Programmatic Environmental Assessment for Marketing Orders for Two New Combusted, Filtered Cigarettes Manufactured by P…

Programmatic Environmental Assessment for Marketing Orders for Two New Combusted, Filtered Cigarettes Manufactured by Philip Morris USA, Inc.

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Programmatic Environmental Assessment for Marketing Orders for Two New Combusted, Filtered Cigarettes Manufactured by Philip Morris USA, Inc.
Prepared by Center for Tobacco Products U.S. Food and Drug Administration
April 4, 2019

Table of Contents
1. Applicant and Manufacturer Information........................................................................................... 3 2. Product Information............................................................................................................................ 3 3. The Need for the Proposed Actions .................................................................................................... 3 4. Alternatives to the Proposed Actions ................................................................................................. 3 5. Potential Environmental Impacts of the Proposed Actions and Alternatives - Manufacturing the
New Products................................................................................................................................... 4 5.1 Affected Environment......................................................................................................... 4 5.2 Air Quality ........................................................................................................................... 5 5.3 Water Resources................................................................................................................. 5 5.4 Soil, Land Use, and Zoning .................................................................................................. 5 5.5 Biological Resources ........................................................................................................... 5 5.6 Regulatory Compliance....................................................................................................... 6 5.7 Socioeconomics and Environmental Justice ....................................................................... 6 5.8 Solid Waste and Hazardous Materials ................................................................................ 7 5.9 Floodplains, Wetlands, and Coastal Zones ......................................................................... 7 5.10 Cumulative Impacts ............................................................................................................ 7 5.11 Impacts of No-Action Alternative ....................................................................................... 8 6. Potential Environmental Impacts of the Proposed Actions and Alternatives � Use of the New Products ........................................................................................................................................... 8 6.1 Affected Environment......................................................................................................... 8 6.2 Air Quality ........................................................................................................................... 8 6.3 Environmental Justice......................................................................................................... 9 6.4 Cumulative Impacts ............................................................................................................ 9 6.5 Impacts of No-Action Alternative ..................................................................................... 10 7. Potential Environmental Impacts of the Proposed Actions and Alternatives � Disposal of the New Products ......................................................................................................................................... 10 7.1 Affected Environment....................................................................................................... 10 7.2 Air Quality ......................................................................................................................... 11 7.3 Water Resources............................................................................................................... 11 7.4 Biological Resources ......................................................................................................... 11 7.5 Solid Waste ....................................................................................................................... 11 7.6 Socioeconomics and Environmental Justice ..................................................................... 12 7.7 Cumulative Impacts .......................................................................................................... 12 7.8 Impacts of No-Action Alternative ..................................................................................... 12 8. List of Preparers ................................................................................................................................ 12 9. A Listing of Agencies and Persons Consulted.................................................................................... 13 10. References......................................................................................................................................... 13 CONFIDENTIAL APPENDIX 1 ........................................................................................................................ 15 Comparison of the New Products to the Corresponding Predicate Products ............................................ 15 CONFIDENTIAL APPENDIX 2 ........................................................................................................................ 16 First- and Fifth-Year Market Volume Projections for the New Products and Percentage of Cigarette Use in the United States Projected to be Attributed to the New Products.......................................... 16
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1.

Applicant and Manufacturer Information

Applicant Name: Applicant Address:
Manufacturer Name: Product Manufacturing Address:

Philip Morris USA Inc. 2325 Bells Road Richmond, VA 23234 Philip Morris USA Inc. 3601 Commerce Road Richmond, VA 23234

2.

Product Information

Submission Tracking Numbers (STN), New Product Names, and Predicate Product Nam es

STN SE0015058 SE0015059

New Product Name Chesterfield Blue Pack l 00's Box Chesterfield Blue Pack Box

Predicate Product Name Basic Lights 100s Box Basic Lights Box

Product Identification

Product Category Product Subcategory Number of Products per Retail Unit

Cigarette Combusted filtered Tw enty cigarettes per pack w it h t en packs per paperboard carton .

Product Package

The box pack consists of a foi l inner liner, inner frame paper, paperboard box, polypropylene outer film, and polypropylene t ear tape.

3.

The Need for the Proposed Actions

The proposed actions, requested by t he applicant, are for t he Food and Drug Administration (FDA) to issue marketing orders under t he provisions of sections 910 and 9050) of the Federa l Food, Drug, and Cosmetic Act after fin ding the new tobacco products subst antially equivalent to the corresponding predicate product s. The applicant w ishes to introduce t he new tobacco products into interstate commerce for commercial distribution in t he United States and submitted to t he Agency four substantial equivalence (SE) reports to obt ain market ing orders. The Agency shall issue the marketing orders if the new products are found substant ially equivalent to the corresponding predicate products. The predicate product s are grandfat hered products commercially marketed in the United States as of February 15, 2007.

The new products differ from the corresponding predicat e products in t he ingredient changes in the base tipping paper, tipping ink extender, tipping ink color, and addit ion of a lip release (Confidential Appendix 1).

4.

Alternatives to t he Proposed Actions

The no-action alternative is FDA does not issue marketing orders for t he new tobacco products.

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5. Potential Environmental Impacts of the Proposed Actions and Alternatives - Manufacturing the New Products
The Agency considered potential environmental impacts that may be affected by manufacturing the new products and found no significant impacts, based on Agency-gathered information and the following information submitted by the applicant:
� The ingredients in the tipping paper and ink in the new products are commonly used in other products currently manufactured at the facility.
� The new products are intended to compete with or replace similar tobacco products currently manufactured at the facility.
� No facility expansion or new construction is expected due to manufacturing the new products. � No increase in the facility production beyond its current permitted production capacity is
expected due to manufacturing the new products.
5.1 Affected Environment
The new and predicate products are manufactured at 3601 Commerce Road, Richmond, VA (Figure 1).

Figure 1. Location of the Manufacturing Facility

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The manufacturing facility is surrounded by a residential development across a road to the north; a twolane divided road and an interstate freeway (I-95) to the east; two hotels, a fast food restaurant, and a gas station at the southeast corner; undeveloped forested land and a petroleum product pumping
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station and delivery terminal to the south; and a railroad to the west with a spur into the manufacturing facility.1
The facility is located in the James River watershed, which occupies the central portion of Virginia and covers 24% of total land area of the state of Virginia.2,3 Land use within the watershed is 65% forest, 19% agriculture and farming, and 12% urbanized area.4
5.2 Air Quality
The Agency does not anticipate that manufacturing the new products would lead to release of new chemicals into the air. The applicant stated that manufacturing the new products is not expected to result in changes in air emissions; accordingly, the applicant concluded that manufacturing the new products would not require revised or new air permits.
5.3 Water Resources
The Agency does not anticipate that manufacturing the new products would cause any new chemicals to be discharged into the water. The new products are intended to compete with or replace similar tobacco products currently manufactured at the facility. The applicant stated that manufacturing the new products is not expected to result in changes in wastewater discharge and therefore, would not require revised or new wastewater discharge permits.
5.4 Soil, Land Use, and Zoning
The Agency does not anticipate that manufacturing the new products would lead to changes in soil, land use, or zoning. No facility expansion or new construction due to manufacturing the new products would be expected. Therefore, no zone change or land conversion of prime farmland, unique farmland, or farmland of statewide importance to non-agricultural use would be anticipated.
5.5 Biological Resources
The Agency does not anticipate manufacturing the new products would jeopardize the continued existence of any listed species, or result in the destruction or adverse modification of the habitat of any such species identified under the Endangered Species Act (ESA). The applicant stated that there are no plans of expanding the facility production beyond its current permitted level. The applicant reviewed the
1 Google. 2018. Map of 3601 Commerce Road, Richmond, VA 23234. Retrieved from Google Maps: www.google.com/maps. August 16, 2018. 2 A watershed is an area of land where all bodies of water drain to a common outlet such as the outflow of a reservoir, mouth of a bay, or any point along a stream channel. Such bodies of water include the following: surface water from lakes, streams, reservoirs and wetlands; the underlying ground water; and rainfall, See https://water.usgs.gov/edu/watershed.html and http://www.dcr.virginia.gov/soil-and-water/document/wshedguideb2b.pdf. 3 Virginia Department of Environmental Quality. Available at: http://deq.state.va.us/Portals/0/DEQ/Water/SWRP/App%20B%20James%20River%20Basin%20Summary.pdf. Accessed August 16, 2018 4 Ibid
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U.S. Fish and Wildlife Services' (U.S. FWS) critical habitat and endangered species maps. According to the maps, three threatened species (two flowering plants, the sensitive joint vetch and the swamp pink, as well as one northern long-eared bat), and one endangered freshwater mussel species are listed in the city of Richmond and the bordering counties (Henrico and Chesterfield Counties).5,6 However, the applicant stated that none of these species are found near the manufacturing facility. The Agency searched the U.S. FWS maps and verified the accuracy of the listed species.
5.6 Regulatory Compliance
The applicant stated that the manufacturing facility complies with all federal, state, and local environmental regulations, including the Clean Air Act, the Clean Water Act and the Resource Conservation and Recovery Act. The manufacturing facility is registered for waste generation under EPA ID# VAD000819466. The applicant provided detailed information for the following air emission and wastewater permits:
(1) Air permits: Title V Air Permit number PRO50076 and a Stationary Source Permit, issued in accordance with applicable U.S. Environmental Protection Agency (EPA) and Virginia Department of Environmental Quality (VA DEQ) regulations.
(2) Wastewater permit: Industrial User Permit number 2149 from the local publicly owned treatment works (POTW) in the City of Richmond. The permit requires compliance with the relevant effluent limitations (40 CFR �� 400 � 699) to ensure the wastewater is of a certain quality for effective treatment at the POTW facility. The applicant stated that the facility submits regular discharge monitoring reports to VA DEQ.
The Agency's search for the manufacturing facility in the EPA's Enforcement and Compliance History Online (ECHO) database did not reveal any violations of the environmental laws and regulations.7
The applicant stated that the facility complies with the ESA and the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).
5.7 Socioeconomics and Environmental Justice
No changes in socioeconomics are anticipated due to manufacturing the new products. The Agency does not anticipate any impacts on employment, revenue, or taxes because the new products are intended to compete with or replace similar tobacco products currently manufactured at the facility.
No changes in impacts on environmental justice are anticipated. The applicant stated that the future year projections of cigarette production at the facility, including the new products, are within the existing permitted manufacturing capacity and would not require facility expansion. Also, as discussed, the emissions and discharges from the facility are not expected to change because of manufacturing the new products. Thus, though 2010 U.S. Census and American Community Survey data show that 80% of
5 U.S. Fish and Wildlife Services (U.S. FWS), available at: https://www.fws.gov/endangered/. Accessed August 16, 2018. 6 Critical habitat maps available at: https://databasin.org/datasets/d579d87eb54f4374a77ea53e7ef66449. 7 EPA ECHO Detailed Facility Report: Philip Morris USA Facility, Richmond, VA. Available at: https://echo.epa.gov/detailedfacility-report?fid=110000869793. Accessed August 16, 2018.
6

the population within a three-mile radius of the manufacturing facility is minority,8 no disproportionate impacts to environmental justice populations would occur as a result of manufacturing the new products. In addition, the facility is not located within an Indian reservation.

5.8 Solid Waste and Hazardous Materials

The Agency does not foresee the introduction of the new products would notably affect the current manufacturing waste generated from the facility production of all combusted, filtered cigarettes. The waste generated due to manufacturing the new products would be handled in the same manner as any other waste generated from any other products manufactured in the same facility.

5.9 Floodplains, Wetlands, and Coastal Zones

There would be no facility expansion due to manufacturing the new products and the applicant did not propose any land disturbance; therefore, there would be no effects on floodplains, wetlands, or coastal zones.

5.10 Cumulative Impacts

The Agency does not anticipate the proposed actions to incrementally increase or change the chemicals

released to the air from the facility due to the tobacco manufacturing. A search in the EPA's Toxic

Release Inventory (TRI) database showed that in 2017, Philip Morris USA manufacturing facility in

Richmond, Virginia released 18,713 pounds of ammonia and 10,683pounds of nicotine and nicotine salts

to air, (a total of 29,396 pounds), but released no other hazardous air pollutants at reportable levels

(Table 1).9 Ammonia's adverse health effects are ocular and respiratory; nicotine and nicotine salts, have

known adverse developmental effects.10 The applicant stated that the facility does not anticipate any

future increased production beyond its current permitted capacity and therefore, a revised or new air

permit would not be required. The TRI database search did not show that the Philip Morris USA

manufacturing facility disposed of, treated, or released into the environment any other reportable

-toxicants associated with manufacturing tobacco products. In addition, EPA's ECHO database did not

show that the facility released the following reportable criteria pollutants: ozone, lead, particulate

matter, or (b)(4)

, at or above the reportable threshold levels to air.

8 EPA ECHO Detailed Facility Report: Demographic profile of surrounding area (3 miles). Available at: https://echo.epa.gov/detailed-facility-report?fid=110000869793. Accessed August 14, 2018. 9 U.S. Environmental Protection Agency (EPA). TRI Data Form R & A Download. Available at: https://www3.epa.gov/enviro/facts/tri/form_ra_download.html. Searched on August 14, 2018. 10 EPA. myRight-to-Know, available at: https://myrtk.epa.gov/info. The site allows for searching the industrial facilities that manage toxic waste chemicals by entering the facility address and clicking on the facility location on the map. Accessed August 14, 2018.
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Table 1 M anagement of Chemical Waste Associated w ith Manufacturing Tobacco Products at Philip M orris USA Facility in 2017

Production-Related Waste Managed or Released

Recycl ed Energy Recovery Treated
On-site Release
Off-site Release

Subtotal Waste Managed

Ammon ia Air
Nicot ine and Nicot ine Salts

Water

Ammon ia Nicot ine and Nicot ine Salts

Land

Ammon ia Nicot ine and Nicot ine Salts

Subtotal Waste Released
Total Production-Related Wast e

Chemical Mass (Pound s)
1 2 6, 0 2 0 0
104,427 230,447 1 8, 713 10,683
0 0 0 0 60,822 90,218 320,665

The applicant does not anticipate manufacturing t he new products would require a revised or new storm water permit or wast e water permit.
5.11 Impacts of No-Action Alternative
The environmenta l impacts of the no-action alternative would not change t he existing condit ion of manufacturing cigarettes, as many similar tobacco products wou ld continue to be market ed in the United States.

6.

Potential Environmental Impacts of t he Proposed Actions and Alternatives - Use of the New

Products

The Agency eva luated potential impact s to resources in the environment t hat may be affected by use of the new products and found no significant impacts based on Agency-gathered information and the applicant's submitted information. Included in t he information t he Agency considered were t he projected market volumes for t he new products and the documented decline in cigarette use in t he United States.

6.1 Affected Env ironment

The affected environment includes human and nat ura l environments in t he United States; t he marketing orders would allow for t he new t obacco products to be sold t o consumers nationwide .

6.2 Air Quality

The Agency does not anticipate new chemicals would be released int o t he environment as a result of use of the new products, relat ive to chemicals released into the environment due to use of other cigarettes already on t he market, because (1) the combustion products from t he new products would be released in the same manner as the combustion products of other market ed cigarettes; (2) t he new

8

products are expected to compete with or replace other currently marketed cigarettes, (Confidential Appendix 2); (3) the ingredients in the new products are used in other currently marketed tobacco products; and (4) the changes in the new products are to components that are not normally combusted, so the Agency does not expect that new or increased air emissions would be associated with use of the new products.
6.3 Environmental Justice
No new emissions are expected due to use of the new products. Therefore, there would be no new disproportionate impacts on minority or low-income populations.
6.4 Cumulative Impacts
The impacts from use of combusted tobacco products include exposure to secondhand smoke (SHS) produced from burned cigarettes. Particles emitted by smoking may remain on surfaces, be re-emitted back into the gas phase, or react with oxidants and other compounds in the environment to yield secondary pollutants, thirdhand smoke (THS). These pollutants coexist in a mixture in the environment alongside SHS (Burton, 2011; Matt et al., 2011).
There is no safe level of exposure to SHS (U.S. Department of Health and Human Services, 2006a and 2006b). Even low levels of SHS can harm children and adults in many ways, including the following:
� The U.S. Surgeon General estimates that living with a smoker increases a nonsmoker's chances of developing lung cancer by 20 to 30% (U.S. Department of Health and Human Services, 2014).
� Exposure to SHS increases school children's risk for ear infections, lower respiratory illnesses, more frequent and more severe asthma attacks, and slowed lung growth. Such exposure can cause coughing, wheezing, phlegm, and breathlessness (U.S. Department of Health and Human Services, 2006a and 2006b).
� SHS causes more than 40,000 deaths a year (U.S. Department of Health and Human Services, 2014).
However, use of cigarettes in the United States is declining according to the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) Statistical Release reports (Figure 2).11 This likely is responsible for the decline in SHS exposure observed in several studies that evaluated the levels of SHS exposure in children and nonsmokers living in homes of smokers (Homa et al., 2015; Yao et al., 2016; other studies). Despite the considerable ethnic and racial disparities in SHS exposure in vulnerable populations, data from the National Health and Nutrition Examination Survey showed a decline in SHS exposure from 1999-2000 to 2011-2012 with the highest prevalence of exposure among non-Hispanic subpopulations (46.8%), compared to Mexican Americans (23.9%) and non-Hispanic whites (21.8%) in 2011-2012 (Homa et al., 2015). There were also significant declines in SHS exposure prevalence noted in the 2000 and 2010 National Health Interview Survey Cancer Control Supplements. Exposure to SHS declined in Hispanics from 16.3% in 2000 to 3.1% in 2010, non-Hispanic Asians from 13.4% in 2000 to 3% in 2010, and nonHispanic blacks from 31.2% in 2000 to 11.5% in 2010 as compared to exposures in non-Hispanic whites, which declined from 25.8% in 2000 to 9.7% in 2010 (Yao et al., 2016).
11 U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) statistical data available at: https://www.ttb.gov/tobacco/tobaccostats.shtml. Accessed March 7, 2018.
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Billion Pieces

Figure 2. Use of Cigarettes in the United States, 1984 � 2017

Total Consumed Cigarettes (Billion Pieces) 700

600

500

400

300

200

100

0 1984

1987

1990

1993

1996

1999 2002 Year

2005

2008

2011

2014

2017

As of September 2018, 28 states and the District of Columbia had implemented comprehensive smokefree laws (American Lung Association, 2018). Such laws are also expected to reduce the levels of nonusers' exposure to SHS and THS.
6.5 Impacts of No-Action Alternative
The environmental impact of the no-action alternative would not change the existing condition of use of cigarettes, as many similar tobacco products would continue to be marketed.
7. Potential Environmental Impacts of the Proposed Actions and Alternatives � Disposal of the New Products
The Agency evaluated potential impacts to resources in the environment that may be affected by disposal of the new products. The Agency found no significant impacts based on publicly available information such as the documented continuous decline in use of cigarettes in the United States, and the applicant's submitted information, including the projected market volumes for the new products.
7.1 Affected Environment
The affected environment includes human and natural environments in the United States; the marketing orders would allow for the new tobacco products to be sold to consumers nationwide.

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7.2 Air Quality
The Agency does not anticipate disposal of the products or the packaging material would lead to the release of new or increased chemicals into the air.
No changes in air quality are anticipated from disposal of the cigarette butts of the new products. The chemicals in the cigarette butts are commonly used in other currently marketed cigarettes. Because the new products are anticipated to compete with or replace other currently marketed cigarettes, the butt waste generated from the new products would replace the same type of waste. Therefore, the fate and effects of any materials emitted into the air from disposal of the new products is anticipated to be the same as any materials from other cigarettes disposed of in the United States.
No changes in air quality from disposal of the packaging materials in the new products would be expected because (1) the paper and plastic components of the packages are more likely to be recycled or at least a portion of the packaging waste is likely to be recycled, (2) the packaging materials are commonly used in the United States, and (3) the waste generated due to disposal of the packaging is a minuscule portion of the municipal solid waste per FDA's experience in evaluating the packaging waste generated from cigarettes.
7.3 Water Resources
No changes in impacts on water resources are expected due to disposal of the cigarette butts and packaging from the new products because the chemicals and packaging materials in the new products are the same or similar to chemicals and packaging materials in currently marketed cigarettes. The new products would compete with or replace similar products currently on the market.
7.4 Biological Resources
The proposed actions are not expected to change the continued existence of any endangered species or result in the destruction or adverse modification of the habitat of any such species, as prohibited under the U.S. ESA. Although disposal of smoldering cigarettes has been implicated in many fire incidents,12, 13 the disposal of the new products is not expected to change the fire frequency because (1) the disposal of the new products is the same as disposal of cigarettes that are currently marketed in the United States, and (2) there would be no anticipated increase in number of cigarettes being disposed of as the new products are anticipated to compete with replace similar marketed cigarettes.
7.5 Solid Waste
The Agency does not foresee the introduction of the new products would notably affect the current cigarette butt and packaging waste generated from all combusted, filtered cigarettes. The waste generated due to disposal of the new products would be in the same manner as any other waste generated from any other combusted, filtered cigarettes manufactured in the United States. The
12 National Fire Protection Association. The smoking-material fire problem. Available at: https://www.nfpa.org/News-andResearch/Fire-statistics-and-reports/Fire-statistics/Fire-causes/Smoking-Materials. Accessed August 16, 2018. 13 UC Davis Health News. Available at: https://www.ucdmc.ucdavis.edu/publish/news/newsroom/2763. Accessed August 16, 2018.
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number of cigarette butts generated is equivalent to the market projections (Confidential Appendix 2) and a portion of those are littered.
7.6 Socioeconomics and Environmental Justice
The Agency does not anticipate changes in impacts on socioeconomic conditions or environmental justice from disposal of the new products. The waste generated due to disposal of the new products is expected to be handled in the same manner as the waste generated from other cigarettes in the United States. No new emissions are expected due to disposal of the new products; therefore, there would be no new disproportionate impacts on minority or low-income populations.
7.7 Cumulative Impacts
A major existing environmental consequence of the use of the new products as well as other conventional cigarettes is littering of discarded cigarette filters or butts, which can persist in the environment for more than 10 years (Novotny and Zhao, 1999). Cigarette butts are among the most common forms of litter found on beaches (Claereboudt, 2004; Smith et al., 1997), near streams, night clubs (Becherucci and Pon, 2014), bus stops (Wilson et al., 2014), roads, and streets (Healton et al., 2011; Patel et al., 2013). Cigarette butts have been found at densities averaging more than four cigarette butts per meter squared of urban environments (Seco Pon and Becherucci, 2012).
Compounds in cigarette butts can leach out into water, potentially threatening human health and the environment, especially marine ecosystems (Kadir and Sarani, 2015). The environmental toxicity of cigarette butts due to air emissions is not well studied. The chemicals in cigarette butts can be the original chemicals in the unsmoked cigarettes or the pyrolysis and distillation products deposited in the cigarette butts. Airborne emissions from cigarette butts after disposal depend on the environmental conditions and the chemicals in the butts. These emissions can be influenced by several factors, such as the cigarette brand, cigarette length, filter material, types of tobacco, ingredients in the cigarette and tobacco fillers, number of puffs, and the mass transfer behavior of combustion products along the cigarette.14
However, the cumulative impacts from cigarette butts is declining because the use of cigarettes in the United States is declining.
7.8 Impacts of No-Action Alternative
The environmental impacts of the no-action alternative would not change the existing condition of disposal of cigarettes and cigarette packaging, as many other similar tobacco products would continue to be marketed in the United States.
8. List of Preparers
The following individuals were primarily responsible for preparing and reviewing this programmatic environmental assessment (PEA):
14 NIST Technical Report 8147 available at: http://dx.doi.org/10.6028/NIST.IR.8147. Accessed August 16, 2018.
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Preparer: William E. Brenner, BS, Center for Tobacco Products
Education: BS in Biology Experience: Five years in various scientific activities Expertise: NEPA analysis, environmental risk assessment, air quality analysis, archaeological and archival preservation
Reviewer: Hoshing W. Chang, PhD, Center for Tobacco Products
Education: MS in Environmental Science and PhD in Biochemistry Experience: 10 years in NEPA practice Expertise: NEPA analysis, environmental risk assessment, wastewater treatment
9. A Listing of Agencies and Persons Consulted
Not applicable.
10. References
American Lung Association. 2018. Smokefree Air Laws. www.lung.org/ourinitiatives/tobacco/smokefree-environments/smokefree-air-laws.html (updated September 7, 2018). Accessed January 8, 2019.
Burton B. Does the smoke ever really clear? Thirdhand smoke exposure raises new concerns. Enviro Health Perspectives. 2011;119(2):A70-A74.
Becherucci ME, Pon JPS. What is left behind when the lights go off? Comparing the abundance and composition of litter in urban areas with different intensity of nightlife use in Mar del Plata, Argentina. Waste Management. 2014;34(8):1351-1355.
Claereboudt MR. Shore litter along sandy beaches of the Gulf of Oman. Marine Pollution Bulletin. 2004;49(9-10):770-777.
Healton CG., Cummings KM, O'Connor RJ, Novotny TE. Butt really? The environmental impact of cigarettes. Tobacco Control. 2011;20(suppl. 1): i1.
Homa DM, Neff LJ, King BA, Caraballo RS, Bunnell RE, Babb SD, Garrett BE, Sosnoff CS, Wang L. Vital signs: Disparities in nonsmokers' exposure to secondhand smoke -- United States, 1999�2012. MMWR Morb Mortal Wkly Rep. 2015;64(4), 103-108.
Kadir AA, Sarani NA. Cigarette butts pollution and environmental impact � A review. Appl Mechanics and Materials. 2015;773-774:1106-1110.
Matt GE, Quintana PJE, Destaillats H, Gundel LA, Sleiman M, Singer BC, Jacob P, Benowitz N, Winickoff JP, Rehan V, Talbot P, Schick SF, Samet J, Wang Y, Hang B, Martins-Green M, Pankow JF, Hovell ME. Thirdhand tobacco smoke: emerging evidence and arguments for a multidisciplinary research agenda. Enviro Health Perspectives. 2011;119(9):1218-1226.
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Novotny TE, Zhao, F. Consumption and production waste: Another externality of tobacco use. Tobacco Control. 1999;8(1):75-80. Patel V, Thomson GW, Wilson, N. Cigarette butt littering in city streets: A new methodology for studying and results. Tobacco Control. 2013;22(1):59-62. Seco Pon JP, Becherucci ME. Spatial and temporal variations of urban litter in Mar del Plata, the major coastal city of Argentina. Waste Management. 2102;32(2):343-348. Smith CJ, Livingston SD, Doolittle DJ. An international literature survey of "IARC Group 1 carcinogens" reported in mainstream cigarette smoke. Food and Chem Toxicol. 1997;35(10-11):1107-1130. U.S. Department of Health and Human Services. 2014. The Health Consequences of Smoking--50 Years of Progress. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, 2014. Printed with corrections, January, 2014. U.S. Department of Health and Human Services. 2006a. The Health Consequences of Involuntary Exposure to Tobacco Smoke. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, 2006. U.S. Department of Health and Human Services. 2006b. The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General: What it Means to You. Consumer Booklet. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, 2006. U.S. Environmental Protection Agency. 2018. Advancing Sustainable Materials Management: 2015 Fact Sheet. Washington, DC: U.S. Environmental Protection Agency, Office of Land and Emergency Management. July 2018. Wilson N, Oliver J, Thomson G. Smoking close to others and butt littering at stops: Pilot observational study. PeerJ. 2014;2:e272. Yao T, Sun HY, Wang Y, Lightwood J, Max W. Sociodemographic differences among U.S. children and adults exposed to secondhand smoke at home: National Health Interview Surveys 2000 and 2010. Public Health Reports. 2016;131:357-366.
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CONFIDENTIAL APPENDIX 1

Comparison of the New Products to the Corresponding Predicate Products

STN
SE0015058 SE0015059
SE0015058 SE0015059

Component
Cigarette
Base t ipping paper

Change from Predicate Product

A m inor decrease in w eight due to removal of

ingredients and other changes in ingredient

- �amounts.
Addition of Removal of

,~(15)'-(4'-)~---, and

SE0015058 SE0015059 SE0015058 SE0015059 SE0015058 SE0015059

Tipping ink Tipping ink extender
Lip release

Removal of brow n and buff inks and replacement of
gold ink with blue ink.
Change in composition and removal o (6) (4
t5 2J
Addition of a lip release.

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CONFIDENTIAL APPENDIX 2
First- and Fifth-Year Market Volume Projections for the New Products and Percentage of Cigarette Use in the United States Projected to be Attributed to the New Products

First- a nd fift h-year market volume projections fo r t he ne w products were compared to t he t otal forecast ed use of cigarettes in t he United States. 15 The projected use of the new products in t he first
and fifth years are I:> 4 an I:> 4 respective ly of t he fo recasted cigarette use in the Unit ed States.

STN
SE0015058 E 15
Total

Projected Market Volume

First Year

Fifth Year

New Product as a

New Product as a

New Product

New Product

Percent of Total

Percent of Total

-----=-- (# of Cigarettes)

Cigarettes Used 16

(# of Cigarettes)

--+---=--

------

Cigarettes Used17

15 The Age ncy used historical data regarding total use of ciga rettes from 2002 to 2017 to mat hematically estimate t he total number of cigarettes used in t he United States. Usi ng t he best-fit t rend line with an R2 value of 0.9786, the forecasted number of cigarettes t hat would be used in t he United States is est imated at 236.26 billion cigarettes in the first year and 210.92 billion cigarettes in the fifth year of ma rketing t he new products. 16 Projected Market Occupat ion of t he New Product in t he United States(%)= Projected Mar ket Volu m e of the New Products (cigarette pieces) lOO
Pr o jected Use ofCigarettes i n United States (cigarette pieces) X
17 Ibid.
16