5.: Appendix Content and File Listing: Environmental Assessments 

Altria Client Services LLC 

USSTC Premarket Tobacco Product Application for VERVE® Chews and VERVE® Discs 

5.: APPENDIX CONTENT AND FILE LISTING: ENVIRONMENTAL 

ASSESSMENTS 

5. APPENDIX CONTENT AND FILE LISTING: ENVIRONMENTAL 

ASSESSMENTS 

Table 5-1: Appendix Content and File Listing1 

File Listing File Format 

Appendix 5-1-1 – Environmental Assessment Report for VERVE Chews Blue Mint PDF 

Appendix 5-1-2 – Environmental Assessment Data Summary for VERVE Chews Blue 

Mint 

PDF 

Appendix 5-1-3 – Environmental Assessment FDA Citations for VERVE Chews Blue 

Mint 

PDF 

Appendix 5-2-1 – Environmental Assessment Report for VERVE Chews Green Mint PDF 

Appendix 5-2-2 – Environmental Assessment Data Summary for VERVE Chews Green 

Mint 

PDF 

Appendix 5-2-3 – Environmental Assessment FDA Citations for VERVE Chews Green 

Mint 

PDF 

Appendix 5-3-1 – Environmental Assessment Report for VERVE Discs Blue Mint PDF 

Appendix 5-3-2 – Environmental Assessment Data Summary for VERVE Discs Blue 

Mint 

PDF 

Appendix 5-3-3 – Environmental Assessment FDA Citations for VERVE Discs Blue 

Mint 

PDF 

Appendix 5-4-1 – Environmental Assessment Report for VERVE Discs Green Mint PDF 

Appendix 5-4-2 – Environmental Assessment Data Summary for VERVE Discs Green 

Mint 

PDF 

Appendix 5-4-3 – Environmental Assessment FDA Citations for VERVE Discs Green 

Mint 

PDF 

Ingredient 1 through Ingredient 78 78 PDFs 

1 VERVE® is a registered trademark; however the ® symbol intentionally does not appear in the file names or in the 

document descriptions provided by the vendors to avoid the use of special characters. 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION Page 1 of 1 
 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION 

FOR THE PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

Memorandum 

To: Altria Client Services LLC on behalf of U.S. Smokeless 

Tobacco Company LLC 

From: 

(b) (4)

Date: May 24, 2018 

Subject: Environmental Assessment for the Premarket 

Tobacco Product Application for the Product 

Identified as VERVE® Chews Blue Mint 

(b) (4)

This environmental assessment was prepared in accordance with 21 CFR 25.40, 

the Food and Drug Administration’s (FDA’s or Agency’s) regulation

implementing the National Environmental Policy Act of 1969. Under NEPA, 

“all applications or petitions requesting Agency action require the submission

of an environmental assessment or a claim of categorical exclusion.”1 

(b) (4)

respectfully submits the 

following environmental assessment in support of the Premarket Tobacco Product 

Application (PMTA) for the product identified as VERVE® Chews Blue Mint 

(referred to throughout this assessment as the “New Product”) pursuant to 21 

CFR 25.20 because there is no applicable categorical exclusion for this type of 

application. 

This environmental assessment was conducted in accordance with 21 CFR 25.40 

and relevant aspects of FDA technical guidance documents including: 

 Environmental Considerations for Tobacco Product Applications Submitted to 

CTP, presented by Cristi Stark, M.S., Associate Director for Science Policy, 

Office of Science, CTP, FDA (August 2016); 

 Guidance for Industry: Environmental Impact Assessments (EIA’s) for

Veterinary Medicinal Products (VMP’s) – Phase I (March 2001); and 

 Guidance for Industry: Environmental Assessment of Drug and Biologics 

Applications (July 1998). 

1 21 CFR 25.15(a) 

(b) (4)
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

P A G E 2 

This environmental assessment was prepared at the direction of Altria Client Services LLC 

(ALCS) on behalf of U.S. Smokeless Tobacco Company LLC (USSTC), a wholly owned 

subsidiary of Altria Group Inc. The potential aquatic, atmospheric, and terrestrial 

environmental impacts of FDA’s approval of the PMTA and subsequent marketing of the 

New Product were considered using a conservative set of assumptions. The assessment 

identified no significant environmental risks, and a Finding of No Significant Impact by 

FDA is warranted for the environmental assessment of the New Product. 

This memorandum contains trade secret and confidential commercial information that 

USSTC considers to be proprietary and highly sensitive, and which is protected from 

disclosure under the Food, Drug and Cosmetic Act §§ 301(j) and 906(c) (21 U.S.C. §§ 331(j) 

and 387f(c)), the Trade Secrets Act (18 U.S.C. § 1905), the Freedom of Information Act (5 

U.S.C. § 552), and FDA’s implementing regulations, 21 CFR Part 20. If FDA receives a 

request for these records and tentatively determines that any portion of this submission is 

disclosable, USSTC requests that FDA provide notice and opportunity for USSTC to object 

to any disclosure in accordance with 21 CFR § 20.47 and 21 CFR § 20.61. USSTC reserves all 

of its legal rights to protect against public disclosure of its trade secret and confidential 

commercial information and to seek legal recourse against anyone who discloses such 

information without legal authorization. 

1. DATE 

May 24, 2018 

2. NAME OF APPLICANT/SUBMITTER 

Altria Client Services LLC on behalf of U.S. Smokeless Tobacco Company LLC 

3. ADDRESS 

2325 Bells Road, Richmond, Virginia 23234 

4. MANUFACTURER 

U. S. Smokeless Tobacco Company LLC 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

PAGE 3 

5. DESCRIPTION OF PROPOSED ACTION

The proposed action is for FDA to issue a market authorization order under Section 

910(c)(l)(A)(i) of the Food, D1ug and Cosmetic Act (FD&C Act)2 to introduce the New 

Product into interstate commerce. Through a PMTA for the New Product, USSTC is 

requesting approval from FDA to introduce the New Product into interstate commerce for 

commercial distribution in the United States. USSTC is including this environmental 

assessment with its sublnittal of the PMTA to FDA for the New Product. 

6. IDENTIFICATION OF THE PRODUCT THAT IS THE SUBJECT OF THE PROPOSED ACTION

6.1. Type of Tobacco Product

Verve® chews are a chewable, non-dissolvable, tobacco-derived nicotine product (known 

as an oral nicotine delivery product). The chewable form of the New Product has a soft, 

flexible texture. 

6.2. Estimated Market Volumes 

The following table presents the estimated first-year and fifth-year market volumes for the 

New Product. These estimated market volumes form the basis for the environmental 

exposure estimates provided in this assessment. 

Table 1- Estimated First-Year and Fifth-Year Market Volumes for the New Product 

Name

New Product

Unit

First-Year Projected 

Market Volume

FifthYear Projected 

Market Volume

VERVE® Chews Tubes3 

Blue Mint

Metiic Tons 

6.3. Product Composition 

The New Product contains tobacco-de1ived nicotine, _______(6f(4t _. non-tobacco 

cellulose fiber, flavo1ings, texture modifiers, binders and colorants. 

2 21 u.s.c. 387j 3 TI1ere are 12 chews in one tube. 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

PAGE 4 

6.3.1. Product 

The formulation of the New Product is given in the following table. All values are reported 

in milligrams (mg). 

Table 2 - Product Formulation 

ID Amount per CAS Number Substance #4 Piece (mg) 

(6f{4}

1 

2 

3 

4 

5 

7 

8 

9 

11 

12 

13 

14 

16 

17 

18 

19 

4 TI1e ID# is a unique number for each ingredient; it corresponds to the list of ingredients in Confidential 

Appendix 5 -1 2. 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

PAGE 5 

Table 2 - Product Formulation 

ID 

#4 

20 

CAS Number Substance Amount per

Piece (mg) 

(b) (4) 

... 

21 ,-

24 ... 

25 ,-

26 ... 

27 ,-

28 ... 

29 ,-

30 ... 

32 ,-

33 ... 

34 ,-

35 ... 

36 ,-

37 ... 

38 ,-

39 ... 

40 ,-

41 ... 

42 ,-
43 

44 

46 

47 

49 

50 

54 

55 

56 

57 

59 

60 

61 

62 

63 

ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

PAGE 6 

Table 2 - Product Formulation 

ID Amount per CAS Number Substance #4 Piece (mg) 

(6)14} 

64 

65 

67 

69 

71 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

PAGE 7 

Table 2 - Product Formulation 

ID Amount per CAS Number Substance #4 Piece (mg) 

72 

73 

74 

75 

76 

78 

(6} 4' 

6.3.1.1. Nicotine 

The maximum nicotine content of the New Product is 1.5 mg per piece. 

6.3.2. Packaging 

Packaging material for the New Product comprises the following components, with weight 

represented on a per product basis. The individual chews (12) are packaged in a Tube which 

contains a tube, button (lid), label and a shrink band. USSTC has designed all packaging 

materials to meet FDA' s standard for direct and indirect food additives set forth in Title 21 

of the Code of Federal Regulations (CFR). 

T bl 3 Ch t . ti d W . .

-ht f P k . . - - M t ' 1 s 

Packaging Component Package Composition Weight (grams) 

(b) (4f

Tube 

Button 

Label 

5 TI1ere are 12 chews per tube, 5 tubes per carton and 5 cartons per case. 
(6J (4' 

ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

PAGE 8 

T bl 3 Ch t . ti d W . . ht f P k . . 

- . - M t ' 1 s 

Packaging Component Package Composition Weight (grams) 

6.4. Location of Manufacture 

The New Product will be manufactured at U.S. Smokeless Tobacco Products LLC, located 

(t>)l.if

. U.S. Smokeless 

Tobacco Products LLC is a business entity of United States Smokeless Tobacco Company 

(USSTC). The 6)1.if' 

Product. 

6.5. Location of Use 

USSTC intends to market the New Product to adult consumers throughout the United 

States. 

6.6. Disposal Sites 

The distribution of waste generated due to disposal of the New Product and/ or packaging 

is expected to correspond to the pattern of product use. Disposed mate1ials will either enter 

the recycling stream or be disposed of in municipal solid waste (MSW) landfills or as litter. 

Additional information is provided in Section 7.1.3 below. 

Tamper Evident Slll'ink 

Band 

Carton 

Carton Shrink Film 

Case 

-

-

-
 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

P A G E 9 

7. ENVIRONMENTAL ISSUES 

7.1. Introduction of the Product into the Environment 

7.1.1. As a Result of Manufacture 

No significant environmental impacts are anticipated as a result of manufacturing the New 

Product. 

(b) (4)

(b) (4)

According to the U.S. Environmental Protection Agency (USEPA)’s most recent National

Biennial Report data 

(https://rcrainfo.epa.gov/rcrainfoweb/action/modules/br/summary/view), 33,646,921 

tons of hazardous wastes were generated across the United States in 2015. Of this amount, 

over 2,688,613 tons were incinerated or used (combusted) for energy recovery. Assuming 

the entire production volume is disposed of by the manufacturing facility, the New Product 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

P A G E 1 0

is expected to generate up to 

(b) (4)

of hazardous waste per year.6 This represents up to 

(b) (4)

of the total hazardous waste in the country and up to 

(b) (4)

of the total hazardous 

waste treated by incineration or used (combusted) for energy recovery in the country. Thus, 

the contribution of the New Product to total hazardous waste generated and treated by 

incineration (or energy recovery) annually in the United States is miniscule. Therefore, 

additional resources (e.g., new incineration or similar treatment facilities, etc.) will not be 

required for disposal of the New Product. 

Section 7.1.3 addresses the solid waste generation expected to result from use of the New 

Product. The New Product following use by consumers is an exempt household hazardous 

waste and is not subject to regulation as hazardous waste. 

No significant environmental impacts are anticipated as a result of manufacturing the New 

Product. 

7.1.2. As a Result of Use 

The aquatic environment is the primary compartment of concern for environmental releases 

resulting from use of the New Product. The New Product is used orally. Therefore, 

exposure to the terrestrial and atmospheric environments is not anticipated. 

7.1.2.1. Aquatic 

7.1.2.1.1. Product 

The New Product ingredients are expected to be released primarily to the aquatic 

environment via excretion as a result of product use. To quantify the anticipated amount of 

each chemical substance contained in the New Product to the aquatic environment, 

(b) (4)

calculated the annual load (kilograms per year, or kg/yr) and the aquatic expected 

introduction concentration (EIC) (micrograms per liter, or μg/L). 

(b) (4)

applied the 

approach FDA established for human drugs and biologics to calculate the aquatic EIC as 

follows: 

6 Maximum US tons of MSW per year = A*B*C; where A = Maximum Annual Shipping Quantity between 1st Year 

and 5th Year (g), B = Weight of product (g), C = 1 / 907,185 g/US Ton (Conversion from g to US Tons) 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

P A G E 1 1

EIC-aquatic (ppb or μg/L) =A * B * C * D, where 

A=kg/yr produced, 

B=1/1.071x1011 L/day entering POTW (Publicly Owned Treatment Works 

facility) 

(Source: Clean Watersheds Needs Survey (NWNS) 2012 Data and Reports, 

Detailed Listing of Waste Water Treatment Plant Flows for the Nation accessible at 

https://ofmpub.epa.gov/apex/cwns2012/f?p=134:4::::RP::), 

C=year/365, 

D=109 μg/kg 

In calculating the aquatic EIC values, 

(b) (4)

maintained the following conservative 

assumptions that were established in FDA guidance:7 

 The kg/year produced is based on the highest quantity expected to be produced for

direct use in any of the next five years;

 All product produced in a year is used and enters the POTW system [The

ingredients are absorbed by the human body during use and 100% of the ingredients

are then excreted to sanitary sewer and to treatment within the POTW];8 

 New Product usage occurs throughout the United States in proportion to the

population and amount of wastewater generated;

 No dilution occurs in receiving waters; and

 There is no metabolism.

The results of these calculations were compared to FDA’s established concentration of 

concern (1 μg/L or ppb). As described in its 2001 technical guidance document, Guidance 

for Industry: Environmental Impact Assessments (EIA’s) for Veterinary Medicinal Products 

(VMP’s) – Phase I, FDA considers this value to be below the level shown to have adverse 

effects in aquatic ecotoxicity studies with human drugs. This was deemed appropriate for 

the current assessment as No Observed Effect Concentration (NOEC) values for each 

substance, where available, are greater than 1 μg/L or ppb. 

A brief summary of publicly available fate and effects data for each ingredient of the New 

Product is provided in Confidential Appendix 5-1-2 for reference. 

7 Guidance for Industry: Environmental Assessment of Drug and Biologics Applications (July 1998) 

8 (b) (4)
ENVIRONMENT AL ASSESSMENT 

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PAGE 12 

T bl 4 A• t' A I L d d EiC f th N P d t 

Substance 

Annual Load 

(kg/yr)9

Aquatic EiC 

(μg/L)10 

(6)14}

9 (annual production forecast)x(relative amount in fonnulation) 10 EiC-aquatic (ppb or μg/L)

=A*B*C"D; where A=kg/yr produced, B=l/1.071xl011 L/day entering POTW 

(Source: Clean Watersheds Needs Smvey (NWNS) 2012 Data and Reports, Detailed Listing of Waste Water 

Treatment Plant Flows for the Nation accessible at https:/ / ofmpub.epa.gov /apex/cwns2012/f?p=134:4::::RP::), 

C=year/365, D=109 μg/kg 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

PAGE 13 

T bl 4 A• t' A I L d d EiC f th N P d t 

Annual Load 

(kg/yr)9

Aquatic EiC 

(μg/L) Substance 10

(6)14'
ENVIRONMENT AL ASSESSMENT 

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PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

PAGE 1 4

T bl 4 A• t' A I L d d EiC f th N P d t 

Substance 

Annual Load 

(kg/yr)9

Aquatic EIC 

(μg/L)10

(6) (41
ENVIRONMENT AL ASSESSMENT 

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PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

PAGE 15 

T bl 4 A• t' A I L d d EiC f th N P d t 

Annual Load 

(kg/yr)9

Aquatic EiC 

(μg/L)10 Substance 

(6)121' 

{6)14' noted that in eve1y case, the aquatic EIC is (6)14� at the point of entry into 

the aquatic environment, which is below the relevant concentration of concern identified in 

FDA guidance. 

7.1.2.1.1.1. Nicotine 

The maximum nicotine content of the New Product is 1.5 mg per piece. 

In Table 4, 6J (4' noted that the EIC calculated for nicotine is (6)14} at the point of 

enhy into the aquatic environment and therefore below FDA' s established concentration of 

concern. Nonetheless, fate and effects data for nicotine are discussed in detail in Sections 

7.2 and 7.3 of this assessment. 

7.1.2.1.2. Packaging 

Packaging is not intended or expected to release chemical substances during use. Releases 

as a result of disposal are discussed in Section 7.1.3 of this assessment. 

7.1.3. As a Result of Disposal 

Following use by consumers, the New Product is an exempt household waste and is not 

subject to regulation as hazardous waste. The New Product will be disposed of in MSW 

landfills or as litter. The associated packaging materials will either be recycled or be 

disposed of in MSW landfills or as litter. The New Product will be disposed of in the same 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

P A G E 1 6

way as other commercially marketed consumer chewable products (e.g., chewing gums or 

chewable tablets). The distribution of waste generated due to disposal of the New Product 

and packaging is expected to correspond to the pattern of product use throughout the 

United States. 

Disposal following use of the New Product is not expected to require additional resources 

for waste disposal. The terrestrial environment is the primary compartment of concern for 

environmental releases of the New Product as a result of disposal. Any release to the aquatic 

environment as a result of disposal is addressed by the calculations conducted in Section 

7.1.2. 

7.1.3.1. Disposal of the Product Following Use 

According to the U.S. Environmental Protection Agency (USEPA) document, Advancing 

Sustainable Materials Management: 2014 Fact Sheet Assessing Trends in Material Generation, 

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

258 million tons of MSW were generated across the United States in 2014. Of this, over 89 

million tons (34.6%) were recycled and composted, more than 136 million tons (52.6%) were 

discarded in a landfill, and more than 33 million tons (12.8%) were combusted with energy 

recovery (USEPA, 2016a). Chewable nicotine products (oral nicotine-delivery products) are 

not expected to be recycled. 

Assuming the entire production volume is disposed of in a landfill, the New Product is 

expected to generate up to 

(b) (4)

of MSW per year. 11 This represents up to 

(b) (4)

of 

the total MSW in the country and up to 

(b) (4)

of MSW that is disposed of in landfills in 

the country. Thus, the contribution of the New Product to total MSW disposed annually in 

the United States is miniscule. Therefore, additional resources (e.g., new landfills, recycling 

centers, etc.) will not be required for disposal following use of the New Product. 

Proper disposal will be to landfill and not directly to the terrestrial environment. Disposal 

to MSW landfills will not result in adverse effects to the environment based on landfill 

design and regulatory requirements. Disposed waste streams within a landfill are 

prevented from entering the environment and ultimately landfill leachate is treated and/or 

sent to POTWs for effective treatment. 

Disposal following use of the New Product is not expected to result in new or additional 

compounds emitted to the environment. USSTC anticipates the New Product will be 

11 Maximum US tons of MSW per year = A*B*C; where A = Maximum Annual Shipping Quantity between 1st 

Year and 5th Year (g), B = Weight of product (g), C = 1 / 907,185 g/US Ton (Conversion from g to US Tons) 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

PAGE 17 

disposed of following use in the same way as other commercially marketed consumer 

chewable products (e.g., chewing gums or chewable tablets). The dishibution of waste 

generated due to disposal of the New Product is expected to correspond to the same pattern 

of product use. No new or additional environmental effects, as defined within 40 CFR 

1508.8, are anticipated. However, improper disposal may occur. The calculations provided 

in Section 7.1.3.2 conservatively address product that is inappropriately disposed of directly 

to the environment. 

7.1.3.2. Terrestrial 

7.1.3.2.1. Product 

Introduction of the New Product to the terresh·ial environment was calculated as surface 

density. Absent guidance from FDA on the appropriate duration to be used for this 

calculation and because it is conservatively assumed there is no metabolism or depletion in 

the environment, a timeframe had to be selected. Therefore, the terrestrial surface density 

of each ingredient was calculated on a per day basis. 

The daily terrestrial surface density values are presented in following table as the 

production tonnage distributed across the surface area of the United States per day 

(nanograms per square meter per day, or ng/m2 per day). These values were based on the 

very conservative assumptions that the entire production volume was introduced to 

commerce and that the New Product is released to the terrestrial environment in its 

complete and unused state. The calculation is shown in the footnote for the table . 

T bl 5 D ·1 T . IS f D VI f h N p d 

Substance Terrestrial Surface Density 

(n�m2 per day) 

(6) (4 

12 Daily f Surface Density (ng/m2 per day) = A*B*C*D*E; where A = mg/yr produced, B = 1/9.158xl06 km2 smace 

area of the United States, C = yeai/365 days, D = 10-6 km2/m2, E = 106 ng/mg 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

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PAGE 18 

T bl 5 D ·1 T . IS f D V I f h N P d 

Terrestrial Surface Density Substance (ng/m2 per day) 

(6)14}
ENVIRONMENT AL ASSESSMENT 

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PAGE 19 

Table 5 - Dail Terrestrial Surface Densi I I 

Terrestrial Surface Density Substance (ng/m2 per day) 
ENVIRONMENT AL ASSESSMENT 

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PAGE 20 

T bl 5 D ·1 T . IS f D V I f h N P d 

Terrestrial Surface Density Substance (ng/m2 per day) 

(6)(4J 

The daily terrestrial surface density values presented as a production tonnage distributed 

across the surface area of the United States are (6J (4' ng/ m2 per day as determined using 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS BLUE MINT 

P A G E 2 1

the calculations shown in the footnote in the table above. The values are so small that 

exposure to the New Product in the terrestrial environment as described here would not 

have a significant effect. 

Based on the mass of non-nicotine ingredients shown in Table 2 and publicly available 

environmental fate and effects data, a single used or unused chew that is improperly 

disposed is not expected to cause localized effects to the terrestrial environment. Adverse 

effects are highly unlikely because improper disposal of chews should occur only on rare 

occasions and the non-nicotine ingredients are expected to exhibit a low order of 

environmental toxicity. 

7.1.3.2.1.1. Nicotine 

The maximum nicotine content of the New Product is 1.5 mg per piece. 

The daily terrestrial surface density value for nicotine as the production tonnage distributed 

across the surface area of the United States per day (ng/m2 per day)13 is 

(b) (4)

ng/m2 per 

day. This was based on the very conservative assumptions that the entire production 

volume was introduced to commerce and that the New Product is released to the terrestrial 

environment in its complete and unused state. 

(b) (4)

13 Daily Surface Density (ng/m2 per day) = A*B*C*D*E; where A = mg/yr produced, B = 1/9.158x106 km2 surface 

area of the United States, C = year/365, D = 10-6 km2/m2

, E = 106 ng/mg 
ENVIRONMENT AL ASSESSMENT 

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7.1.3.3. Disposal of Packaging Following Use 

The New Product's packaging is expected to be disposed of following use in the same way 

as packaging from other commercially marketed consumer chewable products. The 

distribution of waste generated due to disposal of packaging is expected to conespond to 

the same pattern of product use. 

According to the USEPA document, Advancing Sustainable Materials Management: 2014 Fact 

Sheet Assessing Trends in Material Generation, Ree1;cling, Composting, Combustion with Energy 

Recoven; and Landfilling in the United States, 258 million tons of MSW were generated across 

the United States in 2014. Of this, over 89 million tons (34.6%) were recycled and composted, 

more than 136 million tons (52.6%) were discarded in a landfill, and more than 33 million 

tons (12.8%) were combusted with energy recove1y (USEPA, 2016a). Assuming all of the 

New Product packaging is disposed of to landfill, packaging from the New Product is 

expected to generate up to (6J(4' of MSW per year14• This represents up to (6) (4j of 

the total MSW in the country and up to (6)121' of MSW that is disposed of in landfills in 

the country. Thus, the contribution of the New Product's packaging to total MSW disposed 

annually in the United States is miniscule. Therefore, disposal of the New Product's 

packaging following use of the New Product is not expected to require additional resources 

(e.g., new landfills, recycling centers, etc.) for waste disposal. 

Disposal of packaging following use of the New Product is not expected to result in new or 

additional compounds emitted to the environment. The materials used in the packaging of 

the New Product (bf{4'1

(b) <4 ------------- are common packaging materials used for consumer 

products in general. Proper disposal will be to landfill and not directly to the tenestrial 

environment. Disposal to MSW landfills will not result in adverse effects to the environment 

based on landfill design and regulatory requirements. The same or similar compounds and 

types of emissions are anticipated from disposal of the packaging of the New Product as 

those associated with disposal of the packaging of other consumer chewable products or 

consumer products in general. Thus, no new or additional environmental effects, as defined 

within 40 CFR 1508.8, are anticipated. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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7.2. Fate of Product Released into the Environment 

Due to its ecotoxicological relevance, we discuss the fate of nicotine released into the 

environment in this Section even though nicotine is below concentrations of concern based 

on the exposure assessments within this environmental assessment. 

7.2.1. Nicotine 

Quantitative Structure Activity Relationships (QSARs) have been used to describe the 

physical-chemical properties of nicotine and to provide predicted aquatic toxicity values to 

support the use of nicotine as a marker compound. Acceptable QSARs are not available to 

predict toxicity to terrestrial organisms. All QSAR predictions were determined using the 

USEPA’s EpiWeb 4.1.15 

7.2.1.1. Physical Chemical Properties 

The physical-chemical properties of pure nicotine (CAS 54-11-5) and its metabolites are 

presented in the following table. Nicotine’s physical-chemical properties can be used to 

assess the fate of nicotine introduced into the environment. 

Nicotine introduced into water will stay mainly in water and will not readily partition to 

air based on its low Henry’s Law Constant (3x10-9 atmospheres – cubic meters per mole or 

atm-m3/mole) and negative air/water partitioning coefficient (Kaw = -6.910) (USEPA, 

2016b). Nicotine in water should not bioaccumulate or bioconcentrate in aquatic organisms 

(measured log Kow = 1.17) (Hansch, Hoekman, Leo, Zhang, & Li, 1995). The predicted 

bioconcentration factor (log BCF) for nicotine of 0.440 supports this conclusion. 

Nicotine introduced into the soil can volatilize to air based on the vapor pressure of 0.032 

mm Hg (Boublik, 1984). However, the extent to which it actually volatilizes will depend on 

its sorption. The log Koc predicted at neutral pH is 2.720 and indicates that nicotine in soil 

has moderate mobility. The mobility of nicotine, a weak acid (pKa 8.5), is pH dependent and 

will increase at alkaline pH. Because nicotine is highly soluble (predicted solubility 

1.000x106 milligrams per liter, or mg/L) and has a negative Kaw, it will most likely partition 

to soil pore-water rather than air. 

15 The EPI (Estimation Programs Interface) SuiteTM is a Windows®-based suite of physical/chemical property and 

environmental fate estimation programs developed by the USEPA’s Office of Pollution Prevention Toxics and Syracuse 

Research Corporation (SRC). EPI SuiteTM uses a single input to run the following estimation programs: KOWWINTM,

AOPWINTM, HENRYWINTM, MPBPWINTM, BIOWINTM, BioHCwin, KOCWINTM, WSKOWWINTM, WATERNTTM,

BCFBAFTM, HYDROWINTM, KOAWIN and AEROWINTM, and the fate models WVOLWINTM, STPWINTM and 

LEV3EPITM. ECOSARTM, which estimates ecotoxicity, is also included in EPI SuiteTM (USEPA, 2016b).
 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Table 6a – Predicted Physical-Chemical Properties of Nicotine and Related 

Compounds 

Table 6b – Predicted Physical-Chemical Properties of Nicotine and Related 

Compounds 

7.2.1.2. Degradation 

Nicotine lacks hydrolyzable groups and, therefore, will not undergo abiotic hydrolysis. 

However, nicotine has the potential to undergo direct photolysis. Nicotine’s electronic

absorption spectrum shows an intense absorption band at 260-262 nanometers (nm) with 

some absorption above 290 nm (within the spectrum of energies provided by sunlight) 

(Sangster & Stuart, 1965). The predicted photochemical half-life for nicotine in air is 1.4 

hours. Nicotine can also degrade in surface waters via indirect photolysis by naturally 

occurring photosensitizers such as dissolved organic matter and hydroxyl radicals. Thus, 

indirect photolysis can play an important role in the degradation of nicotine. 

Biotransformation of nicotine in soils and water-sediment systems has been documented. In 

soils, nicotine is oxidized by the bacteria Arthrobacter oxydans (now known as Arthrobacter 

nicotinovarans). The relative amounts and conditions of biotransformation will vary with 

soil and bacterial populations. The nature of the transformations in soil is not as well 

defined as those in animals. It has been demonstrated in vitro that the first metabolite of 

nicotine is 6-hydroxynicotine, which further breaks down to 6-hydroxypseudonicotine 

CAS IUPAC Name Water 

Solubility

Vapour 

Pressure

Henry's 

Law 

Constant

Log Kow log Koc Log Koa

mg/L mm Hg atm-m3/mol

54-11-5 3-[(2S)-1-Methyl-2-pyrrolidinyl]pyridine 1 000E+06 3 200E-02 3 000E-09 9 980E-01 2 720E+00 8 080E+00

486-56-6 (5S)-1-Methyl-5-(3-pyridinyl)-2-pyrrolidinone 9 990E+05 3 810E-04 3 330E-12 3 400E-01 2 110E+00 8 038E+00

34834-67-8 (5S)-3-Hydroxy-1-methyl-5-(3-pyridinyl)-2-pyrrolidinone 1 000E+06 2 160E-07 5 200E-13 -1 200E+00 1 010E+00 9 190E+00

171140-40-8 5-(3-Pyridinyl)-2-pyrrolidinone 1 000E+06 1 660E-05 1 520E-12 -3 000E-01 2 100E+00 9 900E+00

16543-55-8 3-[(2S)-1-Nitroso-2-pyrrolidinyl]pyridine 6 030E+05 5 120E-04 1 970E-10 3 210E-01 3 200E+00 8 480E+00

127686-49-1 {Nitroso[4-oxo-4-(3-pyridinyl)butyl]amino}methyl acetate 5 040E+03 5 130E-07 3 000E-14 6 860E-01 2 190E+00 1 260E+01

119738-26-0 (2S)-1-Nitroso-1,2,3,6-tetrahydro-2,3'-bipyridine 3 060E+05 6 040E-05 1 970E-10 5 970E-01 3 470E+00 8 690E+00

1133-64-8 3-[(2S)-1-Nitroso-2-piperidinyl]pyridine 1 960E+05 6 680E-05 8 580E-11 8 120E-01 3 470E+00 8 850E+00

CAS IUPAC Name Log Kaw BCF

Photochemical 

half-life

Half-life 

in water

Half-life 

in soil

hrs days days

54-11-5 3-[(2S)-1-Methyl-2-pyrrolidinyl]pyridine -6.910E+00 4.400E-01 1.410E+00 3.750E+01 7.500E+01

486-56-6 (5S)-1-Methyl-5-(3-pyridinyl)-2-pyrrolidinone -8.040E+00 5.000E-01 4.900E+00 3.750E+01 7.500E+01

34834-67-8 (5S)-3-Hydroxy-1-methyl-5-(3-pyridinyl)-2-pyrrolidinone -1.067E+01 5.000E-01 4.300E+00 3.750E+01 7.500E+01

171140-40-8 5-(3-Pyridinyl)-2-pyrrolidinone -1.027E+01 5.000E-01 7.990E+00 6.000E+01 1.200E+02

16543-55-8 3-[(2S)-1-Nitroso-2-pyrrolidinyl]pyridine -8.160E+00 5.000E-01 5.400E+00 6.000E+01 1.200E+02

127686-49-1 {Nitroso[4-oxo-4-(3-pyridinyl)butyl]amino}methyl acetate -1.191E+01 5.000E-01 4.200E+00 6.000E+01 1.200E+02

119738-26-0 (2S)-1-Nitroso-1,2,3,6-tetrahydro-2,3'-bipyridine -8.090E+00 5.000E-01 1.430E+00 6.000E+01 1.200E+02

1133-64-8 3-[(2S)-1-Nitroso-2-piperidinyl]pyridine -8.030E+00 5.000E-01 3.380E+00 6.000E+01 1.200E+02
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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(oxynicotine) and other compounds. Cotinine, which is a major oxidation product of 

nicotine in the liver, has not been reported to form in soils; however, microorganisms 

isolated from soils in tobacco fields are capable of degrading nicotine to cotinine in solution 

(Wang et al., 2012). 

Nicotine and its metabolite, cotinine, have been reported to biotransform in sediments 

(Bradley, Barber, Kolpin, McMahon, & Chapelle, 2007). Under oxidizing conditions nicotine 

and cotinine degrade completely to CO2 within 72 days. Under anoxic conditions the 

biotransformation of nicotine and cotinine is slower. EpiWeb 4.1 predicts half-lives of 37.5 

days for nicotine and cotinine in water and 75 days in soil under aerobic conditions. 

Data on the transformation products or metabolites of nicotine are very limited. In order to 

have a common frame of reference, we compared the predicted values for nicotine to the 

predicted values for the metabolites. Predicted physical-chemical properties of nicotine 

metabolites and transformation products compare to those of nicotine as follows. Predicted 

log Kow values range from -1.200 to 0.998. Predicted log Koc ranges from 1.010 to 3.470. 

Predicted water solubilities range from 5.040x103 mg/L to 1.000x106 mg/L with nicotine 

being among the more soluble substances. Predicted Henry’s Law Constants range from

3.000x10-14 atm-m3/mole to 3.000x10-9 atm-m3/mole for nicotine and related compounds. 

Predicted photochemical half-lives range from 1.410 to 7.990 days for nicotine and related 

compounds. Predicted half-lives in water are all less than 60 days and half-lives in soil are 

predicted to be less than 120 days. Relative to its metabolites, nicotine is more water soluble 

and more volatile, and degrades somewhat more quickly. Its behavior was deemed similar 

enough to that of its metabolites to serve as an appropriate surrogate in the environmental 

assessment. 

7.3. Environmental Effects of Product Released into the Environment 

Due to its ecotoxicological relevance, we discuss the effects of nicotine released into the 

environment in this Section even though nicotine is below concentrations of concern based 

on the exposure assessments within this environmental assessment. 

7.3.1. Nicotine 

QSAR predictions in Table 7 were used here as a basis of comparison among nicotine and 

related compounds and should be taken as qualitative rather than quantitatively definitive. 

Equations for different classes of compounds used to develop the ECOSAR model within 

OECD Toolbox V2.38 (OECD, 2012) are of differing reliabilities depending on the dataset 

used to develop the equation. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Table 7 - Acute Aquatic Toxicity of Nicotine and Related Compounds 

Predicted algal 96-hr EC50 values range from 17.8 mg/L to 176 mg/L. The predicted EC50

for nicotine (CAS 54-11-5) is 44.7 mg/L. While not predicted to be the most toxic compound, 

nicotine toxicity is within a factor of 2 of the most toxic compounds and likely not 

significantly different (i.e., within the confidence limits of the prediction). Measured 96-hr 

EC50 values for the toxicity of nicotine to the alga Selenastrum capricornutum were 72.9 mg/L 

for growth and 115 mg/L for biomass (Seckar, et al., 2008). The predicted EC50 values for 

nicotine were lower than the measured values but within a factor of 2. 

The predicted 48-hr EC50 of nicotine to Daphnia is 0.2 mg/L. Predicted toxicity values for 

the nicotine metabolites range from 0.22 mg/L to 5,350 mg/L. The measured EC50 value for 

Daphnia pulex is 0.24 mg/L (Savino & Tanabe, 1989). 

The predicted fish 96-hr LC50 for nicotine is 4.86 mg/L. The predicted LC50 values for 

metabolites of nicotine range from 6.55 to 11,000 mg/L. Measured LC50 values for nicotine 

toxicity to Oncorhynchus mykiss larvae are 4 mg/L (96 hrs), 5 mg/L for fry (60 days), and 6 

mg/L for fry (21-31 days). 

Terrestrial toxicity data for invertebrates were of limited availability. Because nicotine has 

a history of use as a pesticide, it is expected that terrestrial invertebrates will be very 

sensitive to nicotine. Rizvi et al. reported that the 24-hr LD50 of nicotine dust was 7.2 

micrograms (μg)/nymph for Dysdercus koenigii (Fabr.) (Rizvi, Ahmed, & Naqvi, 2012). 

Additional toxicity data are included on dermal toxicity to the brown tree snake, oral 

toxicity to rats, and dermal toxicity to rabbits. Terrestrial toxicity to the brown tree snake 

(Boiga irregularis) is reported as 40 milligrams per kilogram (mg/kg) dermally, a dose that 

killed 100% of snakes (Brooks, Savarie, & Johnston, 1998). The oral LD50 dose for nicotine in 

rats is 50 mg/kg to 60 mg/kg (Klaasen, Amdur, & Doull, 1995). The dermal LD50 in rabbits 

is reported as 140 mg/kg (Lewis, 1996). 

Algal Daphnia Fish 

CAS IUPAC Name 96- 48-hr - 96-hr

EC50 EC50 LC50

mg/L mg/L mg/L

54-11-5 3-[(2S)-1-Methyl-2-pyrrolidinyl]pyridine 44.70 0.20 4.86

486-56-6 (5S)-1-Methyl-5-(3-pyridinyl)-2-pyrrolidinone 17.80 1.92E+03 8.11E+02

34834-67-8 (5S)-3-Hydroxy-1-methyl-5-(3-pyridinyl)-2-pyrrolidinone 176.00 5.35E+04 1.11E+04

171140-40-8 5-(3-Pyridinyl)-2-pyrrolidinone 22.20 2.75E+03 1.06E+03

16543-55-8 3-[(2S)-1-Nitroso-2-pyrrolidinyl]pyridine 131.00 0.22 8.66

127686-49-1 {Nitroso[4-oxo-4-(3-pyridinyl)butyl]amino}methyl acetate 42.50 38.00 372.00

119738-26-0 (2S)-1-Nitroso-1,2,3,6-tetrahydro-2,3'-bipyridine 93.30 0.23 7.57

1133-64-8 3-[(2S)-1-Nitroso-2-piperidinyl]pyridine 69.00 0.24 6.55
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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7.4. Use of Resources and Energy 

Based on the estimated maximum annual market volume of the New Product (from the 

five-year projected market volume), the use of resources and energy due to the proposed 

action is expected to be negligible. 

7.4.1. Energy Consumption / Greenhouse Gas Emissions 

The New Product manufacturing process is 

(b) (4)

The process does not emit greenhouse gas (GHG) 

pollutants. Energy consumption due to warehousing and distribution is expected to be 

similar to other consumer products of similar size. 

Additional information on energy and resource sustainability efforts are described in 

Section 7.4.4. 

7.4.2. Compliance with ESA and CITES 

No critical habitat is affected from materials or ingredients used to manufacture the New 

Product. 

No adverse effects are expected 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 Flora and Fauna (CITES) due to the manufacture or marketing 

of the New Product. 

USSTC does not anticipate that any critical habitat or endangered or threatened species will 

be affected from production of the New Product, or from materials or ingredients used to 

manufacture the New Product. Altria and USSTC’s supply contracts and supplier code of 

conduct standards support compliance with applicable laws (refer to Section 7.4.4). For 

more information on supply chain management and responsibility, refer to the Altria 

website and the Corporate Responsibility Progress Report available at 

http://www.altria.com/Interactive/2017CRReport/files/assets/basic-html/page-1.html. 

The manufacturing facilities are not within or in close proximity to a critical habitat of a 

threatened or endangered species. USSTC does not expect the manufacture and commercial 

introduction of the New Product to affect a critical habitat or threaten the existence of listed 

species or destroy or adversely modify any designated critical habitat for that species. This 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

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is based on a review of critical habitat maps 

(https://databasin.org/datasets/d579d87eb54f4374a77ea53e7ef66449) created by the U.S. 

Fish and Wildlife Service (US FWS), which show no critical habitat within close proximity 

to the manufacturing facilities. 

The US FWS’s list of species by county (https://www.fws.gov/endangered/) shows that 

Chesterfield County and Henrico County, Virginia may have one endangered species 

(Clams – James spinymussel (Pleurobema collina)) and three threatened species (Mammals –

Northern Long-Eared Bat (Myotis septentrionalis; Flowering Plants – Sensitive joint-vetch 

(Aeschynomene virginica), Swamp pink (Helonias bullata)). However, these threatened or 

endangered species are not known to be in the vicinity of the manufacturing facility. 

(b) (4)

As described in Section 7.1.1, waste generated as a result of manufacturing the New Product 

will be considered a hazardous waste (nicotine-containing material) and will be disposed 

of at waste incineration facilities or will be recycled via a nicotine reclamation facility. As 

described in Section 7.1.3, the used New Product will be disposed of in the same way as 

other commercially marketed chewable products. The distribution of waste generated due 

to disposal of the New Product and packaging is expected to correspond to the pattern of 

product use in the United States. 

(b) (4)

7.4.3. Compliance with Federal, State and Local Environmental Regulations 

The 

(b) (4)

, where the New Product will be manufactured, 

comply with the Clean Air Act (CAA), Clean Water Act (CWA) and the Resource 

Conservation and Recovery Act (RCRA). Manufacture of the New Product will not result 

in changes in compliance with relevant federal, state and local environmental regulations. 

The facilities’ compliance with the CAA, CWA, the RCRA, and other environmental 

regulations can be assessed on the USEPA’s Enforcement and Compliance History Online 

(ECHO) website. 
 

 

 

 

 

 

 

 

 

 

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USSTC maintains an effective Environmental Management System (EMS) which is 

designed and implemented to integrate environmental programs (including compliance 

and sustainability) into business operations. Key components of the EMS include: 

personnel, policy, directives, guidance and training, data management and assessments. 

Regarding waste management, USSTC seeks to 

The 

Regarding 

hazardous waste management, 

(b) (4)

(b) (4)

(b) (4)

(b) (4)
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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(b) (4)

USSTC’s long-term contracts with material suppliers, and the purchase order terms and 

conditions applicable to suppliers without long-term contracts, contain provisions that 

require compliance with all applicable laws and regulations. Altria’s Supplier Code of

Conduct also addresses compliance with applicable laws, regulations, and standards, 

which includes environmental compliance. 

For 

more information on supply chain management and responsibility, refer to the Altria 

(b) (4)

website and the Corporate Responsibility Progress Report 

(http://www.altria.com/Interactive/2017CRReport/files/assets/basic-html/page1.html).

7.4.4. Environmental Sustainability 

Manufacture of the New Product will not affect environmental sustainability at the 

manufacturing facilities. USSTC has an ongoing initiative to improve environmental 

sustainability across all facilities. One piece of infrastructure that supports this initiative is 

the EMS. 

As a result of these 

efforts, USSTC expects its overall energy use to decrease over time. 

(b) (4)

For more information on USSTC’s environmental sustainability initiatives, refer 

to the Altria website and the Corporate Responsibility Progress Report 

(http://www.altria.com/Interactive/2017CRReport/files/assets/basic-html/page1.html).

(b) (4)

(b) (4)
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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However, the power supplier to these manufacturing facilities is Dominion 

(b) (4)

(b) (4)

Energy which has committed to meeting the renewable portfolio goals and standards set 

by policymakers in Virginia.16 Dominion Energy has set a renewable energy goal in Virginia 

to achieve 15% renewable power by 2025. 

8. MITIGATION MEASURES

(b) (4)

herewith provides the basis for a Finding of No Significant Impact for this 

environmental assessment of the New Product due to de minimis exposure. As such, no 

additional environmental protection measures, mitigation measures or alternative actions 

are necessary to address environmental impacts of the New Product. 

9. ALTERNATIVES TO THE PROPOSED ACTION

Alternative A (No-action alternative): The no-action alternative is to not allow the 

marketing of the New Product in the United States. 

Alternative B (Proposed action): Issuing a Finding of No Significant Impact due to the 

proposed action of granting an order finding that the New Product may be introduced or 

delivered for introduction into interstate commerce under Section 910(c)(1)(A)(i) of the 

FD&C Act. 

The no-action alternative is not expected to significantly change the existing condition. 

Therefore, the difference between the environmental impacts of these two alternatives is 

negligible. 

16 Refer to https://www.dominionenergy.com/renewables 
 

 

 

 

 

 

 

 

 

 

 

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10. LIST OF PREPARERS

In accordance with 40 CFR 1502.17, this section includes a list of names and qualifications 

(including position/title, education, experience, and expertise) of individuals who were 

primarily responsible for preparing and reviewing this environmental assessment. No 

Agencies or persons besides subject matter experts within (b) (4) and ALCS were consulted. 

However, feedback from FDA on prior submissions and examples of Environmental 

Assessments posted by FDA were considered in developing this assessment. 

(b) (4)

Education: M.S. in Chemical Engineering; MBA 

Years of Experience: > 25 years in environmental consulting 

Qualifications: Environmental assessments and audits, environmental risk assessment, 

environmental compliance & assurance activities, air quality, and product stewardship and 

sustainability. 

(b) (4)

Education: B.S. in Chemistry; M.S. in Environmental Engineering 

Years of Experience: > 25 years in environmental management and regulatory activities 

Qualifications: Environmental assessments, environmental risk assessment, environmental 

compliance & assurance activities, life cycle assessment, engineering design of pollution 

control measures, and product stewardship and sustainability. 

(b) (4)

Education: B.S. in Mechanical Engineering 

Years of Experience: 25 years in environmental management and regulatory activities 

Qualifications: Environmental assessments and audits, environmental risk assessment, 

environmental compliance & assurance activities, air quality, Toxic Substances Control Act 

(TSCA) compliance, and product stewardship and sustainability. 
 

 

 

 

 

 

 

 

 

 

 

 

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11. REFERENCES

Boublik, T. (1984). The Vapor Pressure of Pure Substances: Selected Values of the Temperature 

Dependance of the Vapor Pressures of Some Pure Substances in the Normal and Low Pressure 

Region (Vol. 17). Amsterdam: Elsevier. 

Bradley, Barber, Kolpin, McMahon, & Chapelle. (2007). Biotransformation of Caffeine, 

Cotinine and Nicotine in Stream Sediments. Environmental Toxicology and Chemistry, 26(6), 

1116-1121. 

Brooks, J., Savarie, P., & Johnston, J. (1998). The oral and dermal toxicity of nicotine 

derivatives of selected chemicals to brown tree snakes. Wildlife Research, 24, 427-435. 

Hansch, C., Hoekman, D., Leo, A., Zhang, L., & Li, P. (1995). The expanding role of 

quantitative structure-activity (QSAR) in toxicology. Toxicology Letters, 79, 45-53. 

Hazardous Substances Data Bank [Internet]. (2014). Nicotine; Hazardous Substances 

Databank Number: 1107. Accessed 12 Nov. 2016. Bethesda (MD): National Library of 

Medicine (US). Retrieved from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB 

Klaasen, C., Amdur, M., & Doull, J. (1995). Toxicology: The Basic Science of Poisons (5th ed.). 

New York: McGraw-Hill. 

Lewis, R. (1992). Sax's Dangerous Properties of Chemicals (8th ed.). New York: Van Nostrand 

Reinhold. 

OECD. (2012). QSAR Toolbox Version 2.3. Retrieved 2012, from 

http://www.oecd.org/document/23/0,3343,en 2649 34379 33957015 1 1 1 1,00.html 

Rizvi, S., Ahmed, R., Zaidi, R. & Naqvi, S. (1990). Toxicity of nicotine derivatives and their 

effect on the protein pattern of 4th immature stage of red cotton stainer Dysdercus koenigii 

(Fabr) (Hemiptera: Pyrrochoridae).. Pak J Pharm Sci. 3(1):67-76. 

Sangster, A., & Stuart, K. (1965). Ultraviolet Spectra of Alkaloids. Chemical Reviews, 29, 69-

130. 

Savino, J., & Tanabe, L. (1989). Sublethal Effects of Phenanthrene, Nicotine and Pinene on 

Daphnia pulex. Bull. Environ. Contam. Toxicol., 42(5), 778-784. 
 

 

 

 

 

 

 

 

 

 

 

 

 

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Seckar, J., Mari, S., Stavanja, P., Harp, Y., Yi, C., Gardner, & Doi. (2008). Environmental Fate 

and Effects of Nicotine Released During Cigarette Production. Environmental Toxicology and 

Chemistry, 27(7), 1505-1514. 

USEPA. (2016a). Advancing Sustainable Materials Management: 2014 Fact Sheet, EPA-530-

R-17-01, November 2016, Washington, DC.

USEPA. (2016b). Estimation Programs Interface SuiteTM for Microsoft® Windows, v 4.11.

United States Environmental Protection Agency, Washington, DC, USA. 

Wang, H. H., Yin, B., Peng, X. X., Wang, J. Y., Xie, Z. H., Gao, J., & Tang, X. K. (2012). 

Biodegradation of nicotine by newly isolated Pseudomonas sp. CS3 and its metabolites. 

Journal of applied microbiology, 112(2), 258-268. Full text available at: 

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2672.2011.05208.x/full. 

12. APPENDICES

As a final measure of substantiation for the minimal environmental risk associated with 

the use of the New Product, 

(b) (4)

 has included the following Appendices. 

Data summaries provide a brief summation of the available physico-chemical properties, 

toxicology and ecotoxicology data for the product ingredients and are included in 

Confidential Appendix 5-1-2. Data contained in the attached summaries are from publicly 

available compilations from sources including the USEPA and the European Chemicals 

Agency (ECHA). Specific references are noted as appropriate. 

Additional information regarding the regulatory status of product ingredients are 

provided in Confidential Appendix 5-1-3 to further substantiate FDA’s acceptance of

these substances from an environmental perspective. 
 

 

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13. CERTIFICATION 

(b) (4)
APPENDIX 5-1-2 - ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION RESPONSE 

TO ADVICF/INFORMATION REQUEST FOR VERVE® CHEWS BLUE MINT 

Data Summaries 

Emptlj boxes in Data Summaries are intentionally left blank 

Data contained in the attached sununaiies are from readily available compilations from 

sources including the US Environmental Protection Agency (EPA) and the European 

Chemicals Agency (ECHA). Specific references are noted as appropriate. 

Ingredient ID# 

1 

2 

3 

4 

5 

7 

8 

9 

11 

12 

13 

14 

16 

17 

18 

19 

20 

21 

Ingredient Name Link 

(6)14' 

Inet1·edient l.odf 

In!?redient 2.odf 

Inet1·edient 3.odf 

In!?redient 4.odf 

Inet1·edient 5.odf 

In!?redient 7.odf 

Inet1·edient 8.odf 

In!?redient 9.odf 

In2:redient 11. odf 

Ingredient 12.vdf 

In2:redient 13.odf 

Ingredient 14.vdf 

In2:redient 16.odf 

Ingredient 17.vdf 

In2:redient 18.odf 

Ingredient 19. pdf 

In2:redient 20.odf 

Ingredient 21. pdf 

(6) (4l I 
APPENDIX 5-1-2 - ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION RESPONSE 

TO ADVICF/INFORMATION REQUEST FOR VERVE® CHEWS BLUE MINT 

PAGE 2 

Ingredient ID# 

24 

25 

26 

27 

28 

29 

30 

32 

33 

34 

35 

36 

37 

38 

39 

40 

41 

42 

43 

44 

46 

Ingredient Name 

{t>) l.i:J] 

Link 

In2:redient 24.odf 

Ingredient 25.odf 

In2:redient 26.odf 

In2:redient 27.odf 

Ingredient 28.odf 

In2:redient 29. odf 

In2:redient 30.odf 

Ingredient 32.odf 

In2:redient 33.odf 

In2:redient 34.odf 

Ingredient 35.odf 

In2:redient 36.odf 

Ingredient 37.odf 

Ingredient 38.odf 

In2:redient 39. odf 

In2:redient 40.odf 

Ingredient 41.odf 

In2:redient 42.odf 

Ingredient 43.odf 

In2:redient 44.odf 

In2:redient 46.odf 
APPENDIX 5-1-2 - ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION RESPONSE 

TO ADVICF/INFORMATION REQUEST FOR VERVE® CHEWS BLUE MINT 

PAGE 3 

Ingredient ID# 

47 

49 

so 

54 

55 

56 

57 

59 

60 

61 

62 

63 

64 

65 

67 

69 

71 

72 

73 

74 

75 

Ingredient Name 

(6)(41 

Link 

In2:redient 47.odf 

Ingredient 49.odf 

In2:redient 50.odf 

In2:redient 54.odf 

Ingredient 55.odf 

In2:redient 56.odf 

In2:redient 57.odf 

Ingredient 59. odf 

In2:redient 60.odf 

In2:redient 61.odf 

Ingredient 62.odf 

In2:redient 63.odf 

Ingredient 64.odf 

Ingredient 65.odf 

In2:redient 67.odf 

In2:redient 69. odf 

Ingredient 71. odf 

In2:redient 72.odf 

Ingredient 73.odf 

In2:redient 74.odf 

In2:redient 75.odf 
APPENDIX 5-1-2 - ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION RESPONSE 

TO ADVICF/INFORMATION REQUEST FOR VERVE® CHEWS BLUE MINT 

PAGE 4 

Ingredient ID# Ingredient Name Link 

76 (6)14' In2:redient 76.odf 

78 Ingredient 78.odf 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION 

FOR THE PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN 

MINT 

Memorandum 

To: Altria Client Services LLC on behalf of U.S. Smokeless 

Tobacco Company LLC 

From: 

(b) (4)

Date: May 24, 2018 

Subject: Environmental Assessment for the Premarket 

Tobacco Product Application for the Product 

Identified as VERVE® Chews Green Mint 

(b) (4)

This environmental assessment was prepared in accordance with 21 CFR 25.40, 

the Food and Drug Administration’s (FDA’s or Agency’s) regulation

implementing the National Environmental Policy Act of 1969. Under NEPA, 

“all applications or petitions requesting Agency action require the submission

of an environmental assessment or a claim of categorical exclusion.”1 

(b) (4)

respectfully submits the 

following environmental assessment in support of the Premarket Tobacco Product 

Application (PMTA) for the product identified as VERVE® Chews Green Mint 

(referred to throughout this assessment as the “New Product”) pursuant to 21 

CFR 25.20 because there is no applicable categorical exclusion for this type of 

application. 

This environmental assessment was conducted in accordance with 21 CFR 25.40 

and relevant aspects of FDA technical guidance documents including: 

 Environmental Considerations for Tobacco Product Applications Submitted to

CTP, presented by Cristi Stark, M.S., Associate Director for Science Policy,

Office of Science, CTP, FDA (August 2016);

 Guidance for Industry: Environmental Impact Assessments (EIA’s) for

Veterinary Medicinal Products (VMP’s) – Phase I (March 2001); and

 Guidance for Industry: Environmental Assessment of Drug and Biologics

Applications (July 1998).

1 21 CFR 25.15(a) 

(b) (4)
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

P A G E 2 

This environmental assessment was prepared at the direction of Altria Client Services LLC 

(ALCS) on behalf of U.S. Smokeless Tobacco Company LLC (USSTC), a wholly owned 

subsidiary of Altria Group Inc. The potential aquatic, atmospheric, and terrestrial 

environmental impacts of FDA’s approval of the PMTA and subsequent marketing of the 

New Product were considered using a conservative set of assumptions. The assessment 

identified no significant environmental risks, and a Finding of No Significant Impact by 

FDA is warranted for the environmental assessment of the New Product. 

This memorandum contains trade secret and confidential commercial information that 

USSTC considers to be proprietary and highly sensitive, and which is protected from 

disclosure under the Food, Drug and Cosmetic Act §§ 301(j) and 906(c) (21 U.S.C. §§ 331(j) 

and 387f(c)), the Trade Secrets Act (18 U.S.C. § 1905), the Freedom of Information Act (5 

U.S.C. § 552), and FDA’s implementing regulations, 21 CFR Part 20. If FDA receives a 

request for these records and tentatively determines that any portion of this submission is 

disclosable, USSTC requests that FDA provide notice and opportunity for USSTC to object 

to any disclosure in accordance with 21 CFR § 20.47 and 21 CFR § 20.61. USSTC reserves all 

of its legal rights to protect against public disclosure of its trade secret and confidential 

commercial information and to seek legal recourse against anyone who discloses such 

information without legal authorization. 

1. DATE

May 24, 2018 

2. NAME OF APPLICANT/SUBMITTER

Altria Client Services LLC on behalf of U.S. Smokeless Tobacco Company LLC 

3. ADDRESS

2325 Bells Road, Richmond, Virginia 23234 

4. MANUFACTURER

U. S. Smokeless Tobacco Company LLC 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 3 

5. DESCRIPTION OF PROPOSED ACTION

The proposed action is for FDA to issue a market authorization order under Section 

910(c)(l)(A)(i) of the Food, D1ug and Cosmetic Act (FD&C Act)2 to introduce the New 

Product into interstate commerce. Through a PMTA for the New Product, USSTC is 

requesting approval from FDA to introduce the New Product into interstate commerce for 

commercial distribution in the United States. USSTC is including this environmental 

assessment with its sublnittal of the PMTA to FDA for the New Product. 

6. IDENTIFICATION OF THE PRODUCT THAT IS THE SUBJECT OF THE PROPOSED ACTION

6.1. Type of Tobacco Product 

Verve® chews are a chewable, non-dissolvable, tobacco-derived nicotine product (known 

as an oral nicotine delivery product). The chewable form of the New Product has a soft, 

flexible texture. 

6.2. Estimated Market Volumes 

The following table presents the estimated first-year and fifth-year market volumes for the 

New Product. These estimated market volumes form the basis for the environmental 

exposure estimates provided in this assessment. 

Table 1- Estimated First-Year and Fifth-Year Market Volumes for the New Product 

New Product 

Name Unit First-Year Projected Fifth-Year Projected 

Market Volume Market Volume 

. ' 

VERVE® Chews Tubes3 

Green Mint 

Metiic Tons 

6.3. Product Composition 

The New Product contains tobacco-de1ived nicotine, _______(6f(4t _. non-tobacco 

cellulose fiber, flavo1ings, texture modifiers, binders and colorants. 

2 21 u.s.c. 387j 3 TI1ere are 12 chews in one tube. 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 4 

6.3.1. Product 

The formulation of the New Product is given in the following table. All values are reported 

in milligrams (mg). 

Table 2 - Product Formulation 

ID Amount per CAS Number Substance #4 Piece (mg) 

1 

2 

4 

7 

8 

9 

11 

12 

14 

16 

17 

18 

19 

20 

(6f(4} 

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

4 TI1e ID# is a unique number for each ingredient; it corresponds to the list of ingredients in Confidential 

Appendix 5 -2 2. 
· (6 (4 

ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 5 

Table 2 - Product Formulation 

ID Amount per CAS Number Substance #4 

-

Piece (mg) 

21 

24 

25 

26 

28 

29 

30 

32 

33 

34 

35 

36 

37 

38 

39 

40 

41 

42 

43 

44 

)7 j 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 6 

Table 2 - Product Formulation 

ID Amount per CAS Number Substance #4 p·1ece (mg) 

(b) (4 

46 

47 

48 

49 

50 

52 

53 

55 

56 

57 

60 

61 

62 

63 

64 

65 

67 

68 

69 

71 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 7 

Table 2 - Product Formulation 

ID 

#4 CAS Number Substance Amount per Piece (mg) 

72 (6)14 

73 

74 

75 

76 

78 

6.3.1.1. Nicotine 

The maximum nicotine content of the New Product is 1.5 mg per piece. 

6.3.2. Packaging 

Packaging material for the New Product comprises the following components, with weight 

represented on a per product basis. The individual chews (12) are packaged in a Tube which 

contains a tube, button (lid), label and a shrink band. USSTC has designed all packaging 

materials to meet FDA' s standard for direct and indirect food additives set forth in Title 21 

of the Code of Federal Regulations (CFR). 

T bl 3 Ch t . ti d W . .

-ht f P k . .- - M t ' 1 s 

Packaging Component Package Composition Weight (grams) 

(b) (4'

Tube 

Button 

Label 

5 TI1ere are 12 chews per tube, 5 tubes per carton and 5 cartons per case. 
(D)(4 

Product. 

ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 8 

T bl 3 Ch t . ti d W . .

-ht f P k . . - . - M t ' 1 s 

Packaging Component Package Composition Weight (grams) 

6.4. Location of Manufacture 

The New Product will be manufactured at U.S. Smokeless Tobacco Products LLC, located 

(o) l.i:J] 

U.S. Smokeless 

Tobacco Products LLC is a business entity of United States Smokeless Tobacco Company 

(USSTC). The (o)el.i:JJ 

6.5. Location of Use 

USSTC intends to market the New Product to adult consumers throughout the United 

States. 

6.6. Disposal Sites 

The distribution of waste generated due to disposal of the New Product and/ or packaging 

is expected to correspond to the pattern of product use. Disposed mate1ials will either enter 

the recycling stream or be disposed of in municipal solid waste (MSW) landfills or as litter. 

Additional information is provided in Section 7.1.3 below. 
 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

P A G E 9 

7. ENVIRONMENTAL ISSUES

7.1. Introduction of the Product into the Environment

7.1.1. As a Result of Manufacture 

No significant environmental impacts are anticipated as a result of manufacturing the New 

Product. 

(b) (4)

(b) (4)

According to the U.S. Environmental Protection Agency (USEPA)’s most recent National 

Biennial Report data 

(https://rcrainfo.epa.gov/rcrainfoweb/action/modules/br/summary/view), 33,646,921 

tons of hazardous wastes were generated across the United States in 2015. Of this amount, 

over 2,688,613 tons were incinerated or used (combusted) for energy recovery. Assuming 

the entire production volume is disposed of by the manufacturing facility, the New Product 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

P A G E 1 0

is expected to generate up to 

(b) (4)

of hazardous waste per year.6 This represents up to 

(b) (4)

of the total hazardous waste in the country and up to  of the total hazardous

waste treated by incineration or used (combusted) for energy recovery in the country. Thus, 

the contribution of the New Product to total hazardous waste generated and treated by 

incineration (or energy recovery) annually in the United States is miniscule. Therefore, 

additional resources (e.g., new incineration or similar treatment facilities, etc.) will not be 

required for disposal of the New Product. 

Section 7.1.3 addresses the solid waste generation expected to result from use of the New 

Product. The New Product following use by consumers is an exempt household hazardous 

waste and is not subject to regulation as hazardous waste. 

No significant environmental impacts are anticipated as a result of manufacturing the New 

Product. 

7.1.2. As a Result of Use 

The aquatic environment is the primary compartment of concern for environmental releases 

resulting from use of the New Product. The New Product is used orally. Therefore, 

exposure to the terrestrial and atmospheric environments is not anticipated. 

7.1.2.1. Aquatic 

7.1.2.1.1. Product 

The New Product ingredients are expected to be released primarily to the aquatic 

environment via excretion as a result of product use. To quantify the anticipated amount of 

each chemical substance contained in the New Product to the aquatic environment, 

(b) (4)

calculated the annual load (kilograms per year, or kg/yr) and the aquatic expected 

introduction concentration (EIC) (micrograms per liter, or μg/L). 

(b) (4)

applied the 

approach FDA established for human drugs and biologics to calculate the aquatic EIC as 

follows: 

6 Maximum US tons of MSW per year = A*B*C; where A = Maximum Annual Shipping Quantity between 1st Year 

and 5th Year (g), B = Weight of product (g), C = 1 / 907,185 g/US Ton (Conversion from g to US Tons) 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

P A G E 1 1

EIC-aquatic (ppb or μg/L) =A * B * C * D, where 

A=kg/yr produced, 

B=1/1.071x1011 L/day entering POTW (Publicly Owned Treatment Works 

facility) 

(Source: Clean Watersheds Needs Survey (NWNS) 2012 Data and Reports, 

Detailed Listing of Waste Water Treatment Plant Flows for the Nation accessible at 

https://ofmpub.epa.gov/apex/cwns2012/f?p=134:4::::RP::), 

C=year/365, 

D=109 μg/kg 

In calculating the aquatic EIC values, 

(b) (4)

maintained the following conservative 

assumptions that were established in FDA guidance:7 

 The kg/year produced is based on the highest quantity expected to be produced for

direct use in any of the next five years;

 All product produced in a year is used and enters the POTW system [The

ingredients are absorbed by the human body during use and 100% of the ingredients

are then excreted to sanitary sewer and to treatment within the POTW];8 

 New Product usage occurs throughout the United States in proportion to the

population and amount of wastewater generated;

 No dilution occurs in receiving waters; and

 There is no metabolism.

The results of these calculations were compared to FDA’s established concentration of 

concern (1 μg/L or ppb). As described in its 2001 technical guidance document, Guidance 

for Industry: Environmental Impact Assessments (EIA’s) for Veterinary Medicinal Products 

(VMP’s) – Phase I, FDA considers this value to be below the level shown to have adverse 

effects in aquatic ecotoxicity studies with human drugs. This was deemed appropriate for 

the current assessment as No Observed Effect Concentration (NOEC) values for each 

substance, where available, are greater than 1 μg/L or ppb. 

A brief summary of publicly available fate and effects data for each ingredient of the New 

Product is provided in Confidential Appendix 5-2-2 for reference. 

7 Guidance for Industry: Environmental Assessment of Drug and Biologics Applications (July 1998) 8 (b) (4)
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 12 

T bl 4 A• t' A I L d d EiC f th N P d t 

Substance 

Annual Load 

(kg/yr)9

Aquatic EiC 

(μg/L)10

9 (annual production forecast)x(relative amount in fonnulation) 10 EiC-aquatic (ppb or μg/L)

=A*B*C"D; where A=kg/yr produced, B=l/1.071xl011 L/day entering POTW 

(Source: Clean Watersheds Needs Smvey (NWNS) 2012 Data and Reports, Detailed Listing of Waste Water 

Treatment Plant Flows for the Nation accessible at https:/ / ofmpub.epa.gov /apex/cwns2012/f?p=134:4::::RP::), 

C=year/365, D=109 μg/kg 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 13 

T bl 4 A• t' A I L d d EiC f th N P d t 

Annual Load 

(kg/yr)9

Aquatic EiC 

(μg/L)10 Substance 

(6)14'
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 1 4

T bl 4 A• t' A I L d d EiC f th N P d t 

Substance 

Annual Load 

(kg/yr)9

Aquatic EiC 

(μg/L)10 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 15 

T bl 4 A• t' A I L d d EiC f th N P d t 

Substance 

Annual Load 

(kg/yr)9

Aquatic EiC 

(μg/L)10

{6)(4' noted that in eve1y case, the aquatic EIC is (6) (4j at the point of enhy into 

the aquatic envirorunent, which is below the relevant concentration of concern identified in 

FDA guidance. 

7.1.2.1.1.1. Nicotine 

The maximum nicotine content of the New Product is 1.5 mg per piece. 

In Table 4, 6J {4' noted that the EIC calculated for nicotine is (6f(4} at the point of 

enhy into the aquatic envirorunent and therefore below FDA' s established concentration of 

concern. Nonetheless, fate and effects data for nicotine are discussed in detail in Sections 

7.2 and 7.3 of this assessment. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

P A G E 16 

7.1.2.1.2. Packaging 

Packaging is not intended or expected to release chemical substances during use. Releases 

as a result of disposal are discussed in Section 7.1.3 of this assessment. 

7.1.3. As a Result of Disposal 

Following use by consumers, the New Product is an exempt household waste and is not 

subject to regulation as hazardous waste. The New Product will be disposed of in MSW 

landfills or as litter. The associated packaging materials will either be recycled or be 

disposed of in MSW landfills or as litter. The New Product will be disposed of in the same 

way as other commercially marketed consumer chewable products (e.g., chewing gums or 

chewable tablets). The distribution of waste generated due to disposal of the New Product 

and packaging is expected to correspond to the pattern of product use throughout the 

United States. 

Disposal following use of the New Product is not expected to require additional resources 

for waste disposal. The terrestrial environment is the primary compartment of concern for 

environmental releases of the New Product as a result of disposal. Any release to the aquatic 

environment as a result of disposal is addressed by the calculations conducted in Section 

7.1.2. 

7.1.3.1. Disposal of the Product Following Use 

According to the U.S. Environmental Protection Agency (USEPA) document, Advancing 

Sustainable Materials Management: 2014 Fact Sheet Assessing Trends in Material Generation, 

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

258 million tons of MSW were generated across the United States in 2014. Of this, over 89 

million tons (34.6%) were recycled and composted, more than 136 million tons (52.6%) were 

discarded in a landfill, and more than 33 million tons (12.8%) were combusted with energy 

recovery (USEPA, 2016a). Chewable nicotine products (oral nicotine-delivery products) are 

not expected to be recycled. 

Assuming the entire production volume is disposed of in a landfill, the New Product is 

expected to generate up to 

(b) (4)

of MSW per year. 11 This represents up to 

(b) (4)

of 

the total MSW in the country and up to

(b) (4)

 of MSW that is disposed of in landfills in 

the country. Thus, the contribution of the New Product to total MSW disposed annually in 

11 Maximum US tons of MSW per year = A*B*C; where A = Maximum Annual Shipping Quantity between 1st 

Year and 5th Year (g), B = Weight of product (g), C = 1 / 907,185 g/US Ton (Conversion from g to US Tons) 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

P A G E 1 7

the United States is miniscule. Therefore, additional resources (e.g., new landfills, recycling 

centers, etc.) will not be required for disposal following use of the New Product. 

Proper disposal will be to landfill and not directly to the terrestrial environment. Disposal 

to MSW landfills will not result in adverse effects to the environment based on landfill 

design and regulatory requirements. Disposed waste streams within a landfill are 

prevented from entering the environment and ultimately landfill leachate is treated and/or 

sent to POTWs for effective treatment. 

Disposal following use of the New Product is not expected to result in new or additional 

compounds emitted to the environment. USSTC anticipates the New Product will be 

disposed of following use in the same way as other commercially marketed consumer 

chewable products (e.g., chewing gums or chewable tablets). The distribution of waste 

generated due to disposal of the New Product is expected to correspond to the same pattern 

of product use. No new or additional environmental effects, as defined within 40 CFR 

1508.8, are anticipated. However, improper disposal may occur. The calculations provided 

in Section 7.1.3.2 conservatively address product that is inappropriately disposed of directly 

to the environment. 

7.1.3.2. Terrestrial 

7.1.3.2.1. Product 

Introduction of the New Product to the terrestrial environment was calculated as surface 

density. Absent guidance from FDA on the appropriate duration to be used for this 

calculation and because it is conservatively assumed there is no metabolism or depletion in 

the environment, a timeframe had to be selected. Therefore, the terrestrial surface density 

of each ingredient was calculated on a per day basis. 

The daily terrestrial surface density values are presented in following table as the 

production tonnage distributed across the surface area of the United States per day 

(nanograms per square meter per day, or ng/m2 per day). These values were based on the 

very conservative assumptions that the entire production volume was introduced to 

commerce and that the New Product is released to the terrestrial environment in its 

complete and unused state. The calculation is shown in the footnote for the table. 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 1 8

Table 5 - Dail Terrestrial Surface Densi I I 

Terrestrial Surface Density Substance (ng/m2 per day) 

12 Daily f Surface Density (ng/m2 per day) = A*B*C*D*E; where A = mg/yr produced, B = 1/9.158xl06 km2 smace 

area of the United States, C = yeai/365 days, D = 10-6 km2/m2, E = 106 ng/mg 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 19 

Table 5 - Dail Terrestrial Surface Densi I I 

Terrestrial Surface Density Substance (ng/m2 per day) 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 20 

Table 5 - Dail Terrestrial Surface Densi I I 

Substance Terrestrial Surface Density 

(ng/m2 per day) 

. '
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

PAGE 2 1

Table 5 - Dail Terrestrial Surface Densi I I 

Terrestrial Surface Density Substance (ng/m2 per day) 

The daily terrestrial surface density values presented as a production tonnage distributed 

across the surface area of the United States are 6)14' ng/ m2 per day as determined using 

the calculations shown in the footnote in the table above. The values are so small that 

exposure to the New Product in the terrestrial environment as described here would not 

have a significant effect. 

Based on the mass of non-nicotine ingredients shown in Table 2 and publicly available 

environmental fate and effects data, a single used or unused chew that is improperly 

disposed is not expected to cause localized effects to the terrestrial environment. Adverse 

effects are highly unlikely because improper disposal of chews should occur only on rare 

occasions and the non-nicotine ingredients are expected to exhibit a low order of 

environmental toxicity. 

7.1.3.2.1.1. Nicotine 

The maximum nicotine content of the New Product is 1.5 mg per piece. 

The daily terrestrial surface density value for nicotine as the production tonnage distributed 

across the surface area of the United States per day (ng/m2 per day)13 is 6) {4 ng/m2 per 

13 Daily Surface Density (ng/m2 per day) = A*B*C*D*E; where A = mg/yr produced, B = 1/9.158x106 km2 surface 

area of the United States, C = yeai/365, D = 10� km2/m2,E = 106 ng/mg 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

P A G E 2 2

day. This was based on the very conservative assumptions that the entire production 

volume was introduced to commerce and that the New Product is released to the terrestrial 

environment in its complete and unused state. 

(b) (4)

7.1.3.3. Disposal of Packaging Following Use 

The New Product’s packaging is expected to be disposed of following use in the same way

as packaging from other commercially marketed consumer chewable products. The 

distribution of waste generated due to disposal of packaging is expected to correspond to 

the same pattern of product use. 

According to the USEPA document, Advancing Sustainable Materials Management: 2014 Fact 

Sheet Assessing Trends in Material Generation, Recycling, Composting, Combustion with Energy 

Recovery and Landfilling in the United States, 258 million tons of MSW were generated across 

the United States in 2014. Of this, over 89 million tons (34.6%) were recycled and composted, 

more than 136 million tons (52.6%) were discarded in a landfill, and more than 33 million 

tons (12.8%) were combusted with energy recovery (USEPA, 2016a). Assuming all of the 

New Product packaging is disposed of to landfill, packaging from the New Product is 

expected to generate up to 

(b) 

tons of MSW per year14. This represents up to 

(b) (4)

of 

the total MSW in the country and up to

(b) (4)

 of MSW that is disposed of in landfills in 

the country. Thus, the contribution of the New Product’s packaging to total MSW disposed 

annually in the United States is miniscule. Therefore, disposal of the New Product’s

14 (b) (4)
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packaging following use of the New Product is not expected to require additional resources 

(e.g., new landfills, recycling centers, etc.) for waste disposal. 

Disposal of packaging following use of the New Product is not expected to result in new or 

additional compounds emitte__ceto the__envjronment The., materials use__d .in Jhe. packaging of 

(b) <4 the New Product 

(b) (4 --------------are common packaging materials used for consumer 

products in general. Proper disposal will be to landfill and not directly to the terrestrial 

environment. Disposal to MSW landfills will not result in adverse effects to the environment 

based on landfill design and regulatory requirements. The same or similar compounds and 

types of emissions are anticipated from disposal of the packaging of the New Product as 

those associated with disposal of the packaging of other consumer chewable products or 

consumer products in general. Thus, no new or additional environmental effects, as defined 

within 40 CFR 1508.8, are anticipated. 

7.2. Fate of Product Released into the Environment 

Due to its ecotoxicological relevance, we discuss the fate of nicotine released into the 

environment in this Section even though nicotine is below concentrations of concern based 

on the exposure assessments within this environmental assessment. 

7.2.1. Nicotine 

Quantitative Structure Activity Relationships (QSARs) have been used to describe the 

physical-chemical properties of nicotine and to provide predicted aquatic toxicity values to 

support the use of nicotine as a marker compound. Acceptable QSARs are not available to 

predict toxicity to terrestrial organisms. All QSAR predictions were determined using the 

USEPA's EpiWeb 4.1.15 

7.2.1.1. Physical Chemical Properties 

The physical-chemical properties of pure nicotine (CAS 54-11-5) and its metabolites are 

presented in the following table. Nicotine's physical-chemical properties can be used to 

assess the fate of nicotine introduced into the environment. 

15 The EPI (Estimation Programs hlterface) SuiteTM is a Windows®-based suite of physical/chemical property and 

environmental fate estimation progrnms developed by the USEPA's Office of Pollution Prevention Toxics and Syracuse 

Research Corporation (SRC). EPI SuiteTM uses a single input to rw1 the following estimation programs: KOWWINTM, 

AOPvVINTM, HENRYvVINTM, MPBP\i\lJNTM, BIOvVINTM, BioHCwin, KOCvVINTM, WSKOW\i\lJNTM, WATERNTTM, 

BCFBAFTM, HYDROvVINTM, KOAvVIN and AERO\i\lJNTM, and the fate models WVOLvVINTM, STPvVINTM and 

LEV3EPITM. ECOSARTM, which estimates ecotoxicity, is also included in EPI SuiteTM (USEPA, 2016b). 
 

 

 

 

 

 

 

 

 

 

 

 

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Nicotine introduced into water will stay mainly in water and will not readily partition to 

air based on its low Henry’s Law Constant (3x10-9 atmospheres – cubic meters per mole or 

atm-m3/mole) and negative air/water partitioning coefficient (Kaw = -6.910) (USEPA, 

2016b). Nicotine in water should not bioaccumulate or bioconcentrate in aquatic organisms 

(measured log Kow = 1.17) (Hansch, Hoekman, Leo, Zhang, & Li, 1995). The predicted 

bioconcentration factor (log BCF) for nicotine of 0.440 supports this conclusion. 

Nicotine introduced into the soil can volatilize to air based on the vapor pressure of 0.032 

mm Hg (Boublik, 1984). However, the extent to which it actually volatilizes will depend on 

its sorption. The log Koc predicted at neutral pH is 2.720 and indicates that nicotine in soil 

has moderate mobility. The mobility of nicotine, a weak acid (pKa 8.5), is pH dependent and 

will increase at alkaline pH. Because nicotine is highly soluble (predicted solubility 

1.000x106 milligrams per liter, or mg/L) and has a negative Kaw, it will most likely partition 

to soil pore-water rather than air. 

Table 6a – Predicted Physical-Chemical Properties of Nicotine and Related 

Compounds 

Table 6b – Predicted Physical-Chemical Properties of Nicotine and Related 

Compounds 

Henry's Water Vapour CAS IUPAC Name Law Log Kow log Koc Log Koa Solubility Pressure Constant

mg/L mm Hg 3 atm-m /mol

54-11-5 3-[(2S)-1-Methyl-2-pyrrolidinyl]pyridine 1 000E+06 3 200E-02 3 000E-09 9 980E-01 2 720E+00 8 080E+00

486-56-6 (5S)-1-Methyl-5-(3-pyridinyl)-2-pyrrolidinone 9 990E+05 3 810E-04 3 330E-12 3 400E-01 2 110E+00 8 038E+00

34834-67-8 (5S)-3-Hydroxy-1-methyl-5-(3-pyridinyl)-2-pyrrolidinone 1 000E+06 2 160E-07 5 200E-13 -1 200E+00 1 010E+00 9 190E+00

171140-40-8 5-(3-Pyridinyl)-2-pyrrolidinone 1 000E+06 1 660E-05 1 520E-12 -3 000E-01 2 100E+00 9 900E+00

16543-55-8 3-[(2S)-1-Nitroso-2-pyrrolidinyl]pyridine 6 030E+05 5 120E-04 1 970E-10 3 210E-01 3 200E+00 8 480E+00

127686-49-1 {Nitroso[4-oxo-4-(3-pyridinyl)butyl]amino}methyl acetate 5 040E+03 5 130E-07 3 000E-14 6 860E-01 2 190E+00 1 260E+01

119738-26-0 (2S)-1-Nitroso-1,2,3,6-tetrahydro-2,3'-bipyridine 3 060E+05 6 040E-05 1 970E-10 5 970E-01 3 470E+00 8 690E+00

1133-64-8 3-[(2S)-1-Nitroso-2-piperidinyl]pyridine 1 960E+05 6 680E-05 8 580E-11 8 120E-01 3 470E+00 8 850E+00

Photo- Half-life Half-life CAS IUPAC Name Log Kaw BCF chemical in water in soil half-life

hrs days days

54-11-5 3-[(2S)-1-Methyl-2-pyrrolidinyl]pyridine -6.910E+00 4.400E-01 1.410E+00 3.750E+01 7.500E+01

486-56-6 (5S)-1-Methyl-5-(3-pyridinyl)-2-pyrrolidinone -8.040E+00 5.000E-01 4.900E+00 3.750E+01 7.500E+01

34834-67-8 (5S)-3-Hydroxy-1-methyl-5-(3-pyridinyl)-2-pyrrolidinone -1.067E+01 5.000E-01 4.300E+00 3.750E+01 7.500E+01

171140-40-8 5-(3-Pyridinyl)-2-pyrrolidinone -1.027E+01 5.000E-01 7.990E+00 6.000E+01 1.200E+02

16543-55-8 3-[(2S)-1-Nitroso-2-pyrrolidinyl]pyridine -8.160E+00 5.000E-01 5.400E+00 6.000E+01 1.200E+02

127686-49-1 {Nitroso[4-oxo-4-(3-pyridinyl)butyl]amino}methyl acetate -1.191E+01 5.000E-01 4.200E+00 6.000E+01 1.200E+02

119738-26-0 (2S)-1-Nitroso-1,2,3,6-tetrahydro-2,3'-bipyridine -8.090E+00 5.000E-01 1.430E+00 6.000E+01 1.200E+02

1133-64-8 3-[(2S)-1-Nitroso-2-piperidinyl]pyridine -8.030E+00 5.000E-01 3.380E+00 6.000E+01 1.200E+02
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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7.2.1.2. Degradation 

Nicotine lacks hydrolyzable groups and, therefore, will not undergo abiotic hydrolysis. 

However, nicotine has the potential to undergo direct photolysis. Nicotine’s electronic

absorption spectrum shows an intense absorption band at 260-262 nanometers (nm) with 

some absorption above 290 nm (within the spectrum of energies provided by sunlight) 

(Sangster & Stuart, 1965). The predicted photochemical half-life for nicotine in air is 1.4 

hours. Nicotine can also degrade in surface waters via indirect photolysis by naturally 

occurring photosensitizers such as dissolved organic matter and hydroxyl radicals. Thus, 

indirect photolysis can play an important role in the degradation of nicotine. 

Biotransformation of nicotine in soils and water-sediment systems has been documented. In 

soils, nicotine is oxidized by the bacteria Arthrobacter oxydans (now known as Arthrobacter 

nicotinovarans). The relative amounts and conditions of biotransformation will vary with 

soil and bacterial populations. The nature of the transformations in soil is not as well 

defined as those in animals. It has been demonstrated in vitro that the first metabolite of 

nicotine is 6-hydroxynicotine, which further breaks down to 6-hydroxypseudonicotine 

(oxynicotine) and other compounds. Cotinine, which is a major oxidation product of 

nicotine in the liver, has not been reported to form in soils; however, microorganisms 

isolated from soils in tobacco fields are capable of degrading nicotine to cotinine in solution 

(Wang et al., 2012). 

Nicotine and its metabolite, cotinine, have been reported to biotransform in sediments 

(Bradley, Barber, Kolpin, McMahon, & Chapelle, 2007). Under oxidizing conditions nicotine 

and cotinine degrade completely to CO2 within 72 days. Under anoxic conditions the 

biotransformation of nicotine and cotinine is slower. EpiWeb 4.1 predicts half-lives of 37.5 

days for nicotine and cotinine in water and 75 days in soil under aerobic conditions. 

Data on the transformation products or metabolites of nicotine are very limited. In order to 

have a common frame of reference, we compared the predicted values for nicotine to the 

predicted values for the metabolites. Predicted physical-chemical properties of nicotine 

metabolites and transformation products compare to those of nicotine as follows. Predicted 

log Kow values range from -1.200 to 0.998. Predicted log Koc ranges from 1.010 to 3.470. 

Predicted water solubilities range from 5.040x103 mg/L to 1.000x106 mg/L with nicotine 

being among the more soluble substances. Predicted Henry’s Law Constants range from

3.000x10-14 atm-m3/mole to 3.000x10-9 atm-m3/mole for nicotine and related compounds. 

Predicted photochemical half-lives range from 1.410 to 7.990 days for nicotine and related 

compounds. Predicted half-lives in water are all less than 60 days and half-lives in soil are 

predicted to be less than 120 days. Relative to its metabolites, nicotine is more water soluble 

and more volatile, and degrades somewhat more quickly. Its behavior was deemed similar 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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enough to that of its metabolites to serve as an appropriate surrogate in the environmental 

assessment. 

7.3. Environmental Effects of Product Released into the Environment 

Due to its ecotoxicological relevance, we discuss the effects of nicotine released into the 

environment in this Section even though nicotine is below concentrations of concern based 

on the exposure assessments within this environmental assessment. 

7.3.1. Nicotine 

QSAR predictions in Table 7 were used here as a basis of comparison among nicotine and 

related compounds and should be taken as qualitative rather than quantitatively definitive. 

Equations for different classes of compounds used to develop the ECOSAR model within 

OECD Toolbox V2.38 (OECD, 2012) are of differing reliabilities depending on the dataset 

used to develop the equation. 

Table 7 - Acute Aquatic Toxicity of Nicotine and Related Compounds 

Predicted algal 96-hr EC50 values range from 17.8 mg/L to 176 mg/L. The predicted EC50

for nicotine (CAS 54-11-5) is 44.7 mg/L. While not predicted to be the most toxic compound, 

nicotine toxicity is within a factor of 2 of the most toxic compounds and likely not 

significantly different (i.e., within the confidence limits of the prediction). Measured 96-hr 

EC50 values for the toxicity of nicotine to the alga Selenastrum capricornutum were 72.9 mg/L 

for growth and 115 mg/L for biomass (Seckar, et al., 2008). The predicted EC50 values for 

nicotine were lower than the measured values but within a factor of 2. 

The predicted 48-hr EC50 of nicotine to Daphnia is 0.2 mg/L. Predicted toxicity values for 

the nicotine metabolites range from 0.22 mg/L to 5,350 mg/L. The measured EC50 value for 

Daphnia pulex is 0.24 mg/L (Savino & Tanabe, 1989). 

Algal Daphnia Fish 

CAS IUPAC Name 96- 48-hr - 96-hr

EC50 EC50 LC50

mg/L mg/L mg/L

54-11-5 3-[(2S)-1-Methyl-2-pyrrolidinyl]pyridine 44.70 0.20 4.86

486-56-6 (5S)-1-Methyl-5-(3-pyridinyl)-2-pyrrolidinone 17.80 1.92E+03 8.11E+02

34834-67-8 (5S)-3-Hydroxy-1-methyl-5-(3-pyridinyl)-2-pyrrolidinone 176.00 5.35E+04 1.11E+04

171140-40-8 5-(3-Pyridinyl)-2-pyrrolidinone 22.20 2.75E+03 1.06E+03

16543-55-8 3-[(2S)-1-Nitroso-2-pyrrolidinyl]pyridine 131.00 0.22 8.66

127686-49-1 {Nitroso[4-oxo-4-(3-pyridinyl)butyl]amino}methyl acetate 42.50 38.00 372.00

119738-26-0 (2S)-1-Nitroso-1,2,3,6-tetrahydro-2,3'-bipyridine 93.30 0.23 7.57

1133-64-8 3-[(2S)-1-Nitroso-2-piperidinyl]pyridine 69.00 0.24 6.55
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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The predicted fish 96-hr LC50 for nicotine is 4.86 mg/L. The predicted LC50 values for 

metabolites of nicotine range from 6.55 to 11,000 mg/L. Measured LC50 values for nicotine 

toxicity to Oncorhynchus mykiss larvae are 4 mg/L (96 hrs), 5 mg/L for fry (60 days), and 6 

mg/L for fry (21-31 days). 

Terrestrial toxicity data for invertebrates were of limited availability. Because nicotine has 

a history of use as a pesticide, it is expected that terrestrial invertebrates will be very 

sensitive to nicotine. Rizvi et al. reported that the 24-hr LD50 of nicotine dust was 7.2 

micrograms (μg)/nymph for Dysdercus koenigii (Fabr.) (Rizvi, Ahmed, & Naqvi, 2012). 

Additional toxicity data are included on dermal toxicity to the brown tree snake, oral 

toxicity to rats, and dermal toxicity to rabbits. Terrestrial toxicity to the brown tree snake 

(Boiga irregularis) is reported as 40 milligrams per kilogram (mg/kg) dermally, a dose that 

killed 100% of snakes (Brooks, Savarie, & Johnston, 1998). The oral LD50 dose for nicotine in 

rats is 50 mg/kg to 60 mg/kg (Klaasen, Amdur, & Doull, 1995). The dermal LD50 in rabbits 

is reported as 140 mg/kg (Lewis, 1996). 

7.4. Use of Resources and Energy 

Based on the estimated maximum annual market volume of the New Product (from the 

five-year projected market volume), the use of resources and energy due to the proposed 

action is expected to be negligible. 

7.4.1. Energy Consumption / Greenhouse Gas Emissions 

The New Product manufacturing process is 

(b) (4)

. The process does not emit greenhouse gas (GHG) 

pollutants. Energy consumption due to warehousing and distribution is expected to be 

similar to other consumer products of similar size. 

Additional information on energy and resource sustainability efforts are described in 

Section 7.4.4. 

7.4.2. Compliance with ESA and CITES 

No critical habitat is affected from materials or ingredients used to manufacture the New 

Product. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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No adverse effects are expected 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 Flora and Fauna (CITES) due to the manufacture or marketing 

of the New Product. 

USSTC does not anticipate that any critical habitat or endangered or threatened species will 

be affected from production of the New Product, or from materials or ingredients used to 

manufacture the New Product. Altria and USSTC’s supply contracts and supplier code of 

conduct standards support compliance with applicable laws (refer to Section 7.4.4). For 

more information on supply chain management and responsibility, refer to the Altria 

website and the Corporate Responsibility Progress Report available at 

http://www.altria.com/Interactive/2017CRReport/files/assets/basic-html/page-1.html. 

The manufacturing facilities are not within or in close proximity to a critical habitat of a 

threatened or endangered species. USSTC does not expect the manufacture and commercial 

introduction of the New Product to affect a critical habitat or threaten the existence of listed 

species or destroy or adversely modify any designated critical habitat for that species. This 

is based on a review of critical habitat maps 

(https://databasin.org/datasets/d579d87eb54f4374a77ea53e7ef66449) created by the U.S. 

Fish and Wildlife Service (US FWS), which show no critical habitat within close proximity 

to the manufacturing facilities. 

The US FWS’s list of species by county (https://www.fws.gov/endangered/) shows that 

Chesterfield County and Henrico County, Virginia may have one endangered species 

(Clams – James spinymussel (Pleurobema collina)) and three threatened species (Mammals –

Northern Long-Eared Bat (Myotis septentrionalis; Flowering Plants – Sensitive joint-vetch 

(Aeschynomene virginica), Swamp pink (Helonias bullata)). However, these threatened or 

endangered species are not known to be in the vicinity of the manufacturing facility. 

(b) (4)

As described in Section 7.1.1, waste generated as a result of manufacturing the New Product 

will be considered a hazardous waste (nicotine-containing material) and will be disposed 

of at waste incineration facilities or will be recycled via a nicotine reclamation facility. As 

described in Section 7.1.3, the used New Product will be disposed of in the same way as 

other commercially marketed chewable products. The distribution of waste generated due 

to disposal of the New Product and packaging is expected to correspond to the pattern of 
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product use in the United States. 

(b) (4)

7.4.3. Compliance with Federal, State and Local Environmental Regulations 

The 

(b) (4)

, where the New Product will be manufactured, 

comply with the Clean Air Act (CAA), Clean Water Act (CWA) and the Resource 

Conservation and Recovery Act (RCRA). Manufacture of the New Product will not result 

in changes in compliance with relevant federal, state and local environmental regulations. 

The facilities’ compliance with the CAA, CWA, the RCRA, and other environmental 

regulations can be assessed on the USEPA’s Enforcement and Compliance History Online

(ECHO) website. 

USSTC maintains an effective Environmental Management System (EMS) which is 

designed and implemented to integrate environmental programs including (compliance 

and sustainability) into business operations. Key components of the EMS include: 

personnel, policy, directives, guidance and training, data management and assessments. 

(b) (4)

Regarding waste management, USSTC seeks to 

(b) (4)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

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The 

Regarding 

hazardous waste management, 

(b) (4)

(b) (4)

(b) (4)

USSTC’s long-term contracts with material suppliers, and the purchase order terms and 

conditions applicable to suppliers without long-term contracts, contain provisions that 

require compliance with all applicable laws and regulations. Altria’s Supplier Code of

Conduct also addresses compliance with applicable laws, regulations, and standards, 

which includes environmental compliance. 

For 

more information on supply chain management and responsibility, refer to the Altria 

website and the Corporate Responsibility Progress Report 

(http://www.altria.com/Interactive/2017CRReport/files/assets/basic-html/page1.html).

(b) (4)

7.4.4. Environmental Sustainability 

Manufacture of the New Product will not affect environmental sustainability. USSTC has 

an ongoing initiative to improve environmental sustainability across all facilities. One piece 

of infrastructure that supports this initiative is the EMS. 

(b) (4)
 

 

 

 

 

 

 

 

 

 

 

 

 

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(b) (4)

. As a result of these efforts, USSTC expects its overall energy 

use to decrease over time. 

For more information on USSTC’s environmental sustainability initiatives, refer 

(b) (4)

to the Altria website and the Corporate Responsibility Progress Report 

(http://www.altria.com/Interactive/2017CRReport/files/assets/basic-html/page1.html).

However, the power supplier to these manufacturing facilities is Dominion 

(b) (4)

(b) (4)

Energy which has committed to meeting the renewable portfolio goals and standards set 

by policymakers in Virginia.16 Dominion Energy has set a renewable energy goal in Virginia 

to achieve 15% renewable power by 2025. 

8. MITIGATION MEASURES

(b) 

herewith provides the basis for a Finding of No Significant Impact for this 

environmental assessment of the New Product due to de minimis exposure. As such, no 

additional environmental protection measures, mitigation measures or alternative actions 

are necessary to address environmental impacts of the New Product. 

16 Refer to https://www.dominionenergy.com/renewables 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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9. ALTERNATIVES TO THE PROPOSED ACTION 

Alternative A (No-action alternative): The no-action alternative is to not allow the 

marketing of the New Product in the United States. 

Alternative B (Proposed action): Issuing a Finding of No Significant Impact due to the 

proposed action of granting an order finding that the New Product may be introduced or 

delivered for introduction into interstate commerce under Section 910(c)(1)(A)(i) of the 

FD&C Act. 

The no-action alternative is not expected to significantly change the existing condition. 

Therefore, the difference between the environmental impacts of these two alternatives is 

negligible. 

10. LIST OF PREPARERS 

In accordance with 40 CFR 1502.17, this section includes a list of names and qualifications 

(including position/title, education, experience, and expertise) of individuals who were 

primarily responsible for preparing and reviewing this environmental assessment. No 

Agencies or persons besides subject matter experts within 

(b) 

and ALCS were consulted. 

However, feedback from FDA on prior submissions and examples of Environmental 

Assessments posted by FDA were considered in developing this assessment. 

(b) (4)

Education: M.S. in Chemical Engineering; MBA 

Years of Experience: > 25 years in environmental consulting 

Qualifications: Environmental assessments and audits, environmental risk assessment, 

environmental compliance & assurance activities, air quality, and product stewardship and 

sustainability. 

(b) (4)

Education: B.S. in Chemistry; M.S. in Environmental Engineering 

Years of Experience: > 25 years in environmental management and regulatory activities 

Qualifications: Environmental assessments, environmental risk assessment, environmental 

compliance & assurance activities, life cycle assessment, engineering design of pollution 

control measures, and product stewardship and sustainability. 
 

 

 

 

 

 

 

 

 

 

 

 

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(b) (4)

Education: B.S. in Mechanical Engineering 

Years of Experience: 25 years in environmental management and regulatory activities 

Qualifications: Environmental assessments and audits, environmental risk assessment, 

environmental compliance & assurance activities, air quality, Toxic Substances Control Act 

(TSCA) compliance, and product stewardship and sustainability. 

11. REFERENCES

Boublik, T. (1984). The Vapor Pressure of Pure Substances: Selected Values of the Temperature 

Dependance of the Vapor Pressures of Some Pure Substances in the Normal and Low Pressure 

Region (Vol. 17). Amsterdam: Elsevier. 

Bradley, Barber, Kolpin, McMahon, & Chapelle. (2007). Biotransformation of Caffeine, 

Cotinine and Nicotine in Stream Sediments. Environmental Toxicology and Chemistry, 26(6), 

1116-1121. 

Brooks, J., Savarie, P., & Johnston, J. (1998). The oral and dermal toxicity of nicotine 

derivatives of selected chemicals to brown tree snakes. Wildlife Research, 24, 427-435. 

Hansch, C., Hoekman, D., Leo, A., Zhang, L., & Li, P. (1995). The expanding role of 

quantitative structure-activity (QSAR) in toxicology. Toxicology Letters, 79, 45-53. 

Hazardous Substances Data Bank [Internet]. (2014). Nicotine; Hazardous Substances 

Databank Number: 1107. Accessed 12 Nov. 2016. Bethesda (MD): National Library of 

Medicine (US). Retrieved from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB 

Klaasen, C., Amdur, M., & Doull, J. (1995). Toxicology: The Basic Science of Poisons (5th ed.). 

New York: McGraw-Hill. 

Lewis, R. (1992). Sax's Dangerous Properties of Chemicals (8th ed.). New York: Van Nostrand 

Reinhold. 

OECD. (2012). QSAR Toolbox Version 2.3. Retrieved 2012, from 

http://www.oecd.org/document/23/0,3343,en 2649 34379 33957015 1 1 1 1,00.html 

Rizvi, S., Ahmed, R., Zaidi, R. & Naqvi, S. (1990). Toxicity of nicotine derivatives and their 

effect on the protein pattern of 4th immature stage of red cotton stainer Dysdercus koenigii 

(Fabr) (Hemiptera: Pyrrochoridae).. Pak J Pharm Sci. 3(1):67-76. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Sangster, A., & Stuart, K. (1965). Ultraviolet Spectra of Alkaloids. Chemical Reviews, 29, 69-

130. 

Savino, J., & Tanabe, L. (1989). Sublethal Effects of Phenanthrene, Nicotine and Pinene on 

Daphnia pulex. Bull. Environ. Contam. Toxicol., 42(5), 778-784. 

Seckar, J., Mari, S., Stavanja, P., Harp, Y., Yi, C., Gardner, & Doi. (2008). Environmental Fate 

and Effects of Nicotine Released During Cigarette Production. Environmental Toxicology and 

Chemistry, 27(7), 1505-1514. 

USEPA. (2016a). Advancing Sustainable Materials Management: 2014 Fact Sheet, EPA-530-

R-17-01, November 2016, Washington, DC. 

USEPA. (2016b). Estimation Programs Interface SuiteTM for Microsoft® Windows, v 4.11.

United States Environmental Protection Agency, Washington, DC, USA. 

Wang, H. H., Yin, B., Peng, X. X., Wang, J. Y., Xie, Z. H., Gao, J., & Tang, X. K. (2012). 

Biodegradation of nicotine by newly isolated Pseudomonas sp. CS3 and its metabolites. 

Journal of applied microbiology, 112(2), 258-268. Full text available at: 

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2672.2011.05208.x/full. 

12. APPENDICES 

As a final measure of substantiation for the minimal environmental risk associated with 

the use of the New Product, 

(b) 

 has included the following Appendices. 

Data summaries provide a brief summation of the available physico-chemical properties, 

toxicology and ecotoxicology data for the product ingredients and are included in 

Confidential Appendix 5-2-2. Data contained in the attached summaries are from publicly 

available compilations from sources including the USEPA and the European Chemicals 

Agency (ECHA). Specific references are noted as appropriate. 

Additional information regarding the regulatory status of product ingredients are 

provided in Confidential Appendix 5-2-3 to further substantiate FDA’s acceptance of

these substances from an environmental perspective. 
 

 

______________________ 

______________________ 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® CHEWS GREEN MINT 

P A G E 3 5

13. CERTIFICATION

(b) (4)
APPENDIX 5-2-2 - ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION RESPONSE 

TO ADVICF/INFORMATION REQUEST FOR VERVE® CHEWS GREEN MINT 

Data Summaries 

Emptlj boxes in Data Summaries are intentionally left blank 

Data contained in the attached sununaiies are from readily available compilations from 

sources including the US Environmental Protection Agency (EPA) and the European 

Chemicals Agency (ECHA). Specific references are noted as appropriate. 

Ingredient ID# 

1 

2 

3 

4 

5 

7 

8 

9 

11 

12 

14 

16 

17 

18 

19 

20 

21 

24 

In edient Name 

(b) (4) 

Link 

In(tredient l.odf 

lni:tredient 2. odf 

In(tredient 3.odf 

lni:tredient 4. odf 

In(tredient 5.odf 

lni:tredient 7.odf 

In(tredient 8.odf 

lni:tredient 9.odf 

h1gredient ll.odf 

Ingredient 12.vdf 

hwredient 14.odf 

Ingredient 16.vdf 

hwredient 17.odf 

Ingredient 18.vdf 

hwredient 19.odf 

Ingredient 20.vdf 

hwredient 21.odf 

Ingredient 24.vdf 
35 

37 

39 

APPENDIX 5-2-2 - ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION RESPONSE 

TO ADVICF/INFORMATION REQUEST FOR VERVE® CHEWS GREEN MINT 

PAGE 2 

Ingredient ID# In edient Name Link 

25 

26 

28 

29 

30 

32 

33 

34 

36 

38 

40 

41 

42 

43 

44 

46 

47 

48 

49 

(b) (4)

Ingredient 25.vdf 

Ingredient 26.odf 

In2:redient 28.odf 

hwredient 29.odf 

hwredient 30.odf 

hwredient 32.odf 

Ingredient 33.vdf 

Ingredient 34.odf 

hwredient 35.odf 

Ingredient 36.odf 

hwredient 37.odf 

Ingredient 38.odf 

Ingredient 39.vdf 

Ingredient 40.odf 

hwredient 41.odf 

Ingredient 42.ndf 

hwredient 43.odf 

Ingredient 44.odf 

hwredient 46.odf 

Ingredient 47.odf 

hwredient 48.odf 

Ingredient 49.odf 
APPENDIX 5-2-2 - ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION RESPONSE 

TO ADVICF/INFORMATION REQUEST FOR VERVE® CHEWS GREEN MINT 

PAGE 3 

Ingredient ID# 

50 

52 

53 

55 

56 

57 

60 

61 

62 

63 

64 

65 

67 

68 

69 

71 

72 

73 

74 

75 

76 

78 

Ingredient Name Link 

(b) (4)

Ingredient 50.vdf 

Ingredient 52.ndf 

In2:redient 53.odf 

hwredient 55.odf 

hwredient 56.odf 

hwredient 57.odf 

Ingredient 60.vdf 

Ingredient 61.ndf 

hwredient 62.odf 

Ingredient 63.odf 

hwredient 64.odf 

Ingredient 65.odf 

Ingredient 67.vdf 

Ingredient 68.odf 

hwredient 69.odf 

Ingredient 71.odf 

hwredient 72.odf 

Ingredient 73.odf 

hwredient 74.odf 

Ingredient 75.odf 

hwredient 76.odf 

Ingredient 78.odf 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION 

FOR THE PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

Memorandum 

To: Altria Client Services LLC on behalf of U.S. Smokeless 

Tobacco Company LLC 

From: 

(b) (4)

Date: May 24, 2018 

Subject: Environmental Assessment for the Premarket 

Tobacco Product Application for the Product 

Identified as VERVE® Discs Green Mint 

(b) (4)

This environmental assessment was prepared in accordance with 21 CFR 25.40, 

the Food and Drug Administration’s (FDA’s or Agency’s) regulation

implementing the National Environmental Policy Act of 1969. Under NEPA, 

“all applications or petitions requesting Agency action require the submission

of an environmental assessment or a claim of categorical exclusion.”1 

(b) (4)

respectfully submits the 

following environmental assessment in support of the Premarket Tobacco Product 

Application (PMTA) for the product identified as VERVE® Discs Green Mint 

(referred to throughout this assessment as the “New Product”) pursuant to 21 

CFR 25.20 because there is no applicable categorical exclusion for this type of 

application. 

This environmental assessment was conducted in accordance with 21 CFR 25.40 

and relevant aspects of FDA technical guidance documents including: 

 Environmental Considerations for Tobacco Product Applications Submitted to 

CTP, presented by Cristi Stark, M.S., Associate Director for Science Policy, 

Office of Science, CTP, FDA (August 2016); 

 Guidance for Industry: Environmental Impact Assessments (EIA’s) for 

Veterinary Medicinal Products (VMP’s) – Phase I (March 2001); and 

 Guidance for Industry: Environmental Assessment of Drug and Biologics 

Applications (July 1998). 

1 21 CFR 25.15(a) 

(b) (4)
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

P A G E 2 

This environmental assessment was prepared at the direction of Altria Client Services LLC 

(ALCS) on behalf of U.S. Smokeless Tobacco Company LLC (USSTC), a wholly owned 

subsidiary of Altria Group Inc. The potential aquatic, atmospheric, and terrestrial 

environmental impacts of FDA’s approval of the PMTA and subsequent marketing of the 

New Product were considered using a conservative set of assumptions. The assessment 

identified no significant environmental risks, and a Finding of No Significant Impact by 

FDA is warranted for the environmental assessment of the New Product. 

This memorandum contains trade secret and confidential commercial information that 

USSTC considers to be proprietary and highly sensitive, and which is protected from 

disclosure under the Food, Drug and Cosmetic Act §§ 301(j) and 906(c) (21 U.S.C. §§ 331(j) 

and 387f(c)), the Trade Secrets Act (18 U.S.C. § 1905), the Freedom of Information Act (5 

U.S.C. § 552), and FDA’s implementing regulations, 21 CFR Part 20. If FDA receives a 

request for these records and tentatively determines that any portion of this submission is 

disclosable, USSTC requests that FDA provide notice and opportunity for USSTC to object 

to any disclosure in accordance with 21 CFR § 20.47 and 21 CFR § 20.61. USSTC reserves all 

of its legal rights to protect against public disclosure of its trade secret and confidential 

commercial information and to seek legal recourse against anyone who discloses such 

information without legal authorization. 

1. DATE

May 24, 2018 

2. NAME OF APPLICANT/SUBMITTER

Altria Client Services LLC on behalf of U.S. Smokeless Tobacco Company LLC 

3. ADDRESS

2325 Bells Road, Richmond, Virginia 23234 

4. MANUFACTURER

U. S. Smokeless Tobacco Company LLC 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

PAGE 3 

5. DESCRIPTION OF PROPOSED ACTION

The proposed action is for FDA to issue a market authorization order under Section 

910(c)(l)(A)(i) of the Food, D1ug and Cosmetic Act (FD&C Act)2 to introduce the New 

Product into interstate commerce. Through a PMTA for the New Product, USSTC is 

requesting approval from FDA to introduce the New Product into interstate commerce for 

commercial distribution in the United States. USSTC is including this environmental 

assessment with its sublnittal of the PMTA to FDA for the New Product. 

6. IDENTIFICATION OF THE PRODUCT THAT IS THE SUBJECT OF THE PROPOSED ACTION

6.1. Type of Tobacco Product

Verve® discs are a chewable, non-dissolvable, tobacco-de1ived nicotine product (known as 

an oral nicotine-delivery product). The chewable form of the New Product has a soft, 

flexible texture. 

6.2. Estimated Market Volumes 

The following table presents the estimated first-year and fifth-year market volumes for the 

New Product. These estimated market volumes form the basis for the environmental 

exposure estimates provided in this assessment. 

Table 1- Estimated First-Year and Fifth-Year Market Volumes for the New Product 

New Product 

Name Unit First-Year Projected Fifth-Year Projected 

Market Volume Market Volume 

. ' 

VERVE® Discs Tubes3 

Green Mint 

Metiic Tons 

6.3. Product Composition 

The New Product contains tobacco-de1ived nicotine, _______(6f(4t _. non-tobacco

cellulose fiber, flavo1ings, texture modifiers, binders and colorants. 

2 21 u.s.c. 387j 3 TI1ere are 16 discs in one tube. 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

PAGE 4 

6.3.1. Product 

The formulation of the New Product is given in the following table. All values are reported 

in milligrams (mg). 

Table 2 - Product Formulation 

ID Amount per CAS Number Substance #4 Piece (mg) 

(6)(41 1 

3 

6 

7 

9 

10 

15 

17 

22 

23 

26 

31 

36 

45 

50 

51 

4 TI1e ID# is a unique number for each ingredient; it corresponds to the list of ingredients in Confidential 

Appendix 5 -4 -2. 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

PAGE 5 

Table 2 - Product Formulation 

ID Amount per CAS Number Substance #4 Piece (mg) 

(6)1 21 55 

58 

59 

60 

62 

66 

67 

68 

69 

70 

71 

74 

76 

77 

78 

6.3.1.1. Nicotine 

The maximum nicotine content of the New Product is 1.5 mg per piece. 

6.3.2. Packaging 

Packaging material for the New Product comp1ises the following components, with weight 

represented on a per product basis. The individual discs (16) are packaged in a vial which 

contains a vial, cap (lid), cap liner and a label. USSTC has designed all packaging mate1ials 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

PAGE 6 

to meet FDA' s standard for direct and indirect food additives set forth in Title 21 of the 

Code of Federal Regulations (CFR). 

T bl 3 Ch t . ti d W . . ht f P k . . 

- . - M t ' I s 

Packaging Component Package Composition Weight (grams) 

Vial 

Cap 

Cap Liner 

Label 

Carton 

Case 

(b) (4J 

6.4. Location of Manufacture 

The New Product will be manufactured at U.S. Smokeless Tobacco Products LLC, located 

{t>)l.i:J] 

U.S. Smokeless 

Tobacco Products LLC is a business entity of United States Smokeless Tobacco Company 

(USSTC). The (t>) (4 

Product. 

5 TI1ere are 16 discs per tube, 10 tubes per carton and 10 caitons per case. 
 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

P A G E 7 

6.5. Location of Use 

USSTC intends to market the New Product to adult consumers throughout the United 

States. 

6.6. Disposal Sites 

The distribution of waste generated due to disposal of the New Product and/or packaging 

is expected to correspond to the pattern of product use. Disposed materials will either enter 

the recycling stream or be disposed of in municipal solid waste (MSW) landfills or as litter. 

Additional information is provided in Section 7.1.3 below. 

7. ENVIRONMENTAL ISSUES

7.1. Introduction of the Product into the Environment

7.1.1. As a Result of Manufacture 

. 

No significant environmental impacts are anticipated as a result of manufacturing the New 

Product. 

(b) (4)

(b) (4)
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

P A G E 8 

(b) (4)

According to the U.S. Environmental Protection Agency (USEPA)’s most recent National

Biennial Report data 

(https://rcrainfo.epa.gov/rcrainfoweb/action/modules/br/summary/view), 33,646,921 

tons of hazardous wastes were generated across the United States in 2015. Of this amount, 

over 2,688,613 tons were incinerated or used (combusted) for energy recovery. Assuming 

the entire production volume is disposed of by the manufacturing facility, the New Product 

is expected to generate up to 

(b) (4)

of hazardous waste per year.6 This represents up to 

(b) (4)

of the total hazardous waste in the country and up to 

(b) (4)

of the total 

hazardous waste treated by incineration or used (combusted) for energy recovery in the 

country. Thus, the contribution of the New Product to total hazardous waste generated and 

treated by incineration (or energy recovery) annually in the United States is miniscule. 

Therefore, additional resources (e.g., new incineration or similar treatment facilities, etc.) 

will not be required for disposal of the New Product. 

Section 7.1.3 addresses the solid waste generation expected to result from use of the New 

Product. The New Product following use by consumers is an exempt household hazardous 

waste and is not subject to regulation as hazardous waste. 

No significant environmental impacts are anticipated as a result of manufacturing the New 

Product. 

7.1.2. As a Result of Use 

The aquatic environment is the primary compartment of concern for environmental releases 

resulting from use of the New Product. The New Product is used orally. Therefore, 

exposure to the terrestrial and atmospheric environments is not anticipated. 

7.1.2.1. Aquatic 

7.1.2.1.1. Product 

The New Product ingredients are expected to be released primarily to the aquatic 

environment via excretion as a result of product use. To quantify the anticipated amount of 

6 Maximum US tons of MSW per year = A*B*C; where A = Maximum Annual Shipping Quantity between 1st Year 

and 5th Year (g), B = Weight of product (g), C = 1 / 907,185 g/US Ton (Conversion from g to US Tons) 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

P A G E 9 

each chemical substance contained in the New Product to the aquatic environment, 

calculated the annual load (kilograms per year, or kg/yr) and the aquatic expected 

introduction concentration (EIC) (micrograms per liter, or μg/L). 

(b) (4)

applied the 

approach FDA established for human drugs and biologics to calculate the aquatic EIC as 

follows: 

(b) (4)

EIC-aquatic (ppb or μg/L) =A * B * C * D, where 

A=kg/yr produced, 

B=1/1.071x1011 L/day entering POTW (Publicly Owned Treatment Works 

facility) 

(Source: Clean Watersheds Needs Survey (NWNS) 2012 Data and Reports, 

Detailed Listing of Waste Water Treatment Plant Flows for the Nation accessible at 

https://ofmpub.epa.gov/apex/cwns2012/f?p=134:4::::RP::), 

C=year/365, 

D=109 μg/kg 

In calculating the aquatic EIC values, 

(b) (4)

maintained the following conservative 

assumptions that were established in FDA guidance:7 

 The kg/year produced is based on the highest quantity expected to be produced for 

direct use in any of the next five years; 

 All product produced in a year is used and enters the POTW system [The 

ingredients are absorbed by the human body during use and 100% of the ingredients 

are then excreted to sanitary sewer and to treatment within the POTW];8 

 New Product usage occurs throughout the United States in proportion to the 

population and amount of wastewater generated; 

 No dilution occurs in receiving waters; and 

 There is no metabolism. 

The results of these calculations were compared to FDA’s established concentration of 

concern (1 μg/L or ppb). As described in its 2001 technical guidance document, Guidance 

for Industry: Environmental Impact Assessments (EIA’s) for Veterinary Medicinal Products 

(VMP’s) – Phase I, FDA considers this value to be below the level shown to have adverse 

effects in aquatic ecotoxicity studies with human drugs. This was deemed appropriate for 

7 Guidance for Industry: Environmental Assessment of Drug and Biologics Applications (July 1998) 8 (b) (4)
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

PAGE 1 0

the current assessment as No Observed Effect Concentration (NOEC) values for each 

substance, where available, are greater than 1 μg/L or ppb. 

A brief summary of publicly available fate and effects data for each ingredient of the New 

Product is provided in Confidential Appendix 5 -4 -2 for reference. 

T bl 4 A• t' A I L d d EiC f th N P d t 

Annual Load Aquatic EiC 

(μg/L)10 Substance (kg/yr)9

(6)(41 

9 (annual production forecast)x(relative amount in fonnulation) 10 EiC-aquatic (ppb or μg/L)

=A*B*C"D; where A=kg/yr produced, B=l/1.071xl011 L/day entering POTW 

(Source: Clean Watersheds Needs Smvey (NWNS) 2012 Data and Reports, Detailed Listing of Waste Water 

Treatment Plant Flows for the Nation accessible at https:/ / ofmpub.epa.gov /apex/cwns2012/f?p=134:4::::RP::), 

C=year/365, D=109 μg/kg 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

PAGE 1 1

T bl 4 A• t' A I L d d EiC f th N P d t 

Substance 

Annual Load 

(kg/yr)9

Aquatic EiC 

(μg/L)10

{t>) l.i:J] 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

P A G E 1 2

(b) (4)

noted that in every case, the aquatic EIC is 

(b) (4)

at the point of entry into 

the aquatic environment, which is below the relevant concentration of concern identified in 

FDA guidance. 

7.1.2.1.1.1. Nicotine 

The maximum nicotine content of the New Product is 1.5 mg per piece. 

In Table 4, 

(b) (4)

noted that the EIC calculated for nicotine is 

(b) (4)

at the point of 

entry into the aquatic environment and therefore below FDA’s established concentration of

concern. Nonetheless, fate and effects data for nicotine are discussed in detail in Sections 

7.2 and 7.3 of this assessment. 

7.1.2.1.2. Packaging 

Packaging is not intended or expected to release chemical substances during use. Releases 

as a result of disposal are discussed in Section 7.1.3 of this assessment. 

7.1.3. As a Result of Disposal 

Following use by consumers, the New Product is an exempt household waste and is not 

subject to regulation as hazardous waste. The New Product will be disposed of in MSW 

landfills or as litter. The associated packaging materials will either be recycled or be 

disposed of in MSW landfills or as litter. The New Product will be disposed of in the same 

way as other commercially marketed consumer chewable products (e.g., chewing gums or 

chewable tablets). The distribution of waste generated due to disposal of the New Product 

and packaging is expected to correspond to the pattern of product use throughout the 

United States. 

Disposal following use of the New Product is not expected to require additional resources 

for waste disposal. The terrestrial environment is the primary compartment of concern for 

environmental releases of the New Product as a result of disposal. Any release to the aquatic 

environment as a result of disposal is addressed by the calculations conducted in Section 

7.1.2. 

7.1.3.1. Disposal of the Product Following Use 

According to the U.S. Environmental Protection Agency (USEPA) document, Advancing 

Sustainable Materials Management: 2014 Fact Sheet Assessing Trends in Material Generation, 

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

258 million tons of MSW were generated across the United States in 2014. Of this, over 89 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

P A G E 1 3

million tons (34.6%) were recycled and composted, more than 136 million tons (52.6%) were 

discarded in a landfill, and more than 33 million tons (12.8%) were combusted with energy 

recovery (USEPA, 2016a). Chewable nicotine products (oral nicotine-delivery products) are 

not expected to be recycled. 

Assuming the entire production volume is disposed of in a landfill, the New Product is 

expected to generate up to 

(b) (4)

of MSW per year. 11 This represents up to 

(b) (4)

of 

the total MSW in the country and up to

(b) (4)

 of MSW that is disposed of in landfills in 

the country. Thus, the contribution of the New Product to total MSW disposed annually in 

the United States is miniscule. Therefore, additional resources (e.g., new landfills, recycling 

centers, etc.) will not be required for disposal following use of the New Product. 

Proper disposal will be to landfill and not directly to the terrestrial environment. Disposal 

to MSW landfills will not result in adverse effects to the environment based on landfill 

design and regulatory requirements. Disposed waste streams within a landfill are 

prevented from entering the environment and ultimately landfill leachate is treated and/or 

sent to POTWs for effective treatment. 

Disposal following use of the New Product is not expected to result in new or additional 

compounds emitted to the environment. USSTC anticipates the New Product will be 

disposed of following use in the same way as other commercially marketed consumer 

chewable products (e.g., chewing gums or chewable tablets). The distribution of waste 

generated due to disposal of the New Product is expected to correspond to the same pattern 

of product use. No new or additional environmental effects, as defined within 40 CFR 

1508.8, are anticipated. However, improper disposal may occur. The calculations provided 

in Section 7.1.3.2 conservatively address product that is inappropriately disposed of directly 

to the environment. 

7.1.3.2. Terrestrial 

7.1.3.2.1. Product 

Introduction of the New Product to the terrestrial environment was calculated as surface 

density. Absent guidance from FDA on the appropriate duration to be used for this 

calculation and because it is conservatively assumed there is no metabolism or depletion in 

the environment, a timeframe had to be selected. Therefore, the terrestrial surface density 

of each ingredient was calculated on a per day basis. 

11 Maximum US tons of MSW per year = A*B*C; where A = Maximum Annual Shipping Quantity between 1st 

Year and 5th Year (g), B = Weight of product (g), C = 1 / 907,185 g/US Ton (Conversion from g to US Tons) 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

PAGE 1 4

The daily terrestrial surface density values are presented in following table as the 

production tonnage distributed across the surface area of the United States per day 

(nanograms per square meter per day, or ng/m2 per day). These values were based on the 

very conservative assumptions that the entire production volume was introduced to 

commerce and that the New Product is released to the terrestrial environment in its 

complete and unused state. The calculation is shown in the footnote for the table . 

T bl 5 D ·1 T . IS f D VI f h N P d 

Terrestrial Surface Density Substance (ng/m2 per day) 

(6)1 21' 

12 Daily f Surface Density (ng/m2 per day) = A*B*C*D*E; where A = mg/yr produced, B = 1/9.158xl06 km2 smace 

area of the United States, C = yeai/365 days, D = 10-6 km2/m2, E = 106 ng/mg 
ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

PAGE 15 

T bl 5 D ·1 T . IS f D V I f h N P d 

Substance Terrestrial Surface Density 

(ng/m2 per day) 

(b) (4) 

The daily terrestrial surface density values presented as a production tonnage distributed 

across the surface area of the United States are 6)14' ng/ m2 per day as determined using 

the calculations shown in the footnote in the table above. The values are so small that 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

P A G E 1 6

exposure to the New Product in the terrestrial environment as described here would not 

have a significant effect. 

Based on the mass of non-nicotine ingredients shown in Table 2 and publicly available 

environmental fate and effects data, a single used or unused disc that is improperly 

disposed is not expected to cause localized effects to the terrestrial environment. Adverse 

effects are highly unlikely because improper disposal of discs should occur only on rare 

occasions and the non-nicotine ingredients are expected to exhibit a low order of 

environmental toxicity. 

7.1.3.2.1.1. Nicotine 

The maximum nicotine content of the New Product is 1.5 mg per piece. 

The daily terrestrial surface density value for nicotine as the production tonnage distributed 

across the surface area of the United States per day (ng/m2 per day)13 is 

(b) (4)

ng/m2 per 

day. This was based on the very conservative assumptions that the entire production 

volume was introduced to commerce and that the New Product is released to the terrestrial 

environment in its complete and unused state. 

(b) (4)

13 Daily Surface Density (ng/m2 per day) = A*B*C*D*E; where A = mg/yr produced, B = 1/9.158x106 km2 surface 

area of the United States, C = year/365, D = 10-6 km2/m2

, E = 106 ng/mg 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

P A G E 17 

7.1.3.3. Disposal of Packaging Following Use 

The New Product’s packaging is expected to be disposed of following use in the same way

as packaging from other commercially marketed consumer chewable products. The 

distribution of waste generated due to disposal of packaging is expected to correspond to 

the same pattern of product use. 

According to the USEPA document, Advancing Sustainable Materials Management: 2014 Fact 

Sheet Assessing Trends in Material Generation, Recycling, Composting, Combustion with Energy 

Recovery and Landfilling in the United States, 258 million tons of MSW were generated across 

the United States in 2014. Of this, over 89 million tons (34.6%) were recycled and composted, 

more than 136 million tons (52.6%) were discarded in a landfill, and more than 33 million 

tons (12.8%) were combusted with energy recovery (USEPA, 2016a). Assuming all of the 

New Product packaging is disposed of to landfill, packaging from the New Product is 

expected to generate up to 

(b) (4)

of MSW per year14. This represents up to 

(b) (4)

of 

the total MSW in the country and up to

(b) (4)

 of MSW that is disposed of in landfills in 

the country. Thus, the contribution of the New Product’s packaging to total MSW disposed 

annually in the United States is miniscule. Therefore, disposal of the New Product’s

packaging following use of the New Product is not expected to require additional resources 

(e.g., new landfills, recycling centers, etc.) for waste disposal. 

Disposal of packaging following use of the New Product is not expected to result in new or 

additional compounds emitted to the environment. The materials used in the packaging of 

the New Product 

(b) (4)

are common packaging 

materials used for consumer products in general. Proper disposal will be to landfill and not 

directly to the terrestrial environment. Disposal to MSW landfills will not result in adverse 

effects to the environment based on landfill design and regulatory requirements. The same 

or similar compounds and types of emissions are anticipated from disposal of the 

packaging of the New Product as those associated with disposal of the packaging of other 

consumer chewable products or consumer products in general. Thus, no new or additional 

environmental effects, as defined within 40 CFR 1508.8, are anticipated. 

7.2. Fate of Product Released into the Environment 

Due to its ecotoxicological relevance, we discuss the fate of nicotine released into the 

environment in this Section even though nicotine is below concentrations of concern based 

on the exposure assessments within this environmental assessment. 

14 (b) (4)
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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7.2.1. Nicotine 

Quantitative Structure Activity Relationships (QSARs) have been used to describe the 

physical-chemical properties of nicotine and to provide predicted aquatic toxicity values to 

support the use of nicotine as a marker compound. Acceptable QSARs are not available to 

predict toxicity to terrestrial organisms. All QSAR predictions were determined using the 

USEPA’s EpiWeb 4.1.15 

7.2.1.1. Physical Chemical Properties 

The physical-chemical properties of pure nicotine (CAS 54-11-5) and its metabolites are 

presented in the following table. Nicotine’s physical-chemical properties can be used to 

assess the fate of nicotine introduced into the environment. 

Nicotine introduced into water will stay mainly in water and will not readily partition to 

air based on its low Henry’s Law Constant (3x10-9 atmospheres – cubic meters per mole or 

atm-m3/mole) and negative air/water partitioning coefficient (Kaw = -6.910) (USEPA, 

2016b). Nicotine in water should not bioaccumulate or bioconcentrate in aquatic organisms 

(measured log Kow = 1.17) (Hansch, Hoekman, Leo, Zhang, & Li, 1995). The predicted 

bioconcentration factor (log BCF) for nicotine of 0.440 supports this conclusion. 

Nicotine introduced into the soil can volatilize to air based on the vapor pressure of 0.032 

mm Hg (Boublik, 1984). However, the extent to which it actually volatilizes will depend on 

its sorption. The log Koc predicted at neutral pH is 2.720 and indicates that nicotine in soil 

has moderate mobility. The mobility of nicotine, a weak acid (pKa 8.5), is pH dependent and 

will increase at alkaline pH. Because nicotine is highly soluble (predicted solubility 

1.000x106 milligrams per liter, or mg/L) and has a negative Kaw, it will most likely partition 

to soil pore-water rather than air. 

15 The EPI (Estimation Programs Interface) SuiteTM is a Windows®-based suite of physical/chemical property and 

environmental fate estimation programs developed by the USEPA’s Office of Pollution Prevention Toxics and Syracuse 

Research Corporation (SRC). EPI SuiteTM uses a single input to run the following estimation programs: KOWWINTM,

AOPWINTM, HENRYWINTM, MPBPWINTM, BIOWINTM, BioHCwin, KOCWINTM, WSKOWWINTM, WATERNTTM,

BCFBAFTM, HYDROWINTM, KOAWIN and AEROWINTM, and the fate models WVOLWINTM, STPWINTM and 

LEV3EPITM. ECOSARTM, which estimates ecotoxicity, is also included in EPI SuiteTM (USEPA, 2016b).
 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Table 6a – Predicted Physical-Chemical Properties of Nicotine and Related 

Compounds 

Table 6b – Predicted Physical-Chemical Properties of Nicotine and Related 

Compounds 

7.2.1.2. Degradation 

Nicotine lacks hydrolyzable groups and, therefore, will not undergo abiotic hydrolysis. 

However, nicotine has the potential to undergo direct photolysis. Nicotine’s electronic

absorption spectrum shows an intense absorption band at 260-262 nanometers (nm) with 

some absorption above 290 nm (within the spectrum of energies provided by sunlight) 

(Sangster & Stuart, 1965). The predicted photochemical half-life for nicotine in air is 1.4 

hours. Nicotine can also degrade in surface waters via indirect photolysis by naturally 

occurring photosensitizers such as dissolved organic matter and hydroxyl radicals. Thus, 

indirect photolysis can play an important role in the degradation of nicotine. 

Biotransformation of nicotine in soils and water-sediment systems has been documented. In 

soils, nicotine is oxidized by the bacteria Arthrobacter oxydans (now known as Arthrobacter 

nicotinovarans). The relative amounts and conditions of biotransformation will vary with 

soil and bacterial populations. The nature of the transformations in soil is not as well 

defined as those in animals. It has been demonstrated in vitro that the first metabolite of 

nicotine is 6-hydroxynicotine, which further breaks down to 6-hydroxypseudonicotine 

Henry's Water Vapour CAS IUPAC Name Law Log Kow log Koc Log Koa Solubility Pressure Constant

mg/L mm Hg 3 atm-m /mol

54-11-5 3-[(2S)-1-Methyl-2-pyrrolidinyl]pyridine 1 000E+06 3 200E-02 3 000E-09 9 980E-01 2 720E+00 8 080E+00

486-56-6 (5S)-1-Methyl-5-(3-pyridinyl)-2-pyrrolidinone 9 990E+05 3 810E-04 3 330E-12 3 400E-01 2 110E+00 8 038E+00

34834-67-8 (5S)-3-Hydroxy-1-methyl-5-(3-pyridinyl)-2-pyrrolidinone 1 000E+06 2 160E-07 5 200E-13 -1 200E+00 1 010E+00 9 190E+00

171140-40-8 5-(3-Pyridinyl)-2-pyrrolidinone 1 000E+06 1 660E-05 1 520E-12 -3 000E-01 2 100E+00 9 900E+00

16543-55-8 3-[(2S)-1-Nitroso-2-pyrrolidinyl]pyridine 6 030E+05 5 120E-04 1 970E-10 3 210E-01 3 200E+00 8 480E+00

127686-49-1 {Nitroso[4-oxo-4-(3-pyridinyl)butyl]amino}methyl acetate 5 040E+03 5 130E-07 3 000E-14 6 860E-01 2 190E+00 1 260E+01

119738-26-0 (2S)-1-Nitroso-1,2,3,6-tetrahydro-2,3'-bipyridine 3 060E+05 6 040E-05 1 970E-10 5 970E-01 3 470E+00 8 690E+00

1133-64-8 3-[(2S)-1-Nitroso-2-piperidinyl]pyridine 1 960E+05 6 680E-05 8 580E-11 8 120E-01 3 470E+00 8 850E+00

Photo- Half-life Half-life CAS IUPAC Name Log Kaw BCF chemical in water in soil half-life

hrs days days

54-11-5 3-[(2S)-1-Methyl-2-pyrrolidinyl]pyridine -6.910E+00 4.400E-01 1.410E+00 3.750E+01 7.500E+01

486-56-6 (5S)-1-Methyl-5-(3-pyridinyl)-2-pyrrolidinone -8.040E+00 5.000E-01 4.900E+00 3.750E+01 7.500E+01

34834-67-8 (5S)-3-Hydroxy-1-methyl-5-(3-pyridinyl)-2-pyrrolidinone -1.067E+01 5.000E-01 4.300E+00 3.750E+01 7.500E+01

171140-40-8 5-(3-Pyridinyl)-2-pyrrolidinone -1.027E+01 5.000E-01 7.990E+00 6.000E+01 1.200E+02

16543-55-8 3-[(2S)-1-Nitroso-2-pyrrolidinyl]pyridine -8.160E+00 5.000E-01 5.400E+00 6.000E+01 1.200E+02

127686-49-1 {Nitroso[4-oxo-4-(3-pyridinyl)butyl]amino}methyl acetate -1.191E+01 5.000E-01 4.200E+00 6.000E+01 1.200E+02

119738-26-0 (2S)-1-Nitroso-1,2,3,6-tetrahydro-2,3'-bipyridine -8.090E+00 5.000E-01 1.430E+00 6.000E+01 1.200E+02

1133-64-8 3-[(2S)-1-Nitroso-2-piperidinyl]pyridine -8.030E+00 5.000E-01 3.380E+00 6.000E+01 1.200E+02
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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(oxynicotine) and other compounds. Cotinine, which is a major oxidation product of 

nicotine in the liver, has not been reported to form in soils; however, microorganisms 

isolated from soils in tobacco fields are capable of degrading nicotine to cotinine in solution 

(Wang et al., 2012). 

Nicotine and its metabolite, cotinine, have been reported to biotransform in sediments 

(Bradley, Barber, Kolpin, McMahon, & Chapelle, 2007). Under oxidizing conditions nicotine 

and cotinine degrade completely to CO2 within 72 days. Under anoxic conditions the 

biotransformation of nicotine and cotinine is slower. EpiWeb 4.1 predicts half-lives of 37.5 

days for nicotine and cotinine in water and 75 days in soil under aerobic conditions. 

Data on the transformation products or metabolites of nicotine are very limited. In order to 

have a common frame of reference, we compared the predicted values for nicotine to the 

predicted values for the metabolites. Predicted physical-chemical properties of nicotine 

metabolites and transformation products compare to those of nicotine as follows. Predicted 

log Kow values range from -1.200 to 0.998. Predicted log Koc ranges from 1.010 to 3.470. 

Predicted water solubilities range from 5.040x103 mg/L to 1.000x106 mg/L with nicotine 

being among the more soluble substances. Predicted Henry’s Law Constants range from

3.000x10-14 atm-m3/mole to 3.000x10-9 atm-m3/mole for nicotine and related compounds. 

Predicted photochemical half-lives range from 1.410 to 7.990 days for nicotine and related 

compounds. Predicted half-lives in water are all less than 60 days and half-lives in soil are 

predicted to be less than 120 days. Relative to its metabolites, nicotine is more water soluble 

and more volatile, and degrades somewhat more quickly. Its behavior was deemed similar 

enough to that of its metabolites to serve as an appropriate surrogate in the environmental 

assessment. 

7.3. Environmental Effects of Product Released into the Environment 

Due to its ecotoxicological relevance, we discuss the effects of nicotine released into the 

environment in this Section even though nicotine is below concentrations of concern based 

on the exposure assessments within this environmental assessment. 

7.3.1. Nicotine 

QSAR predictions in Table 7 were used here as a basis of comparison among nicotine and 

related compounds and should be taken as qualitative rather than quantitatively definitive. 

Equations for different classes of compounds used to develop the ECOSAR model within 

OECD Toolbox V2.38 (OECD, 2012) are of differing reliabilities depending on the dataset 

used to develop the equation. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Table 7 - Acute Aquatic Toxicity of Nicotine and Related Compounds 

Predicted algal 96-hr EC50 values range from 17.8 mg/L to 176 mg/L. The predicted EC50

for nicotine (CAS 54-11-5) is 44.7 mg/L. While not predicted to be the most toxic compound, 

nicotine toxicity is within a factor of 2 of the most toxic compounds and likely not 

significantly different (i.e., within the confidence limits of the prediction). Measured 96-hr 

EC50 values for the toxicity of nicotine to the alga Selenastrum capricornutum were 72.9 mg/L 

for growth and 115 mg/L for biomass (Seckar, et al., 2008). The predicted EC50 values for 

nicotine were lower than the measured values but within a factor of 2. 

The predicted 48-hr EC50 of nicotine to Daphnia is 0.2 mg/L. Predicted toxicity values for 

the nicotine metabolites range from 0.22 mg/L to 5,350 mg/L. The measured EC50 value for 

Daphnia pulex is 0.24 mg/L (Savino & Tanabe, 1989). 

The predicted fish 96-hr LC50 for nicotine is 4.86 mg/L. The predicted LC50 values for 

metabolites of nicotine range from 6.55 to 11,000 mg/L. Measured LC50 values for nicotine 

toxicity to Oncorhynchus mykiss larvae are 4 mg/L (96 hrs), 5 mg/L for fry (60 days), and 6 

mg/L for fry (21-31 days). 

Terrestrial toxicity data for invertebrates were of limited availability. Because nicotine has 

a history of use as a pesticide, it is expected that terrestrial invertebrates will be very 

sensitive to nicotine. Rizvi et al. reported that the 24-hr LD50 of nicotine dust was 7.2 

micrograms (μg)/nymph for Dysdercus koenigii (Fabr.) (Rizvi, Ahmed, & Naqvi, 2012). 

Additional toxicity data are included on dermal toxicity to the brown tree snake, oral 

toxicity to rats, and dermal toxicity to rabbits. Terrestrial toxicity to the brown tree snake 

(Boiga irregularis) is reported as 40 milligrams per kilogram (mg/kg) dermally, a dose that 

killed 100% of snakes (Brooks, Savarie, & Johnston, 1998). The oral LD50 dose for nicotine in 

rats is 50 mg/kg to 60 mg/kg (Klaasen, Amdur, & Doull, 1995). The dermal LD50 in rabbits 

is reported as 140 mg/kg (Lewis, 1996). 

Algal Daphnia Fish 

CAS IUPAC Name 96- 48-hr - 96-hr

EC50 EC50 LC50

mg/L mg/L mg/L

54-11-5 3-[(2S)-1-Methyl-2-pyrrolidinyl]pyridine 44.70 0.20 4.86

486-56-6 (5S)-1-Methyl-5-(3-pyridinyl)-2-pyrrolidinone 17.80 1.92E+03 8.11E+02

34834-67-8 (5S)-3-Hydroxy-1-methyl-5-(3-pyridinyl)-2-pyrrolidinone 176.00 5.35E+04 1.11E+04

171140-40-8 5-(3-Pyridinyl)-2-pyrrolidinone 22.20 2.75E+03 1.06E+03

16543-55-8 3-[(2S)-1-Nitroso-2-pyrrolidinyl]pyridine 131.00 0.22 8.66

127686-49-1 {Nitroso[4-oxo-4-(3-pyridinyl)butyl]amino}methyl acetate 42.50 38.00 372.00

119738-26-0 (2S)-1-Nitroso-1,2,3,6-tetrahydro-2,3'-bipyridine 93.30 0.23 7.57

1133-64-8 3-[(2S)-1-Nitroso-2-piperidinyl]pyridine 69.00 0.24 6.55
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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7.4. Use of Resources and Energy 

Based on the estimated maximum annual market volume of the New Product (from the 

five-year projected market volume), the use of resources and energy due to the proposed 

action is expected to be negligible. 

7.4.1. Energy Consumption / Greenhouse Gas Emissions 

The process does not emit greenhouse gas (GHG) 

pollutants. Energy consumption due to warehousing and distribution is expected to be 

similar to other consumer products of similar size. 

The New Product manufacturing process is

(b) (4)

Additional information on energy and resource sustainability efforts are described in 

Section 7.4.4. 

7.4.2. Compliance with ESA and CITES 

No critical habitat is affected from materials or ingredients used to manufacture the New 

Product. 

No adverse effects are expected 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 Flora and Fauna (CITES) due to the manufacture or marketing 

of the New Product. 

USSTC does not anticipate that any critical habitat or endangered or threatened species will 

be affected from production of the New Product, or from materials or ingredients used to 

manufacture the New Product. Altria and USSTC’s supply contracts and supplier code of 

conduct standards support compliance with applicable laws (refer to Section 7.4.4). For 

more information on supply chain management and responsibility, refer to the Altria 

website and the Corporate Responsibility Progress Report available at 

http://www.altria.com/Interactive/2017CRReport/files/assets/basic-html/page-1.html. 

The manufacturing facilities are not within or in close proximity to a critical habitat of a 

threatened or endangered species. USSTC does not expect the manufacture and commercial 

introduction of the New Product to affect a critical habitat or threaten the existence of listed 

species or destroy or adversely modify any designated critical habitat for that species. This 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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is based on a review of critical habitat maps 

(https://databasin.org/datasets/d579d87eb54f4374a77ea53e7ef66449) created by the U.S. 

Fish and Wildlife Service (US FWS), which show no critical habitat within close proximity 

to the manufacturing facilities. 

The US FWS’s list of species by county (https://www.fws.gov/endangered/) shows that 

Chesterfield County and Henrico County, Virginia may have one endangered species 

(Clams – James spinymussel (Pleurobema collina)) and three threatened species (Mammals –

Northern Long-Eared Bat (Myotis septentrionalis; Flowering Plants – Sensitive joint-vetch 

(Aeschynomene virginica), Swamp pink (Helonias bullata)). However, these threatened or 

endangered species are not known to be in the vicinity of the manufacturing facility. 

(b) (4)

As described in Section 7.1.1, waste generated as a result of manufacturing the New Product 

will be considered a hazardous waste (nicotine-containing material) and will be disposed 

of at waste incineration facilities or will be recycled via a nicotine reclamation facility. As 

described in Section 7.1.3, the used New Product will be disposed of in the same way as 

other commercially marketed chewable products. The distribution of waste generated due 

to disposal of the New Product and packaging is expected to correspond to the pattern of 

product use in the United States. 

(b) (4)

7.4.3. Compliance with Federal, State and Local Environmental Regulations 

The 

(b) (4)

, where the New Product will be manufactured, 

comply with the Clean Air Act (CAA), Clean Water Act (CWA) and the Resource 

Conservation and Recovery Act (RCRA). Manufacture of the New Product will not result 

in changes in compliance with relevant federal, state and local environmental regulations. 

The facilities’ compliance with the CAA, CWA, the RCRA, and other environmental 

regulations can be assessed on the USEPA’s Enforcement and Compliance History Online

(ECHO) website. 
 

 

 

 

 

 

 

 

 

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USSTC maintains an effective Environmental Management System (EMS) which is 

designed and implemented to integrate environmental programs (including compliance 

and sustainability) into business operations. Key components of the EMS include: 

personnel, policy, directives, guidance and training, data management and assessments. 

Regarding waste management, USSTC seeks to 

The 

(b) (4)

(b) (4)

(b) (4)
 

 

 

 

 

 

 

 

 

 

 

 

 

 

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(b) (4)

USSTC’s long-term contracts with material suppliers, and the purchase order terms and 

conditions applicable to suppliers without long-term contracts, contain provisions that 

require compliance with all applicable laws and regulations. Altria’s Supplier Code of

Conduct also addresses compliance with applicable laws, regulations, and standards, 

which includes environmental compliance. 

For 

more information on supply chain management and responsibility, refer to the Altria 

website and the Corporate Responsibility Progress Report 

(http://www.altria.com/Interactive/2017CRReport/files/assets/basic-html/page1.html). 

(b) (4)

7.4.4. Environmental Sustainability 

Manufacture of the New Product will not affect environmental sustainability. USSTC has 

an ongoing initiative to improve environmental sustainability across all facilities. One piece 

of infrastructure that supports this initiative is the EMS. 

As a result of these efforts, USSTC expects its overall energy 

(b) (4)

use to decrease over time. 

. For more information on USSTC’s environmental sustainability initiatives, refer 

(b) (4)

to the Altria website and the Corporate Responsibility Progress Report 

(http://www.altria.com/Interactive/2017CRReport/files/assets/basic-html/page1.html). 

(b) (4)
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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However, the power supplier to these manufacturing facilities is Dominion 

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

Energy which has committed to meeting the renewable portfolio goals and standards set 

by policymakers in Virginia.16 Dominion Energy has set a renewable energy goal in Virginia 

to achieve 15% renewable power by 2025. 

8. MITIGATION MEASURES 

(b) (4)

herewith provides the basis for a Finding of No Significant Impact for this 

environmental assessment of the New Product due to de minimis exposure. As such, no 

additional environmental protection measures, mitigation measures or alternative actions 

are necessary to address environmental impacts of the New Product. 

9. ALTERNATIVES TO THE PROPOSED ACTION 

Alternative A (No-action alternative): The no-action alternative is to not allow the 

marketing of the New Product in the United States. 

Alternative B (Proposed action): Issuing a Finding of No Significant Impact due to the 

proposed action of granting an order finding that the New Product may be introduced or 

delivered for introduction into interstate commerce under Section 910(c)(1)(A)(i) of the 

FD&C Act. 

The no-action alternative is not expected to significantly change the existing condition. 

Therefore, the difference between the environmental impacts of these two alternatives is 

negligible. 

10. LIST OF PREPARERS 

In accordance with 40 CFR 1502.17, this section includes a list of names and qualifications 

(including position/title, education, experience, and expertise) of individuals who were 

primarily responsible for preparing and reviewing this environmental assessment. No 

Agencies or persons besides subject matter experts within 

(b) 

and ALCS were consulted. 

16 Refer to https://www.dominionenergy.com/renewables 
 

 

 

 

 

 

 

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However, feedback from FDA on prior submissions and examples of Environmental 

Assessments posted by FDA were considered in developing this assessment. 

(b) (4)

Education: M.S. in Chemical Engineering; MBA 

Years of Experience: > 25 years in environmental consulting 

Qualifications: Environmental assessments and audits, environmental risk assessment, 

environmental compliance & assurance activities, air quality, and product stewardship and 

sustainability. 

(b) (4)

Education: B.S. in Chemistry; M.S. in Environmental Engineering 

Years of Experience: > 25 years in environmental management and regulatory activities 

Qualifications: Environmental assessments, environmental risk assessment, environmental 

compliance & assurance activities, life cycle assessment, engineering design of pollution 

control measures, and product stewardship and sustainability. 

(b) (4)

Education: B.S. in Mechanical Engineering 

Years of Experience: 25 years in environmental management and regulatory activities 

Qualifications: Environmental assessments and audits, environmental risk assessment, 

environmental compliance & assurance activities, air quality, Toxic Substances Control Act 

(TSCA) compliance, and product stewardship and sustainability. 
 

 

 

 

 

 

 

 

 

 

 

 

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11. REFERENCES 

Boublik, T. (1984). The Vapor Pressure of Pure Substances: Selected Values of the Temperature 

Dependance of the Vapor Pressures of Some Pure Substances in the Normal and Low Pressure 

Region (Vol. 17). Amsterdam: Elsevier. 

Bradley, Barber, Kolpin, McMahon, & Chapelle. (2007). Biotransformation of Caffeine, 

Cotinine and Nicotine in Stream Sediments. Environmental Toxicology and Chemistry, 26(6), 

1116-1121. 

Brooks, J., Savarie, P., & Johnston, J. (1998). The oral and dermal toxicity of nicotine 

derivatives of selected chemicals to brown tree snakes. Wildlife Research, 24, 427-435. 

Hansch, C., Hoekman, D., Leo, A., Zhang, L., & Li, P. (1995). The expanding role of 

quantitative structure-activity (QSAR) in toxicology. Toxicology Letters, 79, 45-53. 

Hazardous Substances Data Bank [Internet]. (2014). Nicotine; Hazardous Substances 

Databank Number: 1107. Accessed 12 Nov. 2016. Bethesda (MD): National Library of 

Medicine (US). Retrieved from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB 

Klaasen, C., Amdur, M., & Doull, J. (1995). Toxicology: The Basic Science of Poisons (5th ed.). 

New York: McGraw-Hill. 

Lewis, R. (1992). Sax's Dangerous Properties of Chemicals (8th ed.). New York: Van Nostrand 

Reinhold. 

OECD. (2012). QSAR Toolbox Version 2.3. Retrieved 2012, from 

http://www.oecd.org/document/23/0,3343,en 2649 34379 33957015 1 1 1 1,00.html 

Rizvi, S., Ahmed, R., Zaidi, R. & Naqvi, S. (1990). Toxicity of nicotine derivatives and their 

effect on the protein pattern of 4th immature stage of red cotton stainer Dysdercus koenigii 

(Fabr) (Hemiptera: Pyrrochoridae).. Pak J Pharm Sci. 3(1):67-76. 

Sangster, A., & Stuart, K. (1965). Ultraviolet Spectra of Alkaloids. Chemical Reviews, 29, 69-

130. 

Savino, J., & Tanabe, L. (1989). Sublethal Effects of Phenanthrene, Nicotine and Pinene on 

Daphnia pulex. Bull. Environ. Contam. Toxicol., 42(5), 778-784. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Seckar, J., Mari, S., Stavanja, P., Harp, Y., Yi, C., Gardner, & Doi. (2008). Environmental Fate 

and Effects of Nicotine Released During Cigarette Production. Environmental Toxicology and 

Chemistry, 27(7), 1505-1514. 

USEPA. (2016a). Advancing Sustainable Materials Management: 2014 Fact Sheet, EPA-530-

R-17-01, November 2016, Washington, DC. 

USEPA. (2016b). Estimation Programs Interface SuiteTM for Microsoft® Windows, v 4.11.

United States Environmental Protection Agency, Washington, DC, USA. 

Wang, H. H., Yin, B., Peng, X. X., Wang, J. Y., Xie, Z. H., Gao, J., & Tang, X. K. (2012). 

Biodegradation of nicotine by newly isolated Pseudomonas sp. CS3 and its metabolites. 

Journal of applied microbiology, 112(2), 258-268. Full text available at: 

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2672.2011.05208.x/full. 

12. APPENDICES 

As a final measure of substantiation for the minimal environmental risk associated with 

the use of the New Product, 

(b) (4)

 has included the following Appendices. 

Data summaries provide a brief summation of the available physico-chemical properties, 

toxicology and ecotoxicology data for the product ingredients and are included in 

Confidential Appendix 5-4-2. Data contained in the attached summaries are from publicly 

available compilations from sources including the USEPA and the European Chemicals 

Agency (ECHA). Specific references are noted as appropriate. 

Additional information regarding the regulatory status of product ingredients are 

provided in Confidential Appendix 5-4-3 to further substantiate FDA’s acceptance of

these substances from an environmental perspective. 
 

 

______________________ 

______________________ 

ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR THE 

PRODUCT IDENTIFIED AS VERVE® DISCS GREEN MINT 

P A G E 30 

13. CERTIFICATION 

(b) (4)
(b)(4 

58 

APPENDIX 5-4-2 - ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION RESPONSE 

TO ADVICF/INFORMATION REQUEST FOR VERVE® DISCS GREEN MINT 

Data Summaries 

Emptlj boxes in Data Summaries are intentionally left blank 

Data contained in the attached sununaiies are from readily available compilations from 

sources including the US Environmental Protection Agency (EPA) and the European 

Chemicals Agency (ECHA). Specific references are noted as appropriate. 

Ingredient ID# Ingredient Name Link 

1 In(tredient l.odf 

3 Ini:rredient 3.odf 

6 In(tredient 6.odf 

7 Ini:rredient 7.odf 

9 In(tredient 9.odf 

10 InQ"redient 10.pdf 

15 In(tt·edient 15.odf 

17 Imrredient 17.pdf 

22 In(tt·edient 22.odf 

23 Imrredient 23.pdf 

26 In(tt·edient 26.odf 

31 Imrredient 31.pdf 

36 In(tt·edient 36.odf 

45 Imrredient 45.pdf 

so In(tt·edient 50.odf 

51 Imrredient 51.pdf 

55 In(tt·edient 55.odf 

Imrredient 58.pdf 

(6) (4J 
APPENDIX 5-4-2 - ENVIRONMENT AL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION RESPONSE 

TO ADVICF/INFORMATION REQUEST FOR VERVE® DISCS GREEN MINT 

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