Environmental Assessment 

for the Marketing Order for 

NJOY DAILY 

(b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY 

i 

Document Certification 

The undersigned official certifies that the information presented is true, accurate, and complete 

to the best of the knowledge of NJOY, LLC. 

NJOY, LLC 

on behalf of NJOY, LLC 

on behalf of NJOY, LLC 

(b)(4) (b)(4) (b)(4) (b)(4)

(b)(6)

(b)(6)

(b)(4)

(b)(6)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

ii

Document Information

Report Title Environmental Assessment for the Marketing Order for NJOY 

DAILY

Prepared for Center for Tobacco Products

U.S. Food and Drug Administration

Date 

Prepared by: 

(b)(4) (b)(4) (b)(4)

(b)(4) (b)(4)

(b)(4)

(b)(6)
Environmental Assessment for the Marketing Order for NJOY DAILY

iii

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

iv

Table of Contents

1 Executive Summary........................................................................................................... 1

2 Applicant Details and Description of Proposed Action.................................................. 3

2.1 Product Name: NJOY DAILY .............................................................. 3

2.1.1 Product Identification............................................................................................ 4

3 Requested Action............................................................................................................... 8

4 Purpose and Need............................................................................................................10

5 Alternatives.......................................................................................................................12

6 Identification and Characterization of Ingredients of Interest .....................................14

6.1 Screening of Chemicals and Potential Release Scenarios............................................... 14

6.1.1 Process for Selection of Chemicals to Evaluate in the EA ................................ 14

6.1.2 Chemicals Identified for Evaluation in the EA.................................................... 16

6.1.3 Evaluation and Selection of Chemical Release Scenarios................................ 17

7 Potential Environmental Impacts of the Proposed Action Alternative and the 

No Action Alternative.......................................................................................................19

7.1 Affected Environment ........................................................................................................ 19

7.1.1 Regulatory Compliance...................................................................................... 20

7.1.2 Air Quality........................................................................................................... 25

7.1.3 Water Resources: Floodplains, Wetlands (and Waters of the United 

States), and Coastal Zones ............................................................................... 25

7.1.4 Land Use and Zoning......................................................................................... 27

7.1.5 Biological Resources ......................................................................................... 28

7.1.6 Geological Features and Soils ........................................................................... 30

7.1.7 Climate Change ................................................................................................. 30

7.1.8 Solid Waste and Hazardous Waste ................................................................... 31

7.1.9 Cultural Resources............................................................................................. 31

7.1.10 Socioeconomics and Environmental Justice ..................................................... 31

7.1.11 Public Health and Safety.................................................................................... 32

7.2 Environmental Impacts...................................................................................................... 32

7.2.1 Regulatory Compliance...................................................................................... 32

7.2.2 Air Quality........................................................................................................... 32

7.2.3 Water Resources: Floodplains, Wetlands (and Waters of the U.S.), and 

Coastal Zones.................................................................................................... 33

7.2.4 Land Use and Zoning......................................................................................... 35

7.2.5 Biological Resources ......................................................................................... 35

7.2.6 Geological Features and Soils ........................................................................... 36

7.2.7 Climate Change ................................................................................................. 37

7.2.8 Solid Waste and Hazardous Waste ................................................................... 38

7.2.9 Cultural Resources............................................................................................. 39

7.2.10 Socioeconomics and Environmental Justice ..................................................... 39

7.2.11 Public Health and Safety.................................................................................... 40

(b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

v 

8 Cumulative Impacts .........................................................................................................43

9 Mitigation Measures.........................................................................................................45

10 List of Preparers...............................................................................................................47

11 Report Preparation and Review......................................................................................49

12 Agencies and Persons Consulted..................................................................................51

13 References........................................................................................................................53

Figures

Figure 1. NJOY DAILY. ...................................................................................................................... 3

Figure 2. NJOY DAILY – packaging image. ...................................................... 5

Figure 3. NJOY DAILY – Product Insert............................................................................................. 6

Figure 4. Overview of environmental assessment screening standard operating procedure.......... 14

Figure 5. General modeling approach................................................................................ 16

Figure 6. Product flow illustration. .................................................................................................... 20

Figure 7. Location of ............................................................................................... 20

Figure 8. Location of ..................................................................................................... 23

Figure 9. Location of .......................................................................................................... 24

Figure 10. National wetlands inventory map of surrounding wetland types and locations in 

relation to the facility circled in red.................................................................................... 26

Figure 11. National wetlands inventory map of surrounding wetland types and locations in 

relation to the facility circled in red.................................................................................... 27

Figure 12. Map of surrounding conservation lands in relation to the facility circled in red and 

 outlined in purple. .................................................................... 29

Figure 13. Map of surrounding conservation lands in relation to the facility circled in red. ............... 30

Confidential Appendix

Confidential Appendix Section A Confidential Marketing Projections

Confidential Appendix Section B Modeling Output

Confidential Appendix Section C Identification and Characterization of Ingredients of Interest

Confidential Appendix Section D EIC/EEC Calculations and Discussion

(b)(4) (b)(4) (b)(4) (b)(4) (b)(4)(b)(4) (b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

vi

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

1 

1 Executive Summary

The Environmental Assessment (EA) has been prepared for the Proposed Action (manufacturing, use, 

and disposal of NJOY DAILY Electronic Nicotine Delivery System [ENDS] product; NJOY DAILY

Stock Keeping Unit [SKU] in accordance with 21 Code of Federal

Regulations (CFR) 25.20 and 25.40 and the United States (U.S.) Food and Drug Administration (FDA) 

and Council on Environmental Quality (CEQ) regulations implementing the National Environmental Policy 

Act of 1969 (NEPA). The EA is being submitted as part of the NJOY DAILY Pre-Market Tobacco 

Application (PMTA). The format and content of the EA adhere to FDA’s guidance (FDA 1998, 2015,

2019a, 2019b, 2020). The overall conclusion from the assessment is that there are no significant 

environmental risks associated with the manufacture, use, and disposal of NJOY DAILY

(b)(4) (b)(4) (b)(4)

(b)(4)

(b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

2 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

3 

2 Applicant Details and Description of Proposed 

Action 

The Applicant (NJOY, LLC [NJOY]) is seeking marketing authorization for one of its NJOY DAILY. The 

product would be maintained on the market for sale and distribution in the United States. 

> Applicant Name: NJOY, LLC

> Applicant Address: 

> Applicant Contact: 

> Manufacturing Address:

2.1 Product Name: NJOY DAILY

(b)(4) (b)(4) (b)(4) (b)(6) (b)(6) (b)(4)

(b)(6)

(b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

4 

 

(b)(4) (b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

5 

(b)(4) (b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

6 

(b)(4) (b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

7 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

8 

3 Requested Action 

NJOY seeks a marketing order that would permit NJOY’s continued marketing in interstate commerce of 

NJOY DAILY (SKU

Confidential marketing projections for NJOY DAILY for marketing years are 

presented in the Confidential Appendix (Section A).

(b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

9 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

10 

4 Purpose and Need

The need for the Proposed Action, requested by the Applicant, is for the FDA to issue a marketing

authorization order for NJOY DAILY (SKU after finding the new 

tobacco product would be appropriate for the protection of public health. 

The FDA shall review the PMTA, assess the Proposed Action as described in the previous paragraph, 

and subsequently determine whether or not to issue a marketing order for the NJOY product as a 

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

The Proposed Action would provide an alternative to combustible cigarettes.

(b)(4) (b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

11 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

12 

5 Alternatives

Potential alternatives were evaluated in the EA as required by Section 102(2)E of NEPA. The Proposed 

Action, or Proposed Action Alternative (NJOY DAILY and the No Action Alternative 

were compared to determine potential environmental impacts. The No Action Alternative is represented 

by no FDA authorized marketing order for the Proposed Action product in the United States. 

(b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

13 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

14 

6 Identification and Characterization of Ingredients of 

Interest

This section describes the process and results for the identification of ingredients contained in the 

Proposed Action product that were carried forward for evaluation in the EA. The selected ingredients were 

considered in potential discharge/spill release scenarios, and modeling was undertaken to determine 

estimated concentrations that could occur in the environment if a release were to occur. The results of 

Section 6 were included in the environmental impacts assessment (Section 7). 

6.1 Screening of Chemicals and Potential Release Scenarios

6.1.1 Process for Selection of Chemicals to Evaluate in the EA

As summarized in Figure 4, the ingredient screening for the EA consisted of three parts. In Part I, the 

program (EPA 2017) was used to gather lethal 

median concentration (LC501

; lethal concentration resulting in mortality of 50 percent of sample of a 

specific test-animal population), effective median concentration (EC50; concentration of a substance in an 

environmental medium expected to produce a certain effect in 50 percent of test organisms), and chronic 

values (ChV) for various species; these values are used to derive an average normalized toxicity value. In 

Part II, the percentage composition of ingredients in the product was used to derive the average 

normalized relative toxicity values. Ingredients with low average normalized relative toxicity values 

(deemed more toxic) were then selected for the screening level risk assessment using the U.S. 

Environmental Protection Agency (EPA) model, which is considered by the EPA to be a 

conservative estimate of risk (Part III).

Figure 4. Overview of environmental assessment screening standard operating procedure.

6.1.1.1 Part I – Identification of Chemicals of Potential Ecological Concern

 is a predictive ecotoxicity tool provided by the EPA. It is predictive software that estimates the 

acute and chronic aquatic toxicity for aquatic organisms, such as plants, fish, and invertebrates. Below 

are the values for the ingredients.

1. Median Lethal Concentration (LC50):

Several LC50 values are reported and include fish (96-hour), fish (salt water [SW], 96-hour), Daphnid (48-

hour), mysid (96-hour), mysid (SW, 96-hour), earthworms (14 days), green algae (SW, 96-hour), and 

mysid (SW, 48-hour).

1

 LC50 values are a common ecological benchmark concentration used in 

(b)(4) (b)(4) (b)(4)

(b)(4)

(b)(4) (b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

15 

2. Median Effective Concentration (EC50):

Two EC50 values are typically reported, green algae (96-hour) and Lemna gibba (7-day).

3. Chronic Value (ChV):

The ChV is the concentration of a chemical at which adverse effects are observed as a result of long-term 

exposure to the chemical. The ChV is calculated as follows:

CChVV = 10

log〖(LLLLLLLL xx NNLLLLLL)]

2 〗

where LOEC is the lowest observed effect concentration and NOEC is the no-observed-effect 

concentration. 

ChV is available for several species including fish, Daphnid, green algae, fish (SW), and mysid (SW). The 

available values were used to derive an average normalized toxicity value for each ingredient. 

Conservative benchmark toxicity values, representing the minimum value among the species with 

benchmark toxicity values for LC50, EC50, and ChV, were obtained from the program and 

selected for each chemical for further analysis (LC50 conservative (i), EC50 conservative (i) and ChV conservative (i)

below).The selected values were rescaled to values between 0 and 1, with 0 corresponding to chemicals 

that are considered to be the most toxic. The normalized LC50, EC50, and ChV values were calculated as 

follows:

NNNNNNNNNNNNNNNNNNNN LLCC50 (NN,jj) =

LLCC50 cccccccccccccccccccccccc (cc) − LLCC50 mmccccccmmmmmm (jj)

LLCC50 mmccmmccmmmmmm(jj) − LLCC50 mmccccccmmmmmm(jj)

NNNNNNNNNNNNNNNNNNNN EECC50(NN,jj) =

EECC50 cccccccccccccccccccccccc (cc) − EECC50 mmccccccmmmmmm(jj)

EECC50 mmccmmccmmmmmm(jj) − EECC50 mmccccccmmmmmm(jj)

NNNNNNNNNNNNNNNNNNNN CChVV (NN,jj) =

CChVVcccccccccccccccccccccccc (cc) − CChVVmmccccccmmmmmm(jj)

CChVVmmccmmccmmmmmm(jj) − CChVVmmccccccmmmmmm(jj)

where i represents select chemical and j represents target species endpoints across chemicals. 

The conservative values were selected from a range of target species endpoints for the select 

chemical. The maximum and minimum toxicity values were obtained for each chemical and each 

target species endpoint.

WWNNNNWWhttNNNN NNNNNNNNNNNNNNNNNNNN TTNNTTNNTTNNttTT

= 1

3

 × NNNNNNNNNNNNNNNNNNNN LLCC50 +

1

3

 × NNNNNNNNNNNNNNNNNNNN EECC50 +

1

3

 × NNNNNNNNNNNNNNNNNNNN CChVV

6.1.1.2 Part II – Consideration of Ingredient Composition in Formulation

The percent composition (mass/mass [m/m]) of each ingredient was obtained from the manufacturer and 

used to estimate the concentration of each ingredient by assuming an e-liquid density of approximately

1.2 gram per milliliter (g/mL). The concentration is reported in units of milligrams per milliliter (mg/mL). 

Subsequently, the average normalized toxicity value was divided by the concentration of the ingredient to 

obtain the average normalized relative toxicity value. Ingredients with lower average normalized relative 

toxicity values are considered more toxic. 

(b)(4) (b)(4) (b)(4) (b)(4)

The normalized LC50, EC50, and ChV values for each chemical were weighted equally to calculate a 

weighted normalized toxicity score that represents an overall toxicity of each chemical. These values are 

between 0 and 1, with 0 corresponding to chemicals that are considered to be the most toxic. The 

weighted normalized toxicity scores were calculated as follows: 

([ )

( ) ( ) ( )
Environmental Assessment for the Marketing Order for NJOY DAILY

16 

6.1.1.3 Part III – Consideration of Additional Ecotoxicological Data

The potential environmental impacts from ENDS use may occur at any point in the production flow, from 

raw ingredient manufacture through filling, distribution, use, and ultimately disposal. Potential release or 

discharge scenarios were developed (see Section 6.1.3 below and the Confidential Appendix [Section C]) 

to identify potential if unlikely routes of potential environmental impact. Chemicals identified in Part II as 

being of the likely greatest ecotoxicity were incorporated into those release or discharge scenarios 

(developed in part through interviews with the ENDS manufacturer and supporting vendors), and the 

environmental fate of the chemicals under those scenarios was derived using (EPA 2007). 

Several release or discharge scenarios were considered, and scenarios 1, 2, and 6 were evaluated using 

quantitative methods. The general modeling approach is summarized in Figure 5, and model 

output is discussed in Section 7.2 and included in the Confidential Appendix (Section B). 

Figure 5. General modeling approach. 

6.1.2 Chemicals Identified for Evaluation in the EA

(b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

17 

6.1.3 Evaluation and Selection of Chemical Release Scenarios

Reasonable and plausible release scenarios of chemicals to air, water, and the terrestrial environment 

were evaluated and identified for each category, including: (1) manufacturing; (2) product use; and (3) 

disposal (Confidential Appendix [Section C]).

EICs for the aquatic, terrestrial, and atmospheric environments from manufacturing, use, and disposal 

(waste streams, liquid, and packaging) were estimated. FDA (1998: Section III.A.2) describes the method 

for calculating the EIC into the environment. Chemicals may enter the terrestrial environment when solids 

from wastewater treatment are applied to land, or direct discharges to the ground occur during 

manufacturing. Expected environmental concentrations (EECs; or predicted environmental concentrations 

[PECs]) were estimated for the chemicals carried forward into the EA. These estimates represent the 

potential exposure concentrations to ecological receptors in the environment. The factors used to 

calculate the EEC for each chemical/substance in aquatic, terrestrial, and air compartments are described

below. 

EECs were compared to ecological and human health toxicological benchmarks to determine whether 

there could be any potentially significant environmental impacts if a release of select chemicals were to 

occur, as discussed in Section 7.2 and the Confidential Appendix (Section D). Release scenarios for 

manufacturing surface water, manufacturing wastewater, and disposal end of life terrestrial soil were

further evaluated as the most reasonable and appropriate in the EA.

(b)(4) (b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

18 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

19 

7 Potential Environmental Impacts of the Proposed 

Action Alternative and the No Action Alternative

The environmental issues section consists of a succinct description of the potential environmental 

introductions and effects, supported by information that may vary based on the type of Proposed Action

Alternative. Potential environmental introductions resulting from manufacturing, use, and disposal were 

evaluated for the Proposed Action and No Action Alternative. This section provides a description of the 

affected environment (existing conditions) and environmental impacts from the Proposed Action and the 

No Action Alternative. 

The potential environmental impacts due to manufacturing were assessed at manufacturing facilities. 

Waste generated at these facilities and its release to air, wastewater, and solid waste streams were

characterized. Regulatory compliance information was provided by the Applicant and its vendors and is 

summarized in Section 7.1.1. Compliance audits and inspections were not conducted as part of this 

assessment. 

The potential environmental impacts associated with manufacture, use, and disposal of NJOY DAILY

under the Proposed Action were evaluated for the following subjects: 

> Regulatory compliance

> Air quality

> Water resources

> Floodplains, wetlands, and coastal zones

> Land use and zoning

> Biological resources

> Geological features and soils

> Climate change

> Solid waste and hazardous waste

> Cultural resources

> Socioeconomics

> Environmental justice

> Public health and safety

7.1 Affected Environment

Environmental resources that may be affected by the alternatives are described below, along with a 

description of applicable regulations. The evaluation of environmental effects to these resources for each 

alternative is described in Section 7.2. A brief description of the existing resource conditions is provided 

herein. 

Figure 6 presents a generalized illustration of the product flow from vendors to manufacturers, on to 

distribution, and ultimately to the consumer.

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

20 

7.1.1 Regulatory Compliance

Regulatory compliance is integral to the protection of environmental resources by employing institutional 

controls to avoid releases of potentially hazardous materials to the aquatic, terrestrial, and atmospheric 

compartments. A description of the Applicant’s operations and environmental regulatory conditions for 

manufacturing is provided below. 

(b)(4) (b)(4) (b)(4)

(b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

(b)(4)

21 

(b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

22 

(b)(4) (b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

23 

(b)(4) (b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

24 

(b)(4) (b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

25 

7.1.2 Air Quality

7.1.3 Water Resources: Floodplains, Wetlands (and Waters of the United States), and 

Coastal Zones

(b)(4) (b)(4) (b)(4)

(b)(4)

(b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

26 

(b)(4) (b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

27 

7.1.4 Land Use and Zoning 

(b)(4) (b)(4) (b)(4)

(b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

28 

7.1.5 Biological Resources

(b)(4) (b)(4) (b)(4)

(b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

(b)(4)

29 

(b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

30 

7.1.6 Geological Features and Soils

7.1.7 Climate Change 

Anthropogenic greenhouse gas (GHG) emissions since the pre-industrial era have resulted in increased 

atmospheric concentrations of carbon dioxide (CO2), methane, and nitrous oxide (Intergovernmental

Panel on Climate Change 2014). Climate change can have impacts on both natural and human systems, 

including, but not limited to, human health, adverse effects to agriculture and food security, increased 

storm severity, multi-decade droughts, and sea level rise. Increased frequency of severe storms is 

(b)(4) (b)(4) (b)(4)

(b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

31 

anticipated to result in an increase in the extent and frequency of coastal flooding, loss of wetlands, 

erosion, increased flood risk, and increased salinity of rivers, bays, tidal estuaries, and groundwater, 

along with other land impacts throughout the world (Frumhoff et al. 2007).

7.1.8 Solid Waste and Hazardous Waste

7.1.9 Cultural Resources 

7.1.10 Socioeconomics and Environmental Justice

(b)(4) (b)(4) (b)(4)

(b)(4)

(b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

32 

7.1.11 Public Health and Safety

Public health and safety, including, but not limited to, occupational health is a key component of 

manufacturing facility operations in the ENDS industry. Each facility has health and safety practices and 

procedures in place to protect facility workers and to prevent environmental releases that could result in 

exposures to the public.

7.2 Environmental Impacts

7.2.1 Regulatory Compliance 

7.2.1.1 No Action Alternative

Under the No Action Alternative (no marketing order for the Proposed Action product), there would be no 

changes to regulatory compliance related to manufacturing, use, and disposal. The Applicant’s suppliers

provide comparable services (i.e., manufacture of finished e-liquids) to other companies, so their 

operations would be largely unchanged in the absence of the Proposed Action. Further, and 

facilities are both tolling/custom manufacturers, for whom contracting chemical product 

volumes at their facilities up to the maximum permitted quantities is in their own business interest, 

irrespective of the Applicant having their e-liquids manufactured at the facilities or not (no marketing order 

for the Proposed Action product). Potential capacity expansion of the facilities 

with the growing market for e-liquids might be a consideration for the future. Subject to unchanged 

nameplate capacity, under the No Action Alternative, there would be no changes to regulatory compliance 

from current conditions. 

7.2.1.2 Proposed Action Alternative

7.2.1.2.1 Manufacturing the Products

Under the Proposed Action, there would be no anticipated impacts to regulatory compliance from 

manufacturing. Manufacturing facilities are in compliance with local, state, and federal environmental 

regulations. In addition, facilities have protection measures and practices in place to minimize or prevent 

the potential for lack of compliance.

7.2.1.2.2 Use of the Products

There would be no impacts to regulatory compliance related to use of the products under the Proposed 

Action. Product use by consumers occurs outside of the manufacturing facilities and, therefore, would not 

affect their compliance with local, state, and federal environmental regulations.

7.2.1.2.3 Disposal of the Products and Packaging 

There would be no impacts to regulatory compliance related to disposal of the products under the 

Proposed Action. Manufacturers have disposal practices in place, mostly with third-party waste handlers 

and recyclers, to properly manage and remove waste from their facilities (see Section 7.1.1). A 

reasonable assumption is that the amount of used product and packaging material disposed in the 

municipal solid waste stream and from littering would not result in substantial accumulations of material 

that would impact the compliance of waste facilities, including recycling centers and solid waste landfills.

Refer to the Confidential Appendix (Section D) for quantitative littering analysis of disposed product and 

packaging material.

7.2.2 Air Quality

7.2.2.1 No Action Alternative

Under the No Action Alternative, there would be no changes to air quality from current conditions, as 

other comparable products would be manufactured, used, and disposed of in the absence of the 

(b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

33 

Proposed Action. Further, facilities are both tolling/custom manufacturers, for 

whom contracting chemical product volumes at their facilities up to the maximum permitted quantities is in 

their own business interest, irrespective of the Applicant having their e-liquids manufactured at the 

facilities or not (no marketing order for the Proposed Action product). Potential capacity expansion of the 

facilities with the growing market for e-liquids might be a consideration for the 

future. Subject to unchanged nameplate capacity, under the No Action Alternative, there would be no 

changes to air quality from current conditions. 

7.2.2.2 Proposed Action Alternative

7.2.2.2.1 Manufacturing the Products

Under the Proposed Action, there would be no changes to environmental air emissions from 

manufacturing. The manufacturing facilities may produce low concentrations of fugitive volatile organic 

compound (VOC) emissions; however, based on internal audits of local air district requirements by 

manufacturing facilities, the levels of emissions do not appear to reach regulated threshold values for 

VOCs and are therefore not likely to significantly change air quality.

7.2.2.2.2 Use of the Products

Under the Proposed Action, there would be no air quality impacts from product use. Localized air quality 

impacts related to public health are discussed in Section 7.2.11.2.2.

7.2.2.2.3 Disposal of the Products and Packaging

Under the Proposed Action, there would be no impacts to air quality from product disposal due to the lack 

of atmospheric emissions associated with disposal of the product and packaging. Emissions could be 

generated from municipal solid waste transport of disposed product and packaging (Section 7.2.7.2.3); 

however, the incremental contribution of those emissions would be negligible compared to the collective 

emissions associated with waste transport of disposed products and packaging from other ENDS industry 

companies. There will be no new or increased chemicals emitted from the disposal of the used product 

and packaging material (Confidential Appendix [Section D]).

7.2.3 Water Resources: Floodplains, Wetlands (and Waters of the U.S.), and Coastal Zones

7.2.3.1 No Action Alternative

Under the No Action Alternative, there would be no changes to water resources from current conditions, 

as other comparable products would be manufactured, used, and disposed of in the absence of the 

Proposed Action. Further, facilities are both tolling/custom manufacturers, for 

whom contracting chemical product volumes at their facilities up to the maximum permitted quantities is in 

their own business interest, irrespective of the Applicant having their e-liquids manufactured at the 

facilities or not (no marketing order for the Proposed Action product). Potential capacity expansion of the 

facilities with the growing market for e-liquids might be a consideration for the 

future. Subject to unchanged nameplate capacity, under the No Action Alternative, there would be no 

changes to water resources from current conditions

7.2.3.2 Proposed Action Alternative

7.2.3.2.1 Manufacturing of the Products

Under the Proposed Action, manufacturing would not lead to changes in water quality. According to the 

manufacturing facilities, there are no wastewater discharges from their facilities.

Under the Proposed Action, there would be no anticipated impacts to water resources. There are 

jurisdictional wetlands and waters in the vicinities of the facilities; however, e-

(b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

34 

liquid manufacturing activities would not result in either temporary or permanent impacts. Potential facility 

expansions are not being considered in areas immediately adjacent to 

wetlands, floodplains, and coastal zones. Therefore, there would be no impacts to water resources from 

manufacturing under the Proposed Action.

Surface Water Releases 

Down-the-Drain Releases

modeling was also used to assess potential impacts from disposal of the selected ingredient

down-the-drain through the municipal sewer and into the WWTP. The same selected chemicals were 

used for the surface water discharge scenario. The highest percentage of each ingredient in the product 

was used to determine the amount of each ingredient that would be released if containers of finished eliquid were to break (Confidential Appendix [Section C]).

The modeling determined that there would be a very low likelihood of toxicity-related impacts 

from selected ingredients in the down-the-drain scenario (Confidential Appendix [Section B and D]).

7.2.3.2.2 Use of the Products

Under the Proposed Action, there would be no impacts to water resources related to product use.

Exhaled vapor from consumers would not be expected to generate substantial volumes of harmful 

constituents that could deposit to waterbodies and result in decreased water quality or other impairments.

7.2.3.2.3 Disposal of the Products and Packaging

Under the Proposed Action, there would be no impacts to water resources related to product disposal.

The Applicant’s disposal instructions to consumers indicate that product should be recycled as electronic 

waste (e-waste) (Figure 3). The Applicant also recommends that users check local regulations or contact 

local household disposal services and/or recycling facilities for responsible disposal and recycling to 

reduce potential impacts to human health and the environment.

Consumers may also dispose of used products and packaging as litter rather than in the municipal solid 

waste stream. It is a reasonable assumption that the littered material would not accumulate in substantial 

amounts in localized areas. Rather, littered material would more than likely be dispersed in the 

environment, thus not representing point sources of pollution (Section 7.2.8). Under the Proposed Action, 

there would be no changes to the condition of water resources from disposal (Confidential Appendix

[Section D]). 

 

(b)(4) (b)(4) (b)(4) (b)(4)

(b)(4)

(b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

35 

7.2.4 Land Use and Zoning 

7.2.4.1 No Action Alternative

Under the No Action Alternative, the manufacturing facilities would be less likely to expand operations in 

the absence of the Proposed Action. Therefore, no predictable changes to land use and zoning were 

identified. Further, facilities are both tolling/custom manufacturers, for whom 

contracting chemical product volumes at their facilities up to the maximum permitted quantities is in their 

own business interest, irrespective of the Applicant having their e-liquids manufactured at the facilities or 

not (no marketing order for the Proposed Action product). Potential capacity expansion of the facilities 

 with the growing market for e-liquids might be a consideration for the future. 

Subject to unchanged nameplate capacity, under the No Action Alternative, there would be no changes to 

land use and zoning from current conditions.

7.2.4.2 Proposed Action Alternative

7.2.4.2.1 Manufacturing the Products

There could be changes to land use and zoning as a result of a potential expansion of the 

facility. There would be no impacts to land use and zoning under the Proposed Action, as county and 

local building and zoning codes would be adhered to during planning and construction of any proposed 

facility expansions. potential acquisition of a new, larger building would not result in land use 

changes, as the intention would be to identify a building with the same industrial land use and zoning.

7.2.4.2.2 Use of the Products

Under the Proposed Action, there would be no expected changes to land use and zoning related to 

product use.

7.2.4.2.3 Disposal of the Products and Packaging

Under the Proposed Action, there would be no changes to land use and zoning as a result of product 

disposal. Land use and zoning at the manufacturing facilities would not be directly impacted by product 

disposal. In addition, the amount of disposed product and packaging material would not be expected to 

accumulate in large enough volumes and mass to result in solid waste landfill expansions, new landfills, 

or recycling centers for waste disposal. Landfill capacity in the United States is considered sufficient for 

current domestic disposal practices, and projected disposed packaging waste (based on confidential 

marketing projections (Confidential Appendix [Section A]) would not result in impacts to the overall 

capacity of existing or planned waste handling resources (Confidential Appendix [Section D]). There 

would be no new or increased chemicals emitted from the disposal of the bottles and packaging material. 

Therefore, land use and zoning of landfills would not change as a direct result of disposal of the Proposed 

Action product. 

7.2.5 Biological Resources

7.2.5.1 No Action Alternative

Under the No Action Alternative, there would be no changes to the condition of biological resources from 

current conditions, as other comparable products would be manufactured, used, and disposed of in the 

absence of the Proposed Action. Further, facilities are both tolling/custom 

manufacturers, for whom contracting chemical product volumes at their facilities up to the maximum 

permitted quantities is in their own business interest, irrespective of the Applicant having their e-liquids 

manufactured at the facilities or not (no marketing order for the Proposed Action product). Potential 

capacity expansion of the facilities with the growing market for e-liquids might 

be a consideration for the future. Subject to unchanged nameplate capacity, under the No Action 

Alternative, there would be no changes to biological resources from current conditions. 

(b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

36 

7.2.5.2 Proposed Action Alternative

7.2.5.2.1 Manufacturing the Products

No critical habitat for federally listed species is located within the manufacturing facilities’ property 

boundaries. Manufacturing operations would not result in adverse effects to federally listed species found 

in areas around the facilities. Although potentially suitable habitat exists adjacent to the facilities, federally 

listed species are unlikely to occur within the facility property boundaries; therefore it is unlikely that any 

species potentially present in these adjacent areas would be negatively affected.

Modeling of chemicals from potential release scenarios indicated that EECs would be below chronic 

toxicity values for sensitive receptors (Section 7.2.3.2.1; Confidential Appendix [Section D]); thus, adverse 

effects due to chemical exposures would not be likely.

7.2.5.2.2 Use of the Products

Under the Proposed Action, there would not be any significant impacts to biological resources from 

product use. Exhaled vapor from product users would not be expected to generate substantial volumes of 

harmful constituents that could result in adverse impacts to ecological receptors from decreased air 

quality (for respiration) and water quality (ingestion or exposure). 

7.2.5.2.3 Disposal of the Products and Packaging

Under the Proposed Action, it is assumed that used product and packaging would be properly recycled 

and/or disposed of in the municipal solid waste stream. The Applicant’s disposal instructions to 

consumers indicate that the product should be recycled as e-waste (Figure 3). The Applicant also 

recommend that users check local regulations or contact local household disposal services and/or 

recycling facilities for responsible disposal and recycling to reduce potential impacts to human health and 

the environment.

Exposures of leached materials to biological resources could potentially occur due to improper disposal of 

used products as litter in the environment; however, it is not anticipated that disposed products and 

packaging would accumulate in sufficient quantities in single locations. Estimations of residual nicotine in 

littered products indicated that EECs in soil would be below ecotoxicity thresholds; therefore, impacts to 

biological resources would be highly unlikely (Section 7.2.6.2.3; Confidential Appendix [Section D]).

7.2.6 Geological Features and Soils

7.2.6.1 No Action Alternative

Under the No Action Alternative, there would be no changes to geological features and soils from current 

condition, as other comparable products would be manufactured, used, and disposed of in the absence of 

the Proposed Action. Further, facilities are both tolling/custom manufacturers, 

for whom contracting chemical product volumes at their facilities up to the maximum permitted quantities 

is in their own business interest, irrespective of the Applicant having their e-liquids manufactured at the 

facilities or not (no marketing order for the Proposed Action product). Potential capacity expansion of the 

facilities with the growing market for e-liquids might be a consideration for the 

future. Subject to unchanged nameplate capacity, under the No Action Alternative, there would be no 

changes to geological features and soils from current conditions.

7.2.6.2 Proposed Action Alternative

7.2.6.2.1 Manufacturing the Products

Under the Proposed Action, there would be no impacts to geological features and soils (terrestrial 

resources) from chemical releases during manufacturing operations. There could be minor and temporary 

impacts to soils from potential manufacturing facility expansions; however, the potential impacts directly 

(b)(4) (b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

37 

attributable to the Proposed Action would not be measurable, since both facilities produce finished eliquids for companies other than the Applicant. Measures would be employed to minimize effects to native 

soils, including erosion and runoff control during pre-construction and construction activities related to 

facility expansions. 

7.2.6.2.2 Use of the Products

Under the Proposed Action, there would not be significant impacts to geological resources and soils from 

product use. Exhaled vapor from product users would not be expected to generate substantial volumes of 

harmful constituents that could deposit to soil surface and cause adverse effects, such as contamination. 

7.2.6.2.3 Disposal of the Products and Packaging 

Under the Proposed Action, it is assumed that used products and packaging would be properly recycled 

and/or disposed of in the municipal solid waste stream. The Applicant’s disposal instructions to 

consumers indicate that product should be recycled as e-waste (Figure 3). The Applicant also 

recommends that users check local regulations or contact local household disposal services and/or 

recycling facilities for responsible disposal and recycling to reduce potential impacts to human health and 

the environment. Consumers may also dispose of used products and packaging as litter rather than in the 

municipal solid waste stream.

It is a reasonable assumption that littered material would not accumulate in substantial amounts 

in localized areas. Rather, it would more than likely be dispersed in the environment. Under the Proposed 

Action, there would be no changes to the condition of geological resources and soils from littering.

(Section 7.2.8). Quantitative analyses were conducted to estimate EECs in the 

environment via U.S. Roadway and Urban Soil littering scenarios. The amount of disposed product and 

packaging were calculated based on confidential marketing projections. Derived EECs were then 

compared to ecotoxicity thresholds. The results indicated no exceedances of relevant ecotoxicity 

thresholds, and impacts to resources would be highly unlikely (Confidential Appendix [Section D]).

7.2.7 Climate Change

7.2.7.1 No Action Alternative

Under the No Action Alternative, there would be no changes to climate change from current conditions, as 

other comparable products would be manufactured, used, and disposed of in the absence of the 

Proposed Action. The No Action Alternative would not result in significant changes to existing 

manufacturing of comparable nicotine products. These products and other new products would continue 

to be manufactured even in the absence of the Proposed Action. Further, 

facilities are both tolling/custom manufacturers, for whom contracting chemical product volumes at their 

facilities up to the maximum permitted quantities is in their own business interest, irrespective of the 

Applicant having their e-liquids manufactured at the facilities or not (no marketing order for the Proposed 

Action product). Potential capacity expansion of the facilities with the growing 

market for e-liquids might be a consideration for the future. Subject to unchanged nameplate capacity, 

under the No Action Alternative, there would be no changes to climate change from current conditions.

7.2.7.2 Proposed Action Alternative

7.2.7.2.1 Manufacturing the Products

Under the Proposed Action, there could be impacts to climate change from manufacturing. For example, 

GHGs could be produced from product transport (shipping of raw materials and unfinished products 

[between manufacturing facilities] and finished products to retail shelves). However, the potential for 

(b)(4) (b)(4) (b)(4)

(b)(4) (b)(4)

(b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

38 

effects directly attributable to manufacturing of the Proposed Action product would likely be less than 

those associated with comparable ENDS products from other manufacturers. 

7.2.7.2.2 Use of the Products

Under the Proposed Action, there would be no measurable impacts to climate change from product use. 

Exhaled vapor does not contain elevated concentrations of chemicals including VOCs that could impact 

climate change.

7.2.7.2.3 Disposal of the Products and Packaging

Under the Proposed Action, there would be no measurable impacts to climate change from product 

disposal. Spent product does not typically contain volumes of VOCs or other ingredients that can impact

climate change. GHGs could be generated from municipal solid waste transport of disposed product and 

packaging; however, the incremental contribution of those emissions would be negligible compared to the 

collective emissions associated with waste transport of disposed products and packaging from other 

ENDS industry companies. 

7.2.8 Solid Waste and Hazardous Waste

7.2.8.1 No Action Alternative

Under the No Action Alternative, there would be no changes to solid waste and hazardous waste from 

current conditions, as other comparable products would be manufactured, used, and disposed of in the

absence of the Proposed Action. Further, facilities are both tolling/custom 

manufacturers, for whom contracting chemical product volumes at their facilities up to the maximum 

permitted quantities is in their own business interest, irrespective of the Applicant having their e-liquids 

manufactured at the facilities or not (no marketing order for the Proposed Action product). Potential 

capacity expansion of the facilities with the growing market for e-liquids might 

be a consideration for the future. Subject to unchanged nameplate capacity, under the No Action 

Alternative, there would be no changes to solid waste and hazardous waste from current conditions.

7.2.8.2 Proposed Action Alternative

7.2.8.2.1 Manufacturing the Products

Under the Proposed Action, manufacture of the product would likely increase total manufacturing waste

from the facilities. However, the amount of waste directly attributable to the Proposed Action would be 

difficult to determine, since the facilities manufacture similar products for other companies. Therefore, it is

not anticipated that manufacturing the new products would introduce significant amounts of hazardous 

waste. The waste that is generated at compliant manufacturing facilities is removed for disposal by thirdparty waste handlers, so it ends up in solid waste landfills, rather than accumulating in the environment. 

7.2.8.2.2 Use of the Products

Under the Proposed Action, there would be no impacts to hazardous waste during product use. Exhaled 

vapor from product users would not be expected to generate substantial volumes of harmful constituents 

that could deposit and accumulate as hazardous waste in the environment. 

7.2.8.2.3 Disposal of the Products and Packaging

The majority of ENDS products are not recyclable; however, it is assumed that product disposal 

specifications on packaging labels would be followed by consumers, so that the majority of spent product

(containing only a minimal amount of residual ingredients) would enter the recycling stream or be 

disposed of in household solid waste, and ultimately in municipal solid waste landfills. A portion of used 

product and packaging could also be disposed of as litter in the environment. 

(b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

39 

The total mass of 

waste paper-based and plastic-based packaging material that may be disposed of into the natural 

environment has been estimated based in part on marketing projections (Confidential Appendix [Section

A]) and is discussed further in the Confidential Appendix (Section D).

and EECs were determined to be below relevant ecotoxicity thresholds

(Section 7.2.6.2.3; Confidential Appendix [Section D]).

Rather, it would more than likely be dispersed in the environment. 

Under the Proposed Action, there would be no changes to solid waste and hazardous waste from littering.

7.2.9 Cultural Resources

7.2.9.1 No Action Alternative

Under the No Action Alternative, there would be no changes to the current condition of cultural resources, 

as other comparable products would be manufactured, used, and disposed of in the absence of the 

Proposed Action. Further, facilities are both tolling/custom manufacturers, for 

whom contracting chemical product volumes at their facilities up to the maximum permitted quantities is in 

their own business interest, irrespective of the Applicant having their e-liquids manufactured at the 

facilities or not (no marketing order for the Proposed Action product). Potential capacity expansion of the 

facilities with the growing market for e-liquids might be a consideration for the 

future. Subject to unchanged nameplate capacity, under the No Action Alternative, there would be no 

changes to cultural resources from current conditions.

7.2.9.2 Proposed Action Alternative

7.2.9.2.1 Manufacturing the Products

Under the Proposed Action, there would be no anticipated impacts to historic properties or cultural 

resources, as a result of manufacturing activities. There is only one NRHP-listed resource in the vicinity of 

manufacturing operations, approximately 0.85 mile from the facility. Therefore, even in the 

event of a low-probability chemical release, impacts to cultural resources would be highly unlikely. 

7.2.9.2.2 Use of the Products

Under the Proposed Action, there would be no impacts to historic properties or cultural resources from 

product use. Exhaled vapor from product users would not be expected to generate substantial volumes of 

harmful constituents that could deposit and accumulate on cultural resources. 

7.2.9.2.3 Disposal of the Products and Packaging

Under the Proposed Action, there would be no impacts to historic properties or cultural resources from 

product disposal. It is assumed that used products and packing would end up in the municipal solid waste 

stream or as litter in the environment. It was determined that there would be a low likelihood of risk to 

soils from littering, therefore impacts to cultural resources would not be anticipated (Section 7.2.6.2.3; 

Confidential Appendix [Section D]). 

7.2.10 Socioeconomics and Environmental Justice

7.2.10.1 No Action Alternative 

Under the No Action Alternative, there would be no changes to socioeconomics from current conditions, 

because the amount of Proposed Action product does not represent a significant portion of the total 

(b)(4) (b)(4) (b)(4)

(b)(4)

(b)(4)

(b)(4)

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

40 

amount of ENDS products manufactured by the Applicant’s suppliers. Further,

facilities are both tolling/custom manufacturers, for whom contracting chemical product volumes at their 

facilities up to the maximum permitted quantities is in their own business interest, irrespective of the 

Applicant having their e-liquids manufactured at the facilities or not (no marketing order for the Proposed 

Action product). Potential capacity expansion of the facilities with the growing 

market for e-liquids might be a consideration for the future. Subject to unchanged nameplate capacity, 

under the No Action Alternative, there would be no changes to socioeconomics and environmental justice

from current conditions.

No disproportionately high or adverse environmental justice impacts on minority or low-income 

populations is expected under the No Action Alternative.

7.2.10.2 Proposed Action Alternative

7.2.10.2.1 Manufacturing the Products

The Proposed Action would not cause any adverse socioeconomic impacts. The manufacturers are

considering facility expansions or acquisitions of larger facilities (see Section 7.1) that could result in 

temporary jobs during construction, as well as hiring of permanent process engineers, chemists, and 

administrative staff. The creation of new jobs would result in positive socioeconomic benefits; such 

benefits would not be limited to the individual facilities, as increased production would result in new 

employment opportunities in other areas of the product life cycle. In addition, NJOY revenues from sale of 

these products could result in additional jobs at the company beyond vendor manufacturing facilities. New 

jobs, as well as local spending by NJOY staff could contribute to positive economic growth. 

Because no significant impacts to environmental resources were identified, there would be no 

disproportionate impacts to environmental justice populations in the vicinity of the manufacturing facilities. 

7.2.10.2.2 Use of the Products

Under the Proposed Action, no significant impacts to environmental resources from product use were 

identified; therefore, no disproportionate impacts would occur to environmental justice populations. In 

addition, the Proposed Action product is likely used by the same consumers who use other ENDS 

products on the market. Therefore, no disproportionate environmental justice impacts would be 

anticipated, since the ENDS products are essentially competing for the same market share. 

7.2.10.2.3 Disposal of the Products and Packaging

Under the Proposed Action, no significant impacts to environmental resources from disposal were 

identified; therefore, no disproportionate impacts would occur to environmental justice populations. 

7.2.11 Public Health and Safety

7.2.11.1 No Action Alternative

Under the No Action Alternative, there would be no changes to public health and safety from current 

conditions, as other comparable products would be manufactured, used, and disposed of in the absence 

of the Proposed Action. Further, facilities are both tolling/custom manufacturers, 

for whom contracting chemical product volumes at their facilities up to the maximum permitted quantities 

is in their own business interest, irrespective of the Applicant having their e-liquids manufactured at the 

facilities or not (no marketing order for the Proposed Action product). Potential capacity expansion of the 

facilities with the growing market for e-liquids might be a consideration for the 

future. Subject to unchanged nameplate capacity, under the No Action Alternative, there would be no 

changes to public health and safety from current conditions.

(b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

41 

7.2.11.2 Proposed Action Alternative

7.2.11.2.1 Manufacturing the Products

Under the Proposed Action, adverse effects to public health and safety from manufacturing would not be 

expected. The manufacturing facilities are in compliance with local, state, and federal environmental 

regulations, which includes chemical exposure prevention measures, on-site health and safety protocols 

and trained staff, and in-house emergency response procedures and third-party responders. These 

controls would reduce the potential for exposures to workers and the public outside the facility property 

boundaries.

7.2.11.2.2 Use of the Products

7.2.11.2.3 Disposal of the Products and Packaging

Under the Proposed Action, no significant environmental impacts were identified from used products and 

packaging disposal via littering (above); therefore, there would be no impacts to public health and safety 

related to product disposal.

(b)(4) (b)(4) (b)(4)

(b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

42 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

43 

8 Cumulative Impacts

The effects on the environment that result from the incremental effect of the Proposed Action when added 

to other past, present, and reasonably foreseeable future actions was assessed. Other comparable

products currently on the market represent present actions; those products that have been marketed and 

sold in the past but are not longer available to consumers represent past actions; and comparable 

products that will likely be on the market in the future represent reasonably foreseeable future actions.

Overall, no adverse cumulative effects are anticipated as a result of the Proposed Action in combination 

with other past, present, or reasonably foreseeable future actions. There were no actions identified that, 

when considered with product manufacturing, use, and disposal under the Proposed Action, would lead to 

cumulative impacts.

The incremental impacts from the Proposed Action do not contribute significantly to the overall cumulative 

impacts from other actions (past, present, or reasonably foreseeable future actions). 

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

44 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

45 

9 Mitigation Measures

During the review of the available information and the impact assessment, it was determined that no

adverse environmental effects would occur due to the manufacture, use, and disposal of the Proposed 

Action; thus, no mitigation measures are required. Manufacturing facility BMPs including regulatory 

compliance measures and emergency response plans would be sufficient to prevent adverse impacts to 

environmental resources.

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

46 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

47 

10 List of Preparers

(b)(4) (b)(4) (b)(4)

(b)(6)
Environmental Assessment for the Marketing Order for NJOY DAILY

48 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

49 

11 Report Preparation and Review

The EA was prepared in accordance with 21 CFR 25.40.

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

50 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

51 

12 Agencies and Persons Consulted

No agencies or consultants were consulted during preparation of the EA.

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

52 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)
Environmental Assessment for the Marketing Order for NJOY DAILY

53 

13 References

EPA (U.S. Environmental Protection Agency). 2007. Exposure and Fate Assessment Screening Tool 

(E-FAST) Version 2.0 Documentation Manual. Available at: https://www.epa.gov/

sites/production/files/2015-04/documents/efast2man.pdf. Accessed January 2, 2020. 

EPA. 2017. Ecological Structure-Activity Relationship Model (ECOSAR) Class Program. Version 2.0. 

Estimating Toxicity of Industrial Chemicals to Aquatic Organisms using the ECOSAR Class 

Program. Available at: https://www.epa.gov/tsca-screening-tools/ecological-structure-activityrelationships-program-ecosar-operation-manual-v20. 

(b)(4) (b)(4) (b)(4)

(b)(6)

(b)(6) (b)(6)

(b)(6)

(b)(6) (b)(6) (b)(6)

(b)(6)

(b)(6)
Environmental Assessment for the Marketing Order for NJOY DAILY

54 

EPA. 2019a. Final Rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment 

to the P075 Listing for Nicotine. 84 FR 5816. 84(36):5816-5950. February 22.

EPA. 2019b. Outdoor Air Quality Data. Air Quality Statistics Report. Available at: 

https://www.epa.gov/outdoor-air-quality-data/air-quality-statistics-report. Accessed November 21, 

2019.

EPA. 2019c. Outdoor Air Quality Data. Air Quality Index Report. Available at: 

https://www.epa.gov/outdoor-air-quality-data/air-quality-index-report. Accessed November 21, 

2019.

FDA (Food and Drug Administration). 1998. Guidance for Industry: Environmental Assessment of Human 

Drug and Biologics Applications. U.S. Department of Health and Human Services, FDA, Center 

for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research 

(CBER). CMC 6, Revision 1. July.

FDA. 2015. Guidance for Industry: National Environmental Policy Act; Environmental Assessments for 

Tobacco Products; Categorical Exclusions. Small Entity Compliance Guide. U.S. Department of 

Health and Human Services. October.

FDA. 2019a. Premarket Tobacco Product Applications and Recordkeeping Requirements. Proposed 

Rule. U.S. Department of Health and Human Services. 21 CFR 1100, 1107, 1114. 84 FR 50566. 

September 25.

FDA. 2019b. Deemed Tobacco Product Applications - A Public Meeting. October 28–29, 2019. Available 

at: https://www.fda.gov/tobacco-products/ctp-newsroom/deemed-tobacco-product-applicationspublic-meeting-10282019-10292019. 

FDA. 2020. Preparing Tobacco Marketing Applications for Submission by September 9. Presented at tma 

2020 Digital Conference. June 18, 2020.

(b)(4) (b)(4) (b)(4)

(b)(6)

(b)(6)

(b)(6)

(b)(6)

(b)(6) (b)(6) (b)(6)
Environmental Assessment for the Marketing Order for NJOY DAILY

55 

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 52:118–21.

Frumhoff, P.C., J.J. McCarthy, J.M. Melillo, S.C. Moser, and D.J. Wuebbles. 2007. Confronting Climate 

Change in the U.S. Northeast: A Report of the Northeast Climate Impacts Assessment. July 

2007.

USDA (United States Department of Agriculture). 2019. Web Soil Survey: Area of Interest Interactive 

Map. Natural Resources Conservation Service. Available at: 

https://websoilsurvey.sc.egov.usda.gov/App/WebSoilSurvey.aspx. Accessed September 27, 

2019.

(b)(4) (b)(4) (b)(4)

(b)(6) (b)(6) (b)(6) (b)(6) (b)(6)

(b)(6)

(b)(6)

(b)(6) (b)(6)

(b)(6)

(b)(6)
Environmental Assessment for the Marketing Order for NJOY DAILY

56 

United States Fish and Wildlife Service (USFWS). 2019a. Wetlands Mapper: NWI data desktop/mobile 

viewer. Updated 9 October 2019. Available at: https://www.fws.gov/wetlands/data/mapper.html.

Accessed September 27, 2019. 

(b)(4) (b)(4) (b)(4)

(b)(6)
Environmental Assessment for the Marketing Order for NJOY DAILY

57 

This Page Intentionally Left Blank

(b)(4) (b)(4) (b)(4)