Pennsylvania submitted a cigarettes can be difficult to distinguish and that permitting e-cigarettes aboard comment that outlined several reasons from traditional cigarettes. Seattle and aircraft may infringe on the rights of for its opposition to the proposed ban. King County, Washington, which passed individuals with respiratory disabilities. The organization challenged the a regulation prohibiting the use of e- The Center for Smoke-free Department’s statutory authority to cigarette devices in places where Policy submitted a comment strongly in promulgate the rule under 49 U.S.C. smoking is prohibited by law, support of the proposed ban, stating that 41706. The organization reasoned that commented that a precautionary although there is a need for rigorous the statute does not authorize the ban of approach is warranted as the products scientific study of e-cigarettes, it is e-cigarettes because vapor does not are relatively new to the market and known that the vapor emitted from the involve combustion, and thus is vastly research has not conclusively identified devices contains several volatile organic different from tobacco smoke. the components of the vapor that are compounds (e.g., acetone, styrene, and Smokefree Pennsylvania stated that the exhaled. ethyl alcohol acetaldehyde) that can Department falsely alleged that using an We received several comments from cause negative health effects. The e-cigarette is the same as smoking. The other advocacy organizations. The Kentucky Center also commented that organization also challenged the American Cancer Society, American the use of e-cigarettes on aircraft may Department’s statutory authority under Heart Association, American Lung lead people to believe that smoking is 49 U.S.C. 41702, stating that there is no Association, Campaign for Tobacco-Free permitted, and may undermine smoke- evidence that e-cigarettes have harmed Kids, and Legacy submitted a joint free policies. The Tobacco Free anyone or that they pose any health or comment in support of the proposed Coalition of Pinellas County (FL) safety risks to users or non-users. The rule, stating that in the context of expressed similar health concerns. organization alleged that the NPRM smoking prohibitions on aircraft, e- FlyersRights.org, a non-profit airline deceives the public into believing that e- cigarettes should be considered the passenger rights advocacy organization, cigarettes emit smoke and pose health same as traditional cigarettes. The conducted a survey of its members to risks to users and non-users similar to organizations commented that the gauge public opinion on the proposed those posed by cigarette smoke. health consequences of e-cigarette use rule. The survey garnered 987 Furthermore, it argued that none of the are unknown, and therefore restrictions responses, and those who responded studies cited by the Department had on their use inside aircraft are voted overwhelmingly (81.4%) in favor found any hazardous levels of chemicals appropriate until it can be shown with of the NPRM. Support was generally in e-cigarettes. The organization also a high degree of certainty that they pose based on the grounds of public health or asserted that the proposal is no harm to non-users. The organizations cabin comfort. Those opposing the ban unenforceable, as e-cigarette consumers also argued that allowing the use of e- were almost evenly divided in their can use the products discreetly without cigarettes on aircraft would create reasoning, with some doubting that the anyone noticing because the vapor that significant confusion for passengers and e-cigarettes pose any risk, others is emitted is not visible. As evidence of enforcement challenges for airline believing that current research is this assertion, the organization stated personnel, citing an incident on a insufficient to support the regulation, that there have been no citations issued flight on July 13, and still others objecting generally to for violating indoor e-cigarette usage 2011, where a man was arrested for the proposed ban. bans in New Jersey, Seattle, or other pelting a flight attendant with peanuts The following organizations jurisdictions where e-cigarettes have and pretzels after being asked to put submitted comments in opposition to been banned. Finally, the organization away his e-cigarette upon attempting to the proposed rule. Smokin’ Vapor LLC noted that violators of the Department’s smoke the device. The organizations submitted a comment in opposition proposed rule would face a $3,300 fine, also argued that DOT’s proposed rule is stating that e-cigarettes do not burn any which the organization claimed is consistent with the decision in Sottera. matter, and that their ingredients (water, excessive and may violate the 8th Finally, the organizations argued that flavorings, nicotine—when chosen—and Amendment’s prohibition against cruel prohibiting e-cigarette use on aircraft propylene glycol) are safe, and even and unusual punishment. promotes the health goal of reducing the beneficial to users in some instances. The Consumer Advocates for Smoke- use of tobacco products through the The National Vapers Club submitted a Free Alternatives Association (CASAA) promotion of non-smoking comment stating that e-cigarettes do not and the Competitive Enterprise Institute environments. produce smoke and therefore do not (CEI) submitted a comment urging the Americans for Nonsmokers’ Rights create the byproducts of combustion. Department to withdraw its proposed (ANR) submitted a comment in support National Vapers stated that banning e- ban, and cited reasons for its opposition of the proposed rule, stating its belief cigarettes is akin to banning the use of similar to those offered by Smokefree that e-cigarettes should be prohibited in Nicotrol inhalers. The organization Pennsylvania. CASAA and CEI all places where the smoking of tobacco added that e-cigarettes have not been challenged the Department’s statutory products is prohibited. ANR stated that shown to cause any harm to bystanders; authority, arguing that the statutory ban its primary reason for supporting the until such harm is proven, the club on in-flight smoking, 49 U.S.C. 41706, ban is that the devices’ components believes that the ban is unfounded. does not extend to smoke-free products raise significant health concerns. ANR National Vapers also asserted that it is such as e-cigarettes. Also, these also asserted that e-cigarettes can the responsibility of airlines to explain organizations argued that the undermine and cause confusion over the use of e-cigarettes to those who are Department’s reliance on 49 U.S.C compliance with smoke-free rules when uncomfortable with them, and to § 41702 is misplaced, as there is no used on airplanes. Finally, ANR noted alleviate the concerns of those who are research indicating that e-cigarette that there are at least 25 municipalities not familiar with the products. In vapor, with or without nicotine, is that define ‘‘smoking’’ to include the addition, Smokers Fighting harmful to users or bystanders. The use of e-cigarettes and prohibit their use Discrimination, Inc., submitted a organizations cited a Health New in workplaces and public places. comment in opposition to the proposed Zealand report where e-cigarette mist

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was tested for over 50 cigarette smoke asthma should be protected from the FAA regulates smoking aboard aircraft toxicants, and no such toxicants were effects of e-cigarette vapor. Another under its safety mandate. See 14 CFR found. CASAA and CEI additionally reason cited in support of the rule was 121.317, 129.29, 135.127. argued that the Department has failed to the elimination of potential passenger Authority To Regulate E-Cigarettes perform a cost-benefit analysis and has and crew confusion; supporters argued Under 49 U.S.C. 41706 not demonstrated that the ban would that a ban on both traditional cigarettes produce any benefits; the American and e-cigarettes would make We begin with section 41706, the Aviation Institute echoed this view. enforcement of the smoking regulation statutory smoking ban. With respect to Lastly, CASAA and CEI stated that the easier for crewmembers, because e- domestic air transportation, section possible civil penalty of $3,300 for cigarettes resemble traditional 41706(a) provides that ‘‘an individual violating part 252 is not justified, as e- cigarettes. It was also stated that this may not smoke in an aircraft in cigarettes would not impair cabin air proposed rule would create only scheduled passenger interstate or quality or cause damage to aircraft seats minimal inconvenience for smokers and intrastate air transportation; or in an or carpeting. ‘‘vapers,’’ as the existing smoking ban aircraft in nonscheduled passenger We now turn to comments received on aircraft has been in place since 2000. interstate or intrastate air transportation from the public. By the end of the In more recent years, the Department if a flight attendant is a required comment period on November 15, 2011, has noted a substantial increase in crewmember on the aircraft.’’ Similarly, the Department received approximately individual comments supporting the with respect to foreign air 700 total comments; approximately 500 ban. Of the approximately 350 transportation, section 41706(b) of those were from individuals opposed additional individual comments provides that ‘‘the Secretary of to the proposed ban. (Many of the received after the close of the comment Transportation shall require all air comments received in opposition to the period, approximately 60 opposed the carriers and foreign air carriers to proposed rule were identical.) The ban while approximately 290 supported prohibit smoking in an aircraft in purported lack of DOT jurisdictional it. Most commenters supporting the ban scheduled passenger foreign air authority to create the proposed rule cited health concerns, and expressed the transportation; and in an aircraft in and lack of research, data, evidence, or view that e-cigarette aerosol was either nonscheduled passenger foreign air proof to support the rule were common already demonstrated to be harmful, or transportation, if a flight attendant is a themes. Many felt that the Department should be banned unless it is proven to required crewmember on the aircraft.’’ was overstepping its statutory authority, be safe. A number of individuals While section 41706 does not define and argued that e-cigarettes are not expressed impatience at the ‘smoking,’’ nothing in the text of section smoked, but ‘‘vaped’’ (producing water Department’s slow progress in 41706 suggests that the definition of vapor), and as such do not fall within implementing the ban. ‘‘smoking’’ should be limited to the the smoking statute, section 41706. We note that several commenters, combustion of traditional tobacco Also, many felt that the Department both organizations and individuals, products. Instead, Congress vested failed to justify the proposed ban under cited safety reasons as additional broad authority in the Department to section 41702 because it did not provide grounds for supporting the proposed implement the statutory smoking ban. any evidence that e-cigarettes are ban (e.g., potential fire concerns and Specifically, section 41706(d) states that harmful to bystanders. Some hazards associated with the lithium ‘‘the Secretary shall provide such individuals asserted that there have not batteries that power the devices). regulations as are necessary to carry out this section.’’ We interpret section been any reported health issues with DOT Response respect to the devices and stated that 41706 as a whole as vesting the lack of evidence cannot be the basis for After fully considering the comments Department with the authority to define a rule. Many argued that the proposed received, the Department has decided to the term ‘‘smoking,’’ and to refine that rule was an example of unnecessary amend its existing smoking rule to definition as necessary to effectuate the government regulation, and that the explicitly ban the use of e-cigarettes on purpose of the statute while adapting to better approach would be to allow the all flights in passenger interstate, new technologies and passenger industry to devise its own rules for the intrastate and foreign air transportation behavior. Like section 41706, the products. It was also argued that the where other forms of smoking are Department’s regulation in 14 CFR part proposed regulation would be banned. We are primarily concerned 252 did not contain a definition of unenforceable because users can easily with the potential adverse health effects ‘‘smoking’’ prior to the issuance of this hide their use of e-cigarettes. Finally, of secondhand exposure to aerosols final rule. However, the Department has some argued that the civil penalty generated by e-cigarettes, particularly in previously taken the position that the associated with a violation of the the unique environment of an aircraft prohibition against smoking in 49 U.S.C. proposed rule is excessive and illegal cabin. We further believe that the ban 41706 and 14 CFR part 252 should be under the 8th Amendment. on the use of e-cigarettes fulfills the read to ban the use of electronic Supporters of the rule generally statutory mandates of sections 41706, cigarettes on U.S. air carrier and foreign viewed the Department as having the 41702, and 41712. We do not address in air carrier flights in scheduled appropriate authority and stated that the this rulemaking any safety-related issues intrastate, interstate and foreign air unknown risk and potential harmful that may exist with regard to the use of transportation, a position that was noted effects justified the ban. Many voiced e-cigarettes aboard aircraft. The Pipeline in connection with a June 17, 2010 concern over the air quality aboard and Hazardous Materials Safety hearing before the Senate Committee on aircraft, stating that the rights and Administration (PHMSA) regulates Commerce, Science and Transportation. public health concerns of passengers hazardous materials safety 6 and the This final rule formalizes the who are not e-cigarette users should be Department’s interpretation by defining protected, as these people do not have 6 With respect to the Independent Pilots smoking to explicitly include the use of the option of leaving the space. Association’s comment that DOT should expand the ban on e-cigarettes to include cargo flights, we note e-cigarettes. Supporters also raised the point that that the Association’s concern appears to be largely potentially vulnerable passengers, such on the safety hazards of transporting lithium rule addressing this issue. See 79 FR 46011 (August as children, the elderly, and people with batteries. On August 6, 2014, PHMSA issued a final 6, 2014); PHMSA–2009–0095 (HM–224F).

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Some commenters contend that for concern. Also citing public health recognize that the aerosol that is section 41706 cannot be relied upon to concerns were the American Cancer exhaled by users of some e-cigarettes reach this result because it prohibits Society, American Heart Association, and similar electronic apparatus may smoking, and e-cigarettes are ‘‘vaped’’ American Lung Association, Campaign not pose as much harm as smoke and produce a vapor. Although e- for Tobacco-Free Kids, and Legacy. In emitted from combusted tobacco cigarettes typically do not undergo addition, each comment received from products. However, given that studies combustion, they do produce an aerosol the airline industry voiced strong do indicate that both nicotine and other of chemicals and require an inhalation support for the rule, based on the toxicants are found in the exhaled and exhalation action similar to that unknown ingredients in the devices and aerosol, limiting exposures must be which is required when smoking their possible health consequences. considered. Because the potential for traditional cigarettes. E-cigarettes are While the specific hazards of e- harm to consumers from second hand generally designed to look like and be cigarette aerosol have not yet been fully aerosol is even greater in the closed used in the same manner as identified, the Department does not environment of an aircraft, we believe a conventional cigarettes. Further, the believe that it would be appropriate to precautionary approach is warranted. In purpose behind the statutory ban on exempt e-cigarettes from the ban for sum, releasing an aerosol that may smoking aboard aircraft in section 41706 now, pending a more definitive catalog contain harmful substances or and the regulatory ban on smoking of those hazards. Since the NPRM was respiratory irritants in a confined space, tobacco products in part 252 were to issued, research continues to undermine especially when those who are at a improve cabin air quality, reduce the claims that the use of e-cigarettes would higher risk are present, is contrary to the risk of adverse health effects on have no adverse health implications on statutory ban on smoking aboard passengers and crewmembers, and users or others who are nearby. aircraft. enhance passenger comfort. The in- Research has detected toxic chemicals cabin dynamics of e-cigarette use are such as formaldehyde and acetaldehyde Authority To Regulate E-Cigarettes similar enough to traditional smoking to in the aerosol from certain e-cigarettes.9 Under 49 U.S.C. 41702 necessitate including e-cigarette use The aerosol was also found to contain We also find an independent source within the definition of ‘‘smoking.’’ Like acrolein, which can cause irritation to of authority for this rulemaking in traditional smoking, e-cigarette use the nasal cavity and damage to the section 41702, which mandates safe and introduces a cloud of chemicals into the lining of the lungs, and may contribute adequate interstate air transportation. air that may be harmful to passengers to in cigarette The Department’s predecessor, the Civil who are confined in a narrow area smokers.10 Another study identified 22 Aeronautics Board (CAB), relied upon within the aircraft cabin without the chemical elements in e-cigarette aerosol, section 404(a) of the Federal Aviation ability to avoid those chemicals. including lead, nickel, and chromium, Act of 1958 (subsequently re-codified as A recent study published in the among others that can cause adverse 41702), requiring air carriers ‘‘to provide journal Nicotine & Tobacco Research health effects in the respiratory and safe and adequate service, equipment found that e-cigarettes are a source of nervous systems.11 and facilities,’’ as authority to adopt its secondhand exposure to nicotine but Some studies have found that lower first regulation restricting smoking on 7 not to combustion toxicants. The levels of toxicants are observed in e- air carrier flights (ER–800, 38 FR 12207, conclusions of the study were that using cigarette aerosols than in combusted May 10, 1973). At that time, CAB issued e-cigarettes in indoor environments may tobacco smoke.12 However, research on a ‘‘smoking rule’’ under its economic involuntarily expose non-users to near real-use conditions of e-cigarettes regulations titled, ‘‘Part 252—Provision nicotine, and that more research is has found increased indoor air levels of of Designated ‘No Smoking’ Areas needed to evaluate the health polycyclic aromatic hydrocarbons; 1,2- Aboard Aircraft Operated by consequences of secondhand exposure propanediol; 1,2,3-propanetriol; Certificated Air Carriers,’’ which to nicotine, especially among vulnerable glycerine; nicotine; fine particles; mandated designated ‘‘no smoking’’ populations such as children, pregnant ultrafine particles; particle number areas on commercial flights. See 38 FR women, and people with cardiovascular concentrations; and aluminum, all of 12207 (May 10, 1973). The rule predated conditions. More recent research has which raise health concerns.13 We a Congressional ban on smoking on determined that persistent residual scheduled flights. In the preamble to the nicotine on indoor surfaces from e- 9 Goniewicz, M. L., J. Knysak, M. Gawron, et al., 1973 rule, the CAB cited a joint study cigarettes can lead to third hand Levels of Selected Carcinogens and Toxicants in by the FAA and the then Department of exposure through the skin, inhalation, Vapour From Electronic Cigarettes, 23 Tobacco Control 133 (2013), doi: 10.1136/tobaccocontrol– Health, Education, and Welfare that and ingestion long after the air itself has 2012–050859. 8 concluded that the low levels of cleared. 10 Goniewicz, M. L., J. Knysak, M. Gawron, et al., contaminants in tobacco smoke did not Additionally, we find it significant Levels of Selected Carcinogens and Toxicants in represent a health hazard to that the three medical associations that Vapour From Electronic Cigarettes, 23 Tobacco nonsmoking passengers on aircraft; submitted comments cited the unknown Control 133 (2013), doi: 10.1136/tobaccocontrol– 2012–050859. however, the study found that a health risks of exposure to e-cigarette 11 Williams, M., A. Villarreal, K. Bozhilov, et al., significant portion of the nonsmokers aerosol in a confined space as a reason Metal and Silicate Particles Including stated that they were bothered by Nanoparticles Are Present in Electronic Cigarette 7 Jan Czogala et al., Secondhand Exposure to Cartomizer Fluid and Aerosol, 8 Public Library of tobacco smoke. The CAB stated, ‘‘unlike Vapors From Electronic Cigarettes, 16 Nicotine & Science One e57987 (2013), doi: 10.1371/ persons in public buildings, Tobacco Research 655 (2014), doi: 10.1093/ntr/ journal.pone.0057987. nonsmoking passengers on aircraft may ntt203. 12 Goniewicz, M., et al., ‘‘Levels of Selected be assigned to a seat next to, or 8 ML Goniewicz & L Lee, Electronic Cigarettes Are Carcinogens and Toxicants in Vapour from otherwise in close proximity to, persons a Source of Thirdhand Exposure to Nicotine, Electronic Cigarettes,’’ Tobacco Control, 23(2):133– Nicotine Tob Res. 2014 Aug 30. pii:ntu152. [Epub 139, 2014. who smoke and cannot escape this ahead of print]; see also WG Kuschner et al., 13 Schober, W., et al., Use of Electronic Cigarettes Electronic Cigarettes and Thirdhand Tobacco (E-Cigarettes) Impairs and Markewitz, E. Uhde, and T. Salthammer, Does E- Smoke: Two Emerging Challenges for Increases FeNO Levels of E-Cigarette Consumers, Cigarette Consumption Cause Passive Vaping?, 23 the Primary Care Provider, 4 Int J Gen Med. 115 217 Int J Hyg Environ Health 628 (2014), doi: Indoor Air 25 (2013), doi: 10.1111/j.1600– (2011), doi: 10.2147/IJGM.S16908. 10.1016/j.ijheh.2013.11.003; Schripp T., D. 0668.2012.00792.x.

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environment until the end of the flight.’’ exposure to the chemicals contained in consistent with the regulatory text, this The principal basis for the 1973 e-cigarette aerosol. These harms are rule would preclude that option. smoking rule was passenger discomfort unavoidable because passengers who do issues. Just as the CAB relied on the not wish to be exposed to e-cigarette Charter (Non-Scheduled) Flights ‘‘adequate’’ prong of the predecessor to aerosol cannot escape this environment Section 401 of the FAA section 41702 to adopt a smoking ban in until the end of the flight. Modernization and Reform Act of 2012 In sum, we are amending our existing 1973, the Department believes that it prohibited smoking on domestic smoking regulation to explicitly ban the has the authority today to ban the use nonscheduled (charter) passenger flights use of e-cigarettes because we view the of e-cigarettes under section 41702 to that require a flight attendant, and ban to be consistent with the statutory ensure ‘‘adequate’’ service by reducing a directed the Department to prohibit similar kind of passenger discomfort. In mandates of sections 41706, 41702 and smoking on nonscheduled (charter) our view, passenger discomfort arises 41712. We do not believe that it is passenger flights in foreign air from at least two aspects of e-cigarette appropriate, as some commenters have transportation that require a flight aerosol exposure. First, the non-user suggested, to allow the airline industry attendant. In the NPRM in this passenger may feel the direct effects of to adopt its own standards with respect inhaling the aerosol, which, as noted to the inclusion of electronic cigarettes proceeding, we sought comment on the above, has been shown to contain within the prohibition on smoking. We issue of banning smoking on most respiratory irritants. More broadly, recognize that the industry has generally charter flights. We received few passengers may reasonably be banned the use of electronic cigarettes comments on this issue; however, those concerned that they are inhaling on flights, either as a matter of that did comment overwhelmingly unknown quantities of harmful preference or in recognition of the supported the proposal. The Association chemicals, and that they will not be able Department’s well-publicized of Flight Attendants (AFA) stated its to avoid the exposure for the duration enforcement policy. On the other hand, support for the ban, claiming that it of the flight. we believe that without a clear, uniform would be beneficial to the occupational regulation, some carriers may feel free to health of flight attendants and the Authority To Regulate E-Cigarettes adopt policies that allow the use of e- health of the traveling public. AFA Under 49 U.S.C. 41712 cigarettes onboard aircraft. In light of stated that there is virtually universal In addition to the Department’s the potential health hazards posed to agreement that exposure to authority under sections 41716 and flight attendants and fellow passengers, environmental tobacco smoke is 41702, the Department has the authority as well as the potential diminution in harmful to health, and requested that and responsibility to protect consumers air cabin quality posed by the use of DOT acknowledge these findings and from unfair or deceptive practices in air electronic cigarettes in an aircraft cabin, expand the smoking ban to all charter transportation under 49 U.S.C. 41712. we do not believe that a free-market operations. Using this authority, the Department has approach is appropriate or desirable. The Association of Professional Flight found practices to be ‘‘unfair’’ if they are An additional benefit of this rule is Attendants, representing American harmful to passengers but could not be that it eliminates passenger or Airlines flight attendants, stated its reasonably avoided by them. For crewmember confusion with regard to support of the ban to create consistency example, the Department relied upon the permissibility of e-cigarettes by across the industry and argued that no section 41712 and its ‘‘unfair’’ practice creating an explicit ban. In our notice, flight attendant should be subjected to component when promulgating the we stated that through Congressional 14 cigarette smoke on an airplane, given ‘‘Tarmac Delay Rule,’’ in which the correspondence, anecdotal evidence, what is known about secondhand Department addressed problems and online sources, including blogs, we smoke. consumers face when aircraft sit for were made aware that some passengers hours on the airport tarmac. In doing so, have attempted to use e-cigarettes The American Cancer Society, the Department considered the harm to onboard aircraft. The Association of American Heart Association, American the consumer and the fact that the harm Flight Attendants also stated in Lung Association, Campaign for was unavoidable. The Department comments submitted to the Department Tobacco-Free Kids, and Legacy stated concluded that regulatory action was that it receives occasional reports of in- that the health effects of secondhand necessary and that a three-hour time flight passenger use and confusion smoke are well established in scientific limit is the maximum time after which among travelers regarding airline literature. The organizations argued that passengers must be permitted to policies. In the absence of regulation, e- charter flight staff should not be deplane from domestic flights given the cigarette users may believe that an exposed at their workplace to cramped, close conditions in aircraft airline’s policy banning e-cigarettes is secondhand smoke, which has been and the inability of passengers to avoid merely a preference, and that they may shown to increase risk of heart disease, lengthy tarmac delays. Here, as with the continue to use such devices because stroke, and cancer. These organizations tarmac delay rule, the Department they are not prohibited by federal law. expressed their concern that charter believes that the practice of allowing This rule would eliminate any such flight passengers are potentially exposed use of e-cigarettes onboard aircraft arguments with respect to the use of e- to secondhand smoke for extended would be potentially harmful to cigarettes, and provide flight crew with periods of time in a confined space. The passengers and there is no way for the the clear message that e-cigarettes are organizations argued that there is no passenger to reasonably avoid the harm. placed firmly on the same footing as safe level of exposure to secondhand The harms include the potential for traditional tobacco products. The smoke, regardless of the type of plane or decreased cabin air quality, confusion traveling public would also have the flight one takes, and that the current about whether the passenger is being benefit of knowing with certainty that e- regulations do not effectively protect exposed to traditional cigarette smoke, cigarettes are prohibited onboard public health. We received a few and possible health risks arising from aircraft, Moreover, to the extent that comments from the public on this issue, carriers may be inclined to permit e- with most stating their support for the 14 See 74 FR 68983 (December 30, 2009) and 76 cigarettes on the ground that the proposal and some suggesting extending FR 23110 (April 25, 2011). Department’s enforcement policy is not the ban to all flights.

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DOT Response requirement in the existing rule for The Final Regulatory Evaluation We are amending the rule text of part carriers to give notice to each passenger Introduction 252 to implement section 401 of the on a single-entity charter of the smoking In April 2000, the Wendell H. Ford FAA Modernization and Reform Act. procedures for that flight. It would be of Aviation Investment and Reform Act for Section 401 requires U.S. and foreign air limited usefulness to have such a the 21st Century (Pub. L. 106–181) was carriers to ban smoking in requirement where smoking on single- signed into law. Section 708 of the Act nonscheduled passenger interstate, entity charters would not be banned by amended 49 U.S.C. 41706 to impose a intrastate, and foreign air transportation this rule (i.e., on aircraft where a flight ban on smoking on all scheduled where a flight attendant is a required attendant is not a required crewmember, passenger interstate, intrastate, and crewmember. The amendment to part which essentially means aircraft with 19 foreign air transportation. DOT 252 is necessary to harmonize the seats or less). subsequently incorporated this ban in Departmental regulation with the new its rule on smoking on commercial statutory requirement.15 The 2011 Regulatory Analysis and Notices airline flights. Because of confusion as NPRM sought comment on banning A. Executive Order 12866 (Regulatory to whether the use of e-cigarettes was smoking on charter flights that use Planning and Review), Executive Order allowed on aircraft, in September 2011, aircraft with 19 or more passenger seats. 13563 (Improving Regulation and DOT issued a NPRM (see 79 FR 57008), In view of the statutory smoking ban in Regulatory Review) and DOT which proposed to amend 14 CFR part section 401 that was signed into law in Regulatory Policies and Procedures 252 to explicitly include the use of e- 2012, this final rule conforms part 252 cigarettes in the smoking ban. to the requirement in the statute. This final rule has been determined to Specifically, the NPRM proposed to Consequently, this new rule bans be significant under Executive Order define smoking as, ‘‘the smoking of smoking on all nonscheduled passenger 12866 and the Department of tobacco products or use of electronic air transportation where a flight Transportation’s Regulatory Policies and cigarettes and similar products designed attendant is a required crewmember of Procedures. It has been reviewed by the to deliver nicotine or other substances the aircraft. Office of Management and Budget in The rule also continues a ban on to a user in the form of vapor.’’ The smoking on nonscheduled passenger air accordance with Executive Order 12866 NPRM also considered whether to transportation where a flight attendant (Regulatory Planning and Review) and extend the smoking ban (including e- is not a required crewmember of the Executive Order 13563 (Improving cigarettes) to nonscheduled passenger aircraft, except for single entity charters Regulation and Regulatory Review) and flights or air carriers and foreign air and on-demand services of air taxi is consistent with the requirements in carriers between points in the United operators. Under the existing sections both orders. States and between the United States and any foreign point with aircraft that 252.2 and 252.13, U.S. carriers are The Final Regulatory Evaluation, have a designed seating capacity of 19 required to ban smoking on all flights included in this section, qualitatively (scheduled and charter) that use aircraft or more passenger seats. evaluates the benefits and costs of the In February 2012, the FAA with 30 or fewer passenger seats except final rule. Both benefits and costs are for the on-demand services of air taxi Modernization and Reform Act of 2012 expected to be very small because the (Pub. L. 112–95) (the Act) was signed operators. Section 252.19 of the existing final rule only represents a modest rule permits smoking on single-entity into law. Section 401 of the Act change, if any, to existing industry charter flights of U.S. air carriers. In amended 49 U.S.C. 41706 to extend the practice. Nonetheless, the Department other words, under the existing rule, smoking prohibition to aircraft in smoking is allowed on single-entity believes that the rule is necessary for the nonscheduled passenger interstate, charter flights and on-demand services reasons noted below. As discussed intrastate, and foreign air transportation, of air taxi operators regardless of aircraft below, DOT was unable to find any offered by both U.S. and foreign carriers, size. For U.S. carriers, smoking is airline that explicitly states that it if a flight attendant is a required prohibited on all other charter flights allows smoking of any type or includes crewmember. that use aircraft with 30 or fewer accommodating smokers in its business This final rule primarily makes two passenger seats. plan, including e-cigarettes and their regulatory changes. First, it amends the If an aircraft has more than 30 seats, users, and as such, would be affected by existing smoking ban in 14 CFR part 252 under section 252.7 of the existing rule this rule. In fact, the overwhelming to explicitly ban the use of e-cigarettes the air carrier operating the charter majority of passenger seats are on whenever smoking is banned by flight (other than single-entity charters scheduled flights where smoking revising the definition of smoking to or on-demand services of air taxi traditional cigarettes is already banned. cover the use of e-cigarettes. Second, the operators) must establish a non-smoking Moreover and again as discussed below, rule amends 14 CFR part 252 to section for each class of service. As an commercial airlines have interpreted the implement section 401 of the FAA organizational matter, we are existing DOT smoking ban to cover e- Modernization and Reform Act and extends the smoking ban to flights in eliminating this section as it is no longer cigarettes and do not allow their use. nonscheduled interstate, intrastate, and needed because section 401 bans Due to the inability to identify any foreign passenger air transportation smoking on charter flights where a flight specific airlines that would have to where a flight attendant is required. attendant is a required crewmember. All change their policies in response to the charter flights covered under section final rule, it was not possible to quantify Current Industry Practice/Regulatory 252.7 would require a flight attendant as benefits or costs. However, DOT does Baseline that section only applies to aircraft with not rule out the possibility that a few more than 30 seats. In 2014, there were a total of 104 U.S. The only change that is not directly airlines may at times provide services carriers and 151 foreign air carriers required by the statute is eliminating the that could be affected by the rule, and providing service in the United States. therefore provides a qualitative analysis About 75 percent of these carriers 15 For the reasons discussed in the prior section, of potential benefits and costs for those provided scheduled service and the this ban will include the use of e-cigarettes. situations. remaining 25 percent provided only

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

TABLE A.1—CARRIERS OPERATING IN THE U.S. MARKET BY SIZE AND TYPE OF SERVICE

Seats on largest Total carriers Charter only Scheduled aircraft service

U.S. Carriers ...... >60 41 13 28 30–60 15 2 13 <30 48 11 37

U.S. Carrier Total ...... 104 26 78 Foreign Carriers ...... >60 123 12 111 30–60 2 0 2 <30 26 25 1

Foreign Carrier Total ...... 151 37 114 Source: DOT contractor estimates based on 2014 T–100 segment database, 2013 B–43 aircraft inventory, Regional Airline Association 2014 Annual Report and review of carrier Web sites.

14 CFR part 252 currently bans questions have emerged regarding its some airlines cite a ‘‘nuisance factor,’’ smoking on all scheduled passenger applicability to e-cigarettes. DOT has concerns for triggering smoke detection interstate, intrastate, and foreign air stated that e-cigarettes are covered by its equipment, and concerns for other transportation. Thus, as noted above, existing smoking rule, part 252.17 Based passengers’ health. Exhibit A.1 lists the overwhelming majority of flights are upon DOT review of individual Web some typical examples of e-cigarette covered by the general smoking ban (75 sites, U.S. and foreign carriers generally policies taken from a select number of percent of carriers representing 99 appear to be in compliance with this the 104 individual U.S. carrier and 151 percent of passenger enplanements). No interpretation and do not allow their foreign carrier Web sites. regulatory definition of ‘‘smoking’’ is use. While some carriers provide no included in the existing Part 252, and explanation for their interpretation,

EXHIBIT A.1—ELECTRONIC CIGARETTE POLICIES FOR SELECTED CARRIERS

AirTran Airways—‘‘In addition to smoking, the use of chewing tobacco and electronic cigarettes are not permitted onboard any scheduled or pri- vate charter AirTran Airways flight.’’ —‘‘Smoking, chewing tobacco, smokeless tobacco, and the use of electronic smoking devices are not permitted on any Alaska Airlines flight.’’ American—‘‘You can travel with electronic cigarettes in your carry-on baggage, but you are not allowed to use them onboard at any time.’’ Delta—‘‘E-cigarettes cannot be operated at any time on a Delta or Delta Connection Aircraft.’’ JetBlue—‘‘While the majority of electronic cigarettes may be non-hazardous, JetBlue does NOT allow the USE of them on any of our flights, but will allow them in checked or carry-on baggage. It is considered a nuisance item as small amounts of vapor are expelled from the cigarette.’’ Southwest—‘‘Electronic Cigarettes and Smoking Devices’’ are ‘‘never permitted’’ for use on board. United—‘‘The use of electronic, simulated smoking materials (such as electronic cigarettes, pipes or cigars) is prohibited on .’’ Air France—‘‘Use of e-cigarettes is prohibited on all Air France flights. The vapor emitted by these devices may trigger the cabin smoke detec- tors.’’ Air —‘‘The use and charging of electronic cigarettes (eCigarettes) is also not permitted as the vapour may contain levels of nico- tine that are unacceptable to other passengers.’’ British Airways—‘‘We have a no smoking policy on board all our aircraft and in our airport lounges. This includes electronic cigarettes (e-ciga- rettes), as they emit a small amount of mist which can make it appear that a customer is actually smoking.’’ KLM—‘‘All KLM flights are non-smoking flights. Smoking is not permitted at any place or at any time on board our aircraft. This also applies to artificial cigarettes.’’ Lufthansa—‘‘Please note, however, that you are not permitted to smoke electronic cigarettes on board Lufthansa flights.’’ Source: Individual carrier Web sites.

For the remaining 25 percent of complied with the airline’s check-in right to engage in the activity has carriers providing only charter service deadline and who wishes to be seated become difficult, if not impossible. (representing about one percent of there. According to one Web site that assists passenger enplanements), smoking is Apparently, however, charter airlines in booking charters: not prohibited by law in all cases. On have taken a direction similar to rental ‘‘. . . some charter operators such as flights where smoking is not banned by car companies and hotels, where GlobeAir have a strict no-smoking policy law, airlines must have a non-smoking nonsmoking policies are now the across their fleet. ‘It got to the point where 18 section and must accommodate in that norm. Finding a charter that allows in- we felt that smoking on board not only posed section every passenger who has flight smoking or guarantees a smoker’s

16 Source: Bureau of Transportation Statistics, T– 17 See https://www.transportation.gov/sites/ 18 http://usatoday30.usatoday.com/travel/hotels/ 100 Market and Segment (http://www.rita.dot.gov/ dot.gov/files/docs/PolicyOnECigarettes.pdf. 2008-11-17-smoke-free-hotels-no-smoking_N.htm; bts/data_and_statistics/by_mode/airline_and_ http://consumertraveler.com/today/still-smoking- airports/airline_passengers.html). be-careful-before-you-rent-a-car/.

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a health hazard but also increases the risk of maintenance of aircraft in which traditional or electronic cigarettes) does fire,’ says Bernhard Fragner, CEO.’’ 19 smoking is allowed deters carriers from not bear the full cost of the activity. Part And another: allowing the activity, unless of course, of the cost of smoking in an airplane ‘‘Alot (sic) of the air charter aircraft are the increase in expense is justified by a cabin is borne by nearby passengers or now non-smoking due to fact that all airline net increase in demand from smokers flight crew who are unable to regulate flights are now non-smoking flights. Charter (and thus revenues) to cover these their exposure. The costs of involuntary operators complain that the tobacco smell costs.23 It is unclear whether these exposure to smoke or aerosol are in the from smoking gets into the fabric of their incentives apply to e-cigarettes. form of actual adverse health airplanes and bothers the next An internet search yields a few consequences, perception and fear of passenger(s).’’ 20 anecdotes suggesting some smokers adverse health consequences and And, according to a charter company: 21 have been frustrated by the lack of annoyance or irritation regarding options for those who wish to smoke ‘‘All Skyward Aviation aircraft prohibit undesirable odors. Even if a carrier were smoking to ensure the complete safety of during flight, which is a further to disclose that it allowed smoking (of passengers and flight crew members.’’ 22 indication that the industry norm has either traditional cigarettes or e- tended toward smoking prohibition, at cigarettes), patrons may not receive this While some charters address the use of least for traditional cigarettes. There information prior to departure or in the e-cigarettes and include them in their have been some limited attempts to case of some smaller markets, they may smoking prohibitions, it is unknown market flights for smokers or create a not have a convenient option to avoid whether this is standard practice. ‘‘smokers airline’’ which would allow or There are incentives for charter exposure by choosing an airline that even encourage passengers to smoke airlines to voluntarily adopt smoking disallowed use (which could represent during flight. However, none of these bans despite the lack of a legal another type of market failure, but not efforts have been successful to date.24 requirement. In the case of domestic one that is the primary concern of this This probably reflects that a consumer’s charters, assuring the accommodation of regulatory action). decision regarding which flight to Regarding e-cigarettes specifically, nonsmoking passengers in a purchase is complicated, involving they typically do not involve nonsmoking section in accordance with price, availability, safety record or combustion. However, they require an the law could create some planning perceptions, and multiple other inhalation and exhalation action similar difficulties unless a service provider attributes. The ability to smoke on a to smoking traditional cigarettes and knows in advance the smoking status of flight would only be one aspect, and they produce a cloud of aerosol which each passenger; it is easier and requires probably a very small one, in the overall can be mistaken for smoke. E-cigarettes less planning to simply disallow the decision. In addition, one would expect are generally designed to look like and activity. Moreover, to attract customers, that at least some customers would be used in the same manner as many of these carriers advertise receipt purposely avoid flights that allowed conventional cigarettes. Passengers who of various safety certifications (e.g., the smoking. Due to relative importance of do not engage in or understand the FAA’s Diamond Award of Excellence, other attributes (i.e. price), there are process of e-cigarette use can easily Argus rated, AACA Medallion) as part limits to how successful carriers who mistake the act for traditional smoking. of their marketing strategy. Permitting focus exclusively on attracting smokers Thus, even if second-hand exposure to passengers to smoke onboard would be can be. e-cigarette aerosol were ever determined at odds with the standards of the In sum, at least 99 percent of to not lead to the same type of health certifying organizations. Finally, and passenger enplanements occur on flights consequences as exposure to tobacco perhaps most importantly, it is more that prohibit smoking of any type, smoke, nearby passengers may still costly to operate aircraft where smoking including both traditional cigarettes and experience discomfort, stress or some in is permitted. Smoking increases e-cigarettes. The remaining one percent cases display aggression or fear because hardware costs since cabin air filters of enplanements appears to be on they believe their health is threatened. have to be changed more frequently and charter flights that largely prohibit Currently, the state of knowledge avionics need to be cleaned more often. smoking of traditional cigarettes. Some regarding the effects of secondhand The higher expense associated with of the charter companies also extend the exposure to e-cigarette aerosol does not prohibition to e-cigarettes, but the rule out the possibility of actual adverse 19 http://corporatejetinvestor.com/articles/how-to- charter-private-jet-503/. extent of that practice is unknown. health effects to nearby individuals who 20 http://www.usskylink.com/resource/air-charter- Need for the Rule do not directly choose to engage in this faq- activity. In fact, some research supports details.asp?fldNAME=Air%20Charter%20Flights. The involuntary exposure to second- the case that bystanders incur actual 21 A few other examples of explicit smoking hand smoke or e-cigarette aerosol in an adverse health effects when exposed to prohibitions are as follows: Charter Air Transport, airplane cabin represents one classic Inc. states ‘‘Smoking is prohibited on all secondhand e-cigarette aerosol. flights.... NOTE: This includes electronic example of a market failure, an In the absence of a rule, carriers are cigarettes’’ (see http:// externality; the smoker (of either free to make their own determinations www.charterairtransport.com/); Avjet Corporation regarding the use of e-cigarettes. Charter indicates that their entire charter fleet is 23 The increase would need to be net of the operations have historically had nonsmoking (http://www.avjet.com/); ’s reduction in demand from passengers with an policy is that ‘‘Smoking is prohibited on our Flights aversion to smoking. additional flexibility regarding smoking (www.atlasair.com/aa/); and Dynamic Airways 24 The names of these airlines were: Great in general, as long as they accommodate conditions of service include ‘‘Dynamic flights are American Smokers’ Club, Smokers Express, nonsmoking patrons in accordance with non-smoking. Smoking cigarettes, regular and Freedom Air, and Smintair. None ever commenced the law (e.g., no-smoking sections). electronic, is not allowed onboard our aircraft, but commercial operation (see, for example, http:// Scheduled service providers have chewing tobacco is allowed’’ (https:// www.sourcewatch.org/index.php/Smokers_ www.airdynamic.com) . Interestingly one carrier Express_Airlines; http:// chosen to prohibit e-cigarette use and addresses e-cigarette use with no reference to articles.chicagotribune.com/1993-10-03/travel/ charters typically do not allow smoking traditional smoking, ‘‘You’re not allowed to use 9310030004_1_flights-american-trans-air-smokers; of traditional cigarettes (some charters electronic cigarettes on the plane’’ (http:// http:///articles.chicagotribune.com/1993-10-03/ also prohibit e-cigarettes but the degree www.thomson.co.uk/flight/0. travel/9310030027_1_freedom-air-smokers- 22 http://www.skywardaviation.com/76/ passengers; http://www.nytimes.com/2006/09/03/ to which this is standard practice is FAQ.html. business/worldbusiness/03iht-smoke.2683305.html) unknown). Without this rule, it is

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possible that some airlines could relax rule. First, some carriers could incur smoking on their flights so the benefits their current policies, which would new costs relative to the baseline due to of this nature are expected to be small. increase passenger and flight crew the need to more actively enforce their There is no cost to operators for secondhand exposure to aerosols and prohibitions. This could occur if some hardware related to smoking bans. In quite possibly, traditional tobacco consumers mistakenly interpret DOT’s fact, smoking bans reduce hardware smoke in the case of some charters. failure to enact a federal prohibition as costs as cabin air filters do not have to ensuring their right to engage in e- be changed as frequently and avionics Impacts, Benefits and Costs of the Final cigarette use in an airplane cabin. do not have to be cleaned as often, Rule Alternatively, some carriers might lift which is one reason that charter flights In general, the impacts of the rule will their prohibitions, which could reduce have opted to prohibit smoking, even be very modest, and generate little in the burden on the minority of the when allowed by law. The American terms of measurable benefits and costs. population that uses e-cigarettes and Aviation Institute, in its comments on There will probably be no change to the whose activities are now restricted. the NPRM, raised the issue of additional current baseline for scheduled However, removing e-cigarette costs due to new placards and passenger operations. The existing restrictions would reduce benefits notification lights, and re-printing of regulation prohibits smoking on such relative to the current baseline by airline manuals.25 These should not be flights and as described above, airlines exposing other passengers and flight significant costs associated with this that provide scheduled passenger crew to secondhand aerosols. final rule since all aircraft are already service treat the smoking ban as Additionally, airlines would probably required to be equipped with no- covering e-cigarettes. Scheduled need to offer additional training to crew smoking signs and lights. Some operations represent roughly 99 percent members and the pre-flight briefing operators may feel the need to update of passenger enplanements and thus, the would have to be longer, to educate and documents used to communicate to rule can do little to impact current explain what, when and where passengers and employees the activities industry practice overall. particular smoking products may and prohibited by law. However, such For charter (nonscheduled) flight may not be used. document update is not a direct operations, the impacts should also be The nonscheduled segment of the requirement of the final rule and would small. Based upon review of carrier Web industry could potentially experience be voluntary on the part of affected sites and their advertisements, charter greater impact than the scheduled airlines. The costs of updating such companies appear to prohibit smoking service segment, because while some materials should be small since most of traditional cigarettes. Operating a charter airlines explicitly prohibit e- charter flights already do not allow nonsmoking airline is less costly, makes cigarette use, the extent to which this smoking and probably have developed accommodating non-smoking patrons in practice is standard or typical is documents in support of their policies. accordance with the law easier, and unknown. However, the widespread In addition, such documents are assists in the receipt of certain safety adoption of an e-cigarette ban on the routinely updated since laws regarding certifications and perhaps the award of part of scheduled service airlines prohibited behaviors and security government contracts that may serve as suggests that implementing an e- concerns are constantly evolving. An useful marketing tools. While it is not cigarette prohibition is not particularly operator could reduce the costs of known with any certainty whether the costly, at least when a general smoking updating documents to reflect changes prohibitions apply to e-cigarette use, the ban is already in place. To the extent as they pertain to smoking by waiting widespread and seamless adoption of e- that e-cigarette use is allowed on charter until there is a more general need for cigarette bans in the scheduled service flights, a ban will add a burden to updating. component of the industry suggests that smoking patrons who will no longer be To the extent that the rule, in effect, extending the prohibitions to e- able to engage in the activity while in expands the existing ban on smoking cigarettes can be accomplished without flight. The burden to smoking patrons (for traditional tobacco products and its too much difficulty or cost. will probably constitute the primary extension to electronic cigarettes), there burden of the rule with respect to e- Including E-Cigarettes in the General could be a cost to operators in the form cigarettes. However, benefits will accrue Smoking Ban: Benefits and Costs of lost revenue or profits due to a to nearby passengers and crew who no As noted above, the inclusion of e- reduction in demand for flights from longer are exposed to secondhand customers who would wish to smoke on cigarettes in the general smoking ban aerosol. will not affect, but will simply reinforce, those flights. Such costs are largely current industry practice in the Implementation of Section 401 of the speculative since they would apply to scheduled service segment of the airline FAA Modernization and Reform Act: operators who allow smoking and industry. Consequently, the final rule Benefits and Costs consumers who chose their particular probably will produce close to zero The rule amends 14 CFR part 252 to flights based primarily on the ability to benefits and zero costs over the current implement section 401 of the FAA smoke; DOT was unable to identify any baseline when considering impacts Modernization and Reform Act and businesses, successful or otherwise, solely to and resulting from scheduled extends the general smoking ban to operating under this model. Given that service providers. The inclusion of e- nonscheduled interstate, intrastate, and smokers will not have a smoking flight cigarettes may potentially have greater foreign passenger air transportation alternative (except perhaps chartering impact on nonscheduled or charter when a flight attendant is required. To their own private flight where a flight service and these potential impacts, as the extent that charter airlines allow attendant is not required), they will well as benefits and costs, are discussed smoking, the final rule will produce need to choose another transportation below. benefits in terms of reduced secondhand mode such as driving to their Conversely, if DOT were to determine exposure to tobacco smoke, and the destination or if an alternative mode is that e-cigarettes were not covered under resulting positive health effects to 25 Comments of the American Aviation Institute the ban, the current industry nonsmoking passengers and flight crew. in the Matter of Smoking of Electronic Cigarettes on environment could be affected, more so Again based upon a review of charter Aircraft, Docket DOT–OST–2011–0044, September than would be expected under this final airline Web sites, most already prohibit 26, 2011.

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not feasible, they would need to choose Alternatives lessen the economic effect of the rule on to not travel at all, if the ability to smoke DOT has identified only one viable small entities. As discussed below, DOT was the primary consideration in their regulatory alternative: A final rule that finds that this final rule will not have decision-making process. Or they might is limited in scope to solely to a significant economic impact on a choose alternate nicotine delivery implementing Section 401 of the FAA substantial number of small entities. For purposes of rules promulgated by systems, such as patches and gum. The Modernization and Reform Act. Such a the Office of the Secretary of lack of flight alternatives coupled with rule would not alter the definition of Transportation regarding aviation the presence of alternative nicotine smoking to cover e-cigarettes. DOT has economic and consumer matters, an delivery systems will likely limit the determined that the alternative of ‘‘no airline is a small entity for purposes of reduction in demand that the small regulatory action’’ (i.e. the status quo) is number of operators who would allow the Regulatory Flexibility Act if it not viable since the Department is provides air transportation only with smoking could experience. In addition, required to implement Section 401 of any reduction in demand from smokers aircraft having 60 or fewer seats and no the FAA Modernization and Reform more than 18,000 pounds payload may, to some extent, be offset by Act, at a minimum. increased demand from non-smokers. capacity. Referring to Table A.1, this Restricting the rule to Section 401 final rule applies to 63 (15 + 48) small Comparison of Costs to Benefits implementation would represent the U.S. carriers.27 Of these small carriers, minimum regulatory action that the Due to the inability to identify any 50 (13 + 37), or about 79 percent, Department could undertake. To the provide scheduled service and are specific carrier that would need to extent that smoking of traditional change its current practices subject to the general smoking ban. As cigarettes is occurring on nonscheduled noted above, scheduled service significantly, DOT was unable to interstate, intrastate, and foreign quantify the costs and the benefits of the providers have overwhelmingly adopted passenger air transportation when a prohibitions on e-cigarette use. DOT is rule, but believes both are probably very flight attendant is a required crew small. The overwhelming majority of unaware of any small scheduled service member, there would still be some carrier that would need to change its e- passengers travel on scheduled service benefits related to reduced secondhand where smoking, including the use of e- cigarette policy in response to this final smoke exposure from traditional rule. In addition, the widespread cigarettes, is already prohibited. If cigarettes. smoking were to be allowed on industry ban on e-cigarettes suggests This alternative would continue to that it is quite easy to cover e-cigarettes nonscheduled flights, benefits of a ban allow airlines to develop their own would include reductions in potential once a smoking ban is in place. Thus, policies regarding use of e-cigarettes, it is expected that the typical small exposure to secondhand smoke for allowing them to change their current passengers and crewmembers. scheduled service airline will policies if they desire. If a carrier chose experience no impacts due to this rule. Expanding the ban on smoking to cover to change its policy, this would expose e-cigarettes could reduce health hazards The remaining 13 (2 + 11) small passengers and crewmembers to airlines, or roughly 21 percent, provide related to secondhand exposure to potentially harmful health risks. Also, exhaled aerosols. The costs to operators nonscheduled or charter services. Based any change in policy to allow for the use upon a review of their individual Web should be minimal, but some passengers of e-cigarettes would require flight could experience some costs due to a sites, none of these carriers cater their attendants to distinguish among various businesses to smoking patrons (smokers reduced opportunity to smoke. cigarettes and devices to determine The risks and resulting adverse health of either traditional or e-cigarettes). As which are acceptable. For example, the noted above, providers of charter consequences associated with Air Line Pilots Association (ALPA) secondhand exposure to tobacco smoke airplane service have several incentives noted in their comments the possibility to prohibit smoking of traditional are well-documented.26 Existing of passenger and crewmember cigarettes, including lower operating evidence indicates that e-cigarettes may confusion in differentiating e-cigarettes costs, ease of accommodating also have adverse health impacts, not from tobacco cigarettes, as the two nonsmoking patrons, and meeting the just for users, but for those nearby. products can be difficult to distinguish standards necessary for receipt of safety Those seated next to users may not want from each other. In addition, carriers certifications and government contracts. to expose themselves (or their babies or that do not change their policies could In addition, several of the small charter older children) to the risks of these incur new costs due to the need to more airlines have fleets that consist of adverse health impacts and at least actively enforce their prohibitions. This extremely small aircraft (i.e. Cessnas or some crewmembers may prefer to work could occur if some consumers other planes that seat fewer than 10 in an environment free of these risks mistakenly interpret the lack of a federal passengers), and smoking is already since they fly far more frequently than prohibition as ensuring their right to banned on these aircraft (see existing most passengers. Due to the involuntary engage in e-cigarette use in an airplane section 252.13). Moreover, some of these nature of the risk of secondhand cabin. For these reasons, DOT rejected companies provide medical exposure, the Department believes that this alternative. transportation services, which is likely it is prudent to give greater weight to the at odds with a permissive smoking potential benefits of the rule than to the B. Regulatory Flexibility Analysis policy. While it is not known with any inconvenience costs incurred by DOT has examined the economic certainty whether these factors also smoking passengers or any small implications of this final rule for small represent incentives to restrict e- incremental costs incurred by airline entities as required by the Regulatory cigarette use, the swift adoption of e- operators. Flexibility Act (5 U.S.C. 601 et seq.). cigarette bans in the scheduled service Unless an agency determines that a rule component of the industry suggests that 26 See, for example: http://www.cdc.gov/tobacco/ is not expected to have a significant extending the prohibitions to e- data_statistics/fact_sheets/secondhand_smoke/ economic impact on a substantial health_effects// ; http://www.lung.org/stop- smoking/smoking-facts/health-effects-of- number of small entities, the Regulatory 27 RFA analysis is typically limited to domestic secondhand-smoke.html?referrer=https:// Flexibility Act requires the agency to firms because SBA guidelines and definitions www.google.com/ analyze regulatory options that would pertain to U.S.-based entities.

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cigarettes can be accomplished without Policy Act of 1969 (NEPA) (42 U.S.C. amended by section 708 of Pub. L. 106–181 too much difficulty or cost once a ban 4321 et seq.) and has determined that it and section 401 of Pub. L. 112–95, 41711, on smoking is already in place. is categorically excluded pursuant to and 46301. For the reasons described about, the DOT Order 5610.1C, Procedures for ■ 2. Section 252.1 is revised to read as final rule is unlikely to produce a Considering Environmental Impacts (44 follows: significant financial impact on any FR 56420, Oct. 1, 1979). Categorical § 252.1 Purpose. small carrier, and probably will not exclusions are actions identified in an affect their operations in any agency’s NEPA implementing This part implements a ban on meaningful way. Therefore, the procedures that do not normally have a smoking as defined in § 252.3, including Secretary of Transportation certifies that significant impact on the environment the use of electronic cigarettes and the final rule will not have a significant and therefore do not require either an certain other devices, on flights by air economic impact on a substantial environmental assessment (EA) or carriers and foreign air carriers. number of small entities. environmental impact statement (EIS). ■ 3. Section 252.2 is revised to read as follows: C. Executive Order 13132 (Federalism) See 40 CFR 1508.4. In analyzing the applicability of a categorical exclusion, This final rule has been analyzed in § 252.2 Applicability. the agency must also consider whether This part applies to operations of air accordance with the principles and extraordinary circumstances are present criteria contained in Executive Order carriers engaged in interstate, intrastate that would warrant the preparation of and foreign air transportation and to 13132 (‘‘Federalism’’). This regulation an EA or EIS. Id. Paragraph 3.c.6.i of has no substantial direct effects on the foreign air carriers engaged in foreign air DOT Order 5610.1C categorically transportation. States, the relationship between the excludes ‘‘[a]ctions relating to consumer ■ 4. Section 252.3 is revised to read as national government and the States, or protection, including regulations.’’ The follows: the distribution of power and purpose of this rulemaking is to extend responsibilities among the various the smoking ban in 14 CFR part 252 to § 252.3 Definitions. levels of government. It does not contain include all charter flights where a flight As used in this part: any provision that imposes substantial attendant is a required crewmember and Air carrier means a carrier that is a direct compliance costs on State and to ban the use of e-cigarettes. The citizen of the United States undertaking local governments. It does not contain Department does not anticipate any to provide air transportation as defined any provision that preempts state law, environmental impacts, and there are no in 49 U.S.C. 40102. because states are already preempted extraordinary circumstances present in Foreign air carrier means a carrier that from regulating in this area under the connection with this rulemaking. is not a citizen of the United States Airline Deregulation Act, 49 U.S.C. undertaking to provide foreign air G. Unfunded Mandates Reform Act 41713. Therefore, the consultation and transportation as defined in 49 U.S.C. funding requirements of Executive The Department analyzed the final 40102. Order 13132 do not apply. rule under the factors in the Unfunded Smoking means the use of a tobacco D. Executive Order 13084 Mandates Reform Act of 1995. The product, electronic cigarettes whether or Department considered whether the rule not they are a tobacco product, or This rule has been analyzed in includes a federal mandate that may similar products that produce a smoke, accordance with the principles and result in the expenditure by State, local, mist, vapor, or aerosol, with the criteria contained in Executive Order and tribal governments, in the aggregate, exception of products (other than 13084 (‘‘Consultation and Coordination or by the private sector, of $100,000,000 electronic cigarettes) which meet the with Indian Tribal Governments’’). or more (adjusted annually for inflation) definition of a medical device in section Because none of the measures in the in any one year. The Department has 201(h) of the Federal Food, Drug and rule will significantly or uniquely affect determined that this final rule will not Cosmetic Act, such as nebulizers. the communities of the Indian tribal result in such expenditures. ■ 5. Section 252.4 is added to read as governments or impose substantial Accordingly, this final rule is not follows: direct compliance costs on them, the subject to the Unfunded Mandates funding and consultation requirements Reform Act. § 252.4 Smoking ban: air carriers. of Executive Order 13084 do not apply. Air carriers shall prohibit smoking on List of Subjects in 14 CFR Part 252 E. Paperwork Reduction Act the following flights: Air carriers, Aircraft, Consumer (a) Scheduled passenger flights. Under the Paperwork Reduction Act, protection, Smoking. (b) Nonscheduled passenger flights, before an agency submits a proposed except for the following flights where a collection of information to OMB for Issued in Washington, DC, on February 19, 2016 under authority delegated in 49 CFR flight attendant is not a required approval, it must publish a document in 1.27(n). crewmember on the aircraft as the Federal Register providing notice of Kathryn B. Thomson, determined by the Administrator of the and a 60-day comment period on, and General Counsel. Federal Aviation Administration: otherwise consult with members of the (1) Single entity charters. public and affected agencies concerning, For the reasons stated in the (2) On-demand services of air taxi each proposed collection of information. preamble, the Office of the Secretary of operators. This rule imposes no new information Transportation amends 14 CFR part 252 (c) Nothing in this section shall be reporting or record keeping as set forth below: deemed to require air carriers to permit necessitating clearance by the Office of smoking aboard aircraft. Management and Budget. PART 252—[AMENDED] ■ 6. Section 252.5 is revised to read as follows: F. National Environmental Policy Act ■ 1. The authority citation for 14 CFR The Department has analyzed the part 252 is revised to read as follows: § 252.5 Smoking ban: foreign air carriers. environmental impacts of this final rule Authority: Pub. L. 101–164; 49 U.S.C. (a)(1) Foreign air carriers shall pursuant to the National Environmental 40102, 40109, 40113, 41701, 41702, 41706 as prohibit smoking on flight segments that

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occur between points in the United DEPARTMENT OF HEALTH AND submit product information concerning States, and between the United States HUMAN SERVICES devices to FDA’s Global Unique Device and any foreign point, in the following Identification Database (GUDID). The types of operations: Food and Drug Administration final rule incorporated a direct avenue (i) Scheduled passenger foreign air for the labeler to communicate with 21 CFR Parts 801 and 830 FDA’s GUDID via a UDI email address. transportation. [Docket No. FDA–2011–N–0090] This rule updates §§ 801.55(b)(2), (ii) Nonscheduled passenger foreign 801.57(c)(2), and 830.110(a) by air transportation, if a flight attendant is Unique Device Identification System; replacing the old email address with a a required crewmember on the aircraft Editorial Provisions; Technical new one. as determined by the Administrator of Amendment List of Subjects the Federal Aviation Administration or a foreign carrier’s government. AGENCY: Food and Drug Administration, 21 CFR Part 801 HHS. (2) Nothing in this section shall be Labeling, Medical devices, Reporting ACTION: Final rule; technical deemed to require foreign air carriers to and recordkeeping requirements. amendment. permit smoking aboard aircraft. 21 CFR Part 830 (b) A foreign government objecting to SUMMARY: The Food and Drug Administration (FDA or Agency) is Administrative practice and the application of paragraph (a) of this procedure, Incorporation by reference, section on the basis that paragraph (a) amending the Unique Device Identification (UDI) System regulation Labeling, Medical devices, Reporting provides for extraterritorial application and recordkeeping requirements. of the laws of the United States may to make editorial changes. This technical amendment updates the email Therefore, under the Federal Food, request and obtain a waiver of Drug, and Cosmetic Act and under paragraph (a) from the Assistant address associated with FDA’s UDI system, which allows FDA to obtain authority delegated to the Commissioner Secretary for Aviation and International information and offer support and of Food and Drugs, 21 CFR parts 801and Affairs, provided that an alternative assistance on medical devices through 830 are amended as follows: smoking prohibition resulting from their distribution and use, ensuring PART 801—LABELING bilateral negotiations is in effect. consistency with the requirements in § 252.7 [Removed] the Federal Food, Drug, and Cosmetic ■ 1. The authority citation for 21 CFR Act (the FD&C Act). This change is part 801 continues to read as follows: ■ 7. Section 252.7 is removed. necessary to ensure that the UDI team continues to maintain regular email Authority: 21 U.S.C. 321, 331, 351, 352, ■ 8. Section 252.8 is revised to read as 360i, 360j, 371, 374. communications with device labelers. follows: DATES: This rule is effective March 4, ■ 2. In § 801.55, revise paragraph (b)(2) § 252.8 Extent of smoking restrictions. 2016. to read as follows: The restrictions on smoking described FOR FURTHER INFORMATION CONTACT: § 801.55 Request for an exception from or in §§ 252.4 and 252.5 shall apply to all Adaeze Teme, Center for Devices and alternative to a unique device identifier locations within the aircraft. Radiological Health, Food and Drug requirement. Administration, 10903 New Hampshire * * * * * §§ 252.13 and 253.15 [Removed] Ave., Bldg. 66, Rm. 5574, Silver Spring, (b) * * * MD 20993–0002, 240–402–0768. (2) In all other cases, by email to: ■ 9. Sections 252.13 and 253.15 are SUPPLEMENTARY INFORMATION: FDA is [email protected], or by removed. updating the UDI email address in the correspondence to: UDI Regulatory ■ 10. Section 252.17 is revised to read following regulations that set forth the Policy Support, Center for Devices and as follows: procedures for notifying the Agency Radiological Health, Food and Drug when: (1) Requesting an exception from Administration, 10903 New Hampshire § 252.17 Enforcement. or alternative to a unique device Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993–0002. Air carriers and foreign air carriers identifier requirement (§ 801.55 (21 CFR shall take such action as is necessary to 801.55)); (2) requesting continued use of * * * * * ensure that smoking by passengers or legacy FDA identification numbers ■ 3. In § 801.57, revise the second crew is not permitted where smoking is assigned to devices (§ 801.57 (21 CFR sentence of paragraph (c)(2) to read as 801.57)); and (3) applying for prohibited by this part, including but follows: accreditation as an issuing Agency not limited to aircraft lavatories. (§ 830.110 (21 CFR 830.110)). § 801.57 Discontinuation of legacy FDA identification numbers assigned to devices. § 252.19 [Removed] Specifically, the Agency is removing an old email address and replacing it * * * * * ■ 11. Section 252.19 is removed. with a new one, thereby maintaining (c) * * * [FR Doc. 2016–04799 Filed 3–3–16; 8:45 am] consistency with the requirements of (2) **** A request for continued use of an assigned labeler code must be BILLING CODE 4910–9X–P the FD&C Act (21 U.S.C. 321 et seq.). In the Federal Register of September submitted by email to: GUDIDSupport@ 24, 2013 (78 FR 58786), FDA issued a fda.hhs.gov, or by correspondence to: final rule to establish a system to UDI Regulatory Policy Support, Center adequately identify devices through for Devices and Radiological Health, distribution and use. The rule required Food and Drug Administration, 10903 the label of medical devices to include New Hampshire Ave., Bldg. 66, Rm. a UDI, except where an exception or 3303, Silver Spring, MD 20993–0002. alternative applies. The labeler must * * * * *

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