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Home My WebLink AboutOrdinance No. 2780-2014CITY OF KENAI ORDINANCE NO. 2780 -2014 Suggested by: Mayor Porter AN ORDINANCE OF THE COUNCIL OF THE CITY OF KENAI, ALASKA, AMENDING KMC 12.40.010- DEFINITIONS, TO INCLUDE AND REGULATE THE USE OF ELECTRONIC CIGARETTES AND THE SMOKING OF NON - TOBACCO PLANT BASED MATERIALS THE SAME AS THE CITY CURRENTLY REGULATES SMOKING TOBACCO. WHEREAS, Kenai Municipal Code Chapter 12.40 - Regulation of Smoking, currently regulates smoking tobacco products but does not specifically address use of electronic cigarettes or smoking other non - tobacco substances; and, WHEREAS, use of electronic cigarettes has noticeably increased recently; and, WHEREAS, the safety of electronic cigarettes and associated vapor to the user and third parties is disputed; and, WHEREAS, the US Food and Drug Administration is moving towards regulation of e- cigarettes, but does not currently regulate them; and, WHEREAS, the use of electronic cigarettes in restaurants and other places where cigarette smoking is currently prohibited can be concerning and distracting to other patrons; and, WHEREAS, many other municipalities across the country are regulating electronic cigarettes the same or similar to tobacco cigarettes; and, WHEREAS, it is important to protect the public that chooses not to ingest certain products from any substance, whether tobacco or other plant matter, that is exhaled and may be inhaled by third parties; and, WHEREAS, like the smoking of tobacco, passage of this Ordinance would prohibit use of electronic cigarettes and the smoking of other plant based matter, in and within specified distances of indoor eating establishments, bowling alleys, businesses and outdoor areas posted as no smoking, as well as healthcare facilities. NOW, THEREFORE, BE IT ORDAINED BY THE COUNCIL OF THE CITY OF KENAI, ALASKA, that Section 1. Form: That this is a code ordinance New Text Underlined; [DELETED TEXT BRACKETED] Ordinance No. 2780 -2014 Page 2 of 3 Section 2. Amendment of Section 12.40.010 of the Kenai Municipal Code: That Kenai Municipal Code, Section 12.40.010 - Definitions, is hereby amended as follows: 12.40.010 Definitions. "Bar" means a premises licensed under AS 04.11.090 which does not employ any person under the age of twenty-one (21) and which does not serve any person under the age of twenty-one (21) unless accompanied by a parent or guardian, and where tobacco smoke cannot filter into any other area where smoking is prohibited through a passageway, ventilation system or other means. A "bar" does not include areas in an eating establishment where alcoholic beverages may be served. "Business" means any legal entity, whether for profit or not for profit, that provides goods or services, including, but not limited to, a sole proprietorship, partnership, limited liability company, corporation, trust, membership organization or similar entity. "Eating establishment" means any restaurant, coffee shop, cafeteria, luncheonette, sandwich stand, soda fountain, private or public school cafeteria, fast food service and other establishments, including any bar area of any such establishment which is not an enclosed area, the primary purpose of which is to give or offer for sale food to the public and where cooked or otherwise prepared food is sold to the public for consumption on the premises, as well as kitchens in which food is prepared. "Electronic cigarette" means any electronically actuated device which in device, whether manufactured, distributed marketed or sold as an electronic "Enclosed area" means a ventilated area so that air from a smoking area is not drawn into or across the nonsmoking area where all space between a floor and ceiling is enclosed on all sides by solid walls or windows, exclusive of doors or passage ways, which extend from the floor to the ceiling, including all space therein screened by partitions which do not extend between the floor and ceiling or are not solid. The doors of an enclosed area should remain closed whenever practicable. "Health care facility" means a business, office or institution that provides medical or mental health treatment. "Operator" means and includes the owner, proprietor, manager, lessee, lessor, licensee or any other person exercising control over any eating establishment, business or bar. "Smoking" means either (11 the burning, inhaling or exhaling of a tobacco or inhaling or exhaling of other plant based material or carrying any lighted pipe, cigar, cigarette or other combustible substance that is intended to be inhaled in any manner or in any form; or (21 the use of any electronic cigarette Section 3. Severability: That if any part or provision of this ordinance or application thereof to any person or circumstances is adjudged invalid by any court of competent New Text Underlined; [DELETED TEXT BRACKETED] Ordinance No. 2780 -2014 Page 3 of 3 jurisdiction, such judgment shall be confined in its operation to the part, provision, or application directly involved in all controversy in which this judgment shall have been rendered, and shall not affect or impair the validity of the remainder of this title or application thereof to other persons or circumstances. The City Council hereby declares that it would have enacted the remainder of this ordinance even without such part, provision, or application. Section 4. Effective Date: That pursuant to KMC 1.15.070(fl, this ordinance shall take effect 30 days after adoption. PASSED BY THE COUNCIL OF THE CITY OF KENAI, ALASKA, this 20th day of August, 2014. ATT Sandy odi , Ci Clerk Introduced: July 2, 2014 Adopted: August 20, 2014 Effective: September 19, 2014 New Text Underlined; [DELETED TEXT BRACKETED] u "Villaye with a Past, C# tvith a Future" 210 Fidalgo Avenue, Kenai, Alaska 99611 -7794 Telephone: 907 - 283 -7535 / FAX: 907 - 283 -3014 MEMORANDUM TO: City Councilors FROM: Mayor Porter DATE: June 26, 2014 SUBJECT: Ordinance No. 2780 -2014, E- Cigarettes The City currently regulates where tobacco cigarettes can be smoked in public as well as in certain private establishments such as restaurants and healthcare facilities. Electronic cigarettes, which involve vaporizing certain substances, have become more noticeable and popular. Many municipalities and airlines across the country already regulate electronic cigarettes the same as tobacco. The FDA does not regulate electronic cigarettes but is in the process of doing so. The safety of these devices to the user and third party is contested and debated. However, until and unless it is conclusively determined that electronic cigarettes are safe with regards to second hand "smoke" I strongly believe the City should protect its residents the same as they are protected from second hand smoke from tobacco. I have also included in this Ordinance a reference to smoking other plant based material. Again, like with electronic cigarettes this is a proactive measure to protect non - smokers from those who choose to smoke, whether it is tobacco or some other substance such as marijuana. With the upcoming vote on Ballot Measure 2, An Act to Tax and Regulate the Production, Sale, and Use of Marijuana, this Ordinance is timely. This Ordinance would not interfere with any state or federal regulation regarding electronic cigarettes or marijuana, as it does not make either permissible or impermissible, but only prohibits their use in certain places, the same as tobacco is regulated. Your consideration is appreciated. YACity Council\Memorandums\2014 0626 E- Cigarettes Memo.docx THE STATE °fALASKA GOVERNOR SEAN PARNELL Electronic Cigarette and Aerosol Emissions Product Update and Position Department of Health and Social Services DIVISION OF PUBLIC HEALTH Director's Office 3601 C Street, Suite 756 Anchorage, Alaska 995035924 Main: 907.269.8126 Fax: 907.269.2048 Electronic cigarettes (e- cigarettes, a -cigs, e- hookah or vape pens) are marketed by the Tobacco Industry and other manufacturers as a new nicotine delivery system. These battery- powered devices heat nicotine, flavor additives and other chemicals, to produce an aerosol inhaled by the user. Their production is unregulated and varies widely - recent research and consumer experience reflect questionable product quality, content and safety.' With only limited research to date, the presence of toxins and cancer - causing agents as well as the health effects of their use are not yet fully known. Chemical and Toxin Emissions in E- Cigarette Aerosol • E- cigarettes do not just emit "harmless water vapor." Secondhand e- cigarette aerosol (incorrectly called vapor by the industry) contains nicotine, ultrafine particles and low levels of toxins that are known to cause cancer .2 The FDA's initial investigation into the content of e- cigarettes found the aerosol potentially hazardous to the public's health due to tobacco - specific nitrosamines and other volatile organic compounds.3 • Studies have shown the presence of heavy metals and carcinogens in e- cigarette aerosol. "•5,6 • Propylene glycol, a chemical that is used as a base in e- cigarette solution, is one of the primary components in the aerosol emitted by e- cigarettes. • Short term exposure causes eye, throat and airway irritation! • Long term inhalation exposure can result in children developing asthma.s • Because they look like traditional cigarettes and emit the aerosol, e- cigarettes have the potential to negatively impact social norms and make smokefree workplace policies harder to enforce. In some states and communities, the public is being protected from potential health harms through local ordinances and regulations prohibiting e- cigarette use in indoor environments. Industry Marketing and the Rise in Youth E- Cigarette Use • The U.S. Food and Drug Administration (FDA) does not currently regulate these products. • Marketers use child - friendly flavors such as "Gumi Bean" or "Mount N' Do "9, themes of rebellion, and celebrity endorsements - strategies long used to market traditional cigarettes to children. • Sales of e- cigarettes in the U.S. have doubled since 2011 to $1.7 billion in 2013.3 • Although youth smoking rates have decreased, ecigarette use has risen across the U.S. and, alarmingly, doubled among middle and high school students between 2011 and 2012.10 m ■ Eknrom� 16 I.5 21 u,Pn 14 11 q 10 a6 8 6 0.6 2 9 2011 2012 1011 1012 Nid9•Sdwd HeA.sd W Suwd SmdenH Use of Cigarettes and Electronic Cigarettes by U.S. Students in 2011 and 2012. Data are from the Centers for Disease Control and Prevention Electronic Cigarette and Aerosol Emissions Product Update and Position Page 2 Lack of Reliability, Safety Require Regulation and Extensive Research E- cigarettes contain varying levels of nicotine - a tobacco - derived product — which can initiate and/or prolong nicotine addiction.1 • These unregulated products may provide uncontrolled doses of nicotine and other harmful chemicals - users have no way of being certain how much is being inhaled or exhaled. I I • Ingestion or skin contact with nicotine solution from a cartridge can lead to nicotine poisoning and can be deadly, especially to children and animals. Accidental nicotine poisonings and lethal doses are a serious concern because the refill "juice" is not sold in child - resistant containers. • Dozens of Alaskan youth are treated for nicotine poisoning every year. 12 • Nicotine affects the nervous system and heart, and can negatively affect the developing brain. It should not be made available to minors. E- Cigarettes are Not an FDA- approved Cessation Device • The FDA has not approved e- cigarettes as an effective method to help smokers quit. • FDA- approved tobacco cessation products provide controlled doses of nicotine and have been tested and regulated as cessation products. • Alaska's Tobacco Quit Line is a free service for all Alaskans ready to quit tobacco. Counseling and FDA - approved Nicotine Replacement Therapies, when used in combination, have been shown to be a safe and effective way to quit. Call 1 -800 QUIT NOW or visit www.alaskaguitline.com to enroll today. Alaska has seen tremendous progress in reducing smoking but we must remain ever vigilant to protect our young people. Because they are unregulated, the e- cigarette industry has grown markedly over the last few years using old tactics like celebrities to promote and glamorize their use, addicting those most impressionable. More research is needed on the long- term health effects, but we can take steps today to protect our young people. Ward B. Hurlburt, M.D., MPH Chief Medical Officer, Alaska Department of Health and Social Services May 21, 2014 'US Food and Drug Administration Evaluation of e- cigarettes. 2009. Available at: htta:/ /www fda cov/ downloads / Drugs /ScienceResearch /UCM1732S0 odf. Accessed March 4, 2014 ' Grana, R; Benowitz, N; Glantz, S. "Background Paper on E- cigarettes," Center for Tobacco Control Research and Education, University of California, San Francisco and WHO Collaborating Center an Tobacco Control. December 2013. ' Fairchild, Amy L PhD, MPH, Sayer, Ronald PhD, Colgrove, James PhD, MPH, New England Journal of Medicine January 23, 2014; 370:293 -295. Accessed from: http:/ /www neim.org/doi(fii!!LI—O 305UNEJMp1313940?oue TOC& ` Williams, M, Villarreal, A, Bozhilov, K, Lin, S, Talbot, P. Metal and silicate particles including nanoparticies are present in electronic cigarette cartomlzer fluid and aerosol. PLaS ONE. Sept. 2013. s Goniewiu, ML, Knysak, J, Gawron, M, et al. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tobacco Control. 2013. 6 Schripp, T, Markewitz, D, Uhde, E, Salthammer, T. Does e- cigarette consumption cause passive vaping? Indoor Air. 2013. ' Wieslander, G; Norblick, D; Lindgren, T. "Experimental exposure to propylene glycol mist in aviation emergency training: acute ocular and respiratory effects." Occupational and Environmental Medicine 58:10 649 -655, 2001. ° Choi, H; Schmidbauer,N; Spengler,J; Bornehag, C., "Sources of Propylene Glycol and Glycol Ethers in Air at Home," Internationallournal of Environmental Research and Public Health 7(12):4213-4237, December 2010. ' Fatboy Vapors: eUquid Menu http:l/www .fatbowaporsalaska.com/4leliquid-2/`cldy g 10 Centers for Disease Control and Prevention. Tobacco Product Use Among Middle and High School Students —United States, 2011 and 2012. Morbidity and Mortality Weekly Report 2013;62(45):893 -7 [accessed 2014 Feb 141. U.S. Food and Drug Administration. "FDA and Public Health Experts Warn About Electronic Cigarettes." July 22, 2009. Available at: to: / /www fda Alaska Poison Control System, AMERICANS FOR NONSMOKERS' RIGHTS Defending your right to breathe smokefree air since 1976 Electronic (e -) Cigarettes and Secondhand Aerosol "7f you are around somebody who is using e- cigarettes, you are breathing an aerosol of exhaled nicotine, ultra -fine particles, volatile organic compounds, and other toxins," Dr. Stanton Glantz, Director for the Center for Tobacco Control Research and Education at the University of California, San Francisco. Current Legislative Landscape • As of January 2, 2014, 108 municipalities and three states include e- cigarettes as products that are prohibited from use in smokefree environments. Constituents of Secondhand Aerosol E- cigarettes do not just emit "harmless water vapor." Secondhand e- cigarette aerosol (incorrectly called vapor by the industry) contains nicotine, ultrafine particles and low levels of toxins that are known to cause cancer. • E- cigarette aerosol is made up of a high concentration of ultrafine particles, and the particle concentration is higher than in conventional tobacco cigarette smoke.' • Exposure to fine and ultrafine particles may exacerbate respiratory ailments like asthma, and constrict arteries which could trigger a heart attack .2 At least 10 chemicals identified in e- cigarette aerosol are on California's Proposition 65 list of carcinogens and reproductive toxins, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986. The compounds that have already been identified in mainstream (MS) or secondhand (SS) e- cigarette aerosol include: Acetaldehyde (MS), Benzene (SS), Cadmium (MS), Formaldehyde (MS,SS), Isoprene (SS), Lead (MS), Nickel (MS), Nicotine (MS, SS), N- Nitrosonornicotine (MS, SS), Toluene (MS, SS) .3A • E- cigarettes contain and emit propylene glycol, a chemical that is used as a base in e- cigarette solution and is one of the primary components in the aerosol emitted by e- cigarettes. • Short term exposure causes eye, throat, and airway irritation.' • Long term inhalation exposure can result in children developing asthma .6 • Even though propylene glycol is FDA approved for use in some products, the inhalation of vaporized nicotine in propylene glycol is not. Some studies show that heating propylene glycol changes its chemical composition, producing small amounts of propylene oxide, a known carcinogen.' • There are metals in e- cigarette aerosol, including chromium, nickel, and tin nanoparticles.8 • FDA scientists found detectable levels of carcinogenic tobacco - specific nitrosamines in e- cigarette aerosol.9 2530 San Pablo Avenue, Suite J . Berkeley, California 94702 . (510) 841 -3032 / FAX (510) 841 -3071 www.no- smoke.org . am @no - smoke.org • People exposed to e- cigarette aerosol absorb nicotine (measured as cotinine), with one study showing levels comparable to passive smokers.10 • Diethylene Glycol, a poisonous organic compound, was also detected in e- cigarette aerosol." • Exhaled e- cigarette aerosol contained propylene glycol, glycerol, flavorings, and nicotine, along with acetone, formaldehyde, acetaldehyde, propanal, diacetin, and triacitine.12 • Many of the elements identified in the aerosol are known to cause respiratory distress and disease. The aerosol contained particles >1 pm comprised of tin, silver, iron, nickel, aluminum, and silicate and nanoparticles ( <100 nm) of tin, chromium and nickel. The concentrations of nine of eleven elements in e- cigarette aerosol were higher than or equal to the corresponding concentrations in conventional cigarette smoke.73 • E- cigarettes cause exposure to different chemicals than found in conventional cigarettes and there is a need for risk evaluation for both primary and passive exposure to the aerosol in smokers and nonsmokers. 14 • Short tens use of e- cigarettes has been shown to increase respiratory resistance and impair lung function, which may result in difficulty breathing. 15 • Overall, e- cigarettes are a new source of Volatile Organic Compounds (VOCs) and ultrafine /fine particles in the indoor environment, thus resulting in "passive vaping. "" E- cigarette aerosol is a new source of pollution and toxins being emitted into the environment. We do not know the long -term health effects of e- cigarette use and although the industry marketing of the product implies that these products are harmless, the aerosol that e- cigarettes emit is not purely water vapor. May be reprinted with appropriate attribution to Americans for Nonsmokers' Rights, © 2014 REFERENCES 1 Fuoco, F.C.; Buonanno, G.; Stabile, L.; Vigo, P., "Influential parameters on Particle concentration and size distribution in the mainstream of e- cigarettes " Environmental Pollution 184: 523 -529, January 2014. z Grana, R; Benowitz, N; Glantz, S. "Background Paper on E- cigarettes " Center for Tobacco Control Research and Education, University of California, San Francisco and WHO Collaborating Center on Tobacco Control. December 2013. 3 Goniewicz, M.L.; Knysak, J.; Gawron, M.; Kosmider, L.; Sobczak, A.; Kurek, J.; Prokopowicz, A.; Jablonska - Czapla, M.; Rosik - Dulewska, C.; Havel, C.; Jacob, P.; Benowitz, N., "Levels of selected carcinogens and toxicants in vapour from electronic cigarettes." Tobacco Control [Epub ahead of print], March 6, 2013. 4 Williams, M.; Villarreal, A.; Bozhilov, K.; Lin, S.; Talbot, P., "Metal and silicate particles including nanoparticles are present in electronic cigarette cartomizer fluid and aerosol " PLoS ONE8(3): e57987, March 20, 2013. s Wieslander, G; NorWck, D; Lindgren, T. "Experimental exposure to propylene glycol mist in aviation emergency training acute ocular and respiratory effects." Occupational and Environmental Medicine 58:10 649 -655, 2001. 6 Choi, H; Schmidbauer,N; Spengler,J; Bornehag, C., "Sources of Propylene Glycol and Glycol Ethers in Air at Home," Internotionallournal of Environmental Research and Public Health 7(12): 4213 -4237, December 2010. r Henderson, TR; Clark, CR; Marshall, TC; Hanson, RL; & Hobbs, CH. "Heat degradation studies of solar heat transfer fluid" Solar Energy, 27, 121 -128. 1981. 2 8 Williams, M.; Villarreal, A.; Bozhilov, K.; Lin, S.; Talbot, P., "Metal and silicate Particles including nanoparticles are present in electronic cigarette cartomizer fluid and aerosol," PLoS ONE8(3): e57987, March 20, 2013. 9 Westenberger, B.1., "Evaluation of e- cigarettes " St. Louis, MO: U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, May 4, 2009. 10 Flouris, A.D.; Chorti, M.S.; Poulianiti, K.P.; Jamurtas, A.Z.; Kostikas, K.; Tzatzarakis, M.N.; Wallace, H.A.; Tsatsaki, A.M.; Koutedakis, Y., "Acute impact of active and Passive electronic cigarette smoking on serum cotinine and lung function.'. Inhalation Toxicology 25(2): 91 -101, February 2013. 11 Westenberger, B.1., "Evaluation of e- cigarettes " St. Louis, MO: U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, May 4, 2009. 12 Schripp, T.; Markewitz, D.; Uhde, E.; Salthammer, T., "Does e- cigarette consumption cause Passive vaping7 " Indoor Air 23(1): 25 -31, February 2013. 13 Williams, M.; Villarreal, A.; Bozhilov, K.; Lin, S.; Talbot, P., "Metal and silicate particles including nanoparticles are present in electronic cigarette cartomizer fluid and aerosol," PLoS ONE8(3): e57987, March 20, 2013. 1° Pellegrino, R.M.; Tinghino, B.; Mangiaracina, G.; Marani, A.; Vitah, M.; Protano, C.; Osborn, J.F.; Cattaruzza, M.S., "Electronic cigarettes an evaluation of exposure to chemicals and fine particulate matter (PM)," Annali Di Igiene 24(4):279 -88, July- August 2012. 1s Vardavas, C.I.; Anagnostopoulos, N.; Kougias, M.; Evangelopoulou, V.; Connolly, G.N.; Behrakis, P.K., "Short -term Pulmonary effects of using an electronic cigarette: impact on resoiratory flow resistance impedance and exhaled nitric owde," Chest 141(6): 1400 -1406, June 2012. 16 Schripp, T.; Markewitz, D.; Uhde, E.; Salthammer, T., "Does e- cigarette consumption cause passive vaping? " Indoor Air 23(1): 25 -31, February 2013. 1402 [FS -39] Press Release Embargoed until 1 p.m. ET Contact: CDC Media Relations Thursday, April 3, 2014 (404) 639 -3286 New CDC study finds dramatic increase in e- cigarette - related calls to poison centers Rapid rise highlights need to monitor nicotine exposure through e- cigarette liquid and prevent future poisonings The number of calls to poison centers involving e- cigarette liquids containing nicotine rose from one per month in September 2010 to 215 per month in February 2014, according to a CDC study published in today's Morbidity and Mortality Weekly Report. The number of calls per month involving conventional cigarettes did not show a similar increase during the same time period. More than half (51.1 percent) of the calls to poison centers due to e- cigarettes involved young children 5 years and under, and about 42 percent of the poison calls involved people age 20 and older. The analysis compared total monthly poison center calls involving e- cigarettes and conventional cigarettes, and found the proportion of e- cigarette calls jumped from 0.3 percent in September 2010 to 41.7 percent in February 2014. Poisoning from conventional cigarettes is generally due to young children eating them. Poisoning related to e- cigarettes involves the liquid containing nicotine used in the devices and can occur in three ways: by ingestion, inhalation or absorption through the skin or eyes. "This report raises another red flag about e- cigarettes — the liquid nicotine used in e- cigarettes can be hazardous," said CDC Director Tom Frieden, M.D., M.P.H. "Use of these products is skyrocketing and these poisonings will continue. E- cigarette liquids as currently sold are a threat to small children because they are not required to be childproof, and they come in candy and fruit flavors that are appealing to children." E- cigarette calls were more likely than cigarette calls to include a report of an adverse health effect following exposure. The most common adverse health effects mentioned in e- cigarette calls were vomiting, nausea and eye irritation. DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR DISEASE CONTROL AND PREVENTION 3aC SAFER -HEALTH I ER- PEOPLE' Data for this study came from the poison centers that serve the 50 states, the District of Columbia, and U.S. Territories. The study examined all calls reporting exposure to conventional cigarettes, e- cigarettes, or nicotine liquid used in e- cigarettes. Poison centers reported 2,405 e- cigarette and 16,248 cigarette exposure calls from September 2010 to February 2014. The total number of poisoning cases is likely higher than reflected in this study, because not all exposures might have been reported to poison centers. "The most recent National Youth Tobacco Survey showed e- cigarette use is growing fast, and now this report shows e- cigarette related poisonings are also increasing rapidly," said Tim McAfee, M.D., M.P.H., Director of CDC's Office on Smoking and Health. "Health care providers, e- cigarette companies and distributors, and the general public need to be aware of this potential health risk from e- cigarettes." Developing strategies to monitor and prevent future poisonings is critical given the rapid increase in e- cigarette related poisonings. The report shows that e- cigarette liquids containing nicotine have the potential to cause immediate adverse health effects and represent an emerging public health concern. U.S. Department of Health and Human Services CDC works 24/7 saving lives, protecting people from health threats, and saving money through prevention. Whether these threats are global or domestic, chronic or acute, curable or preventable, natural disaster or deliberate attack, CDC is the nation's health protection agency. a `� 3lAVICy.41 DEPARTMENT OF HEALTH AND HUMAN SERVICES JJ CENTERS FOR DISEASE CONTROL AND PREVENTION n a SAFER -HEALTH I ER • PEOPLE" As founder of ROC the Kenai, a youth sponsored program dedicated to promoting the respect of our community, I strongly support Mayor Porter's ordinance to regulate e- cigarettes the same as traditional cigarettes, cigars, and tobacco pipes. In order to become more knowledgeable and supportive about this topic, I conducted my own research to find some facts. These facts are from the American Journal of Preventive Medicine, the New York Times, the New England Journal of Medicine, the Juneau Empire and National Public Radio. E- cigarettes are marketed as a "safer, harmless, and cleaner" way to deliver a puff of nicotine. Nicotine is a drug that causes a sudden "kick" when inhaled through the lungs. After the "kick" dissolves, then depression occurs, causing the smoker to want more. Nicotine is extraordinarily addicting and of concern. It is a stimulant, and in larger doses, it is toxic. E- cigarettes can cause people who are not using nicotine — like teens or non- smokers — to start to use nicotine. Other facts include... • e- cigarettes as quitting aids can be ineffective due to the fluctuating nicotine content. Most cartridges have a range of up to 20 milligrams of nicotine. However, refill kits allow consumers to fill used cartridges with replacement solutions at much higher doses. Instructions for filling cartridges with marijuana hash oil can be easily accessed on the Internet. The safety of inhaling propylene glycol [Wo, dW4&.7S C_WVn C_Q�e.. wii-vex (A [�\ttr cuLv" G wvcs over an extended period of time has not been studied in humans. E- cigarettes are creating, once again, an allure and prestige around the act of smoking. They target youth in glamorizing, sexualizing, advertisements. There is a concern that E- cigarettes are going to renormalize smoking. The amount of youth using E- cigarettes" doubled between 2011 -2012. Not only does the high tech aspect appeal to youth, but the many flavors, such as grape and candy flavors are also attractive. Council, I ask you this: What kind of message would be sent to the youth of our community by allowing the use of E- cigarettes in public places? What would your reaction be if patrons of our beautiful library began puffing on E- cigarettes in the presence of children? This became a real problem in Juneau, where Robert Barr, director of the downtown library said that since e- cigarettes became popular, he has had about six instances in which library patrons either asked if they could use an e- cigarette inside or just took one out without asking and started puffing. With e- cigarettes left out of the city's secondhand smoke control code, library staff couldn't legally say no, and they couldn't do (9, anything when other patrons complained about the vapor. We certainly don't want vapors in city buildings and other public places. Let's not promote the use of a thinly disguised dispenser of nicotine as "harmless ". I ask the City of Kenai to stand for healthy, clean air. Most importantly, be proactive and positive for the youth in this community. Take the stance that,', of any kind, is not allowed in public places. Let's keep moving forward in the prevention of smoking in community areas, not backwards. Respect the health of our citizens, respect our youth and respect our community. Statement from specialists in nicotine science and public health policy Dr Margaret Chan Director General World Health Organisation Geneva CC: FCTC Secretariat, Parties to the FCTC, WHO Regional Offices 26 May 2014 Dear Dr Chan Reducing the toil of death and disease from tobacco— tobacco harm reduction and the Framework Convention on Tobacco Control (FCTC) We are writing in advance of important negotiations on tobacco policy later in the year at the FCTC Sixth Conference of the Parties. The work of WHO and the FCTC remains vital in reducing the intolerable toil of cancer, cardiovascular disease and respiratory illnesses caused by tobacco use. As WHO has stated, up to one billion preventable tobacco - related premature deaths are possible in the 21st Century. Such a toll of death, disease and misery demands that we are relentless in our search for all possible practical, ethical and lawful ways to reduce this burden. It is with concern therefore that a critical strategy appears to have been overlooked or even purposefully marginalised in preparations for FCTC COP -6. We refer to 'tobacco harm reduction'- the idea that the 1.3 billion people who currently smoke could do much less harm to their health if they consumed nicotine in low -risk, non - combustible form. We have known for years that people 'smoke for the nicotine, but die from the smoke': the vast majority of the death and disease attributable to tobacco arises from inhalation of tar particles and toxic gases drawn into the lungs. There are now rapid developments in nicotine -based products that can effectively substitute for cigarettes but with very low risks. These include for example, e- cigarettes and other vapour products, low - nitrosamine smokeless tobacco such as snus, and other low -risk non - combustible nicotine or tobacco products that may become viable alternatives to smoking in the future. Taken together, these tobacco harm reduction products could play a significant role in meeting the 2025 UN non - communicable disease (NCD) objectives by driving down smoking prevalence and cigarette consumption. Indeed, it is hard to imagine major reductions in tobacco - related NCDs without the contribution of tobacco harm reduction. Even though most of us would prefer people to quit smoking and using nicotine altogether, experience suggests that many smokers cannot or choose not to give up nicotine and will continue to smoke if there is no safer alternative available that is acceptable to them. We respectfully suggest that the following principles should underpin the public health approach to tobacco harm reduction, with global leadership from WHO: Statement from specialists in nicotine science and public health policy 1. Tobacco harm reduction is part of the solution, not part of the problem. It could make a significant contribution to reducing the global burden of non - communicable diseases caused by smoking, and do so much faster than conventional strategies. If regulators treat low -risk nicotine products as traditional tobacco products and seek to reduce their use without recognising their potential as low -risk alternatives to smoking, they are improperly defining them as part of the problem. 2. Tobacco harm reduction policies should be evidence -based and proportionate to risk, and give due weight to the significant reductions in risk that are achieved when a smoker switches to a low risk nicotine product. Regulation should be proportionate and balanced to exploit the considerable health opportunities, while managing residual risks. The architecture of the FCTC is not currently well suited to this purpose. 3. On a precautionary basis, regulators should avoid support for measures that could have the perverse effect of prolonging cigarette consumption. Policies that are excessively restrictive or burdensome on lower risk products can have the unintended consequence of protecting cigarettes from competition from less hazardous alternatives, and cause harm as a result. Every policy related to low risk, non - combustible nicotine products should be assessed for this risk. 4. Targets and indicators for reduction of tobacco consumption should be aligned with the ultimate goal of reducing disease and premature death, not nicotine use per se, and therefore focus primarily on reducing smoking. In designing targets for the non - communicable disease (NCD) framework or emerging Sustainable Development Goals it would be counterproductive and potentially harmful to include reduction of low -risk nicotine products, such as e- cigarettes, within these targets: instead these products should have an important role in meeting the targets. 5. Tobacco harm reduction is strongly consistent with good public health policy and practice and it would be unethical and harmful to inhibit the option to switch to tobacco harm reduction products. As the WHO's Ottawa Charter states: "Health promotion is the process of enabling people to increase control over, and to improve, their health". Tobacco harm reduction allows people to control the risk associated with taking nicotine and to reduce it down to very low or negligible levels. 6. It is counterproductive to ban the advertising of e- cigarettes and other low risk alternatives to smoking. The case for banning tobacco advertising rests on the great harm that smoking causes, but no such argument applies to e- cigarettes, for example, which are far more likely to reduce harm by reducing smoking. Controls on advertising to non- smokers, and particularly to young people are certainly justified, but a total ban would have many negative effects, including protection of the cigarette market and implicit support for tobacco companies. It is possible to target advertising at existing smokers where the benefits are potentially huge and the risks minimal. It is inappropriate to apply Article 13 of the FCTC (Tobacco advertising, promotion and sponsorship) to these products. Statement from specialists in nicotine science and public health policy 7. It is inappropriate to apply legislation designed to protect bystanders or workers from tobacco smoke to vapour products. There is no evidence at present of material risk to health from vapour emitted from e- cigarettes. Decisions on whether it is permitted or banned in a particular space should rest with the owners or operators of public spaces, who can take a wide range of factors into account. Article 8 of the FCTC (Protection from exposure to tobacco smoke) should not be applied to these products at this time. 8. The tax regime for nicotine products should reflect risk and be organised to create incentives for users to switch from smoking to low risk harm reduction products. Excessive taxation of low risk products relative to combustible tobacco deters smokers from switching and will cause more smoking and harm than there otherwise would be. 9. WHO and national governments should take a dispassionate view of scientific arguments, and not acceptor promote flawed media or activist misinterpretations of data. For example, much has been made of 'gateway effects', in which use of low -risk products would, it is claimed, lead to use of high -risk smoked products. We are unaware of any credible evidence that supports this conjecture. Indeed, similar arguments have been made about the use of smokeless tobacco in Scandinavia but the evidence is now clear that this product has made a significant contribution to reducing both smoking rates and tobacco - related disease, particularly among males. 10. WHO and parties to the FCTC need credible objective scientific and policy assessments with an international perspective. The WHO Study Group on Tobacco Product Regulation (TobReg) produced a series of high quality expert reports between 2005 and 2010. This committee should be constituted with world -class experts and tasked to provide further high -grade independent advice to the WHO and Parties on the issues raised above. The potential for tobacco harm reduction products to reduce the burden of smoking related disease is very large, and these products could be among the most significant health innovations of the 21'` Century — perhaps saving hundreds of millions of lives. The urge to control and suppress them as tobacco products should be resisted and instead regulation that is fit for purpose and designed to realise the potential should be championed by WHO. We are deeply concerned that the classification of these products as tobacco and their inclusion in the FCTC will do more harm than good, and obstruct efforts to meet the targets to reduce non - communicable disease we are all committed to. We hope that under your leadership, the WHO and FCTC will be in the vanguard of science- based, effective and ethical tobacco policy, embracing tobacco harm reduction. We would be grateful for your considered reaction to these proposals, and we would like to request a meeting with you and relevant staff and a small delegation of signatories to this letter. This statement and any related information will be available on the Nicotine Science and Policy web site (http: / /nicotinepolicy.net) from 29 May 2014. Yours sincerely, Statement from specialists in nicotine science and public health policy Signatories this statement at 26 May 2014 Professor David Abrams Professor of Health Behavior and Society. The Johns Hopkins Bloomberg School of Public Health. Maryland. USA. Professor of Oncology (adjunct). Georgetown University Medical Center, Lombardi Comprehensive Cancer Center. Washington DC. United States of America Professor Tony Axell Emeritus Professor Geriatric Dentistry Consultant in Oral Medicine Sweden Professor Pierre Bartsch Respiratory physician, Faculty of Medicine University of Liege Belgium Professor Linda Bauld Professor of Health Policy Director of the Institute for Social Marketing Deputy Director, UK Centre for Tobacco and Alcohol Studies University of Stirling United Kingdom Professor Ron Borland Nigel Gray Distinguished Fellow in Cancer Prevention at Cancer Council Victoria Professorial Fellow School of Population Health and Department of Information Systems University of Melbourne, Australia Professor John Britton Professor of Epidemiology; Director, UK Centre for Tobacco & Alcohol Studies, Faculty of Medicine & Health Sciences University of Nottingham, United Kingdom Associate Professor Chris Bullen Director, National Institute for Health Innovation School of Population Health, University of Auckland, New Zealand Professor Emeritus Andre Castonguay Faculty of Pharmacy Universite Laval, Quebec, Canada. Dr Lynne Dawkins Senior Lecturer in Psychology, Co- ordinator: Drugs and Addictive Behaviours Research Group School of Psychology, University of East London, United Kingdom Professor Ernest Drucker Professor Emeritus Department of Family and Social Medicine, Montefiore Medical Center /Albert Einstein College of Medicine Mailman School of Public Health Columbia University United States of America Professor Jean Franyois Etter Associate Professor Institut de saute globale, Faculte de medecine, Universite de Geneve, Switzerland Dr Karl Fagerstrom President, Fagerstrom Consulting AB, Vaxholm, Sweden Dr Konstantinos Farsalinos Researcher, Onassis Cardiac Surgery Center, Athens, Greece Researcher, University Hospital Gathuisberg, Leuven, Belgium Professor Antoine Flahault Directeur de I'Institut de Sante Globale Faculte de Medecine, Universite de Geneve, Suisse/ Institute of Global Health, University of Geneva, Switzerland Professor of Public Health at the Faculte de Medecine, Universite Paris Descartes, Sorbonne Paris Cite, France Statement from specialists in nicotine science and public health policy Dr Coral Gartner Professor Didier Jayle Senior Research Fellow Professeur d'addictologie University of Queensland Centre for Conservatoire National des Arts et Metiers Clinical Research Paris, The University of Queensland, France Australia Dr Guillermo Gonzalez Psychiatrist Comisibn de Rehabilitacion an Enfermedad Mental Grave Clinica San Miguel Madrid, Spain Dr Nigel Gray Member of Special Advisory Committee on Tobacco Regulation of the World Health Organization Honorary Senior Associate Cancer Council Victoria Australia Professor Peter Hajek Professor of Clinical Psychology and Director, Health and Lifestyle Research Unit UK Centre for Tobacco and Alcohol Studies Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry Queen Mary University of London, United Kingdom Professor Wayne Hall Director and Inaugural Chair, Centre for Youth Substance Abuse Research University of Queensland Australia Professor John Hughes Professor of Psychology, Psychiatry and Family Practice University of Vermont United States of America Professor Martin Jarvis Emeritus Professor of Health Psychology Department of Epidemiology & Public Health University College London, United Kingdom Dr Martin Juneau Directeur, Direction de la Prevention Institut de Cardiologie de Montreal Professeur Titulaire de Clinique Faculty de Medecine, University de Montreal, Canada Dr Michel Kazatchkine Member of the Global Commission on Drug Policy Senior fellow, Global Health Program, Graduate institute, Geneva, Switzerland Professor Demetrios Kouretas School of Health Sciences and Vice Rector University of Thessaly, Greece Professor Lynn Kozlowski Dean, School of Public Health and Health Professions, Professor of Community Health and Health Behavior, University at Buffalo, State University of New York, United States of America Professor Eva Kralfkova Institute of Hygiene and Epidemiology Centre for Tobacco - Dependence First Faculty of Medicine Charles University in Prague and General University Hospital in Prague, Czech Republic Professor Michael Kunze Head of the Institute for Social Medicine Medical University of Vienna, Austria Dr Murray Laugesen Director Health New Zealand, Lyttelton, Christchurch, New Zealand Statement from specialists in nicotine science and public health policy Dr Jacques Le Houezec Consultant in Public Health, Tobacco dependence, Rennes, France Honorary Lecturer, UK Centre for Tobacco Control Studies, University of Nottingham, United Kingdom Dr Kgosi Letlape President of the Africa Medical Association Former President of the World Medical Association Former Chairman of Council of the South African Medical Association South Africa Dr Karl Erik Lund Research director Norwegian Institute for Alcohol and Drug Research, Oslo, Norway Dr Gerard Mathern President de I'Institut Rhone -Alpes de Tabacologie Saint- Chamond, France Professor Richard Mattick NHMRC Principal Research Fellow Immediate Past Director NDARC (2001- 2009) National Drug and Alcohol Research Centre ( NDARC) Faculty of Medicine The University of New South Wales, Australia Professor Ann McNeill Professor of Tobacco Addiction Deputy Director, UK Centre for Tobacco and Alcohol Studies National Addiction Centre Institute of Psychiatry King's College London, United Kingdom Dr Hayden McRobbie Reader in Public Health Interventions, Wolfson Institute of Preventive Medicine, Queen Mary University of London, United Kingdom Dr Anders Milton Former President of the Swedish Red Cross Former President and Secretary of the Swedish Medical Association Former Chairman of the World Medical Association Owner & Principal Milton Consulting, Sweden Professor Marcus Munafo Professor of Biological Psychology MRC Integrative Epidemiology Unit at the University of Bristol UK Centre for Tobacco and Alcohol Studies School of Experimental Psychology University of Bristol, United Kingdom Professor David Nutt Chair of the Independent Scientific Committee on Drugs (UK) Edmund J Safra Professor of Neu ropsychopharmacology Head of the Department of Neuropsychopharmacology and Molecular Imaging Imperial College London, United Kingdom Dr Gaston Ostiguy Professeuragrege Directeur de la Clinique de cessation tabagique Centre universitaire de sante McGill (CUSM) Institut thoracique de Montreal, Canada Professor Riccardo Polosa Director of the Institute for Internal Medicine and Clinical Immunology, University of Catania, Italy. Dr Lars Ramstr6m Director Institute for Tobacco Studies Toby, Sweden Statement from specialists in nicotine science and public health policy Dr Martin Raw Special Lecturer UK Centre for Tobacco and Alcohol Studies Division of Epidemiology and Public Health University of Nottingham, United Kingdom Professor Andrzej Sobczak Department of General and Inorganic Chemistry, Faculty of Pharmacy and Laboratory Medicine, Medical University of Silesia, Katowice, Poland Institute of Occupational Medicine and Environmental Health Sosnowiec, Poland Professor Gerry Stimson Emeritus Professor, Imperial College London; Visiting Professor, London School of Hygiene and Tropical Medicine United Kingdom Professor Tim Stockwell Director, Centre for Addictions Research of BC Professor, Department of Psychology University of Victoria, British Columbia, Canada Professor David Sweanor Adjunct Professor, Faculty of Law, University of Ottawa Special Lecturer, Division of Epidemiology and Public Health, University of Nottingham, United Kingdom Professor Umberto Tirelli Director Department of Medical Oncology National Cancer Institute of Aviano Italy Professor Umberto Veronesi Scientific Director IEO Istituto Europeo di Oncologia Former Minister of Health, Italy Professor Kenneth Warner Avedis Donabedian Distinguished University Professor of Public Health Professor, Health Management & Policy School of Public Health University of Michigan United States of America Professor Robert West Professor of Health Psychology and Director of Tobacco Studies Health Behaviour Research Centre, Department of Epidemiology & Public Health, University College London United Kingdom Professor Dan Xiao Director of Department Epidemiology WHO Collaborating Center for Tobacco or Health Beijing Institute of Respiratory Medicine, Beijing Chao -Yang Hospital, China Dr Derek Yach Former Executive Director, Non - Communicable Diseases Former Head of Tobacco Free Initiative, World Health Organisation (1995 -2004) Senior Vice President Vitality Group plc Director, Vitality Institute for Health Promotion United States of America Comments Directed to the FDA Deeming Docket ID: FDA - 2014 -N -0189; RIN:0910 -AG38 Electronic cigarettes are not tobacco products and should not be treated as such. Deeming them as tobacco is a grave error with deadly consequences for more than 40 million American smokers who will be denied access to an alternative that is more than 1,000 times safer than combustible tobacco. The proposed deeming regulations would remove more than 99% of electronic cigarette (ecig) products from the market and deliver the entire ecig business into the hands of Big Tobacco, doing more damage to public health than any cigarette company ever accomplished. This is because many of its premises are constructed on faulty assumptions (http:/ /link. springer.com /article /10....204- 013- 1127 -0), junk science ( http: / /tobaccoanalysis. blogspot.com /...ttle- more.html), and unsubstantiated propaganda (http: // tobaccoanalysis . blogspot.com /...rettes- by.html) from the tobacco control industry (TCI). "No Evidence" One of the most Flagrant exaggerations perpetrated by TCI and unfortunately reiterated numerous times by this proposed regulation is in the assertion that little or nothing is known about ecigs, that health effects are completely unknown, and that very little research had been done on the subject. These statements are demonstrably false in light of the recent systematic literature review published by Zyoud et al ( 2014 ;http: / /www.biomedcentral.com /content 458 -14 -667 oddf). These authors searched for all available peer- reviewed literature on the subject of ecigs and retrieved 356 documents, among which 31.5% were original journal articles, 16% letters to the editor, 7.9% review articles, and 44.6% documents that were classified as other types of publications. The retrieved documents were published in 162 peer - reviewed journals, by scientists from 27 countries. These authors also found that FDA was the most productive institution for articles related to ecigs. All 356 documents discussed by Zyoud et al (2014) should be mandatory reading for any professional and /or regulator with a serious and honest commitment to improving public health and reducing smoking rates. All ought to be critically reviewed, referenced, and thoroughly discussed by any evidence -based regulatory document related to ecigs. The critical review ought to be performed by qualified, impartial scientists with the motivation and ability to distinguish slanted junk science and deceptive inference from rigorous studies employing the scientific method, using appropriate analyses, and coming to defensible conclusions. None of these appear to apply to the current version of the proposed deeming regulation. "Cardiac Effects" Existing research already indicates that the risk profile of ecigs is actually vanishingly small. For example, a recent study by Farsalinos et al. (2014; litti)://www.ncbi.nlm.nih.govlpubmed/24958250) examined the acute effects of ecig use on cardiac function and contrast these against the effects of smoking combustible tobacco cigarettes. The study concluded that "acute smoking causes a delay in myocardial relaxation, electronic cigarette use has no immediate effects. Electronic cigarettes' role in tobacco harm reduction should be studied intensively in order to determine whether switching to electronic cigarette use may have long -term beneficial effects on smokers' health." Another study conducted research on the direct effects of ecig vapor on cultured myocardial cells (http:/Iwww.mdi)i.com/1660-4601/10/10/514 ) and concluded that ecig vapor was significantly less toxic than tobacco smoke extract. The toxicity of vapor to myocardial cells in culture was generally low, and only observable at the highest concentrations tested. Moreover it was not related to nicotine content, rather to specific constituents of flavoring additives. The majority of the vapor samples were found to have no adverse effects on cardiac cells, with cell survival rates similar to controls. However, there were 4 samples showing reduced cell survival suggesting that a very small proportion of flavorings may cause some harm, albeit orders of magnitude lower compared to tobacco cigarettes. Even the worst performing e- liquids in this study were 3 times less harmful compared to cigarette smoke. Since flavors play an important role in the acceptance and success of ecigs, all flavors should be tested in order to identify which may be harmful to use. Taken together, these results strongly indicate that the risk profile of ecigs is vanishingly small, and may well be reduced even further by thoughtful research of flavoring compounds. The FDA has a mandate and a moral obligation to protect public health by encouraging all smokers to switch to far less hazardous electronic cigarettes and to fund research that will further improve their risk profile. Researchers who are not conflicted by any current or previous association with the tobacco control industry, pharmaceuticals, or tobacco should be supported and encouraged to pursue these studies. Continued improvement and innovation of electronic cigarettes is in the interest of public health, not snubbing them by deeming as tobacco products. "Burstyn Study" The evaluation of the health effects of ecigs in Section IV.B is particularly egregious, being wrought with deprecated information, inaccuracies, and prejudice. Conspicuously, this section does not reference the single most comprehensive review study to date on the risks posed by ecig use published by Burstyn (2013). This study reviewed more than 9000 observations of the chemistry of ecig aerosol and compared them against worst -case exposure scenarios. The results unequivocally indicate that the vast majority of predicted exposures are «1% of Threshold Limit Values (TLV) for involuntary workplace exposures. The study concludes that "there was no evidence of potential for exposures of e- cigarette users to contaminants that are associated with risk to health at a level that would warrant attention if it were an involuntary workplace exposures by approaching half of TLV." And further that "exposures of bystanders are likely to be orders of magnitude less, and thus pose no apparent concern." This study should be mandatory reading for any professional and /or regulator with a serious and honest commitment to improving public health and reducing smoking rates. "Hyperbole" FDA states: "There are no significant safety concerns associated with using more than one OTC NRT [over the counter nicotine replacement therapy] at the same time, or using an OTC NRT at the same time as another nicotine- containing product— including a cigarette." (http: / /www.fda.gov /forconsumers /cons... /ucm345087. htm) New research from Europe verifies the safety of ecig liquids and concludes "most of the media and regulatory attention surrounding the risks of nicotine solutions were hyperbole." (http: / /ecita. org. uk /docs /EU_Classifi...l_ toxicity. pdf) Electronic cigarette liquids with a concentration of less than 2.5% (25 mg /ml) should not be classified as a hazardous substance for acute oral or dermal toxicity (under the EC regulations, which are aligned with the UN Globally Harmonized System of Classification and Labeling of Chemicals). Higher nicotine concentrations (up to 5% or 50 mg /ml for dermal classification, and even higher for oral classification) should be considered as CLIP category 4, the same labeling requirement used for liquid hand soap. This report was peer- reviewed and endorsed by three prominent health researchers, as documented here:http://www.ecita.org.uk/blog/index.p ... c-is-e-liquid/ "Youth and Quitting Studies" All available (and respectable) scientific evidence indicates that electronic cigarettes (e -cigs or ecigs) are a major positive development in the public health field and have helped tens of millions of smokers (worldwide) switch to an alternative that is much safer than combustible tobacco. In addition, this evidence thoroughly and definitively debunks the "gateway" myth maliciously invented and propagated by the tobacco control industry. The following studies reinforce these statements and should be reviewed by any professional and /or regulator with a serious and honest commitment to improving public health and reducing smoking rates. A new report from ASH Scotland (httr):/Zwww.ashscotland.org.ukZmedia/ rt %2007 141df) . found: - 22% of teens (13 -18 years) smoked one or more cigarettes per week, - 15% of teen smokers used an e-cig one or more times per week, - 2% of teen nonsmokers used an e-cig one or more times per week, - 39% of teens reported ever use of an e-cig, - Among teen smokers who used a -cigs, 290/a did so to quit smoking, 23% did so to reduce cigarette consumption, - 53% of teens agreed that a -cigs are less harmful than cigarettes, while 12% disagreed, - 12% of teens thought cigarette smoking was cool, and 12% thought e-cig use was cool A similar survey from Wales (ASH Wales: http: / /www,ashwales.org.uk /creo file . march 2014. f) had even stronger evidence that e- cigarettes help smokers quit as well as categorically do not entice non - smoking youth: - 56.1% of teen smokers ever used an e-cig, - 3.8% of teens who never smoked had ever used an e-cig, - 33.7% of teen smokers currently use a -cigs, - 5.6% of teen exsmokers currently use a -cigs - .3% of teens who never smoked currently use a -cigs Older results from England also agree (http: / /www.ash.org.uk /files /documents /ASH 891.1)df): - The success rate for smoking cessation in the UK by use of an ecig is 33% - The number of UK vapers has tripled in the last 2 years [1] - There are more than 2 million vapers in the UK although some have now totally quit (ceased use of any /ail inhalation products) - About 20% of smokers are now vapers or have totally quit both smoking and vaping by use of an ecig - About 700,000 vapers have quit smoking by use of an ecig or have totally quit - So around 7% [2] of UK smokers have quit by use of an ecig, and clearly that number will rise significantly over time - The number of non - smokers who are regular ecig users is almost unmeasurabiy small - The number of minors (under -18s) who are regular ecig users is almost unmeasurably small In addition, based on results from a recent publication from Harvard, Dr. Konstantinos Farsalinos, cardiologist at the Onassis Cardiac Surgery Centre in Athens, told the New Scientist; "This study verifies that e- cigarette use does not renormalize smoking. The results show minimal adoption by non - smokers." (htti)s://uk.news.vahoo.com/harvard-st 6 html #gHLTvUi). The FDA has a mandate and a moral obligation to protect public health by actively seeking and critically reviewing all the available evidence, as well as funding additional research that will further improve our understanding of ecigs. Researchers who are not conflicted by any current or previous association with tobacco control, pharmaceuticals, or Big Tobacco should be supported and encouraged to pursue these studies. Continued improvement and innovation of electronic cigarettes is in the interest of public health, not snubbing them by deeming as tobacco products. Burstyn (2013): http: // publichealth. drexel .edu /— /med...ealth /ms08.pdf Technical Report July - August 2013 Peering through the mist: What does the chemistry of contaminants in electronic cigarettes tell us about health risks? Igor Burstyn, PhD Department of Environmental and Occupational Health School of Public Health Drexel University 1505 Race St., Mail Stop #1034 Philadelphia, PA 19102 USA Tel: 215.762.2909 1 Fax: 21S.762.8846 fgor.burstyn@dre)tel.edu Abstract The aim of this paper is to review available data on chemistry of aerosols and liquids of electronic cigarettes and to make predictions about compliance with occupational exposure limits of personal exposures of vapers (e- cigarette users) to compounds found in the aerosol. Both peer- reviewed and "grey" literatures were accessed and more than 9000 observations of highly variable quality were extracted. Comparisons to the most universally recognized workplace exposure standards, Threshold Limit Values (TLVs), were conducted under "worst case" assumptions about both chemical content of aerosol and liquids as well as behavior of vapers. The calculations reveal that there was no evidence of potential for exposures of e- cigarette users to contaminants that are associated with risk to health at a level that would warrant attention if it were an involuntary workplace exposures by approaching half of TLV. The vast majority of predicted exposures are <<l% of TLV. Predicted exposures to acrolein and formaldehyde are typically <5% TLV. Considering exposure to the aerosol as a mixture of contaminants did not indicate that exceeding half of TLV for mixtures was plausible. Only exposures to the declared major ingredients -- propylene glycol and glycerin -- warrant attention because of precautionary nature of TLVs for exposures to hydrocarbons with no established toxicity. Comparing the exposure to nicotine to existing occupational exposure standards is not valid so long as nicotine - containing liquid is not mislabeled as nicotine -free. It must be noted that the quality of much of the data that was available for these assessment was poor, and so much can be done to improve certainty in this risk assessment. However, the existing research is of the quality that is comparable with most workplace assessments for novel technologies. In summary, an analysis of current state of knowledge about chemistry of liquids and aerosols associated with electronic cigarettes indicates that there is no evidence that vaping produces inhalable exposures to contaminants of the aerosol that would warrant health concerns by the standards that are used to ensure safety of workplaces. However, the aerosol generated during vaping as a whole (contaminants plus declared ingredients), if it were an emission from industrial process, creates personal exposures that would justify surveillance of health among exposed persons in conjunction with investigation of means to keep health effects as low as reasonably achievable. Exposures of bystanders are likely to be orders of magnitude less, and thus pose no apparent concern. Keywords: vaping, e- cigarettes, tobacco harm reduction, risk assessment, aerosol, occupational exposure limit Technical Report July - August 2013 Introduction Electronic cigarettes (also known as e- cigarettes) are generally recognized as a safer alternative to combusted tobacco products (reviewed in [1]), but there are conflicting claims about the degree to which these products warrant concern for the health of the vapers (e- cigarette users). A vaper inhales aerosol generated during heating of liquid contained in the e- cigarette. The technology and patterns of use are summarized by Etter [1], though there is doubt about how current, complete and accurate this information is. Rather conclusive evidence has been amassed to date on comparison of the chemistry of aerosol generated by electronic cigarettes to cigarette smoke [2 -8]. However, it is meaningful to consider the question of whether aerosol generated by electronic cigarettes would warrant health concerns on its own, in part because vapers will include persons who would not have been smokers and for whom the question of harm reduction from smoking is therefore not relevant, and perhaps more importantly, simply because there is value in minimizing the harm of those practicing harm reduction. One way of approaching risk evaluation in this setting is to rely on the practice, common in occupational hygiene, of relating the chemistry of industrial processes and the emissions they generate to the potential worst case of personal exposure and then drawing conclusions about whether there would be interventions in an occupational setting based on comparison to occupational exposure limits, which are designed to ensure safety of unintentionally exposed individuals. In that context, exposed individuals are assumed to be adults, and this assumption appears to be suitable for the intended consumers of electronic cigarettes. "Worst case" refers to the maximum personal exposure that can be achieved given what is known about the process that generates contaminated atmosphere (in the context of airborne exposure considered here) and the pattern of interaction with the contaminated atmosphere. It must be noted that harm reduction notions are embedded in this approach since it recognizes that while elimination of the exposure may be both impossible and undesirable, there nonetheless exists a level of exposure that is associated with negligible risks. To date, a comprehensive review of the chemistry of electronic cigarettes and the aerosols they generate has not been conducted, depriving the public of the important element of a risk - assessment process that is mandatory for environmental and occupational health policy making. The present work considers both the contaminants present in liquids and aerosols as well as the declared ingredients in the liquids. The distinction between exposure to declared ingredients and contaminants of a consumer product is important in the context of comparison to occupational or environmental exposure standards. Occupational exposure limits are developed for unintentional exposures that a person does not elect to experience. For example, being a bread baker is a choice that does not involve election to be exposed to substances that cause asthma that are part of the flour dust (most commonly, wheat antigens and fungal enzymes). Therefore, suitable occupational exposure limits are created to attempt to protect individuals from such risk on the job, with no presumption of "assumed risk" inherent in the occupation. Likewise, special regulations are in effect to protect persons from unintentional exposure to nicotine in workplaces (http://www.cdc.gov/niosh/"d`ocs/81-123/pdfs/0446.pdf; accessed July 12, 20131, because in environments where such exposures are possible, it is reasonable to protect individuals who do not wish to experience its effects. In other words, occupational exposure limits are based on protecting people from involuntary and unwanted exposures, and thus can be seen as appropriately more stringent than the standards that might be used for hazards that people intentionally choose to accept. By contrast, a person who elects to lawfully consume a substance is subject to different risk tolerance, as is demonstrated in the case of nicotine by the fact that legally sold cigarettes deliver doses of nicotine that exceed occupational exposure limits[9]: daily intake of 20 mg of nicotine, assuming nearly 100% absorption in the lungs and 2 Technical Report July - August 2013 inhalation of 4 m3 of air, corresponds to roughly 10 times the occupational exposure limit of 0.5 mg /m3 atmosphere over 8 hours[10]. Thus, whereas there is a clear case for applicability of occupational exposure limits to contaminants in a consumer product (e.g. aerosol of electronic cigarettes), there is no corresponding case for applying occupational exposure limits to declared ingredients desired by the consumer in a lawful product (e.g. nicotine in the aerosol of an electronic cigarette). Clearly, some limits must beset for voluntary exposure to compounds that are known to be a danger at plausible doses (e.g. limits on blood alcohol level while driving), but the regulatory framework should reflect whether the dosage is intentionally determined and whether the risk is assumed by the consumer. In the case of nicotine in electronic cigarettes, if the main reason the products are consumed is as an alternative source of nicotine compared to smoking, then the only relevant question is whether undesirable exposures that accompany nicotine present health risks, and the analogy with occupational exposures holds. In such cases it appears permissible to allow at least as much exposure to nicotine as from smoking before admitting to existence of new risk. It is expected that nicotine dosage will not increase in switching from smoking to electronic cigarettes because there is good evidence that consumers adjust consumption to obtain their desired or usual dose of nicotine[l l]. The situation is different for the vapers who want to use electronic cigarettes without nicotine and who would otherwise not have consumed nicotine. For these individuals, it is defensible to consider total exposure, including that from any nicotine contamination, in comparison to occupational exposure limits. In consideration of vapers who would never have smoked or would have quit entirely, it must be remembered that the exposure is still voluntary and intentional, and comparison to occupational exposure limits is legitimate only for those compounds that the consumer does not elect to inhale. The specific aims of this review were to: 1. Synthesize evidence on the chemistry of liquids and aerosols of electronic cigarettes, with particular emphasis on the contaminants. 2. Evaluate the quality of research on the chemistry of liquids and aerosols produced by electronic cigarettes. 3. Estimate potential exposures from aerosols produced by electronic cigarettes and compare those potential exposures to occupational exposure standards. Methods Literature search Articles published in peer- reviewed journals were retrieved from PubMed ( http: / /www.nrbi.nlm.nih.gov /oubmed /) using combinations of the following keywords: "electronic cigarettes ", "e- cigarettes ", "smoking alternatives ", "chemicals ", "risks ", "electronic cigarette vapor ", "aerosol ", "ingredients ", "e- cigarette liquid ", "e -cig composition ", "e- cig chemicals ", "e -cig chemical composition ", "e juice electronic cigarette ", "electronic cigarette gas ", "electronic cigars ". In addition, references of the retrieved articles were examined to identify further relevant articles, with particular attention paid to non -peer reviewed reports and conference presentations. Unpublished results obtained through personal communications were also reviewed. The Consumer Advocates for Smoke -free Alternatives Association (CASAA) was asked to review the retrieved bibliography to identify any reports or articles that were missed. The papers and reports were retained for analysis if they reported on the chemistry of e- cigarette liquids or aerosols. No explicit quality control criteria were applied in selection of literature for examination, except that secondary reporting of analytical results was not used. Where substantial methodological problems that precluded interpretation of analytical results were noted, these are described below. For each article that contained relevant analytical results, the compounds quantified, limits of detection, and analytical results were summarized in a spreadsheet. Wherever possible, individual analytical results (rather than averages) were recorded (see electronic Appendix A: Technical Report July - August 2013 ht tys : / /dI.dronboxuserconteni.com /m '4285761 /CASAA /eAnnendixA xlsx). Data contained in Appendix A is not fully summarized in the current report but can be used to investigate a variety of specific questions that may interest the reader. Each entry in Appendix A is identified by a Reference Manage ID that is linked to source materials in a list in Appendix B (linked via RefID: htti3s://dI.droi)boxusercontent com/u/4285761 /CASAA!AMbendixB rttl and attached electronic copies of all original materials (Biobliography.zip: httos : / /dI.dropboxusercontent.com/u /4285761 /C.ASAA/bibliograi)hv zin). Comparison of observed concentrations in aerosol to occupational exposure limits For articles that reported mass or concentration of specific compounds in the aerosol (generated by smoking machines or from volunteer vapers), measurements of compounds were converted to concentrations in the "personal breathing zone,' which can be compared to occupational exposure limits (OELs). The 2013 Threshold Limit Values (TLVs)[10] were used as OELs because they are the most up to date and are most widely recognized internationally when local jurisdictions do not establish their own regulations (see http: / /www ilo ora /oshene/ Mart- iv /occuiiatioual4ivpicnelitem/575 accessed July 3, 2013). Whenever there was an uncertainty in how to perform the calculation, a "worst case" scenario was used, as is the standard practice in occupational hygiene, where the initial aim is to recognize potential for hazardous exposures and to err on the side of caution. The following assumptions were made to enable the calculations that approximate the worst -case personal exposure of a vaper (Equation 1): 1. Air the vaper breathes consists of a small volume of aerosol generated by e- cigarettes that contains a specific chemical plus pristine air; 2. The volume of aerosols inhaled from e- cigarettes is negligible compared to total volume of air inhaled; 3. The period of exposure to the aerosol considered was normalized to 8 hours, for comparability to the standard working shift for which TLVs were developed (this does not mean only 8 hours worth of vaping was considered (see point 4) but rather that amount of breathing used to dilute the day's worth of vaping exposure was 8 hours); 4. Consumption of 150 puffs in 8 hours (an upper estimate based on a rough estimate of 150 puffs by atypical vaper in a day[1]) was assumed to be conservative; S. Breathing rate is 8 liters per minute [12,13]; 6. Each puff contains the same quantity of compounds studied. [rngjma] = mg/puff x puffs /(8 fir day) x 1 /(ma air inhaled in 8 hr) Eq. 1 The only exception to this methodology was when assessing a study of aerosol emitted by 5 vapers in a 60 m3 room over 5 hours that seemed to be a sufficient approximation of worst -case "bystander" exposure[6]. All calculated concentrations were expressed as the most stringent (lowest) TLV for a specific compound (i.e. assuming the most toxic form if analytical report is ambiguous) and expressed as "percent of TLV ". Considering that all the above calculations are approximate and reflecting that exposures in occupational and general environment can easily vary by a factor of 10 around the mean, we added a 10 -fold safety factor to the "percent of TLV" calculation. Details of all calculations are provided in an Excel spreadsheet (see electronic Appendix C: https://dI.di-onboxiisercontent.com/u/4285761 /C.ASAAJMpoendixC xlsx). No systematic attempt was made to convert the content of the studied liquids into potential exposures because sufficient information was available on the chemistry of aerosols to use those studies rather than making the necessary ' Atmosphere that contains air inhaled by a person 4 Technical Report July - August 2013 simplifying assumptions to do the conversion. However, where such calculations were performed in the original research, the following approach as used: under the (probably false —see the literature on formation of carbonyl compounds below) assumption of no chemical reaction to generate novel ingredients, composition of liquids can be used to estimate potential for exposure if it can be established -how much volume of liquid is consumed irr given 8 hours, following an algorithm analogous to the one described above for the aerosols (Equation 2): [mg /m3] = mg /(mL liquid) x (mL liquid) /puff x puffs /(8 hr day) x 1 /(m3 air inhaled in 8 hr) Eq. 2 Comparison to cigarette smoke was not performed here because the fact that e- cigarette aerosol is at least orders of magnitude less contaminated by toxic compounds is uncontroversial [2 -8]. Results and discussion General comments on methods In excess of 9,000 determinations of single chemicals (and rarely, mixtures) were reported in reviewed articles and reports, typically with multiple compounds per electronic cigarette tested [2- 8,14 -42]. Although the quality of reports is highly variable, if one assumes that each report contains some information, this asserts that quite a bit is known about composition of e- cigarette liquids and aerosols. The only report that was excluded from consideration was work of McAuley et ai.[23] because of clear evidence of cross - contamination — admitted to by the authors —with cigarette smoke and, possibly, reagents. The results pertaining to non- detection of tobacco-specific nitrosamines (TSNAs) are potentially trustworthy, but those related to PAH are not since it is incredible that cigarette smoke would contain fewer polycyclic aromatic hydrocarbons (PAH; arising in incomplete combustion of organic matter) than aerosol of e- cigarettes that do not burn organic matter [23]. In fairness to the authors of that study, similar problems may have occurred in other studies but were simply not reported, but it is impossible to include a paper in a review once it is known for certain that its quantitative results are not trustworthy. When in doubt, we erred on the side of trusting that proper quality controls were in place, a practice that is likely to increase appearance of atypical or erroneous results in this review. From this perspective, assessment of concordance among independent reports gains higher importance than usual since it is unlikely that two experiments would be flawed in the same exact manner (though of course this cannot be assured). It was judged that the simplest form of publication bias— disappearance of an entire formal study from the available literature —was unlikely given the exhaustive search strategy and the contested nature of the research question. It is clearly the case that only a portion of all industry technical reports were available for public access, so it is possible that those with more problematic results were systematically suppressed, though there is no evidence to support this speculation. No formal attempt was made to ascertain publication bias in situ though it is apparent that anomalous results do gain prominence in typical reviews of the literature: diethylene glycol[43,44] detected at non - dangerous levels (see details below) in one test of 18 of early - technology products by FDA[22] and one outlier in measurement of formaldehyde content of exhaled air [4] and aldehydes in aerosol generated from one e- cigarette in Japan [37]. It must be emphasized that the alarmist report of aldehydes in experiments presented in [37] is based on the concentration in generated aerosol rather than air inhaled by the vaper over prolonged period of time (since vapers do not inhale only aerosol). Thus, results reported in [37] cannot be the basis of any claims about health risk, a fallacy committed both by the authors themselves and commentators on this work [44]. Technical Report July - August 2013 It was also unclear from [37] what the volume of aerosol sampled was— a critical item for extrapolating to personal exposure and a common point of ambiguity in the published reports. However, in a personal exchange with the authors of [37][July 11, 2013], it was clarified that the sampling pump drew air at 500 mL /min through e- cigarette for 10 min, allowing more appropriate calculations for estimation of health risk that are presented below. Such misleading reporting is common in the field that confuses concentration in the aerosol (typically measured directly) with concentration in the air inhaled by the vaper (never determined directly and currently requiring additional assumptions and modeling). This is important because the volume of aerosol inhaled (maximum —8 L/day) is negligible compared to the volume of air inhaled daily (8L /min); this point is illustrated in the Figure. A similar but more extreme consideration applies to the exposure of bystanders which is almost certainly several orders of magnitude lower than the exposure of vapers. In part this is due to the absorption, rather than exhalation, of a portion of the aerosol by the vapers: there is no equivalent to the "side- stream" component of exposure to conventional cigarettes, so all of the exposure to bystanders results from exhalation. Furthermore, any environmental contamination that results from exhalation of aerosol by vaper will be diluted into the air prior to entering a bystander's personal breathing zone. Lastly, the number of puffs that affects exposure to bystander is likely to be much smaller than that of a vaper unless we are to assume that vaper and bystander are inseparable. It is unhelpful to report results in cigarette - equivalents, as in [42], because this does not enable one to estimate exposures of vapers. Moreover, there is no value in comparison of the content of e- cigarette aerosol to cigarette smoke when the two products produce emissions that are orders of magnitude apart. To be useful for risk assessment, the results on the chemistry of the aerosols and liquids must be reported in a form that enables the calculations in Equations 1 and 2. It must be also be noted that typical investigations consisted of qualitative and quantitative phases such that quantitative data is available mostly on compounds that passed the qualitative screen. This biased all reports on concentration of compounds towards both higher levels and chemicals which a particular lab was most adept at analyzing. Declared Ingredients. comparison to occupational exposure limits Propylene glycol and glycerin have default or precautionary TLV of 10 mg/m3 over 8 hours set for all organic mists with no specific exposure limits or identified toxicity ( http:// www .osha.gov /dts /chemicalsamoline /data /CH 243600 html; accessed July 5, 2013). These interim TLVs tend to err on the side of being too high and are typically lowered if evidence of harm to health accumulates. For example, in a study that related exposure of theatrical fogs (containing propylene glycol) to respiratory symptoms [45], "mean personal inhalable aerosol concentrations were 0.70 mg /m3 (range 0.02 to 4.1)" [46]. The only available estimate of propylene concentration of propylene glycol in the aerosol indicates personal exposure on the order of 3 -4 mg/m3 in the personal breathing zone over 8 hours (under the assumptions we made for all other comparisons to TLVs) [2]. The latest (2006) review of risks of occupational exposure to propylene glycol performed by the Health Council of the Netherlands (known for OELs that are the most protective that evidence supports and based exclusively on scientific considerations rather than also accounting for feasibility as is the case for the TLVs) recommended exposure limit of 50 mg/m3 over 8 hours; concern over short -term respiratory effects was noted [httn: / /www.gezondheidsraad.nl /sites /default /files /2007020SH odf; accessed July 29, 2013]. Assuming extreme consumption of the liquid per day via vaping (5 to 25 ml /day and 50 -95% propylene glycol in the liquid)b, levels of propylene glycol in inhaled air can reach 1-6 mg /m3. It has been suggested that propylene glycol is b This estimate of consumption was derived from informal reports from vaping community; 5 ml /day was identified as a high but not rare quantity of consumption and 25 mVday was the high end of claimed use, though some skepticism was expressed about 6 Technical Report July - August 2013 very rapidly absorbed during inhalation [4,6] making the calculation under worst case scenario of all propylene glycol becoming available for inhalation credible. It must also be noted that when consuming low- nicotine or nicotine -free liquids, the chance to consume larger volumes of liquid increases (large volumes are needed to reach the target dose or there is no nicotine feedback), leading to the upper end of propylene glycol and glycerin exposure. Thus, estimated levels of exposure to propylene glycol and glycerin are close enough to TLV to warrant concern. Nicotine is present in most liquids and has TLV of 0.5 mg /m3 for average exposure intensity over 8 hours. If approximately 4 m3 of air is inhaled in 8 hours, the consumption of 2 mg nicotine from e- cigarettes in 8 hours would place the vaper at the occupational exposure limit. For a liquid that contains 18 mg nicotine /ml, TLV would be reached upon vaping - 0.1 -0.2 ml of liquid in a day, and so is achieved for most anyone vaping nicotine - containing e- cigarettes[1]. Results presented in [24] on 16 e- cigarettes also argue in favor of exceedance of TLV from most any nicotine - containing e- cigarette, as they predict >2mg of nicotine released to aerosol in 150 puffs (daily consumption figure adopted in this report). But as noted above, since delivery of nicotine is the purpose of nicotine - containing e- cigarettes, the comparison to limits on unintended, unwanted exposures does not suggest a problem and serves merely to offer complete context. If nicotine is present but the liquid is labeled as zero - nicotine [24,43], it could be treated as a contaminant, with the vaper not intending to consume nicotine and the TLV, which would be most likely exceeded, is relevant. However, when nicotine content is disclosed, even if inaccurately, then comparison to TLV is not valid. Accuracy in nicotine content is a concern with respect to truth in advertising rather than unintentional exposure, due to self - regulation of consumption by persons who use e- cigarettes as a source of nicotine. Overall, the declared ingredients in the liquid would warrant a concern by standards used in occupational hygiene, provided that comparison to occupational exposure limits is valid, as discussed in the introduction. However, this is not to say that the exposure is affirmatively believed to be harmful; as noted, the TLVs for propylene glycol and glycerin mists is based on uncertainty rather than knowledge. These TLVs are not derived from knowledge of toxicity of propylene glycol and glycerin mists, but merely apply to any compound of no known toxicity present in workplace atmosphere. This aspect of the exposure from e- cigarettes simply has little precedent (but see study of theatrical fogs below). Therefore, the exposure will provide the first substantial collection evidence about the effects, which calls for monitoring of both exposure levels and outcomes, even though there are currently no grounds to be concerned about the immediate or chronic health effects of the exposure. The argument about nicotine is presented here for the sake of completeness and consistency of comparison to TLVs, but in itself does not affect the conclusions of this analysis because it should not be modeled as if it were a contaminant when declared as an ingredient in the liquid. Polycyclic Aromatic Hydrocarbons Polycyclic aromatic hydrocarbons (PAH) were quantified in several reports in aerosols [5,6,42] and liquids [7,18,41]. These compounds include well -known carcinogens, the levels of which are not subject to TLV but are instead to be kept "as low as reasonably achievable" (the so called ALARA principle)[10]. For PAH, only non - carcinogenic pyrene that is abundant in the general environment was detected at 36 ng/cartridge in 5 samples of liquid [7]; PAHs were not detected in most of the analyses of aerosols, except for chrysene in the analysis of the aerosol of one e- cigarette[42]. Tobacco - Specific Nitrosamines whether the latter quantity was truly possible. High - quality formal studies to verify these figures do not yet exist but they are consistent with report of Etter (2012). 7 Technical Report July - August 2013 The same risk assessment considerations that exist for PAH also hold for carcinogenic tobacco - specific nitrosamines (TSNAs)[47] for which no occupational exposure limits exist because (a) these exposures do not appear to occur in occupational settings often enough to warrant development of TLVs, and (b) it is currently accepted in establishing TLVs that carcinogens do not have minimal thresholds of toxicity. As expected because the TSNAs are contaminants of nicotine from tobacco leaf, there is also evidence of association between nicotine content of the liquid and TSNA concentrations, with reported concentrations <5 ng/cartridge tested [7]. Smaller studies of TSNA content in liquids are variable, with some not reporting any detectable levels [17,32,34] and others clearly identifying these compounds in the liquids when controlling for background contamination (n= 9)[22]. Analyses of aerosols indicate that TSNAs are present in amounts that can results in doses of <ng /day[5,32] to µg /day [8] (assuming 150 puffs /day) (see also [42]). The most comprehensive survey of TSNA content of 105 samples of liquids from 11 manufactures indicates that almost all tested liquids ( >90 %) contained TSNAs in µg /L quantities [35]. This is roughly equivalent to 1 /1000 of the concentration of TSNAs in modern smokeless tobacco products (like snus), which are in the ppm range [47]. The TSNA concentration of the liquids is orders of magnitude less than smokeless tobacco products, though the actual dosage from e- cigarettes vs. smokeless tobacco remains to be clearly understood. For example, 10 pg/L (0.01 ppm) of total TSNA in liquid[35] can translate to a daily dose of 0.000025 - 0.00005 µg from vaping (worst case assumption of 5 ml /day); if 15 g of snus is consumed a day [48] with 1 ppm of TSNAs [47] and half of it were absorbed, then the daily dose is estimated to be 0.008 µg, which is 160 -320 times that due to the worst case of exposure from vaping. Various assumptions about absorption of TSNAs alter the result of this calculation by a factor that is dwarfed in magnitude compared to that arising from differences considered above. This is reassuring because smokeless tobacco products, such as snus, pose negligible cancer risk[49], certainly orders of magnitude smaller than smoking (if one considers the chemistry of the products alone). In general, it appears that the cautious approach in face of variability and paucity of data is to seek better understanding of predictors of presence of TSNA in liquids and aerosols so that measures for minimizing exposure to TSNAs from aerosols can be devised. This can include considering better control by manufactures of the nicotine. Volatile Organic Compounds Total volatile organic compounds (VOC) were determined in aerosol to be non- detectable[3] except in one sample that appeared to barely exceed the background concentration of 1 mg /m3 by 0.73 mg /m3[6]. These results are corroborated by analyses of liquids[18] and most likely testify to insensitivity of employed analytic methods for total VOC for characterizing aerosol generated by e- cigarettes, because there is ample evidence that specific VOC are present in the liquids and aerosols.` Information on specific commonly detected VOC in the aerosol is given in Table 1a. It must be observed that these reported concentrations are for analyses that first observed qualitative evidence of the presence of a given VOC and thus represent worst case scenarios of exposure when VOC is present (i.e. zero exposures are missing from the overall summary of worst case exposures presented here). For most VOC and aldehydes, one can predict the concentration in air inhaled by a vaper to be «1% of TLV. The only exceptions to this generalization are: (a) acrolein: —1% of TLV (average of 12 measurements) and measurements at a mean of 2% of TLV ( average of 150 measurements)[39,40] and (b) formaldehyde: between 0 and 3% of TLV based on 18 tests (average of 12 measurements at 2% of TLV, the most reliable test) and an average of 150 results at 4% of TLV [39,40]. `The term "VOC" loosely groups together all organic compounds present in aerosol and because the declared ingredients of aerosol are organic compounds, it follows that "VOC are present" 8 Technical Report July - August 2013 Levels of acrolein in exhaled aerosol reported in [6] were below 0.0016 mg/m3 and correspond to predicted exposure of <1% of TLV (Table 2). It must re- emphasized that all calculations based on one electronic cigarette analyzed in [37] are best treated as qualitative in nature (i.e. indicating presence of a compound without any particular meaning attached to the reported level with respect to typical levels) due to great uncertainty about whether the manner in which the e- cigarette was operated could have resulted in overheating that led to generation of acrolein in the aerosol. In fact, a presentation made by the author of [37] clearly stated that the "atomizer, generating high concentration carbonyls, had been burned black" [39,40]. In unpublished work,[39] there are individual values of formaldehyde, acrolein and glyoxal that approach TLV, but it is uncertain how typical these are because there is reason to believe the liquid was overheated; considerable variability among brands of electronic cigarettes was also noted. Formaldehyde and other aldehydes, but not acrolein, were detected in the analysis one e- cigarette [421. The overwhelming majority of the exposure to specific VOC that are predicted to result from inhalation of the aerosols lie far below action level of 50% of TLV at which exposure has to be mitigated according to current code of best practice in occupational hygiene[501. Finding of an unusually high level of formaldehyde by Schripp et oL [41— 0.5 ppm predicted vs. 15- minute TLV of 0.3 ppm (not given in Table 2) — is clearly attributable to endogenous production of formaldehyde by the volunteer smoker who was consuming e- cigarettes in the experimental chamber, since there was evidence of build -up of formaldehyde prior to vaping and liquids used in the experiments did not generate aerosol with detectable formaldehyde. This places genera lizability of other findings from [41 in doubt, especially given that the only other study of exhaled air by vapers who were not current smokers reports much lower concentrations for the same compounds [6] (Table 2). It should be noted that the report by Romagna et ol.[6] employed more robust methodology, using 5 volunteer vapers (no smokers) over an extended period of time. Except for benzene, acetic acid and isoprene, all calculated concentrations for detected VOC were much below 1% of TLV in exhaled air [6]. In summary, these results do not indicate that VOC generated by vaping are of concern by standards used in occupational hygiene. Diethylene glycol and ethylene glycol became a concern following the report of theircletection by FDA[43], but these compounds are not detected in the majority of tests performed to date [3,14,16,18,22]. Ten batches of the liquid tested by their manufacture did not report any diethylene glycol above 0.05% of the liquid [41]. Methods used to detect diethylene glycol appear to be adequate to be informative and capable of detecting the compound in quantities «1% of TLV[14,16,22]. Comparison to TLV is based on a worst case calculation analogous to the one performed for propylene glycol. For diethylene glycol, TLV of 10 mg /m3 is applicable (as in the case of all aerosols with no know toxicity by inhalation), and there is a recent review of regulations of this compound conducted for the Dutch government by the Health Council of the Netherlands (jurisdiction with some of the most strict occupational exposure limits) that recommended OEL of 70 mg /m3 and noted lack of evidence for toxicity following inhalation [htta: / /www.gezondheidsraad.nl /sites /default /files /2007030SH odf; accessed July 29; 2013]. In conclusion, even the quantities detected in the single FDA result were of little concern, amounting to less than 1% of TLV. Inorganic compounds Special attention has to be paid to the chemical form of compounds when there is detection of metals and other elements by inductively coupled plasma mass spectrometry (ICP- MS)[8,25]. Because the parent molecule that occurs in the aerosol is destroyed in such analysis, the results can be alarmist and not interpretable for risk assessment. For example, the presence of sodium (4.18 µg /10 puffs)[251 does not mean that highly reactive and toxic sodium metal is in the aerosol, which would be impossible given its reactivity, but most likely means the presence of the ubiquitous compound that contains sodium, dissolved table salt (NaCI). If so, the corresponding daily dose of NaCl that arises from 0 Technical Report July - August 2013 these concentrations from 150 puffs is about 10,000 times lower than allowable daily intake according to CDC (http: / /www.cdc.goy /features /dssodium /• accessed July 4, 2013). Likewise, a result for presence of silica is meaningless for health assessment unless the crystalline form of SiO2 is known to be present. When such ambiguity exists, a TLV equivalence calculation was not performed. We compared concentrations to TLVs when it was even remotely plausible that parent molecules were present in the aqueous solution. However, even these are to be given credence only in an extremely pessimistic analyst, and further investigation by more appropriate analytical methods could clarify exactly what compounds are present, but is not a priority for risk assessment. It should also be noted that one study that attempted to quantify metals in the liquid found none above 0.1 -0.2 ppm levels [7] or above unspecified threshold [18]. Table lb indicates that most metals that were detected were present at <1% of TLV even if we assume that the analytical results imply the presence of the most hazardous molecules containing these elements that can occur in aqueous solution. For example, when elemental chromium was measured, it is compared to TLV for insoluble chromium IV that has the lowest TLV of all chromium compounds. Analyses of metals given in [42] are not summarized here because of difficulty with translating reported units into meaningful terms for comparison with the TLV, but only mercury (again with no information on parent organic compound) was detected in trace quantities, but arsenic, beryllium, chromium, cadmium, lead and nickel were not. Taken as the whole, it can be inferred that there is no evidence of contamination of the aerosol with metals that warrants a health concern. Consideration of exposure to a mixture of contaminants All calculations conducted so far assumed only one contaminant present in clean air at a time. What are the implications of small quantities of various compounds with different toxicities entering the personal breathing zone at the same time? For evaluation of compliance with exposure limits for mixtures, Equation 3 is used: OEIm;.,e =In l(c,lmd, Eq.3 where C; is the concentration of the i`" compound (i= l,...,n, where n >1 is the number of ingredients present in a mixture) in the contaminated air and TLVi is the TLV for the ith compound in the contaminated air; if OELm „,,,,e> 1, then there is evidence of the mixture exceeding TLV. The examined reports detected no more than 5 -10 compounds in the aerosol, and the above calculation does not place any of them out of compliance with TLV for mixture. Let us imagine that 50 compounds with TLVs were detected. Given that the aerosol tends to contain various compounds at levels, on average, of no more than 0.5% of TLV (Table 1), such a mixture with 50 ingredients would be at 25% of TLV, a level that is below that which warrants a concern, since the "action level” for implementation of controls is traditionally set at 50% of TLV to ensure that the majority of persons exposed have personal exposure below mandated limit [50]. Pellerino et al.[2] reached conclusions similar to this review based on their single experiment: contaminants in the liquids that warrant health concerns were present in concentrations that were less than 0.1% of that allowed by law in the European Union. Of course, if the levels of the declared ingredients (propylene glycol, glycerin, and nicotine) are considered, the action level would be met, since those ingredients are present in the concentrations that are near the action level. There are no known synergistic actions of the examined mixtures, so Equation 3 is therefore applicable. Moreover, there is currently no reason to suspect that the trace amounts of the contaminants will react to create compounds that would be of concern. 10 Technical Report July - August 2013 Conclusions By the standards of occupational hygiene, current data do not indicate that exposures to vapers from contaminants in electronic cigarettes warrant a concern. There are no known toxicological synergies among compounds in the aerosol, and mixture of the contaminants does not pose a risk to health. However, exposure of vapers to propylene glycol and glycerin reaches the levels at which, if one were considering the exposure in connection with a workplace setting, it would be prudent to scrutinize the health of exposed individuals and examine how exposures could be reduced. This is the basis for the recommendation to monitor levels and effects of prolonged exposure to propylene glycol and glycerin that comprise the bulk of emissions from electronic cigarettes other than nicotine and water vapor. From this perspective, and taking the analogy of work on theatrical fogs [45,461, it can be speculated that respiratory functions and symptoms (but not cancer of respiratory tract or non - malignant respiratory disease) of the vaper is of primary interest. Monitoring upper airway irritation of vapers and experiences of unpleasant smell would also provide early warning of exposure to compounds like acrolein because of known immediate effects of elevated exposures (http://www.atsdr.cdc.gov/toxprofiles/tP124-c3.i3df, accessed July 11, 2013). However, it is questionable how much concern should be associated with observed concentrations of acrolein and formaldehyde in the aerosol. Given highly variable assessments, closer scrutiny is probably warranted to understand sources of this variability, although there is no need at present to be alarmed about exceeding even the occupational exposure limits, since occurrence of occasional high values is accounted for in established TLVs. An important clue towards a productive direction for such work is the results reported in [39,401 that convincingly demonstrate how heating the liquid to high temperatures generates compounds like acrolein and formaldehyde in the aerosol. A better understanding about the sources of TSNA in the aerosol may be of some interest as well, but all results to date consistently indicate quantities that are of no more concern than TSNA in smokeless tobacco products. Exposures to nicotine from electronic cigarettes is not expected to exceed that from smoking due to self- titration[111; it is only a concern when a vaper does not intend to consume nicotine, a situation that can arise from incorrect labeling of liquids[24,43). The cautions about propylene glycol and glycerin apply only to the exposure experienced by the vapers themselves. Exposure of bystanders to the listed ingredients, let alone the contaminants, does not warrant a concern as the exposure is likely to be orders of magnitude lower than exposure experienced by vapers. Further research employing realistic conditions could help quantify the quantity of exhaled aerosol and its behavior in the environment under realistic worst -case scenarios (i.e., not small sealed chambers), but this is not a priority since the exposure experienced by bystanders is clearly very low compared to the exposure of vapers, and thus there is no reason to expect it would have any health effects. The key to making the best possible effort to ensure that hazardous exposures from contaminants do not occur is ongoing monitoring of actual exposures and estimation of potential ones. Direct measurement of personal exposures is not possible in vaping due to the fact the aerosol is inhaled directly, unless, of course, suitable biomarkers of exposure can be developed. The current review did not identify any suitable biomarkers, though cotinine is a useful proxy for exposure to nicotine- containing liquids. Monitoring of potential composition of exposures is perhaps best achieved though analysis of aerosol generated in a manner that approximates vaping, for which better insights are needed on how to modify "smoking machines" to mimic vaping given that there are documented differences in inhalation patterns[511. These smoking machines would have to be operated under a realistic mode of operation of the atomizer to ensure that the process for generation of contaminants is studied under realistic temperatures. To estimate dosage (or exposure in personal breathing zone), information on the chemistry of aerosol has to be combined with models of the inhalation pattern of vapers, mode of operation of e- cigarettes and quantities of liquid consumed. Assessment of 11 Technical Report July - August 2013 exhaled aerosol appears to be of little use in evaluating risk to vapers due to evidence of qualitative differences in the chemistry of exhaled and inhaled aerosol. Monitoring of liquid chemistry is easier and cheaper than assessment of aerosols. This can be done systematically as a routine quality control measure by the manufacturers to ensure uniform quality of all production batches. However, we do not know how this relates to aerosol chemistry because previous researchers have failed to appropriately pair analyses of chemistry of liquids and aerosols. It is standard practice in occupational hygiene to analyze the chemistry of materials generating an exposure, and it is advisable that future studies of the aerosols explicitly pair these analyses with examination of composition of the liquids used to generate the aerosols. Such an approach can lead to the development of predictive models that relate the composition of the aerosol to the chemistry of liquids, the e- cigarette hardware, and the behavior of the vaper, as these, if accurate, can anticipate hazardous exposures before they occur. The current attempt to use available data to develop such relationships was not successful due to studies failing to collect appropriate data. Systematic monitoring of quality of the liquids would also help reassure consumers and is best done by independent laboratories rather than manufactures to remove concerns about impartiality (real or perceived). Future work in this area would greatly benefit from standardizing laboratory protocols (e.g. methods of extraction of compounds from aerosols and liquids, establishment of "core" compounds that have to be quantified in each analysis (as is done for PAH and metals), development of minimally informative detection limits that are needed for risk assessment, standardization of operation of "vaping machine ", etc.), quality control experiments (e.g. suitable positive and negative controls without comparison to conventional cigarettes, internal standards, estimation of %recovery, etc.), and reporting practices (e.g. in units that can be used to estimate personal exposure, use of uniform definitions of limits of detection and quantification, etc.), all of which would improve on the currently disjointed literature. Detailed recommendations on standardization of such protocols lie outside of scope of this report. All calculations conducted in this analysis are based on information about patterns of vaping and the content of aerosols and liquids that are highly uncertain in their applicability to "typical" vaping as it is currently practiced and says even less about future exposures due to vaping. However, this is similar to assessments that are routinely performed in occupational hygiene for novel technology as it relied on "worst case" calculations and safety margins that attempt to account for exposure variability. The approach adopted here and informed by some data is certainly superior to some currently accepted practices in the regulatory framework in occupational health that rely purely on description of emission processes to make claims about potential for exposure (e.g.[52)). Clearly, routine monitoring of potential and actual exposure is required if we were to apply the principles of occupational hygiene to vaping. Detailed suggestions on how to design such exposure surveillance are available in [53]. In summary, analysis of the current state of knowledge about the chemistry of contaminants in liquids and aerosols associated with electronic cigarettes indicates that there is no evidence that vaping produces inhalable exposures to these contaminants at a level that would prompt measures to reduce exposure by the standards that are used to ensure safety of workplaces. Indeed, there is sufficient evidence to be reassured that there are no such risks from the broad range of the studied products, though the lack of quality control standards means that this cannot be assured for all products on the market. However, aerosol generated during vaping on the whole, when considering the declared ingredients themselves, if it were treated in the same manner as an emission from industrial process, creates personal exposures that would justify surveillance of exposures and health among exposed persons. Due to the uncertainty about the effects of these quantities of propylene glycol and glycerin, this conclusion holds after setting aside concerns about health effects of nicotine. This conclusion holds notwithstanding the benefits of tobacco harm reduction, since 12 Technical Report July - August 2013 there is value in understanding and possibly mitigating risks even when they are known to be far lower than smoking. I must be noted that the proposal for such scrutiny of "total aerosol' is not based on specific health concerns suggested by compounds that resulted in exceedance of occupational exposure limits, but is instead a conservative posture in the face of unknown consequences of inhalation of appreciable quantities of organic compounds that may or may not be harmful at doses that occur during vaping. Key Conclusions: • Even when compared to workplace standards for involuntary exposures, and using several conservative (erring on the side of caution) assumptions, the exposures from using e- cigarettes fall well below the threshold for concern for compounds with known toxicity. That is, even ignoring the benefits of e- cigarette use and the fact that the exposure is actively chosen, and even comparing to the levels that are considered unacceptable to people who are not benefiting from the exposure and do not want it, the exposures would not generate concern or call for remedial action. • Expressed concerns about nicotine only apply to vapers who do not wish to consume it; a voluntary (indeed, intentional) exposure is very different from a contaminant. • There is no serious concern about the contaminants such as volatile organic compounds (formaldehyde, acrolein, etc.) in the liquid or produced by heating. While these contaminants are present, they have been detected at problematic levels only in a few studies that apparently were based on unrealistic levels of heating. • The frequently stated concern about contamination of the liquid by a nontrivial quantity of ethylene glycol or diethylene glycol remains based on a single sample of an early technology product (and even this did not rise to the level of health concern) and has not been replicated. • Tobacco - specific nitrosamines (TSNA) are present in trace quantities and pose no more (likely much less) threat to health than TSNAs from modern smokeless tobacco products, which cause no measurable risk for cancer. • contamination by metals is shown to be at similarly trivial levels that pose no health risk, and the alarmist claims about such contamination are based on unrealistic assumptions about the molecular form of these elements. • The existing literature tends to overestimate the exposures and exaggerate their implications. This is partially due to rhetoric, but also results from technical features. The most important is confusion of the concentration in aerosol, which on its own tells us little about risk to heath, with the relevant and much smaller total exposure to compounds in the aerosol averaged across all air inhaled in the course of a day. There is also clear bias in previous reports in favor of isolated instances of highest level of chemical detected across multiple studies, such that average exposure that can be calculated are higher than true value because they are "missing" all true zeros. Routine monitoring of liquid chemistry is easier and cheaper than assessment of aerosols. Combined with an understanding of how the chemistry of the liquid affects the chemistry of the aerosol and insights into behavior of vapers, this can serve as a useful tool to ensure the safety of e- cigarettes. The only unintentional exposures (i.e., not the nicotine) that seem to rise to the level that they are worth further research are the carrier chemicals themselves, propylene glycol and glycerin. This exposure is not known to cause health problems, but the magnitude of the exposure is novel and thus is at the levels for concern based on the lack of reassuring data. 13 Technical Report July - August 2013 Acknowledgements Funding for this work was provided by The Consumer Advocates for Smoke -free Alternatives Association ( CASAA) Research Fund. CASAA is an all- volunteer, donation-funded, non- profit organization devoted to defending consumer access to and promoting tobacco harm reduction; for more information, see htto: / /casaa.ore /. CASAA exercised no editorial control over the author's writing or analysis: the author, not the (under, had full control of the content. The author is thankful to Dr Carl V Phillips, the CASAA Scientific Director, for frank discussion of relevant scientific matters, as well as Drs. Uchiyama and Laugesen for access to presently unpublished data. Lastly, the contribution of Charity Curtis, Masters of Public Health student at Drexel University to the initial literature search was greatly appreciated. 14 Technical Report July - August 2013 Figure: Illustrating the difference between concentrations In the aerosol generated by vaping and inhaled air in a day. PonelA shows black square that represents aerosol contaminated by some compound as it would be measured by a "smoking machine" and extrapolated to dosage from vaping in one day. This black square is located inside the white square that represents total uncontaminated air that is inhaled in a day by a vaper. The relative sizes of the two squares are exaggerated as the volume of aerosol generated in vaping relative to inhaled air is much smaller in the figure. Panel 8 shows how exposure from contaminated air (black dots) is diluted over a day for appropriate comparison to occupational exposure limits that are expressed in terms of "time- weighted average" or average contamination over time rather than as instantaneous exposures (with the exception of "ceiling limits" that do not affect the vast majority of comparisons in this report). Exposure during vaping occurs in a dynamic process where the atmosphere inhaled by the vaper alternates between the smaller black and larger white squares in Panel A. Thus, the concentration of contaminants that a vaper is exposed to over a day is much smaller than that which is measured in the aerosol (and routinely improperly cited as reason for concern about "high" exposures). Q L 15 0 Technical Report July - August 2013 Table la: Exposure predictions based on analysis of aerosols generated by smoking machines: Volatile Organic Compounds Compound N# Estimated concentration in personal breathing zone Ratio of most stringent TLV ( %) Reference PPM mg /m Calculated directly Safety factor 10 Acetaldehyde 1 0.005 0.02 0.2 [5] 3 0.003 0.01 0.1 [4] 12 0.001 0.004 0.04 [81 1 0.00004 0.0001 0.001 [3] 1 0.0002 0.001 0.008 [3] 150 0.001 0.004 0.04 [39,40] 1 0.008 0.03 3 [37] Acetone 1 0.002 0.0003 0.003 [37] 150 0.0004 0.0001 0.001 [39,40] Acrolein 12 0.001 1 13 [8] 150 0.002 2 20 [39,40] 1 0.006 6 60 [37] Butanal 150 0.0002 0.001 0.01 [39,40] Crotonaldebyde 150 0.0004 0.01 0.1 [39,40] Formaldehyde 1 0.002 0.6 6 151 3 0.008 3 30 [4] 12 0.006 2 20 [8] 1 <0.0003 <0.1 <1 [3] 1 0.0003 0.1 1 [3] 150 0.01 4 40 [39,40] 1 0.009 3 30 [37] Glyoxal 1 0.002 2 20 [37] 150 0.006 6 60 [39,40] o-Methylbenzaldehyde 12 0.001 0.05 0.5 [8] p,m- Xylene 12 0.00003 0.001 0.01 [8] Propanal 3 0.002 0.01 0.1 [4] 150 0.0006 0.002 0.02 [39,40] 1 0.005 0.02 0.2 [37] Toluene 12 0.0001 0.003 0.03 [8] Valeraldehyde 150 0.0001 1 0.0001 0.001 [39,40] 9 average is presented when 1v >r 16 Technical Report July - August 2013 Table lb: Exposure predictions based on analysis of aerosols generated by smoking machines: Inorganic Compounds" Element quantified Assumed compound containing the element for comparison with TLV Estimated concentration in personal breathing zone (mg/ml Ratio of most stringent TLV ( %) Reference Calculated directly Safety factor 10 Aluminum Respirable Al metal & insoluble compounds 1 0.002 0.2 1.5 [251 Barium Be & insoluble compounds 1 0.00005 0.01 0.1 [251 Boron Boron oxide 1 0.02 0.1 1.5 [25] Cadmium Respirable Cd & compounds 12 0.00002 1 10 [8] Chromium Insoluble Cr (IV) courDounds I 3E -05 0.3 3 [25] Copper Cu fume 1 0.0008 0.4 4.0 [251 Iron Soluble iron salts, as Fe 1 0.002 0.02 0.2 [25] Lead Inorganic compounds as Ph 1 7E -05 0.1 1 [25] 12 0.000025 0.05 0.5 [8] Magnesium Inhalable magnesium oxide 1 0.00026 0.003 0.03 [25] Manganese Inorganic compounds, as Mn 1 8E -06 0.04 0.4 [25] Nickel Inhalable soluble inorganic compounds, as Ni 1 2E -05 0.02 0.2 [25] 12 0.00005 0.05 0.5 [8] Potassium KOH 1 0.001 0.1 1 [25] Tin Organic compounds, as So 1 0.0001 0.1 1 [25] Zinc Zinc chloride fume 1 0.0004 0.04 0.4 [25] Zirconium Zr and cumpounds 1 3E -05 0.001 0.01 [25] Sulfur SOz I 0.002 0.3 3 [25] # The actual molecular form in the aerosol unknown and so worst case assumption was made if it was physically possible (e.g. it is not possible for elemental lithium & sodium to be present in the aerosol); there is no evidence from the research that suggests the metals were in the particular highest risk form, and in most cases a general knowledge of chemistry strongly suggests that this is unlikely. Thus, the TLV ratios reported here probably do not represent the (much lower) levels that would result if we knew the molecular forms. ## average is presented when N >l 17 Technical Report July - August 2013 Table 2: Exposure predictions for volatile organic compounds based on analysis of aerosols generated by volunteer vapers Compound N# Estimated concentration in personal breathing zone (pPm) Ratio of most stringent TLV ( %) Reference Calculated directly Safety factor 10 2- butanone (N EK) 3 0.04 0.02 0.2 [4] 1 0.002 0.0007 0.007 [6] 2- furaidehyde 3 0.01 0.7 7 [41 Acetaldehyde 3 0.07 0.3 3 [4] Acetic acid 3 0.3 3 30 [4] Acetone 3 0.4 0.2 2 [4] Acrolein 1 <0.001 <0.7 <7 [6] Benzene 3 0.02 3 33 (4) Butyl hydroxyl toluene 1 4E -05 0.0002 0.002 [61 Isoprene 3 0.1 7 70 [4] Limonene 3 0.009 0.03 0.3 [4] 1 2E-05 0.000001 0.00001 [6] m,p- Xyelen 3 0.01 0.01 01 [4] Phenol 3 0.01 0.3 3 [4] Propanal 3 0.004 0.01 0.1 [4] Toluene 3 0.01 0.07 0.7 [4] # average is presented when N >1 18 Technical Report July- August 2013 Reference List 1. Etter JF: The Electronic Cigarette : an Alternative to Tobacco? Jean- Frangois Etter; 2012. Pellegrino RM, Tinghino B, Mangiaracina G, Marani A, Vitali M, Protano C et al.: Electronic cigarettes: an evaluation of exposure to chemicals and fine particulate matter (PM). Ann Ig 2012, 24: 279 -288. 3. e5moking Institute. Assessment of e- cigarette safety by comparing the chemical composition of e- cigarette aerosol and cigarette smoke from reference traditional cigarette. http : / /www.esmokinginstitute.com /en /node /31 .2013. Ref Type: Electronic Citationhttp : / /www.esmokinginstitute.ccm /en /node /31 4. Schripp T, Markewitz D, Uhde E, Salthammer T: Does e- cigarette consumption cause passive vaping? Indoor Air 2013, 23: 25 -31. 5. Lauterbach 1H, Laugesen M: Comparison of toxicant levels in mainstream aerosols generated by Ruyan® electronic nicotine delivery systems(ENDS) and conventional cigarette products. 14 March, 2012; 2012.http://www.healthnz.co.nz/News2Ol2SOTposterl861.pd f 6. Romagna G, Zabarini L, Barbiero L, Boccietto E, Todeschi S, Caravati E et al.. Characterization of chemicals released to the environment by electronic cigarettes use (C1earStream -AIR project): is passive vaping a reality? 9- 1 -2012. XIV Annual Meeting of the SRNT Europe 2012, Helsinki, Finland. Ref Type: Reporthttp / /clearstream flavourart it/ site /wp- content /uploads /2012/09/CSA ItaEne pdf 7. Laugesen M. Safety report on the Ruyan® e- cigarette cartridge and inhaled aerosol. Edited by Health New Zealand Ltd. 2008. Ref Type: Report www.healthnz_c.o.nz 8. Goniewicz ML, Knysak J, Gawron M, Kosmider L, Sobczak A, Kurek 1 et al.: Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control 2013. Benowitz NL, Jacob P, III: Daily intake of nicotine during cigarette smoking. Clin Phormocol Ther 1984, 35: 499- 504. 10. The American Conference of Governmental Industrial Hygienists: 2013 threshold limit values for chemical substances and physical agents & biological exposure indices. Cincinnati, OH: ACGIH; 2013. 11. Scherer G: Smoking behaviour and compensation: a review of the literature. Psychophormacology (Berl) 1999, 145: 1 -20. 12. Ganong WF: Review of rrJedica/physio%gy, 15 edn. London: Prentice Hall; 1995. 13. Holmes 1R. How Much Air Do We Breathe? Research Note 94 -11. 1994. California Environmental Protection Agency. Ref Type: Reporthttp://www.arb.ca.gov/research/resnotes/notes/94-li.htm 14. Alliance Technologies L. Chemical composition of "Instead" electronic cigarette smoke juice and vapor. 2009. Ref Type: Reportwww.alliancetechgroup.com ,M] Technical Report July - August 2013 15. Alliance Technologies L. Characterization of liquid "Smoke Juice" for electronic cigarettes. 2009. Ref Type: Reportwww.attiancetech8roup.com 16. Alliance Technologies L. Characterization of Regal cartridges for electronic cigarettes. 2009. Ref Type: Reportwww.altiancetecheroup.com 17. Alliance Technologies L. Characterization of regal cartridges for electronic cigarettes - Phase II. 2009. Ref Type: Reportwww.alliancetecheroup.com 18. eSmoking Institute. Identifying the concentration of chemical compounds and heavy metals in liquids. http://www.esmokinginstitute.com/en/node/32. 2013. Ref Type: Electronic Citationhttp : / /www.esmokinginstitute.com /en /node /32 19. Evans Analytical Group. Gas chromatography mass spectroscopy(GC -MS) analysis report; JOB NUMBER C09Y8961. 2009. Ref Type: Reportwww.eaalabs.com 20. Coulson H. Analysis of components from Gamucci electronic cigarette cartridges, tobacco flavour regular smoking liquid; Report number: E98D. Edited by LPD Laboratory Services, Blackburn MicroTech Solutions Ltd. 2009. Ref Type: Reportwww.lpolabservices.co.uk 21. Ellicott M. Analysis of components from "e -Juice XX HIGH 36mg/ml rated Nicotine Solution" ref S 55434; Report Number: E249A. Edited by LPD Laboratory Services, Blackburn MicroTech Solutions Ltd. 2009. Ref Type: Reportwww.lpolabservices.co.uk 22. Westenberger BJ. Evaluation of e- cigarettes; DPATR- FY- 09 -23. Edited by US Food and Drug Administration. 2009. Ref Type: Reporthttp: / /www.fda.eov/ downloads / drugs /Scienceresearch /UCM173250 pdf 23. McAuley TR, Hopke PK, Zhao J, Babaian S: Comparison of the effects of e- cigarette vapor and cigarette smoke on indoor air quality. Inhol Toxicol2012, 24: 850 -857. 24. Goniewicz ML, Kuma T, Gawron M, Knysak J, Kosmider L: Nicotine levels in electronic cigarettes. Nicotine Tab Res 2013, 15: 158 -166. 25. Williams M, Villarreal A, Bozhilov K, Lin S, Talbot P: Metal and silicate particles including nanoparticles are present in electronic cigarette cartomizer fluid and aerosol. PLoS One 2013, 8: e57987. 26. Laugesen M. Ruyan® E- cigarette bench -top tests. Society for Research on Nicotine and Tobacco, Dublin, April 30, 2009-2009. Ref Type: Abstract 27. TytgatJ. "Super Smoker" expert report. Edited by CATHOLIC UNIVERSITY L. 2007. Ref Type: Report 28. Valance C, Ellicott M. Analysis of chemical components from high, med & low nicotine cartridges; Report Number: D318. Edited by LPD Laboratory Services, Blackburn MicroTech Solutions Ltd. 2008. Ref Type: Reportwww.lpolabservices.co.uk 20 Technical Report July - August 2013 29. Kubica P, Kot -Wasik A, Wasik A, Namiesnik J: "Dilute & shoot" approach for rapid determination of trace amounts of nicotine in zero -level e- liquids by reversed phase liquid chromatography and hydrophilic interactions liquid chromatography coupled with tandem mass spectrometry- electrospray ionization. J ChromatogrA 2013, 1289: 13 -18, 30. Trehy ML, Ye W, Hadwiger ME, Moore TW, Allgire 1F, Woodruff JT et al.: Analysis of Electronic Cigarette Cartridges, Refill Solutions, and Smoke for Nicotine and Nicotine Related Impurities. Journal of Liquid Chromatography & Related Technologies 2011, 34: 1442 -1458. 31. Graves I. Report no. 468304. 60 ml sample of mist from 11 mg nicotine e- cigarette cartridge. Thermal desorption tubes. 468304. 9 -5 -2008. Hamilton, New Zealand, Hill Laboratories. Ref Type: Report 32. Pattison J, Valenty SJ. Material characterization report. 0910.14. 10 -21 -2009. Analyze Inc. Ref Type: Repartanalyzeinc. comhttp: // vapersclub .com /NJOYvaporstudy.pdf 33. Sodoma A, Caggiano CM. Material characterization report. 0706.04. 6 -28 -2007. Analyze Inc. Ref Type: Reporthttp: / /truthaboutecies.com /science /16.pdf 34. Anspach T. Determination of tobacco - specific nitrosamines (TSNA) in aroma fluid for e- cigarettes. 11- 57021. 9 -1- 2011. Eurofins Dr.Specht Laboratorien. Ref Type: Reporthttp : / /clearstream.flavourart.it /site /wp- content/ uploads / DATI / vari /nitrosaminanalyse %20Virginia %2018 pdf 35. Kim HJ, Shin HS: Determination of tobacco - specific nitrosamines in replacement liquids of electronic cigarettes by liquid chromatography- tandem mass spectrometry. J ChromatogrA 2013, 1291: 48 -55. 36. Hadwiger ME, Trehy ML, Ye W, Moore T, Allgire 1, Westenberger B: Identification of amino- tadalafil and rimonabant in electronic cigarette products using high pressure liquid chromatography with diode array and tandem mass spectrometric detection. J ChromatogrA 2010, 1217: 7547 -7555. 37. Uchiyama 5, Inaba Y, Kunugita N: Determination of acrolein and other carbonyls in cigarette smoke using coupled silica cartridges impregnated with hydroquinone and 2,4- dinitrophenylhydrazine. J ChromatogrA 2010,1217:4383-4388. 38. Uchiyama S. Determination of acrolein and other carbonyls in cigarette smoke using coupled silica cartridges impregnated with hydroquinone and 2,4- dinitrophenylhydrazine. 2013. Ref Type: Personal Communication 39. Uchiyama S. <unpublished concentrations from experiments presented in https: / /www.istaee.ist.eo.lp /article /bunsekikaeaku /60/10/60 1D 791/ pdf through personal communications>. 2013. Ref Type: Unpublished WorkUchiyama _E- cigarette_rm1851.PDF 40. Ohta K, Uchiyama S, Inaba Y, Nakagome H, Kunugita N: Determination of Carbonyl Compounds Generated from the Electronic Cigarette Using Coupled Silica Cartridgeslmpregnated with Hydroquinone and 2,4- Dinitropheny1hydrazine. BUNSEKI KAGAKU 2011, 60: 791 -797. 41. emmoke. Analytical reports on batches of e- liquids. http:// www. esmoke.net /pages.php ?pageid =20. 2009. 7 -11- 2013. 21 Technical Report July - August 2013 Ref Type: Electronic Citationhttp: / /www.esmoke net /pages PhOpageid =20 42. Murphy J, Wong E, Lawton M. Chemical and operational assessment of the Ruyan classic e- cigarette. Report P-474. 2 -8 -2010. British American Tobacco. Ref Type: Report 43. Trtchounian A, Talbot P: Electronic nicotine delivery systems: is there a need for regulation? Tob Control 2011, 20: 47 -52. 44. Etter JF, Bullen C, Flouris AD, Laugesen M, Eissenberg T: Electronic nicotine delivery systems: a research agenda. Tob Control 2011, 20: 243 -248. 45. Varughese 5, Teschke K, Brauer M, Chow Y, van NC, Kennedy SM: Effects of theatrical smokes and fogs on respiratory health in the entertainment industry. Am J Ind Med 2005, 47: 411 -418. 46. Teschke K, Chow Y, van NC, Varughese S, Kennedy SM, Brauer M: Exposures to atmospheric effects in the entertainment industry. J Occup Environ Hyg 2005, 2: 277 -284. 47. Hecht S5, Hoffmann D: Tobacco - specific nitrosamines, an important group of carcinogens in tobacco and tobacco smoke. Carcinogenesis 1988, 9: 875 -884. 48. Digard H, Errington G, Richter A, McAdam K: Patterns and behaviors of snus consumption in Sweden. Nicotine Tob Res 2009, 11: 1175 -1181. 49. Phillips CV, Sargent C, Rabiu D, Rodu B. Calculating the comparative mortality risk from smokeless tobacco vs. smoking. American Journal of Epidemiology, 163 (11):5189, 2006. American Journal of Epidemiology 163[11), 5189. 2006. Ref Type: Abstract 50. Liedel NA, Busch KA, Crouse WE. Exposure measurement action level and occupational environmental variability. HEW Publication No. (NIOSH) 76 -131. 1975. Cincinnati, OH, US Departement of Health, Education, and Welfare, Public Health Service, Center for Disease Control, National Institute for Occupational Safety and Health, Division of Laboatories and Criteria Development. Ref Type: Report http: / /www.cdc.gov /niosh /dots /76- 131 /pdfs /76 -131 odf 51. Trtchounian A, Williams M, Talbot P: Conventional and electronic cigarettes (e- cigarettes) have different smoking characteristics. Nicotine Tob Res 2010, 12: 905 -912. 52. Tischer M, Bredendiek - Kamper 5, Poppek U, Packroff R: How safe is control banding? Integrated evaluation by comparing OELs with measurement data and using monte carlo simulation. Ann Occup Hyg 2009, 53: 449 -462. 53. British Occupational Hygiene Society, Nederlandse Vereniging voor Arbeidshygiene. Testing compliance with occupational exposure limits for airborne substances. 2011. Ref Type: Report 22