U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

PMTA Coversheet: Environmental Science 

SUBMISSION INFORMATION

Applicant Philip Morris Products S.A. 

Product Manufacturer Philip Morris Products S.A. 

Submission Date 05-15-2017 FDA Receipt Date I os-1s-2017 

Primary STN(s) PM0000424 Marlboro H eatsti cks1 

1 May be sold individually or as co-packaged product.

PM0000425 Marlboro Smooth Menthol Heatsticks1 

PM0000426 Marlboro Fresh Menthol Heatsticks1 

PM0000479 IQOS System Holder and Charger1 

Cross-referenced

Submission(s)

Cross-referenced STN Primary STN(s)

MR0000059 APPLIES TO PM0000424-PM0000426, PM0000479 

MR0000060 

MR0000061 

MR0000133 

MF0000013 

MF0000243 

MF0000264 
STN PM0000424- PM0000426, PM0000479 Page 2 of 4 

Amendments

Amendment STN Primary STN Description FDA Receipt Date

PM0000440 PM0000424-426, Resubmitted label images 06-21-2017 

PM0000479 

PM0000443 PM0000424-426, Request for A/I Request letter 08-31-2017 

PM0000479 response extension; confirmed battery 

samples 

PM0000457 PM0000424-426, Response to 11/22/17 A/I Request 12-26-2017 

PM0000479 letter 

PM0000458 PM0000424-426, Response to 11/22/17 A/I Request 12-22-2017 

PM0000479 letter 

PM0000461 PM0000424-426, Ongoing study data 12-08-2017 

PM0000479 

PM0000464 PM0000424-426, Response to 3/2/18 EA A/I Request 03-29-2018 

PM0000479 letter 

PM0000466 PM0000424-426, Pl Characterization study update 04-26-2018 

PM0000479 

PM0000467 PM0000424-426, Response to 4/23/18 A/I Request letter 05-23-2018 

PM0000479 

PM0000468 PM0000424-426, Response to 6/6/18 teleconference 06-13-2018 

PM0000479 questions 

PM0000475 PM0000424-426, Response to 7 /18/18 teleconference 08-03-2018 

PM0000479 questions 

PM0000476 PM0000424-426, Response to 8/20/18 A/I Request 09-05-2018 

PM0000479 

PM0000478 PM0000424-426, Corrected versions of two study 09-25-2018 

PM0000479 reports 

Version Date: 08/15/2018 
STN PM0000424- PM0000426, PM0000479 

NEW TOBACCO PRODUCT

STN PM0000424 

Product Name Marlboro Heatsticks1 

Product Category

Product-Sub Category

Package Type

Cigarettes 

Non-Com busted 

Box 

Package Quantity

Characterizing Flavor

Length

Diameter

20 Heatsticks 

None 

45mm 

7.42 mm 

Ventilation Not Applicable 2 

2 For this product neither filter efficiency or ventilation are used to control aerosol deliveries. 

Source of Energy Electric (rechargeable battery)3 

Page 3 of 4 

3 The components and assemblies control the delivery of energy. The critical items include the Heater Printed Circuit Board 

Assembly (PCBA) including the heating blade and the battery. 

STN PM0000425 

Product Name Marlboro Smooth Menthol Heatsticks1 

Product Category Cigarettes 

Product-Sub Category

Package Type

Package Quantity

Characterizing Flavor

Length

Diameter

Non-Com busted 

Box 

20 Heatsticks 

Menthol 

45mm 

7.42 mm 

Ventilation Not Applicable2 

Source of Energy Electric (rechargeable battery) 3 

STN PM0000426 

Product Name Marlboro Fresh Menthol Heatsticks1 

Product Category Cigarettes 

Product-Sub Category

Package Type

Non-Com busted 

Box 

Package Quantity

Characterizing Flavor

Length

Diameter

20 Heatsticks 

Menthol 

45mm 

7.42 mm 

Ventilation Not Applicable2 

Source of Energy Electric (rechargeable battery)3 

STN PM0000479 

Product Name IQOS System Holder and Charger1 

Product Category Cigarettes 

Product-Sub Category

Package Type

Non-Com busted 

Box 

Package Quantity 1 Holder, 1 Charger 

Version Date: 08/15/2018 
Characterizing Flavor None 

Length 93.60 mm (Holder) 

Diameter 15.04 mm (Holder) 

Length 112.50 mm (Charger) 

Width 51.20 mm (Charger) 

Ventilation Not Applicable2 

Source of Energy Electric (rechargeable battery)3 

Additional Properties Depth: 21.86 mm (Charger) 

Battery Capacity:i _______ (b) _(4) ______ :Holder) 

Wattage: (bl (4) ~harger) 4 

4 Wattage provided for the charger battery 

..!---,......;......,. ....... --....... ------

Battery Capacity:i (b) (4) -~Charger) 

STN PM0000424- PM0000426, PM0000479 Page 4 of 4 

------------, 

Version Date: 08/15/2018 
Programmatic Environmental Assessment: 

Marketing Orders 

for 

Marlboro Heatsticks, 

Marlboro Smooth Menthol Heatsticks, 

Marlboro Fresh Menthol Heatsticks, and IQOS System Holder 

and Charger 

by 

Philip Morris Products S.A. 

Prepared by: 

Center for Tobacco Products 

U.S. Food and Drug Administration 

March 15, 2019 
Cover Sheet 

Responsible Agency: U.S. Food and Drug Administration 

Proposed Action: Marketing orders for Philip Morris Products S.A.'s Marlboro Heatsticks, Marlboro 

Smooth Menthol Heatsticks, Marlboro Fresh Menthol Heatsticks, and IQOS 

System Holder and Charger 

Location: United States 

Agency contact: Hashing Chang, Center for Tobacco Products, U.S. Food and Drug Administration, 

10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2707 

Designation: Final programmatic environmental assessment 

Abstract: This document reviews the potential environmental impacts from marketing 

three flavors of tobacco heatsticks and a heated tobacco product holder and 

charger in the United States, and from the no-action alternative of the Agency 

not issuing marketing orders for these products. The Agency did not identify any 

significant environmental impacts from the proposed actions. 

Comments Due Date: Not applicable 
Table of Contents 

1. Introduction ........................................................................................................................................ 1 

1.1 Background ......................................................................................................................... 1 

1.2 Purpose of and Need for Action ......................................................................................... 1 

1.3 Relevant Laws and Requirements ....................................................................................... 1 

1.4 Related Actions ................................................................................................................... 2 

1.5 Scope of Environmental Assessment .................................................................................. 3 

2. Proposed Actions and Alternative ....................................................................................................... 3 

2.1 Proposed Actions ................................................................................................................ 3 

2.2 No Action ............................................................................................................................ 6 

2.3 Comparison of Proposed Actions and Alternative .............................................................. 6 

2.4 Mitigation Measures ........................................................................................................... 8 

3. Affected Environment and Potent ial Environmental Impact s ............................................................ 8 

3.1 Potential Impacts from Manufacturing .............................................................................. 8 

3.2 Air Quality ........................................................................................................................... 8 

3.2.1 Affected Environment ............................................................................................. 8 

3.2.2 Potential Impacts from Proposed Actions .............................................................. 9 

3.2.3 Potential Impacts from No Action ........................................................................ 11 

3.3 Biological Resources ......................................................................................................... 12 

3.3. 1 Affected Environment ........................................................................................... 12 

3.3.2 Potential Impacts from Proposed Actions ............................................................ 12 

3.3.3 Potential Impacts from No Action ........................................................................ 14 

3.4 Environmental Justice ....................................................................................................... 14 

3.4.1 Affected Environment. .......................................................................................... 14 

3.4.2 Potent ial Impacts fro m Proposed Act ions ............................................................ 14 

3.4.3 Potential Impacts from No Action ........................................................................ 15 

3.5 Human Healt h and Safety ................................................................................................. 16 

3.5.1 Affected Environment ........................................................................................... 16 

3.5.2 Potential Impacts from Proposed Actions ............................................................ 16 

3.5.3 Potential Impacts fro m No Action ........................................................................ 17 

3.6 Solid Waste and Hazardous Materials .............................................................................. 17 

3.6.1 Affected Environment ........................................................................................... 17 

3.6.2 Potential Impacts from Proposed Actions ............................................................ 17 

3.6.3 Potential Impacts from No Action ........................................................................ 19 

ii 
3.7 Water Resources ............................................................................................................... 20 

3.7.1 Affected Environment ........................................................................................... 20 

3. 7.2 Potential Impacts fro m Proposed Actions ............................................................ 20 

3. 7.3 Potential Impact s from No Act ion ........................................................................ 20 

3.8 Cumulative Impacts .......................................................................................................... 20 

4. List of Agencies and Persons Consulted ............................................................................................ 21 

5. References Cited ............................................................................................................................... 21 

Confidential Appendix: Product and Packaging Waste Impacts Based on Confidential Market Projections 

....................................................................................................................................................... 24 

ii i 
Acronyms and Abbreviations 

CEQ Council on Environmental Quality 

CFR Code of Federal Regulations 

CITES Convention on International Trade in Endangered Species of Wild Flora and Fauna 

CO2 carbon dioxide 

COreq carbon dioxide equivalents 

ETS environmental tobacco smoke 

FD&C Act Federal Food, Drug, and Cosmetic Act 

FDA Food and Drug Administration 

FONSI finding of no significant impact 

GHG greenhouse gas 

HPHC harmful or potentially harmful chemical 

MRTPA modified risk tobacco product application 

MSW municipal solid waste 

NEPA National Environmental Policy Act 

PEA programmatic environmental assessment 

PMP Philip Morris Products, S.A. 

PMTA premarket tobacco product application 

THS tobacco heating system 

WARM Waste Reduction Model 

iv 
1. Introduction 

1.1 Background 

On May 12, 2017, Philip Morris Products S.A. (PMP) submitted premarket tobacco product applications 

(PMTAs) for three flavors of heatsticks and the IQOS system holder and charger. In the PMTAs, PMP 

requests the U.S. Food & Drug Administration (FDA) to permit marketing of these new tobacco products 

by issuing marketing orders under section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 

(Public Law 111-31). 

Issuing new tobacco product marketing orders is a federal action for which FDA must consider 

environmental impacts before deciding to proceed, in accordance with the requirements of the National 

Environmental Policy Act (NEPA). FDA prepared this programmatic environmental assessment (PEA) to 

evaluate the potential for significant environmental impacts from the proposed marketing orders for the 

new products. This PEA conforms to the Council on Environmental Quality's (CEQ's) NEPA regulations 

applicable to all agencies (40 Code of Federal Regulations [CFR] Part 1500) and FDA's agency-specific 

NEPA regulations (21 CFR Part 25). If a PEA concludes that a proposed action would not have significant 

environmental impacts, then an agency issues a finding of no significant impact (FONS!) to document 

this conclusion, completing the NEPA process. If a potentially significant impact is identified, then the 

agency proceeds to prepare an environmental impact statement. 

Section 1 of this PEA describes the purpose of and need for action, identifies relevant laws and 

requirements, describes a related action, and summarizes the scope of this PEA. Section 2 identifies the 

proposed actions and alternative. Section 3 presents the environmental impact analysis. Sections 4 and 

5 list the preparers and the agencies and persons consulted, respectively. 

1.2 Purpose of and Need for Action 

Purpose: Upon receipt of a PMTA, FDA considers the submission, using criteria detailed in section 910(c) 

of the FD&C Act, and issues an order that either allows or denies introduction or delivery for 

introduction of the new product into interstate commerce. The purpose of FDA's PMTA review and 

subsequent order is to make a finding as to whether marketing orders for the new products would be 

appropriate for the protection of public health. The determination is made with respect to the risk and 

benefits to the population as a whole, including users and nonusers of the tobacco product, and taking 

into account (a) the increased or decreased likelihood that existing users of tobacco products will stop 

using such products; and (b) the increased or decreased likelihood that those who do not use tobacco 

products will start using such products (section 910(c)(4) of the FD&C Act). 

Need: FDA's responsibility to review a PMTA, make a finding as described in the previous paragraph, and 

subsequently determine whether or not to issue a marketing order for the new product is a statutory 

requirement under section 910(c) of the FD&C Act. 

1.3 Relevant Laws and Requirements 

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), comprising Chapter IX of 

the FD&C Act, was signed into law on June 22, 2009. The Tobacco Control Act gives FDA authority to 

1 
regulate the manufacture, distribution, and marketing of tobacco products, including reviewing PMTAs 

and determining whether to issue marketing orders. 

NEPA and CEQ's implementing regulations (40 CFR Part 1500) apply to all federal agency actions, 

including actions mandated by other laws such as the Tobacco Control Act. FDA's NEPA regulations 

detail procedures for applying NEPA to FDA programs, and specifically require compliance with three 

additional environmental protection programs. 

• FDA's NEPA regulations specifically require compliance with the Convention on International 

Trade in Endangered Species of Wild Flora and Fauna (CITES) (21 CFR 25.21 (b)). CITES provides 

varying degrees of protection to more than 35,000 species, aiming to ensure that international 

trade in specimens of wild animals and plants does not threaten their survival. There are 

currently 183 nations and regional economic integration organizations, known as parties, that 

have voluntarily agreed to be bound by CITES. In January 1974, the United States was the first 

party to join CITES. 

• Compliance with the U.S. Endangered Species Act is also specifically required by FDA's NEPA 

regulations (21 CFR 25.21 (b)). This Act is intended to prevent the further decline of endangered 

and threatened species in the United States and to restore these species and their habitats. 

Section 7 of the Act requires that, when federal agency actions may affect an endangered or 

threatened species, the federal agencies must consult with the U.S. Fish and Wildlife Service or 

the National Marine Fisheries Service to ensure the action does not jeopardize the species or 

destroy its habitat. 

• The third specific requirement named in FDA's NEPA regulations (21 CFR 25.60) is Executive 

Order 12114, "Environmental Effects Abroad of Major Federal Actions." FDA must consider 

potentially significant impacts that occur in other nations or the global commons when 

conducting a NEPA analysis of actions under an agency program. 

CEQ's NEPA regulations state that the significance of environmental impacts (and thus the justification 

for a FONS!) is in part indicated by whether the action may violate federal, state, or local laws or 

requirements imposed for the protection of the environment (40 CFR 1508.27(b)(10)). Therefore, 

compliance with resource-specific requirements is evaluated where applicable throughout this PEA. 

1.4 Related Actions 

On December 5, 2016, PMP submitted modified risk tobacco product applications (MRTPAs) requesting 

marketing orders under section 911(g) of the FD&C Act for the same three flavors of heatsticks and IQOS 

system holder and charger that are the subject of this PEA. For an applicant to commercially market a 

modified risk product, FDA must determine that the applicant has demonstrated that the product, as 

actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to 

individual tobacco users, and benefit the health of the population as a whole taking into account users 

of tobacco products and persons who do not currently use tobacco products (sections 911(g)(l) and 

911(g)(2) of the FD&C Act). Although the potential environmental impacts would be like those from the 

PMTA marketing orders, FDA would prepare a separate PEA for the distinct agency action of issuing 

modified risk tobacco product marketing orders for these same new products. FDA's review of the IQOS 

M RTPAs is ongoing as of the date of this PEA. 

2 
1.5 Scope of Environmental Assessment 

Scoping is the process for determining the scope of issues to be addressed in a NEPA document and for 

identifying the significant issues related to a proposed action. For this PEA, scoping methods consisted 

of (1) internal Agency scoping, in which environmental and other scientific staff within the FDA Center 

for Tobacco Products reviewed the products' manufacturing, use, and disposal information to identify 

potential areas of environmental impact for review in this PEA; and (2) reviewing each of the 252 public 

comment submissions posted to date in docket FDA-2017-D-3001 (www.regulations.gov) for MRTPAs 

for the same three products. Internal Agency scoping served as the basis for the format and content of 

this PEA. The MRTPA docket did not contain any public comments that identified potential 

environmental concerns within the scope of this analysis in addition to those evaluated in this PEA. 

The scope of a NEPA analysis is defined by the range of actions, alternatives, and impacts that it 

considers (40 CFR 1508.25). Using input from the scoping process described above, this PEA evaluates 

the following: 

• The actions in this PEA are issuing marketing orders for four new tobacco products. The decision 

on whether to take these actions and issue the marketing orders is a result of FDA's reviews of 

the PMTAs for the new products. FDA did not identify any connected actions. 1 

1 Actions are connected if they automatically trigger other actions, cannot or will not proceed unless other actions 

are taken previously or simultaneously, or are interdependent parts of a larger action and depend on the larger 

action for their justification (40 CFR 1508.25 ). 

FDA also did not 

identify any cumulative or similar actions, given that FDA acceptance, filing, and detailed review 

and consideration of any future marketing applications from this or other applicants for 

products that are similar or have similar environmental impacts would be speculative. 

• The alternatives in this PEA are the courses of action available to FDA under Chapter IX of the 

FD&C Act, described in detail in Sections 2.1 and 2.2. As the proposed actions, FDA may issue 

marketing orders for one or more of the new products. The no-action alternative in this PEA is 

the case in which FDA would deny the PMTAs and not issue marketing orders. 

• The impacts evaluated in this PEA, described in Section 3, include direct, indirect, and 

cumulative impacts to environmental resources. 

2. Proposed Actions and Alternative 

2.1 Proposed Actions 

FDA proposes to issue marketing orders authorizing introduction or delivery for introduction of four new 

tobacco products into interstate commerce in the United States. The applicant's PMTAs seek FDA's 

marketing orders under section 910(c)(A)(i) of the FD&C Act for the four products listed in Table 1. 

3 
Table 1. Description of New Products 

STN*

*STN = submission tracking number. 

Name Descr,". Description

PM0000424 Marlboro Heatsticks • pack of 20 heatsticks 

• carton of 10 packs 

PM0000425 Marlboro Smooth Menthol 

Heatsticks 

• pack of 20 heatsticks 

• carton of 10 packs 

PM0000426 Marlboro Fresh Menthol 

Heatsticks 

• pack of 20 heatsticks 

• carton of 10 packs 

PM0000479 IQOS System Holder and 

Charger 

As packaged for sale to the consumer, the IQOS system is 

accompanied by the following accessories: AC adaptor, USB 

charging cable, cleaning brush, user guide. 

The products would be manufactured outside of the United States, as follows: 

(b) (4) 

Figure 1 depicts the IQOS system components and details of the holder and heatstick designs. 

4 
Figure 1. IQOS System Components Source: PMP 2017.
The heatstick, which resembles a short cigarette, contains tobacco that is ground and reconstituted into 

sheets (termed cast-leaf) following the addition of water, glycerin, guar gum, and cellulose fibers. The 

heatstick contains two filters: a polymer-film filter to cool the aerosol and a low-density cellulose 

acetate mouthpiece filter that mimics a cigarette. When the user places the heatstick in the open end of 

the holder, a ceramic blade with a platinum heating element inserts into the tobacco plug. The user 

turns on a switch and the electronically controlled blade heats the tobacco to produce an aerosol, 

inhaled by the user through the mouthpiece filter. The blade heats the tobacco for a fixed period of 

approximately six minutes and allows up to fourteen puffs to be taken during that time. The tobacco 

does not ignite and the heatstick is not consumed or decreased in size during use. Electronic controls 

prevent the temperature of the blade from exceeding 350°C. The material inhaled from one heatstick 

contains approximately 70 percent of the nicotine as the material inhaled from a combusted cigarette. 

The holder has sufficient electrical charge for use of a single heatstick. After each heatstick use, the 

holder must be recharged by inserting it into the charger. The charger stores an amount of energy to 

recharge the holder approximately 20 times and is itself recharged using an included AC adaptor. i(b)(4)! 

j (b)(4) L--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 'i . . 

The applicant estimated that approximately 17 percent of combusted cigarette users in the United 

States would be exclusive or dual users of the new products within 10 years. The new products - IQOS 

devices including the holder and charger, accessories, and heatsticks in packs and cartons - would be 

available for purchase at IQOS-branded stores as well as traditional convenience stores nationwide. The 

new products would be sold in paper, cardboard, and plastic packaging materials typical of consumer 

tobacco and electronic products. 

2.2 No Action 

The no-action alternative is for FDA to deny the PMTA applications. The new products would not be 

marketed in the United States and, for the purposes of the analysis in this PEA, it is assumed that the 

combusted cigarette market would retain its current and projected future user base. 

2.3 Comparison of Proposed Actions and Alternative 

Air quality Negligible to minor impacts from No exposure to secondhand IQOS aerosol. 

secondhand IQOS aerosol on indoor air Continued environmental tobacco smoke 

quality based on available data. exposure for non-users from combusted 

cigarettes, at levels proportional to the 

overall rate of cigarette use. 

No greenhouse gases (GHGs) in IQOS GHG emissions from comparable level of 

aerosol. combusted cigarette use would be 

negligible compared to total U.S. 

greenhouse gas emissions from all 

sources. 

Negligible GHG emissions from disposing Negligible GHG emissions from disposing 

of the product waste and packaging from of product waste and packaging from 

new products. comparable volume of combusted 

cigarettes. 

6 

Environmental Potential Environmental Impacts

Resource Proposed Actions No Action
Environmental 

Resource

Potential Environmental Impacts

Proposed Actions No Action

Biological resources No effects to aquatic species expected No change in current levels of aquatic 

from urinary biomarkers in surface water. species exposure to excreted biomarkers. 

Slight increase in the potential for tobacco No change in current terrestrial wi ldlife 

exposure to terrestrial wild life but impact exposures to littered combusted cigarette 

cannot be concluded to be significant. butts. 

Leachate exposure to aquatic species from No change in current aquatic species 

littered heatsticks is possible but impact exposures to leachate from littered 

cannot be concluded to be significant. combusted cigarette butts. 

Environmental No indication that never smokers in low- Minority and low-income populations 

justice income or minority populations would would continue to initiate, use, and quit 

disproportionately adopt use of the new combusted cigarettes at rates seen in 

products. current trends for each subpopulation. No 

changes in any disproportionate impacts 

to minority or low-income populations 

would occur. 

Human health (NEPA Only within the context of and for the No change in current levels of health 

context only) purposes of NEPA analysis, health impacts impacts to users from combusted 

to users are classified as "not significant" cigarettes. 

if Agency review recommends issuing 

marketing orders under the Tobacco 

Control Act. 

Negligible to minor impacts from No exposure to secondhand IQOS aerosol. 

secondhand IQOS aerosol on indoor air Continued environmental tobacco smoke 

quality based on available data. exposure for non-users from combusted 

cigarettes, at levels proportional to the 

overall rate of cigarette use. 

No significant impacts related to battery 

safety. 

Solid waste and Negligible addition to nationwide levels of Negligible contribution to nationwide 

hazardous materials recycling and MSW generation from levels of recycling and MSW generation 

disposal of used heatsticks and packaging. from disposal of combusted cigarette 

butts and packaging. 

Negligible increase (by weight) in tobacco No change in overall level of cigarette butt 

product litter as heatsticks are not litter. 

consumed during use. 

Negligible risk of littered heatstick igniting Continued risk at same levels of fire from 

a wildland fire. unattended cigarettes or unextinguished 

littered cigarette butts. 

No significant impacts from electronic 

device and lithium battery disposal. 

Water resources No effects to water quality expected from No change in levels of excreted 

urinary biomarkers from use of new biomarkers from combusted cigarette use 

products in surface water. in surface water. 

Leachate entering surface water bodies No change in levels of leachate from 

from littered heatsticks is possible but littered combusted cigarette butts 

impact on water quality cannot be entering surface water bodies. 

concluded to be significant. 

7 
2.4 Mitigation Measures 

No mitigation measures are identified. 

3. Affected Environment and Potential Environmental Impacts 

Potential impacts from product manufacturing and the proposed actions and no action are discussed in 

Section 3.1. Sections 3.2 to 3.8 discuss the potential direct, indirect, and cumulative impacts on 

environmental resources from product use and disposal under the proposed actions and no action. 

In this PEA, the relevant impacts from the no-action alternative are those associated with ongoing use 

and disposal of 17 percent of the combusted cigarette market in the United States, the percent 

estimated by the applicant that would switch to the new product. 

The following environmental resources typically evaluated in a NEPA document are not affected by the 

proposed actions or no action and are not evaluated further in this PEA: historic and cultural resources; 

floodplains, wetlands, and coastal zones; soils; land use and zoning; and socioeconomic conditions. 

3.1 Potential Impacts from Manufacturing 

In this PEA, FDA has used compliance with relevant laws and regulations as a reasonable indicator of the 

environmental impacts from manufacturing from the proposed actions. Detailed site-specific analysis of 

impacts at the current manufacturing facilities would not be comprehensive since (1) the applicant has 

published several announcements of plans for additional manufacturing locations for this product line, 

and (2) FDA's marketing orders for new tobacco products are not limited to the output of a specific 

manufacturing facility, as long as the product itself meets the exact specifications identified in the order. 

The applicant stated that the three manufacturing facilities that currently contribute to IQOS production 

each comply with all environmental laws and regulations that apply to their location. The applicant 

provided, where applicable to each facility, documentation in the form of air emissions permits and 

monitoring data, wastewater permits and analyses, workplace noise levels, offsite noise measurements, 

hazardous waste management systems, occupational health and safety management systems, and 

environmental management systems. No significant environmental impacts are expected from 

manufacturing the new products under the proposed actions. 

No environmental impacts would occur from a lack of manufacturing for the U.S. market if the 

marketing orders were not issued under the no-action alternative. 

3.2 Air Quality 

3.2.1 Affected Environment 

This PEA qualitatively evaluated impacts to air in the immediate vicinity of IQOS from the chemical 

aerosol mixture emitted by the product. Users may dispose of waste products and packaging anywhere 

in the United States. 

8 
3.2.2 Potential Impacts from Proposed Actions 

3.2.2.1 Use 

An individual uses the IQOS system by inhaling the mainstream aerosol generated by the product and 

exhaling secondhand aerosol to the environment. The applicant stated that the IQOS system does not 

emit sidestream aerosol directly from the heatstick during use; however, FDA did not identify any study 

that evaluated this question. 

When used outdoors, localized aerosol would be present during and following IQOS use. Aerosol in an 

outdoor environment would disperse quickly with negligible impact to outdoor air quality. 

Information on IQOS mainstream aerosol chemistry and toxicity provides data relevant to analyzing 

impacts from secondhand exposure to non-users. FDA reviewed studies submitted by the applicant as 

well as reported in published scientific literature (FDA, 2018a). The agency's conclusions to date are 

summarized as follows: 

• Aerosol chemistry. The applicant claims that the IQOS system heats but does not burn tobacco, 

resulting in significantly reduced concentrations of harmful or potentially harmful constituents 

(HPHCs) compared to combusted cigarettes. HPHCs were present at lower levels in aerosol from the 

IQOS heatsticks compared to mainstream cigarette smoke. HPHCs are 54 to 99.9 percent lower in 

IQOS aerosol when compared per unit (heatstick vs. cigarette) and 25 to 99.8 percent lower for 

comparable nicotine levels. Since the IQOS system heats tobacco at a temperature lower than 350°C 

(compared to 600°C for combusted cigarettes), it is expected that the amounts of compounds 

formed by combustion and pyrolysis will be substantially lower than for combusted cigarettes. 

However, other compounds would still be expected to be present in the aerosol. These compounds 

could include pyrolysis products of glycerol and propylene glycol that evaporate at temperatures 

less than 350°C; compounds transferred intact from the IQOS heatstick to the aerosol by 

evaporation; and pesticides that are not burned and evaporate at temperatures less than 350°C. The 

applicant identified between 53 and 62 compounds that are at higher levels in the aerosol of the 

heatsticks compared to the smoke of the 3R4F reference cigarette. These compounds include 

propylene glycol and its known degradation products of glycerol, glycidol, and acetol. FDA's 

laboratory independently tested two more compounds produced by pyrolysis of glycerol-acrolein 

and formaldehyde-and found them to be significantly lower in the IQOS aerosol than in the smoke 

from cigarettes. 

• Nonclinical studies. Nonclinical studies reported biomarkers of exposure to several constituents 

commonly measured in smoking studies. Apart from nicotine, the measured biomarkers of exposure 

in the blood and urine of test subjects were considerably reduced from those found after 

combusted cigarette exposure, to levels comparable to those in test subjects that were not exposed 

to cigarette smoke. Similar results were seen in clinical studies. FDA review of a carcinogenicity 

study of IQOS is ongoing and results were not available at the time of this PEA. Overall, data from 

the nonclinical studies submitted by the applicant indicated that IQOS aerosol did not produce any 

new adverse effects in addition to those produced by exposure to cigarette smoke. These studies 

suggest that IQOS aerosol has lower toxic potential than cigarette smoke under the conditions used 

in the assays and for the non-cancer endpoints measured. To be clear, IQOS aerosols did induce 

toxicity in in vitro and in vivo studies, but only at higher concentrations when compared to reference 

cigarette smoke. 

9 
The applicant referenced three publications comparing indoor air quality after IQOS or combusted 

cigarette use. 

• A Philip Morris USA study reported substantial reductions (41 percent or more) in all analytes 

tested in the air of a room after use of a heated tobacco product compared to combusted 

cigarettes (Frost-Pineda et al., 2008). It is not clear how the tested system compares to the 

current IQOS system, the methods are not fully described, the discussion of results is incomplete 

(however, the results appear to favor the heated tobacco system), and the health significance of 

the reported results as well as untested emissions is not evaluated in the study or the 

applicant's summary of the study. 

• Another Philip Morris-led study (Tricker et al., 2009) similarly reported reductions of 80 to 90 

percent or more for approximately 30 endpoints in each of four test room scenarios after use of 

a heated tobacco product compared to combusted cigarettes. It is not clear how the tested 

system compares to the current IQOS system. The authors summarized results in terms of 

percent relative concentration for the respective changes from background for the heated 

tobacco product and combusted cigarettes, although the study did present the actual levels 

measured. The published report did not account for notable variations in background 

concentrations among the scenarios that were compared to each other and affected the 

conclusions drawn. 

• The applicant provided a presentation (Goujon-Ginglinger, 2015) and a published journal article 

(Mitova et al., 2016) for a third Philip Morris study. The study compared the levels of 18 

chemical endpoints-6 markers of environmental tobacco smoke, 4 carbonyls, 5 volatile organic 

compounds, and 3 gases-in the air of a study room after use of combusted cigarettes or the 

IQOS product. The authors concluded using IQOS increased only acetaldehyde and nicotine 

concentrations above background levels, and that these increases were less than the levels 

measured after use of combusted cigarettes. While informative, the pre-determined set of 

analytes evaluated, all of which are associated with combusted cigarettes, limits the application 

of the conclusions. 

The applicant submitted additional aerosol chemistry studies in the months since FDA prepared the 

January 2018 summary (FDA, 2018a), with similar findings that did not change the conclusions for the 

purposes of this NEPA analysis. Overall, the information available at this time indicates that exhaled 

aerosol (assumed similar to mainstream aerosol) from IQOS is not free of HPHCs or other toxic 

chemicals. An exposure-response relationship specific to secondhand aerosol exposure has not been 

established that could quantify health risks to non-users from inhaling this complex mixture of 

chemicals. Thus, in absolute terms, the potential impact of IQOS use on indoor air quality is considered a 

data gap in this NEPA evaluation. However, comparing the substances identified in mainstream IQOS 

aerosol to those found in smoke from combusted cigarettes, the overall indication at this time is that 

relative impacts to indoor air quality would be less than those from combusted cigarette use. Accepting 

that the applicant's stated marketing focus is for IQOS to replace (partially or completely) combusted 

cigarette use by current smokers, impacts from secondhand IQOS aerosol on indoor air quality are 

considered, on balance, to be minor to negligible based on data available at this time. This qualitative 

conclusion is subject to change in the case of new data, applies only to exposure of non-users to 

secondhand IQOS aerosol, and does not offer any finding as to the relative risk to users from IQOS 

compared to combusted cigarettes. 

10 
Greenhouse gases (GHGs), such as carbon dioxide (CO2), methane, nitrous oxide, and others, can 

contribute to climate change. Studies submitted by the applicant did not identify any GHGs in IQOS 

aerosol. Therefore, use of the new products would not contribute to climate change. 

3.2.2.2 Disposal 

Landfill disposal or incineration of the used products and packaging will produce GHGs. Landfills are the 

third largest source of human-related methane emissions in the United States, accounting for 

approximately 15.4 percent of these emissions in 2015 (EPA, 2017). 

FDA estimated the GHG emissions from disposal of the product and packaging waste using the emission 

rates in the Waste Reduction Model (WARM), v. 14 (EPA, 2016a). WARM calculates GHG emissions from 

different material types commonly found in municipal solid waste (MSW). FDA estimated the product 

and packaging waste generated from the new products as well as a representative combusted cigarette 

product (Confidential Appendix) and applied rates for recycling, landfill disposal, and combustion with 

energy recovery for the various material types (EPA, 2016b). Total GHG emissions from disposing of the 

product waste and packaging from the new products is estimated to be a negligible fraction (less than 

0.00005 percent) of the approximately 6.511 billion metric tons of COreq generated in the United 

States from all sources in 2016 (the most recent year for which an estimate is available). 

3.2.3 Potential Impacts from No Action 

3.2.3.1 Use 

There would be no exposure to secondhand IQOS aerosol under the no-action alternative. 

Smokers of combusted cigarettes who converted to using the new products are assumed to continue 

smoking cigarettes. When using combusted cigarettes, the user inhales mainstream smoke and exhales 

secondhand smoke to the environment. This secondhand smoke, along with sidestream smoke emitted 

directly by the burning tip of a cigarette, is referred to as environmental tobacco smoke (ETS). There is 

no safe level of exposure to ETS (HHS, 2006a, 2006b). Even low levels of ETS 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 percent (HHS, 2006a, 2006b). 

• Exposure to ETS increases school children's risk for ear infections, lower respiratory illnesses, 

more frequent and more severe asthma attacks, and slowed lung growth. ETS exposure can 

cause coughing, wheezing, phlegm, and breathlessness (HHS, 2006a, 2006b). 

• ETS causes more than 40,000 deaths a year (HHS, 2014). 

Under the no-action alternative, individuals would continue to have ETS exposure from combusted 

cigarettes at levels proportional to the overall rate of cigarette use, as influenced by indoor smoking 

restrictions in any specific location. Exposed individuals would continue to be at risk for health effects 

such as those described above. 

Cigarette combustion releases CO2, methane, and nitrous oxide. FDA estimated that cigarette use under 

the no-action alternative would emit less than 0.00005 percent of the total GHGs emitted in the United 

States from all sources (Confidential Appendix). 

11 
3.2.3.2 Disposal 

FDA estimated cigarette and packaging waste disposal volumes for a representative cigarette product, 

assuming use rates equal to the marketing projections for heatsticks under the proposed actions 

(Confidential Appendix). WARM was used to estimate GHG emissions from disposal of this cigaretterelated waste, as adjusted for rates of recycling, landfill disposal, and combustion with energy recovery 

for the various material types. GHG emissions from product and packaging disposal of this volume of 

combusted cigarettes is estimated to be a negligible fraction (approximately 0.00002 percent) of the 

6.511 billion metric tons of COreq emitted in the United States from all sources. 

3.3 Biological Resources 

3.3.1 Affected Environment 

The new products could interact with any terrestrial or aquatic environment nationwide where the 

products are used, disposed of, or transported through environmental fate processes. Aquatic species 

could be exposed to excreted biomarkers in receiving waters for municipal wastewater. Terrestrial and 

aquatic species could contact or ingest littered heatsticks or leachate from heatsticks at locations of 

improper disposal. 

3.3.2 Potential Impacts from Proposed Actions 

3.3.2.1 Use 

Potential Impacts to Terrestrial Species 

No impacts to terrestrial wildlife were identified from use of the new products. 

Potential Impacts to Aquatic Species 

Inhaling a heated tobacco product exposes the user to the range of chemicals in that product, as well as 

chemicals formed by pyrolysis or thermal degradation. Some of these parent chemicals or their 

metabolites can be identified and measured in the user's blood, saliva, exhaled breath, tissues, or urine. 

These are called biomarkers of exposure. Multiple published studies have documented the presence in 

municipal wastewater of biomarkers of tobacco exposure. Examples include Andra and Makris (2011), 

Bradley et al. (2007), Bueno et al. (2011), Gao et al. (2018), and Kolpin et al. (2002). Aquatic species 

could be exposed to excreted biomarkers in natural waters receiving treated municipal wastewater. 

There is little to no information on how much these concentrations may be reduced during municipal 

wastewater treatment or data on the toxicity of these chemicals to aquatic species. 

The applicant submitted studies comparing several biomarkers of exposure to HPHCs following IQOS use 

to the same biomarkers following combusted cigarette use (PMP, 2017). In general, the studies found 

that 15 of 16 biomarkers of exposure to HPHCs or HPHC metabolites were reduced among smokers 

completely switching to IQOS and that reductions were similar in magnitude to the reductions seen in 

smokers who abstained. Biomarkers of exposure to nicotine were similar for IQOS and combusted 

cigarette use. These findings are consistent with a recently published study funded by another tobacco 

company that included the IQOS system in the products assessed (Gale et al., 2018). 

12 
Comparing predicted toxicity levels based on structural analysis (OECD, 2018) to levels measured or 

estimated in wastewater in the studies cited above indicates that effects to aquatic species would not 

be expected from the potential urinary biomarker levels in surface water, based on the limited available 

information. 

3.3.2.2 Disposal 

Potential Impacts to Terrestrial Species 

Users of the new products are assumed to litter a portion of the used heatsticks at a rate similar to the 

littering rate for combusted cigarette butts. Section 3.6.3.2 discusses the estimated littering rates. 

Terrestrial wildlife may encounter and interact with littered heatsticks, and may use them as nesting 

materials, exposing their young at vulnerable life stages. Because the tobacco in a heatstick is not 

consumed during use, there is increased potential compared to combusted cigarettes for wildlife 

exposure to tobacco and the toxic chemicals it contains, specifically nicotine and tobacco-specific 

nitrosamines. Using the solid waste estimates for the new products (Section 3.6.3.2) and assuming the 

same littering rate applies to used heatsticks as for cigarette butts, the potential tobacco filler material 

(not including the filters) littered in the environment could be increased by approximately 0.16 percent

under the proposed actions. No methodology is available to reasonably estimate the fraction of the total 

cigarette or heatstick litter that finds its way into animal or bird nests, or to estimate population-level 

impacts to terrestrial wildlife from this or other routes of tobacco exposure. Therefore, although an 

increase in the potential for tobacco exposure to terrestrial wildlife is likely, a significant impact as a 

result of the proposed actions cannot be concluded. 

2 

2 Estimated based on projected tobacco fi ll er in littered heatsticks (Confidential Append ix) compared to 110 mg 

tobacco per cigarette butt multiplied by 34 percent littering rate of the 247 billion cigarettes consumed in the 

United Stat es in 2017 (TTB, 2018). 

Potential Impacts to Aquatic Species 

As summarized by Wallbank et al. (2017), leachate from cigarette butts has demonstrated toxicity to fish 

and aquatic invertebrates in laboratory studies, but real-world concentrations of leachate have not been 

reliably estimated for purposes of assessing risk to aquatic wildlife. Information supplied by the 

applicant identified the chemicals found in used and un-used heatsticks. Toxicity data are available for 

many of these chemicals, and the toxicity of the mixture of these chemicals in heatstick leachate could 

be estimated based on their solubilities and individual toxicities. However, risk estimation would also 

require measuring or modeling the concentration of leachate in the water inhabited by aquatic species. 

Any concentrations can vary greatly, including in the same location at different times, because aquatic 

habitats have distinct volumes, inflows, outflows, and evaporative loss rates; and the number of 

heatsticks or cigarette butts polluting any specific habitat can vary from none to many, depending on 

human activity and transfer from upstream locations. Without a basis for estimating water 

concentrations, this analysis cannot quantitatively predict the aquatic species impact from littered 

heatsticks or cigarette butts at this time. 

The applicant's submissions assessed risk to aquatic species from the chemicals in all un-used heatsticks 

produced in one year diluted in the entire wastewater volume of the United States. They concluded that 

the estimated aquatic concentrations were below potential levels of concern in the aquatic 

13 
environment. The Agency expects that there would be wide (likely orders of magnitude) variation in 

aquatic concentrations in various real-world locations. 

In summary, although there is a potential for aquatic species to be exposed to leachate from littered 

heatsticks, it is difficult to frame an analysis to predict the level of risk from the illegal activity of littering 

on a nationwide basis. Therefore, a significant impact to aquatic species as a result of the proposed 

actions cannot be concluded with any certainty. 

3.3.3 Potential Impacts from No Action 

3.3.3.1 Use 

Under the no-action alternative, aquatic wildlife would have continued exposure to excreted biomarkers 

in natural waters receiving treated municipal wastewater. Comparing predicted toxicity levels based on 

structural analysis (OECD, 2018) to levels measured or estimated in wastewater in the studies cited in 

Section 3.3.2.1 indicates that effects to aquatic species would not be expected from the potential 

urinary biomarker levels in surface water, based on the limited available information. Risk levels could 

change with trends in rates of combusted cigarette use. 

3.3.3.2 Disposal 

Under the no-action alternative, terrestrial wildlife would continue to be exposed to littered combusted 

cigarette butts. Aquatic species would continue to be exposed to leachate from littered combusted 

cigarette butts at levels that vary with the littering rate near or upstream of the habitat and the 

characteristics of the water body. The occurrence of both impacts would vary with trends in rates of 

combusted cigarette use. 

3.4 Environmental Justice 

Executive Order 12898 requires federal agencies to identify and address, as appropriate, 

disproportionately high and adverse human health or environmental effects of programs, policies, and 

activities on minority populations and low-income populations. 

3.4.1 Affected Environment 

The new products could be used and disposed of nationwide under the proposed actions. Minority and 

low-income populations throughout the United States are the affected environment for environmental 

justice. 

3.4.2 Potential Impacts from Proposed Actions 

3.4.2.1 Use 

Because the new products consist of heating and inhaling a tobacco product, there is an inherent human 

health impact from their use. Section 3.5.2 discusses the significance in terms of NEPA of this human 

health impact. This section addresses whether the health impact would disproportionately affect 

minority or low-income populations. 

14 
The applicant submitted studies evaluating adult former and never smokers' intentions to use the new 

products following exposure to product information, labeling, and advertising. These studies found that 

former and never smokers' intentions to use the new products appeared similar to their intentions to 

use e-cigarettes, although the applicant provided no statistical tests of these differences. Among neversmokers, young adults and youth are at higher risk than others of initiating use of tobacco products; 

logically, this would also apply to IQOS. Most people who use tobacco products begin when they are 

adolescents or young adults (DHHS, 2014) for various psychological reasons (Reyna and Farley, 2006). 

The IQOS device and its labels, labeling, and advertising materials have a sophisticated, high-tech 

appearance that may be attractive to the general population (similar to other "tech" items), including 

young people. The applicant stated that its marketing and advertising plans have features that will 

reduce the risk of youth uptake, such as advertising and promotion targeted directly at adult smokers 

and age restrictions to access its product website. Age restrictions on buying tobacco products vary 

among the city, county, and state laws across the United States, with a baseline nationwide restriction 

against individuals under 18 years old purchasing any category of tobacco products. 

FDA reported that cross-sectional data from Wave 1 of the Population Assessment of Tobacco and 

Health study (FDA, 2018b) - a uniquely large, long-term study of tobacco use and health in the United 

States - indicate that 35.6 percent of adult (25 years or older) established cigarette smokers use 

menthol-flavored cigarettes. Studies summarized by the Truth Initiative (2016) show that youth, female 

smokers, racial/ethnic minorities, sexual minorities, and those with mental illness strongly favor 

menthol-flavored cigarettes. The three new heatstick products are two menthol products and one 

unflavored product. Regardless of the comparative sales plans for the new menthol products and the 

new unflavored product, the Agency does not have any indication that never smokers in low-income or 

minority populations would disproportionately adopt use of the new products, particularly since there is 

an upfront cost that could partially or completely offset any particular appeal to low-income 

populations. 

3 

3 The Truth Initiative is a national public health foundation established as part of the Master Settlement Agreement 

between the attorneys general of 46 states, the District of Columbia, 5 U.S. territories, and the tobacco industry. It 

was previously known as the American Legacy Foundation. The Truth Initiative is reducing U.S. youth tobacco 

product use and youth substance abuse, and preventing diseases associated with use of tobacco products in the 

United States. 

3.4.2.2 Disposal 

No significant human health or environmental impacts were identified as a result of disposal of the new 

products. Thus, no disproportionate impacts to minority or low-income populations would occur. 

3.4.3 Potential Impacts from No Action 

3.4.3.1 Use 

Under the no-action alternative, minority and low-income populations would continue to initiate, use, 

and quit combusted cigarettes at rates seen in current trends for each subpopulation. No changes in 

disproportionate impacts to minority or low-income populations would occur. 

15 
3.4.3.2 Disposal 

Under the no-action alternative, no changes are expected to the human health and environmental 

impacts associated with disposal of combusted cigarettes. Thus, no changes in any disproportionate 

impacts to minority or low-income populations would occur. 

3.5 Human Health and Safety 

3.5.1 Affected Environment 

The new products could be used and disposed of nationwide under the proposed actions. Individuals 

throughout the United States comprise the affected environment for human health impacts. 

3.5.2 Potential Impacts from Proposed Actions 

3.5.2.1 Use 

The Tobacco Control Act states "A consensus exists within the scientific and medical communities that 

tobacco products are inherently dangerous and cause cancer, heart disease, and other serious adverse 

health effects." Section 910(c) of the Act specifies FDA's considerations, including public health 

concerns, in determining whether or not to issue marketing orders for new tobacco products. FDA's 

Center for Tobacco Products conducts a multidisciplinary scientific review of applications for new 

products to make these determinations. The potential for health impacts from use of the new products 

is classified as "not significant" within this PEA only within the context of and for the purposes of a NEPA 

analysis. 

Section 3.2.2.1 of this PEA analyzes impacts to non-users of the new products who would be exposed to 

exhaled aerosol. This analysis concludes that impacts from secondhand IQOS aerosol on indoor air 

quality are considered, on balance, to be minor to negligible based on data available at this time. 

The new products are powered by lithium ion batteries, one each in the holder and charger (Section 

2.1). Safety issues, including injuries from explosion or fire, have been reported for lithium ion batteries 

in some pocket-carried rechargeable consumer products such as e-cigarettes and mobile phones. The 

applicant stated that the new products and batteries incorporate design features and have been tested 

to international industry standards to mitigate and reduce the risk of battery explosion or overheating. 

Also, there have been no incidents to date of these batteries exploding in the foreign markets where the 

new products have already been available (FDA, 2018c). The applications reported that the batteries 

comply with the following standards: IEC 62133, 4 

4 International Electrotechnical Commission: IEC 62133 Secondary cells and batteries containing alkaline or other 

non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, 

for use in portable applications. 

UL 1642, 5 

5 Underwriters Laboratories: UL 1642-Standard for Lithium Batteries. 

and UN38.36 

6 United Nations: Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria. Section 

38.3-Lithium metal and lithium ion batteries. 

(PMP, 2017). Based on this 

information, no significant impacts are expected related to battery safety. 

16 
3.5.2.2 Disposal 

For the new products, no significant human health impacts were identified as a result of disposal of used 

heatsticks, packaging materials, and devices. Section 3.6 provides additional analysis of impacts from 

proper and improper (littering) disposal. 

3.5.3 Potential Impacts from No Action 

3.5.3.1 Use 

Under the no-action alternative, there would be no new or different health impacts to users or nonusers. Combusted cigarette smokers and nearby non-users would continue to have the known risks of 

using tobacco (Section 3.5.2.1, first sentence) or exposure to ETS (Section 3.2.3.1). There would be no 

changes in current levels of these impacts. 

3.5.3.2 Disposal 

There would be no new or different health impacts. Disposal of cigarette butts and packaging would 

continue at rates corresponding to current and future rates of combusted cigarette use. Section 3.6 

provides additional analysis of impacts from proper and improper (littering) disposal. 

3.6 Solid Waste and Hazardous Materials 

3.6.1 Affected Environment 

The new products could be used and disposed of nationwide under the proposed actions. 

3.6.2 Potential Impacts from Proposed Actions 

3.6.2.1 Use 

Generation and management of solid waste and hazardous materials would not be affected by use of 

the new products under the proposed actions. 

3.6.2.2 Disposal 

Municipal Solid Waste 

After using the new products, users may recycle the packaging material or dispose of the used heatsticks 

and packaging as MSW or litter. Used heatstick and packaging disposal contributes to using landfill 

capacity. 

In 2014, approximately 258.46 million tons of trash were generated in the United States, and 

approximately 89.4 million tons of this material were recycled and composted, equivalent to an overall 

34.6 percent recycling rate. Paper and paperboard account for 68.61 million tons (26.5 percent) of the 

total MSW generated in 2014. Of the total paper and paperboard MSW, 44.4 million tons (64.7 percent) 

were recycled, 19.47 million tons (28.4 percent) were disposed of in landfills, and 4.74 million tons (6.9 

percent) were combusted with energy recovery (EPA, 2016b). 

17 
The Agency used the projected market volumes for the first and fifth years of marketing the new 

products to estimate the waste from disposal of used heatsticks and packaging, accounting for recycling 

of packaging waste as part of overall U.S. recycling of MSW. The estimated waste from used heatstick 

and packaging disposal would be miniscule compared to the total MSW forecasted to be discarded in 

the United States (Confidential Appendix). No significant impact to MSW management capacity would 

occur. 

littered Used Heatsticks 

In this PEA, used heatsticks were assumed to be littered at the same rate as cigarette butts from 

combusted cigarettes. Because a heatstick is not consumed during use, there would be an increased 

total amount of litter generated from the total number of heatsticks compared to the same number of 

cigarette butts. The total mass of heatsticks assumed to be littered would represent a negligible 0.03 

percent (by weight) increase in the total litter from all 247 billion cigarette butts consumed in 2017 in 

the United States (TTB, 2018) (Confidential Appendix). 

Improper disposal (littering) of used heatsticks was also evaluated for the potential to ignite dry 

vegetation and cause a fire. The applications stated that the temperature of the heater blade does not 

exceed 350°C; the temperature of the tobacco within the heatstick would be lower. The National 

Wildfire Coordinating Group (NWCG, 2016) stated that "Under normal conditions, forest fuels will ignite 

and burn when exposed to a heat source that is capable of raising them to a temperature of between 

451 and 750°F [232 and 399°C]. Research places the average ignition temperature at about 500-600°F 

[260-316°C]." Although the temperature within a heatstick during use is within the range at which 

vegetation will ignite, "a competent ignition source must produce sufficient heat over a sufficient 

duration of time" to raise vegetation to its ignition temperature (NWCG, 2016). Because the heatstick 

does not support self-sustaining combustion (PMP, 2017) and would quickly cool when discarded, it is 

unlikely to be able to transfer enough heat for ignition. Therefore, the risk of causing a wildland fire 

would be negligible. 

Device Disposal 

i (b)(4) i 

'rPMP, ·2017;· FDA,-2018cJ..:FDA_estimated-the vofume·of m·ixed-m.ateriai"waste thafwo"uld-be generated' 

by discarded devicesi (b) (4) ibased on the applicant's sales projections for the new 

products (Confidential Appendix/. Consum~rs may dispose of used devices similarly to other used small 

electronics, as household waste that enters the MSW management stream. Potential disposal of the 

devices as MSW was included in the MSW generation estimates described above, with no significant 

impact on waste management capacity identified. 

The manufacturer stated that the device is guaranteed for one year (FDA, 2018c); it is likely then that 

some portion of the used devices would not enter the MSW stream but might be returned to the 

manufacturer for repair or replacement. Used devices disposed of by the applicant would be handled in 

accordance with their commercial or manufacturing recycling program and waste management policies, 

in compliance with applicable laws and regulations. 

The holder and charger each contain a lithium ion battery. The user guide for the new products (PMP, 

2017) states that the "product contains no user-serviceable parts. Do not attempt to ... replace any of 

the components' batteries" (PMP, 2017). Therefore, consumers are not expected to handle or dispose of 

18 
lithium ion batteries as separate items in either the recycling or MSW streams. Lithium ion batteries 

replaced by the applicant or disposed of as part of the used device disposal would be handled in 

accordance with the consumers' commercial or manufacturing recycling program and waste 

management pol icies, in compliance with applicable laws and regulations. 

3.6.3 Potential Impacts from No Action 

3.6.3.1 Use 

Generation and management of solid waste and hazardous materials would not be affected by the 

absence of the new products or continued use of combusted cigarettes under the no-action alternative. 

3.6.3.2 Disposal 

Municipal Solid Waste 

The no-action alternative would not change trends in the nationwide use of combusted, filtered 

cigarettes. Thus, no changes are expected in trends in the overall level of MSW generated from cigarette 

butts and cigarette packaging disposed of in the United States. In addition, for a representative cigarette 

type and its packaging, a volume of cigarettes comparable to the market projections for the new 

products would generate a negligible MSW volume of the 258.46 million tons of MSW generated 

nationwide (Confidential Appendix). 

littered Cigarette Butts 

The environmental effects of cigarette butt litter were summarized as follows (Novotny et al., 2015): 

Cigarette butts are the most commonly discarded piece of waste global ly and are the most 

frequent item of litter picked up on beaches and water edges worldwide ... The nonbiodegradable cellulose acetate filter attached to most manufactured cigarettes is the main 

component of cigarette butt waste ... Hazardous substances have been identified in cigarette 

butts - including arsenic, lead, nicotine and ethyl phenol. These substances are leached from 

discarded butts into aquatic environment s and soil. 

Littered cigarette butts are a notable worldwide environmental concern. A 2009 study found that 65 

percent of cigarettes disposed of in five types of non-residential public locations (recreation sites, 

bars/restaurants, retail stores, medical/hospital facilities, and a city center) were littered (Action 

Research, 2009). Adjusting this result for the proportion of time spent outside of the home compared to 

the time at home (not sleeping or bathing) (EPA, 2011), a littering rate of 34 percent of total used 

cigarettes was estimated. 

Unattended and incompletely extinguished cigarettes can start fires in buildings and in the natural 

environment. Smoking is associated with 14 percent of fatal residential building fires and 11 percent of 

brush, grass, and forest fires (USFA, 2017; Ahrens, 2013). 

The no-action alternative would not change trends in the nationwide use of combusted, filtered 

cigarettes. No changes are expected in the overall level of cigarette butt litter in the United States or 

fires ignited by unattended cigarettes or incompletely extinguished littered cigarette butts. 

19 
3.7 Water Resources 

3.7.1 Affected Environment 

The new products could interact with water resources nationwide where the products are used, 

disposed of, or transported through environmental fate processes. 

3.7.2 Potential Impacts from Proposed Actions 

3.7.2.1 Use 

Excreted biomarkers could be released to water systems receiving municipal wastewater. There is little 

to no information on how much these concentrations may be reduced during municipal wastewater 

treatment. As described in Section 3.3.2.1, 15 of 16 biomarkers of exposure to HPHCs or HPHC 

metabolites were similar in magnitude to smokers who abstained, and biomarkers of exposure to 

nicotine were similar for IQOS and combusted cigarette use. Therefore, similar or lower levels of 

biomarkers in wastewater are expected under the proposed actions. 

3.7.2.2 Disposal 

Surface water could be contaminated by leachate from heatsticks littered directly into water or where 

stormwater runoff transports the littered heatsticks or their leachate to surface water. As described in 

Section 3.3.2.2, although there is a potential for leachate from littered heatsticks to contaminate surface 

water, it is difficult to frame an analysis to predict the level of risk from this illegal activity on a 

nationwide basis. Therefore, a significant impact to surface water quality as a result of the proposed 

actions cannot be concluded with any certainty. 

3.7.3 Potential Impacts from No Action 

3.7.3.1 Use 

Under the no-action alternative, excreted biomarkers would continue to be released to natural waters 

receiving treated municipal wastewater. As described in Section 3.3.3.2, these levels would not be 

expected to affect water quality at levels impacting aquatic species habitat. There would be no new or 

increased risks from surface water used as a drinking water source. Risk levels could change with trends 

in rates of combusted cigarette use. 

3.7.3.2 Disposal 

Under the no-action alternative, surface water bodies would continue to receive leachate, directly and 

in stormwater runoff, from littered combusted cigarette butts. The leachate concentrations would vary 

with the littering rate near or upstream of the water body and the characteristics of the water body. The 

occurrence of impacts would vary with trends in rates of combusted cigarette use. 

3.8 Cumulative Impacts 

NEPA analysis of cumulative impacts considers the proposed actions' potential impacts together with 

any impacts from past, present, and reasonably foreseeable future actions regardless of the entity 

undertaking those actions. 

20 
In this PEA, other actions considered for cumulative effects are use and disposal of combusted 

cigarettes, consumer disposal of other waste including small electronic devices, and GHG emissions from 

all other sources. Each of these actions was considered throughout the analyses in Sections 3.2 through 

3.7 for the resources to which they are relevant. No significant cumulative impacts are expected. 

4. List of Agencies and Persons Consulted 

No agencies or persons were consulted during preparation of this PEA. All information was obtained 

from the applicant or publicly available information sources. 

5. References Cited 

Action Research. 2009. Littering Behavior in America: Results of a National Study. Keep America 

Beautiful. www.kab.org/ 

Ahrens, M. 2013. Brush, Grass, and Forest Fires. Fire Analysis and Research Division, National Fire 

Protection Association. Quincy, MA. 

Andra, S.S., and K.C. Makris. 2011. Tobacco-specific nitrosamines in water: An unexplored 

environmental health risk. Environment International 37:412-417. 

Bradley, P.M., L.B. Barber, D.W. Kolpin, P.B. McMahon, and F.H. Chapelle. 2007. Biotransformation of 

caffeine, cotinine, and nicotine in stream sediments: Implications for use as wastewater indicators. 

Environmental Toxicology and Chemistry 26(6):1116-1121. 

Frost-Pineda, K., B.K. Zedler, Q. Liang, and H.J. Roethig. 2008. Environmental tobacco smoke (ETS) 

evaluation of a third-generation electrically heated cigarette smoking system (EHCSS). Regulatory 

Toxicology and Pharmacology 52:118-121. 

Gale, N., M. McEwan, A.C. Eldridge, I.M. Fearon, N. Sherwood, E. Bowen, S. McDermott, E. Holmes, A. 

Hedge, S. Hossack, L. Wakenshaw, J. Glew, O.M. Camacho, G. Errington, J. McAughey, J. Murphy, C. Liu, 

and C.J. Proctor. 2018. Changes in biomarkers of exposure on switching from a conventional cigarette to 

tobacco heating products: A randomized controlled study in healthy Japanese subjects. Nicotine & 

Tobacco Research. Advanced access publication, June 15, 2018, 1-8. 

Gao, J., J. Li, G. Jiang, Z. Yuan, G. Eaglesham, A. Covaci, J.F. Mueller, and P.K. Thai. 2018. Stability of 

alcohol and tobacco consumption biomarkers in a real rising main sewer. Water Research 138:19-26. 

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23 
Confidential Appendix: Product and Packaging Waste Impacts Based on 

Confidential Market Projections 

Contents: 

1- Market Projections 

2 - Packaging and Components 

3 - Tobacco in Litter 

4 - MSW Generation 

5 - GHG Emissions 

6 - References Cited 

1 - Market Projections 

STN Product 

First Year Fifth Year 

Ho~d~~~~=!er) I _Heatsticks ______ {Ho~d~~~~Oh~:erJ I ______ Heatsticks _______ ·-·-·-·, 

PM0000424 Marlboro Heatsticks 

(b) (4) PM0000425 

Marlboro Smooth Menthol 

Heatsticks 

PM0000426 

Marlboro Fresh Menthol 

Heatsticks 

- No action: representative 

combusted cigarette* 

0 11,700,000,000 0 22,400,000,000 

*"Market projections" for no-action alternative are based on the number of combusted cigarettes that the new products would replace. 

2 - Packaging and Components 

Cardboard and Paper Packaging Weights 

I 

I I I I 

I I I I I I I I 

STN Product Heatstick/Cigarette Pack Heatstick/Cigarette Carton Heatstick/Cigarette Shipping Box 

PM0000479 System 

{Holder+ Charger) 

Packaging 

PM0000479 System 

{Holder+ Charger) 

Shipping Box 

Pack• hinge lid and 

inner frame !eJ Heatsticks per pack carton(g} 

Packs per 

carton Box M Cartons per box 

System outer 

packaae {al 

Systems 

per 

package Box (Rl 

Systems 

per box 

PM0000424 Marlboro Heatsticks 

(b) (4) PM0000425 Marlboro Smooth Menthol 

Heatsticks 

PM0000426 Marlboro Fresh Menthol 

Heatsticks 

- No action: representative 

combusted cigarette* 5.65 I 20 18.96 I 10 638 I 60 0 I 1 0 I 1 

"'Packaging assumptions for no-action alternative are based on Marlboro combusted cigarette hard pack packaging. 

24 
PM0000479 

System (Holder+ 

Pack Carton Charger} 

STN Product 

inner trays+ 

Tear tape+ overwrap Tear tape+ charger 

{g} overwrap (g} overwrap+ twist 

PM0000424 Marlboro Heat sticks 

Marlboro Smooth Menthol 

PM0000425 

Heatsticks (b) (4) 

Marlboro Fresh Menthol 

PM0000426 

Heatsticks 

·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·. 

No action : representative - 0.384 0 0 

combusted cigarette* 

PM0000479 System 

{Holder+ Charger 

STN Product including 

Accessories} 

Al wrap on swabs 

(g for 10 per device) 

PM0000424 Marlboro Heat sticks 

Marlboro Smooth Menthol 

PM0000425 

Heatst icks (b) (4) 

Marlboro Fresh Menthol 

PM0000426 

Heatsticks ·-·-· 

No action : representative - 0 

combusted cigarette* 

Plastic Packaging and Components Weights 

*Packaging assumptions for no-action alternative are based on Marlboro combusted cigarette hard pack packaging. 

Metal Packaging Weights 

*Packaging assumptions for no-action alternative are based on Marlboro combusted cigarette hard pack packaging. 

25 
Mixed (Metal+ Plastic+ Paper) or Other Material Weights 

STN Product 

Pack 

PM0000479 

System (Holder+ 

Charger including 

Accessories) 

PM0000479 System Components 

Inner liner (paper+ Al) 

(g for 2 per pack) 

Disposable 

Polypropylene + 

Cotton + Alcohol 

Swabs 

{g for 10 per Holder (g) 

Charger 

(g) 

Device lifetime: 

11 heatsticks/day 

*365 days 

(heatsticks per 

device) 

PM0000424 Marlboro Heatsticks 

(b) (4) PM0000425 

Marlboro Smooth Menthol 

Heatsticks 

PM0000426 

Marlboro Fresh Menthol 

Heatsticks 

·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ·-·-·-·-·-·-·-·-·-·-·-·-·-·-· ·-·-·-·-·-·-·-·--·-·-·-·-·-·-·-·-·-·-·-·-·-· . 

- No action: representative 

combusted cigarette* 

0.9 0 0 0 NA 

*Packaging assumptions for no-action alternative are based on Marlboro combusted cigarette hard pack packaging. 

3 - Tobacco in Litter 

Used heatsticks were assumed to weigh the same as un-used heatsticks and contain the same weight of 

tobacco filler, as measured by FDA (2017). 

Cigarette butt weight was estimated as fo 11 ows: ··-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

• Butt length was based on ISD_.3.3.0.8_Ld.caft.re.vjsio.ns.U., : 

• Length of rod comb~sted .. ;;;.!_, __________________ (bH4L. _______________ i (b) (4) ! 

• ;_C.m:nb.u5.t.1;.d..w.1;igb-1= ~ ( b) ( 4) r i <:~~:;~~~!: ~----_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-i~;_-i~!_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_] 

! (b) (4) i i-·-·-·-·-·-·-·-·-·-·-·-·-·-·-· 

26 
The used heatstick and cigarette butt littering rate was assumed to be 34 percent, as discussed in 

Section 3.6.3.2. 

STN Product 

Littered Heatsticks 

and Butts 

(short tons) 

Tobacco Filler in Littered 

Heatsticks and Butts 

(short tons) 

Yearl I Years Yearl I Years -

PM0000424 Marlboro Heatsticks 

(b) (4) 

PM0000425 

Marlboro Smooth Menthol 

Heatsticks 

PM0000426 

Marlboro Fresh Menthol 

Heatsticks 

Sum, new products 

- No action: representative 

combusted cigarette* 

---- 1,697·-·-·r -· 3 ,249·-·-·r-·-----482 _________ T _________ 9-23 --------T 

*Litter volumes for no-action alternative are based on the number of combusted cigarettes 

that the new products would replace and the characteristics of the 3R4F reference cigarette. 

4 - MSW Generation 

MSW generation was estimated using the following general equation: 

Marketing projection x packaging weight x fraction of material not recycled 

Recycling rates are 64.7, 9.5, and 34 percent for cardboard/paper, plastic, and metal, respectively (EPA, 

2016a). 

STN Product 

MSW (short tons) 

Butts or Used 

Heats ticks Paper+ Cardboard Plastic Metal Mixed/Other Total 

Year 1 I Years Year 1 I Years Year 1 I Years Year 1 I Years Year 1 I Years Year 1 I Years 

PM0000424 + 

PM0000479 

Marlboro Heatsticks + IQOS 

System 

(b) (4) 

PM0000425 + 

PM0000479 

Marlboro Smooth Menthol 

Heatsticks + I QOS System 

PM0000426 + 

PM0000479 

Marlboro Fresh Menthol 

Heatsticks + I QOS System 

Sum, new products i 

- No action: representative 

combusted cigarette* 

---3,294 -·-1-·-6,307 -·-1-·-1,960·-·r-3,752·-·r-· 224 -·-r·-· 429·-·-·r-·-o----·-r·---o----·-r·-383 ·-·-r·-733 ·-·-r· 5,861 ___ r 11,221 T 

*Assumptions for no-action alternative are based on the number of combusted cigarettes that the new products would replace, characteristics of the 3R4F reference cigarette, and 

Marlboro combusted cigarette hard pack packaging. 

27 
5 - GHG Emissions 

GHG emissions from use were calculated by multiplying the market projections (see first page of this 

appendix) by the COreq generation rates listed in Section 3.2.2.1. 

GHG emissions from disposal were calculated using the estimated MSW (above) and the COreq 

generation rates from WARM (EPA, 2016b) for each waste type, as follows: 

Waste 

Metric tons CO2-eq generated per short ton 

WARM category 

Landfilled MSW I Incinerated MSW 

·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·--·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- -·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·- Cigarette butts 

(b) (4) 

Cardboard/paper 

Plastics 

Metals 

Mixed materials 

STN Product 

Greenhouse Gas Emissions, COreq 

(metric tons per year) 

Use Disposal Total 

_____ Year_1_ I_ Year_S __ ·-·-· Year _1 _I _____ Year 5 _______ ___ Year_ 1 __ I__ Year_ 5 ___ . 

PM0000424 + 

PM0000479 

Marlboro Heatsticks + IQOS 

Svstem 

(b) (4) 

PM0000425 + 

PM0000479 

Marlboro Smooth Menthol 

Heatsticks + IQOS System 

PM0000426 + 

PM0000479 

Marlboro Fresh Menthol 

Heatsticks + IQOS System 

Sum, new products 

- No action: representa tive 

combusted cigarette* 

------1,499---·-·r-2,870 ___ T ______ 740·-------

1

--------1,416---·-·r·-2,238·-·-r ·-4,286 _____ -

·-·. 

*Assumptions for no-action alternative are based on the number of combusted cigarettes that the new products would 

replace, characte ristics of the 3R4F reference cigarette, and Marlboro combusted cigarette hard pack packaging. 

6 - References Cited 

U.S. Environmental Protection Agency. 2016a. Advancing sustainable materials management: Facts and 

figures. Office of Land and Emergency Management. www.epa.gov/sites/production/fi les/2016-

11/ documents/2014 smmfact sheet 508.pdf 

U.S. Environmental Protection Agency. 2016b. Waste Reduction Model (WARM), v. 14. 

www.epa.gov/warm 

U.S. Food and Drug Administration. 2017. Southeast Tobacco Laboratory (STL) Reports 431_1004895, 

431_1005247, and 431_1005341. Atlanta, GA. 

28