Page 1 of 20 

Environmental Assessment for Vuse Solo Power Unit 

Prepared for: 

United States Food and Drug Administration 

Prepared by: 

RAI Services Company 

Date: 

Oct 20, 2020 

Page 1 of 16 
3.1 

3.2 

5.2 

13. 

Page 2 of 20 

Table of Contents 

1. APPLICANT AND MANUFACTURING INFORMATION .......................................................................... 3 

2. EXECUTIVE SUMMARY ....................................................................................................................... 3 

3. PRODUCT INFORMATION .................................................................................................................. 4 

Product Name and Variants ...................................................................................................... 4 

Product Description .................................................................................................................. 4 

3.3 Product Packaging Description .................................................................................................. 4 

3.4 Product Composition ................................................................................................................ 5 

3.5 Actual and Projected Sales Volumes .......................................................................................... 5 

4. DESCRIPTION OF PROPOSED ACTION ................................................................................................ 5 

4.1 Proposed Action ........................................................................................................................ 5 

4.2 Need for Action ........................................................................................................................ 5 

4.3 Alternatives to the Proposed Action .......................................................................................... 5 

4.4 Location of Manufacturing ........................................................................................................ 5 

4.5 Location(s) of Use ..................................................................................................................... 6 

4.6 Location of Disposal .................................................................................................................. 6 

5. POTENTIAL ENVIRONMENTAL IMPACTS FROM PRODUCT MANUFACTURING ................................... 6 

5.1 Description of the Manufacturing Process(es) ........................................................................... 6 

Releases to the Environment From Manufacturing ................................................................... 6 

5.3 Environmental Release/ Disposal Regulations and Compliance Procedures .............................. 7 

5.4 Environmental Justice ............................................................................................................... 7 

5.5 Impacts of the No-Action Alternative ......................................................................................... 7 

6. POTENTIAL ENVIRONMENTAL IMPACTS FROM PRODUCT USE .......................................................... 7 

6.1 Description of Product Use ....................................................................................................... 7 

6.2 Releases to the Environment From Product Use ........................................................................ 7 

6.3 Environmental Justice ............................................................................................................... 7 

6.4 Impacts of the No-Action Alternative ........................................................................................ 7 

7. POTENTIAL ENVIRONMENTAL IMPACTS FROM PRODUCT DISPOSAL ................................................ 8 

7.1 Assumptions Used in Calculating Environmental Fate ............................................................... 8 

7.2 Equations Used to Calculate Loadings from Product Disposal. .................................................... 8 

7.3 Contribution to Total Municipal Waste Load .............................................................................. 8 

7.3.1 Extended Analysis for Disposal of Lithium-ion Batteries .......................................................... 10 

7.3.2 Extended Analysis for Electronic Waste Disposal. ..................................................................... 11 

7.4 Environmental Justice ............................................................................................................. 12 

7.5 Impacts of the No-Action Alternative ....................................................................................... 12 

8. MITIGATION MEASURES .................................................................................................................. 12 

9. COMPLIANCE WITH ENVIRONMENTAL ACTS ................................................................................... 12 

10. LIST OF PREPARERS .......................................................................................................................... 13 

11. LIST OF AGENCIES AND PERSONS CONSULTED ................................................................................ 14 

12. CERTIFICATION ................................................................................................................................ 15 

LIST OF APPENDICES ........................................................................................................................ 16 

Page 2 of 16
Page 3 of 20 

1. APPLICANT AND MANUFACTURING INFORMATIONt

Applicant:

RAI Services Company 1 (RAIS) on behalf of R.J. Reynolds Vapor Company (RJRV) 

401 N. Main Street 

Winston-Salem, NC 27101 

Manufacturer: 

b)(4) 

2. EXECUTIVE SUMMARY

This environmental assessment has been prepared as required under 21 CFR 25.15 in accordance 

with 21 CFR 25.40, Food and Drug Administration's (FDA's or Agency's) regulation implementing the 

National Environmental Policy Act of 1969. The regulation, 21 CFR 25.15(a), states that "all 

applications or petitions requesting Agency action require the submission of an environmental 

assessment or a claim of categorical exclusion." RAI Services Company conducted the 

environmental assessment in accordance with 21 CFR 25.20 and 25.40 and relevant aspects of FDA 

technical guidance document(s), including the Guidance for Industry: Environmental Assessment of 

Drug and Biologics Applications (July 1998). 2 

This assessment was prepared by RAIS as part of the Premarket Tobacco Product Applications 

(PMTA) for the Vuse Solo family of products. The potential environmental impacts of the proposed 

action considering manufacturing, use, and disposal of the product are detailed below. The overall 

conclusion from the assessment is that there are no adverse environmental impacts identified for 

the Vuse Solo Power Unit. 

1 RAI Services Company ("RAIS") is a wholly owned subsidiary of Reynolds American Inc. ("RAI") that coordinates 

regulatory compliance for RA l's subsidiary companies. Throughout this application, we refer to "RAIS" or "the 

Company." For clarity and ease of review, all of the following subsidiaries of RAI are included within these terms: (1) 

RAI Services Company, the legal entity that prepared and filed the application on behalf of its affiliated subsidiaries, 

which is responsible for the scientific research supporting the application; (2) R.J. Reynolds Vapor Company, the PMTA 

applicant and the legal entity responsible for marketing products under the Vuse brand; and (3) R.J. Reynolds Tobacco 

Company, the legal entity responsible for providing analytical and other support services, which is registered under 

Section 905 as the importer of record of the Vuse Solo product. 2 U.S. Food & Drug Administration. (1998). "Guidance for Industry: Environmental Assessment of Drug and Biologicse

Applications." U.S. Department of Health and Human Services, Food & Drug Administration, Center for Drug Evaluation 

and Research (CDER), Center for Biologics Evaluation and Research (CBER), July 1998, CMC6, Revision 1. 

Page 3 of 16 
3.1 

3.2 

Page 4 of 20 

3. PRODUCT INFORMATION

Product Name and Variants 

Vuse Solo is a closed format ENDS device sold as Power Unit components and pre-filled e-liquid 

cartridges. For this environmental assessment, only the Vuse Solo Power Unit is assessed. In use, 

the Power Unit is connected to a pre-filled e-liquid cartridge. Environmental assessments for the 

cartridge products in the Vuse Solo family, including thete-liquids contained in the cartridges, have 

been prepared separately. Table 1 lists the category and FDA-registered name for the product 

being assessed. 

Table 1: Product Information 

Registered Product Name Vuse Solo Power Unit 

Product Category ENDS 

Subcategory ENDS Component 

Product Packaging Paperboard, cardboard 

Package Quantity 1 Power Unit 

Product Description 

The Vuse Solo Power Unit is shown in Figure 1. The nominal length is 87 mm and the nominal 

diameter is 9.6 mm. 

Figure 1: Vuse Solo Power Unit 

f<----------- (87mm)------------

-

The Vuse Solo Power Unit houses the electronics of the device and contains several essential 

elements: the lithium-ion battery, the controller, the puff sensor, and the LED. The lithium-ion 

battery is UL 1642 certified, non-removable, and can last for 6 months or more of regular use. The 

Power Unit parts are contained within a stainless steel outer tube. 

Product Packaging Description 

The Vuse Solo Power Unit is packaged with an accessory USB charger both seated in a molded pulp 

tray. The tray and an instruction insert are enclosed in a paperboard box that is labelled for sale to 

the consumer. 

The retail packs of Power Units are further bundled in paperboard cartons and cardboard cases for 

shipping and distribution. 

Page 4 of 16 

3.3 
3.4 

3.5 

b)(4) 

Page 5 of 20 

Product Composition 

Components of the product and packaging are describerl[!.!?J! ""Clll.a1JetL;,aJ-1ll .. 'D.e""_a.t, "1.Ctt"L"U.tll";

t it.J:•0,!'-111~as,'""'-

according to the standard International System of Unitsfb

l(4

l

Actual and Projected Sales Volumes 

b)(4) 

4. DESCRIPTION OF PROPOSED ACTION

4.1 Proposed Action 

This environmental assessment is submitted as part of the PMTA for the Vuse Solo Power Unit. The 

proposed action is for FDA to issue a market authorization for the new product under section 

910(c)(l)(A)(i) oftt he FD&C Act. 3 

4.2 Need for Action 

RJRV markets Vuse Solo through interstate commerce in the United States (U.S.) and its territories 

and has submitted this environmental assessment as part of a PMTA to obtain a market 

authorization pursuant to Section 910(c)(l)(A)(i) of the FD&C Act. 

4.3 Alternatives to the Proposed Action 

The no-action alternative is for FDA to not issue a market authorization order for the Vuse Solo 

Power Unit. RAIS has not identified significant differences in environmental impacts between the 

proposed and alternative actions. 

4.4 Location of Manufacturing 

Vuse Solo Power Units and finished products are manufactured and packaged in by a 

contract manufacturer. 

Table 2 lists the manufacturing site for the production of the Power Units and finished packaged 

products. 

3 U.S. Food & Drug Administration. (2009a). "Section 910 of the Federal Food, Drug, and Cosmetic Act-Application fore

Review of Certain Tobacco Products." Availableefrom: https://www.fda.gov/tobacco-products/rules-regulations-andguidance/section-910-federal-food-drug-and-cosmetic-act-application-review-certain-tobacco-products 

Page S of 16 

(b) (4)
Page 6 of 20 

Table 2: Manufacturing Facility 

Manufacturer I Facility Address I Latitude, longitude 

(b)(4) 

11 (b)(4) I 

Part 

Power Units and 

Finished Products 

4.5 location(s) of Use 

The products will be distributed and sold for use across the United States and its territories. 

4.6 location of Disposal 

Vuse Solo Power Units are reusable and rechargeable. These units can last 6 months or more and 

can be recycled rather than going to a waste stream, so disposal will occur infrequently. Power 

Units that are not recycled are likely to be disposed of as municipal solid waste (MSW). Packaging 

materials are likely to be disposed of as MSW. Packaging materials may also be recycled. It is 

possible that a very small percentage of the product could be improperly disposed of directly into 

the environment as litter corresponding with use patterns across the U.S. 

5. POTENTIAL ENVIRONMENTAL IMPACTS FROM PRODUCT MANUFACTURING

5.1 Description of the Manufacturing Process(es) 

Vuse Solo Power Units are assembled through manual processes from component parts at the 

manufacturer shown in Table 2. All of the manufacturing and packaging operations occur in (b�114�ll

Following manufacturing, the finished product is imported to the U.S. and stored at a distribution 

center in North Carolina prior to commercial distribution. 

5.2 Releases to the Environment From Manufacturing 

Manufacturing of the Vuse Solo Power Unit does not result in the release of significant amounts of 

materials to the environment and does not consume significant amounts of natural resources. The 

components of the device do not contain new or unique compounds that would present different 

environmental impacts as compared to the production of other battery-powered electronic devices. 

Manufacturing of the product will not require additional resources (e.g., landfills, recycling centers) 

for disposal of manufacturing waste. 

No additional environmental controls are needed due to manufacturing of the product. 

No expansions of the manufacturing facilities are expected due to the manufacturing of the 

product. 

Page 6 of 16 
5.3 

Page 7 of 20 

Environmental Release/ Disposal Regulations and Compliance Procedures 

b)(4) 

5.4 Environmental Justice 

The products are manufactured outside of the U.S., therefore there are no anticipated impacts to 

minority or low-income populations within the U.S. 

5.5 Impacts of the No-Action Alternative 

The environmental impact of the no-action alternative would not change the existing condition of 

manufacturing of tobacco products and would not differ from the proposed action. 

6. POTENTIAL ENVIRONMENTAL IMPACTS FROM PRODUCT USE

6.1 Description of Product Use 

Once the Vuse Solo Power Unit is connected to a cartridge, the product is activated by drawing air 

through the mouth-end of the cartridge. This puffing action and the resulting pressure differential 

activates the pressure sensor in the power unit. Activation of the pressure sensor signals the 

microcontroller in the power unit to send power to the heater in the cartridge. During the puff, the 

heater aerosolizes e-liquid within the cartridge which is then drawn through a hole in the mouthend of the cartridge. 

During charging, the Vuse Solo Power Unit is connected to the accessory USB charger which is in 

turn plugged into a standard USB port to provide electrical power to charge the battery in the Vuse 

Solo Power Unit. 

As noted previously, environmental assessments for the Vuse Solo Cartridges, including theteliquids within the cartridges, have been prepared separately. 

6.2 Releases to the Environment From Product Use 

As an electronic device, the Vuse Solo Power Unit generates no terrestrial, aquatic, or atmospheric 

releases during use or charging. 

6.3 Environmental Justice 

No emissions are expected due to use of the product, therefore, there would be no 

disproportionate impacts on minority, low-income, or other sensitive populations from product use. 

6.4 Impacts of the No-Action Alternative 

The environmental impacts of the no-action alternative would not change the existing condition of 

use of cigarettes or other E NDS products. 

Page 7 of 16 
Page 8 of 20 

7. POTENTIAL ENVIRONMENTAL IMPACTS FROM PRODUCT DISPOSAL

7.1 Assumptions Used in Calculating Environmental Fate 

Upon purchase of the product, the consumer will remove the packaging material. Paper and 

paperboard components of the packaging can be recycled. The preferred method to dispose of 

paper and cardboard packaging is through a local recycling program. Most retail outlets will have a 

recycling program in place for disposal of shipping boxes. Municipal waste sites are acceptable 

disposal methods for packaging if local paper and paperboard recycling is not an option. It is 

anticipated that both the recyclable and non-recyclable packaging will, at times, be disposed of as 

solid waste. Therefore, the environmental loadings for this EA will be calculated as if all packaging 

material is disposed of as municipal solid waste (MSW). The potential for intentional or 

unintentional introduction directly into the environment is expected to be minimal for this product 

because the Power Unit is a reusable device and replaced infrequently. 

The UL 1642 certified lithium-ion battery in the Power Unit is expected to last for 6 months or more, 

at which point the Power Unit will need to be replaced. Like many ENDS manufacturers, RJRV has 

provided ready access for consumers to information regarding disposal of the product. Text on the 

Vuse Solo packaging materials directs the consumer to visit www.vusevapor.com for important 

product information before use. On the website, under the Frequently Asked Questions (FAQs), the 

question of disposal of the Vuse product is addressed. A statement from that website directs the 

consumer to "Please dispose of Vuse cartridges, tanks, power units, and chargers responsibly. Your 

Vuse power unit contains a lithium-polymer battery, which should not be disposed of with regular 

household waste, crushed (e.g., trash compactor), or burned. Contact your local waste management 

officials for more information about disposing of batteries in accordance with state and local 

requirements." Once the Power Unit is ready to be disposed of, it is expected to be properly 

disposed of through e-waste recycling services or in MSW landfills. While the Power Units 

containing the lithium-ion battery and printed circuit boards are expected to be disposed of 

properly, it is possible that some may be discarded directly into the environment. This would result 

in only minor, localized exposure from materials in the Power Unit entering the environment. 

Therefore, this EA will conservatively evaluate the load placed on municipal solid waste as if all 

Power Units were disposed of as trash. 

7.2 Equations Used to Calculate Loadings from Product Disposal 

(b)(4) 

Contribution to Total Municipal Waste Load 

Product waste must be examined in the context of the total MSW load in the United States. MSW is 

comprised of packaging, food waste, yard trimmings, furniture, electronics, tires, appliances, etc. 

Page 8 of 16 

7.3 
- -

- 0

Page 9 of 20 

Waste generation in the United States has been increasing on an annual basis between 1960 and 

2017 as shown in Figure 2. 4 In 2017, approximately 243 million metric tons of MSW was generated 

(values converted from short tons as originally reported). The annual increase has slowed but 

continues to rise. 

Figure 2: MSW Generation Rates in the U.S. 

JOO-.----------------------------- 10

250; 

. 8 

200, 

' 6 

- 150:

/ . ' 

100, ·,'-' 

• 2

10, 

o I

1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 2016 2017 

-A- - Total MSW generation - Per capita generatione

Of the 243 million metric tons of waste, approximately 61 million metric tons were recycled, 24 

million metric tons were com posted, 31 million metric tons were combusted with energy recovery, 

and 127 million metric tons were landfilled. According to Figure 3 below, 5 in 2017, paper and 

paperboard were most commonly recycled and accounted for 65.7% of overall recycled materials. 

Metals, glass, and plastics accounted for 12.4%, 4.5%, and 4.4% respectively. It can be assumed 

that the Vuse Solo packaging materials that are disposed of as MSW are similarly recycled. 

4 U.S. EPA. (2019). Advancing Sustainable Materials Management: 2017 Fact Sheet Assessing Trends in Material

Generation, Recycling, Composting, Combustion with Energy Recovery and Landfilling in the United States. Available 

from: https ://www.epa.gov/sites/ prod uctio n/fi les/2019-11/ d ocu ments/2017 _facts_ and_ figures_ fact_ sheet_ fin a L pdf

5 Ibid.

Page 9 of 16 

Total MSW generation (million tons)

Per capita generation (lbs/person/day)
Page 100120 

Figure 3: MSW Recycling by Material in the U.S. 

Rubber, lec1ther & textile; 

Woocl

4 5'·,

6 3°,, 

, 

Glass

4.5%

Metals 

12.4% 

Other 

2 2°,, 

b)(4) 

of the new product is not expected to require additional resources for managing MSW. 

7.3.1 Extended Analysis for Disposal of Lithium-ion Batteries 

The lifespan of lithium-ion batteries, and therefore the Power Units which use them, varies based 

on frequency of use. The UL 1642 certified battery in the Vuse Solo Power Unit should last 6 

months or more. Despite uncertainty in the length of time the lithium-ion batteries last before 

disposal, total annual disposal volumes are reasonably well estimated from thetprojected sales 

volumes for thetPower Units. 

Kang et al. measured leaching rates from lithium-ion batteries. 6 Their results suggested that 

according totfederal regulations, sometlithium-ion batteries would be classified as hazardous due to 

their lead (Pb) content. Newer lithium-ion batteries such as those used in the Vuse Solo Power Unit 

contain neither lead nor cadmium and therefore are considered universal wastetrather than 

hazardous waste (https://www.epa.gov/hw/universal-waste). The battery used intVuse Solo is a 

lithium-ion battery encased in a polymer pouch, sometimes referred to as lithium-polymer. The 

6 Kang, D. H., Chen, M., Ogunseitan, 0. A. (2013). "Potential Environmental and Human Health Impacts of Rechargeable 

Lithium Batteries in Electronic Waste." Environmental Science & Technology. 47(10): 5495-503. 

Page 10 of 16 
https://www.benchmarkminerals.com/who-is-winning-the-global-lithium-ion-battery-armsPage 11 0120 

terms are used interchangeably in this document. If the battery case is broken, battery solvents 

may leach out and carry other soluble chemicals with them into the landfill. 

By EPA regulation (40 C.F.R. Part 258), solid waste facilities built after October 9, 1993 must be 

equipped with composite liners and leachate collection systems to prevent leaching of waste into 

soil and water. Those built before October 9, 1993 are not required to retrofit with these liners but 

are required to monitor groundwater and take corrective action as needed. Therefore, unrestricted 

release of any potential lithium-ion battery leachate, and especially the small fraction potentially 

contributed byte-cigarette batteries, to the terrestrial or aquatic environment is unlikely. 

For 2019, the annual global production of lithium-ion batteries was estimated at 160 GWh 7• The 

specific energy of lithium-ion cells typically ranges from about 150 to 200 Wh/kg, giving a global 

production of at least 800,000 metric tons. Conservatively, assuming that the United States uses 

lithium-ion batteriesfb

l(4

l

only 5% of global production this would result in an annual U.S. usae:e of 40 000 metric tons of 

(b)(4) 

7.3.2 Extended Analysis for Electronic Waste Disposal 

Ideally, the consumer would recycle the entire product. Conservatively, we assume that all of the 

electronic components are disposed of properly and then end up in municipal solid waste sites. 

Duan et al. (2013) reported that of the 258.8 million units of used electronics generated in the U.S. 

in 2010 8, 171.4 million units were collected. On a weight basis, 1.5 million metric tons of used 

electronics were generated in the U.S. About 8.5% of the electronics collected were exported for 

recycling on a unit basis and about 3.1% on a weight basis. TVs and computer monitors dominated 

the waste on a weight basis, but mobile phones dominated on a unit basis. 

In addition, the composition of the new product was reviewed to address any potential 

environmental release or exposure concerns. Based on this review, the electronic components are 

understood to meet requirements for the current Restriction of Hazardous Substances in Electrical 

and Electronic Equipment (RoHS 2) 9 and Registration, Evaluation, Authorisation and Restriction of 

7 

Benchmark Mineral Intelligence. (Jan 19, 2019). Who is Winning the Global lithium Ion Battery Arms Race?. 

Retrieved Nov 1, 2019 from

race/

8 Duan, H., Miller, T. R., Gregory, J., Kirchain, R. (2013). "Quantitative Characterization of Domestic and Transboundarye

Flows of Used Electronics Analysis of Generation, Collection, and Export in the United States." StEP (Solving the EWaste Problem) December 2013. 9 

Restriction of Hazardous Substances in Electrical and Electronic Equipment, Directive 2011/65/EU. Available from: 

http:// ec. e u ropa. eu/environ me nt/waste/ro hs _ eee/ legis _ en . htm

Page 11 of 16 
Page 120120 

Chemicals (REACH) 10 regulations. No significant adverse effects resulting from environmental 

release or exposure are anticipated. 

(b)(4) 

7.4 Environmental Justice 

There are no significant changes to socioeconomic conditions or environmental justice from the 

disposal of the product. Product and packaging waste would be recycled or disposed of in the same 

manner as waste from other tobacco products. 

7.5 Impacts of the No-Action Alternative 

The environmental impacts of the no-action alternative would not change the existing condition of 

disposal of other competing tobacco products and associated packaging waste as these products 

would continue to be sold and used across the U.S. 

8. MITIGATION MEASURES

Based upon the review of potential environmental impacts detailed above, RAIS concludes there are 

no adverse environment impacts for the Vuse Solo Power Unit. Therefore, no mitigation measures 

are discussed. 

9. COMPLIANCE WITH ENVIRONMENTAL ACTS

No adverse effects on a species or the critical habitat of a species identified under the Endangered 

Species Act ("ESA") or the Convention on International Trade in Endangered Species of Wild Fauna 

and Flora ("CITES") are expected due to the proposed action. The locations of Vuse Solo 

manufacturing are not within or in close proximity to a habitat, critical or otherwise, of a threatened 

or endangered species per ha bi tat maps made available by the U.S. Fish and Wildlife Service 11.

RAIS has completed a review of (a) endangered and threatened species listed by the U.S. Fish and 

Wildlife Service for both animals 12 and plants 13 and (b) the endangered and threatened species 

10 Registration, Evaluation, Authorisation and Restriction of Chemicals, Regulation {EC) No 1907/2006. Available from:

http:// ec. e u ro pa. eu/ environment/ chem ica Is/reach/reach_ en .h tm

11 U.S. Fish & Wildlife Services. Critical Habitat for Threatened & Endangered Species Maps. Available from:

http:/ /fws. maps. arcg is.com/ho me/web map /viewer. html ?we bma p=9d8de Se 2 65ad4fe0989 3cf7 Sb8d bfb 77 Accessed 

and reviewed on November 1S, 2019. 

12 U.S. Fish & Wildlife Services. ECOS Environmental Conservation Online System:

http:// ecos. fws.gov /tess _pub lie/reports/ ad-hoc -speciesre port ?ki ngdom=V & kingdom= l&statu s= E &status= T&statu s= Em E&statu s= Em T &status= EX PE&status= EXP N&statu s=SAE 

&statu s=SA T& fcritha b=on & fstatu s=on &fs pecru le=on& finv pop=o n&fgrou p=on & head er=L isted +Animals Accessed on 

November 15, 2019. 

Page 12 of 16 
Page 13 of 20 

listed in Appendices I, II, and 111 14 of the Convention on International Trade in Endangered Species of 

Wild Fauna and Flora. Based on that review, RAIS is not aware of any information to suggest that 

the manufacture and commercial distribution of Vuse Solo products would specifically jeopardize 

the existence of listed species or destroy or adversely modify any designated critical habitat for such 

species. To the best of our knowledge, none of the materials used in the manufacture of Vuse Solo 

products are listed by either the U.S. Fish and Wildlife Service or the CITES as sourced from 

endangered or threatened species. 

Therefore, no adverse effects specific to a species or the critical habitat of a species identified under 

ESA and/or CITES associated with the manufacture and commercial distribution of the Vuse Solo 

products have been identified, and no adverse environmental effects associated with the proposed 

action are anticipated. We are also unaware of any information that suggests manufacture of the 

new product would result in the take, as that term is defined in the Endangered Species Act, 16 

U.S.C. 1362, or 50 CFR 216.3, of an endangered or threatened species. 

Further, RAIS is not aware of information to suggest that there are any extraordinary circumstances 

in these cases indicative of any adverse environmental impact as a result of the proposed action. 

Extraordinary circumstances include situations where: (1) unique emission circumstances are not 

adequately addressed by general or specific emission requirements (including occupational) 

promulgated by Federal, State or local environmental agencies and the emissions may harm the 

environment; (2) a proposed action threatens a violation of Federal, State or local environmental 

laws or requirements (40 CFR 1508.27(b)(10)); and (3) production associated with a proposed action 

may adversely affect a species or the critical habitat of a species determined under the ESA or the 

CITES to be endangered or threatened, or wild fauna or flora that are entitled to special protection 

under some other Federal law. To the best of our knowledge, no situations such as these apply to 

the manufacture of the product. 

10. LIST OF PREPARERS

Paul H. Ayres, Ph.D., D.A.B.T (1986-2016) 

Director, Scientific & Regulatory Affairs 

RAI Services Company 

Education: 1983. Ph.D. in Interdisciplinary Toxicology, University of Arkansas Medical Sci enc es 

Experience: 35+ years in toxicology and tobacco science 

13 U.S. Fish & Wildlife Services. ECOS Environmental Conservation Online System: 

http:// eco s. fws .gov /tess _pub lie/ reports/ ad-hoc-speciesre port ?kingdom= P &statu s=E &status= T &status= E m E&statu s= Em T &status= EXP E &status= EXP N &statu s=SA E&statu s=SAT 

& fc rith ab=o n& fstatu s=o n &fs pee ru le=on &fin vpo p=on &fg ro u p=o n &ffa mi ly=on & head er= Listed+ Plants Accessed on 

November 15, 2019. 

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

https:/ /cites.org/sites/default/files/eng/app/2019/E-Appendices-2019-11-26. pdf Listing valid from November 26, 2019 

and accessed on December 5, 2019. 

Page 13 of 16 
Page 14of20 

Lance Dooly, B.S. 

Sr. Scientist, Scientific & Regulatory Affairs 

RAI Services Company 

Education: 1995. B.S. Physics, B.S. Chemistry, Georgia Institute of Technology 

Experience: 20+ years in tobacco science and product development 

11. LIST OF AGENCIES AND PERSONS CONSULTED

In accordance with 40 CFR 1508.9, this section includes a list of agencies and persons consulted in 

preparation of this environmental assessment. Feedback from FDA on prior submissions and 

examples of Environmental Assessments posted by FDA were considered in preparation of this 

assessment. 

Agencies and Persons Consulted Consultation 

Endangered Species Acte(ESA) 

( https://www.fws.gov/endangered/esalibrary/pdf/ESAall.pdf) 

Consulted endangered animal and plant species to confirm 

none of these materials are used to manufacture the new 

product 

Convention on International Trade in 

Endangered Specieseof Wild Fauna andeFlora 

(CITES) 

(https://www.cites.org/) 

Consulted the endangered and threatened species in 

Appendices I, II, and Ill to confirm none of these materials 

are used to manufacture the new product 

National Environmental Policy Act {NEPA) 

( https://www.epa.gov/nepa) Consulted on process and compliance with the Act 

Max Hopkins, Sr. Staff Engineer 

Environment, Health & Safety {EHS) 

R.J. Reynolds Tobacco Company 

Consulted on RAI environmental programs, and to confirm 

compliance, no Notices of Violation, and all applicable 

permits associated with federal, state, and local 

environmental regulations. EHS collaborates with the 

following external partnersl(b)(4) 

b)(4) 

Page 14 of 16 
Page 15of20 

DocuSign Envelope ID: 78AB6FC2-BB84-4EFC-BAC2-77CBC785453D 

12. CERTIFICATION

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

the best of the knowledge of RAIS. 

(b)(6) 30-0ct-20 I 11 :31 EDT

Michael W. Ogden, Ph.D. Date 

Senior Vice President -Scientific & Regulatory Affairs 

Page 15 of 16 
Page 16of20 

b)(4) 

Page 16 of 16
fb

_

l(

_

4

_

1 location

0

Subject: Pleasfbl(4) 

Page 17of20 

Certificate Of Completion 

Envelope Id: 78AB6FC2BB844EFCBAC277CBC785453D Status: Completed 

lvuse Solo Power Unit EA revised 29OCT2020-sig pg.pd/ 

Source Envelope: 

Document Pages: 1 Signatures: Envelope Ori inator: 

Certificate Pages: 4 Initials: O (b)(6) 

AutoNav: Disabled 401 N. Main Street 

Envelopeld Stamping: Enabled Winston-Salem. NC 27101 

Time Zone: (UTC-05:00) Eastern Time (US & Canada) l

(b)(6) ric",;

·'c'"m

Record Tracking 

Status: Original 

10/30/2020 10:1 1 :07 AM 

Signer Events 

Michael W. Ogden 

fbJ(6) l@rirt.com 

RAI Services Company 

Security Level: Email, Account Authentication 

(Required) 

Electronic Record and Signature Disclosure: 

Accepted: 8/1 1/2020 10:56:15 AM 

ID: 12ee347e-b138-4270-95cb-c619721 cd5a2 

In Person Signer Events 

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Sent: 10/30/2020 10 1 3:04 AM 

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Page 18 of 20 

Electronic Record and Signature Disclosure 
Page 19of20 

Electronic Record and Signature Disclosure created on: 7/2412020 12:00 12 PM 

Parties agreed to: Michael W. Ogden 

ELECTRONIC RECORD AND SIGNATURE DISCLOSURE 

From time to time, RAI Services (we, us or Company) may be required by law to provide to you 

certain written notices or disclosures. Described below are the terms and conditions for providing 

to you such notices and disclosures electronically through th (bl(4l !system. Please read the 

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to your satisfaction and agree to this Electronic Record and Signature Disclosure (ERSD), please 

confirm your agreement by selecting the check-box next to 'I a ree to use electronic records and 

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limited period of time (usually 30 days) after the documents are first sent to you. Note: All

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In accordance with the procedures described herein, we will provide electronically to you 

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(b) (4)

(b) (4)
ext to 'I ::i bl(4l 

Page 20 of 20 

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(b) (4)

(b) (4)
Page 1 of 1 

U.S. FOOD & DRUG 

ADMIN ISTRATION 

FINDING OF NO SIGNIFICANT IMPACT 

Marketing Orders for 

Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% Gl, and 

Vuse Replacement Cartridge Original 4.8% G2 

Marketed by R.J. Reynolds Vapor Company 

The Center for Tobacco Products of the Food and Drug Administration (FDA) has carefully considered 

the potential environmental impact of these actions and has concluded that these actions will not have 

significant effects on the quality of the human environment. Therefore, environmental impact 

statements are not required. 

R.J. Reynolds Vapor Company wishes to introduce one electronic nicotine delivery (END) component and 

two closed e-liquids into interstate commerce for commercial distribution in the United States and 

submitted to FDA premarket tobacco product applications to obtain marketing orders under the 

provisions of section 910 of the Federal Food, Drug, and Cosmetic Act. 

FDA reviewed the applicant's environmental assessments (EA), dated October 20, 2020, for the three 

ENDS tobacco products in accordance with the Council on Environmental Quality's regulations (40 CFR 

1500-1508) implementing the National Environmental Policy Act (NEPA) and FDA's NEPA regulations (21 

CFR 25.40). The EAs concluded that the marketing orders would have no significant impact. The 

applicant's EAs are available to the public upon request. 

The applicant's EAs evaluated potential environmental effects due to manufacturing, use, and disposal 

of the new products. No increased or new types of environmental impacts due to manufacturing the 

new products are anticipated. FDA does not foresee that use of the new products would result in new or 

different environmental impacts. FDA believes that the disposal of the new products is the same as the 

disposal conditions of other ENDS components and closed e-liquids that are currently marketed in the 

United States. Therefore, FDA does not foresee significant adverse impacts to the environment due to 

the proposed actions from manufacturing, use, and disposal of the new products. 

Digitally signed by Luis G. Valerio -S 

Date: 2021.1 0.08 09:54:25 -04'00' 

Approved by 

Luis G. Valerio, Jr., Ph.D., ATS 

Associate Director 

Division of Nonclinical Science 

Office of Science 

Center for Tobacco Products 

U.S. Food and Drug Administration