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TABLE OF CONTENTS

ENVIRONMENTAL ASSESSMENT TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION 

FOR LOGIC® VAPELEAF RECHARGEABLE ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS)

PRODUCTS................................................................................................................................................................... 3 

1. DATE ........................................................................................................................................................................ 4 

2. NAME OF APPLICANT/SUBMITTER .................................................................................................................. 5 

3. ADDRESS ................................................................................................................................................................ 5 

4. MANUFACTURER .................................................................................................................................................. 5 

5. DESCRIPTION OF PROPOSED ACTION ............................................................................................................. 6 

5.1. Requested Action ................................................................................................................................................... 6 

5.2. Need for Action ...................................................................................................................................................... 6 

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

6.1. Type of Tobacco Product ....................................................................................................................................... 6 

6.2. Name of Products ................................................................................................................................................... 7 

6.3. Product Composition .............................................................................................................................................. 8 

6.3.1. Components and Parts ......................................................................................................................................... 8 

6.3.1.1. Cartridge (E-liquid) .......................................................................................................................................... 8 

6.3.1.2. Tobacco Capsule .............................................................................................................................................. 8 

6.3.1.2.1 Nicotine ..........................................................................................................................................................11 

6.3.1.3. Battery Unit ......................................................................................................................................................11 

6.3.1.4. USB Charger ....................................................................................................................................................11 

6.3.2. Packaging ............................................................................................................................................................12 

6.4. Location of Use ......................................................................................................................................................12 

6.5. Disposal Sites .........................................................................................................................................................12 

7. ENVIRONMENTAL ISSUES ................................................................................................................................ 13 

7.1. Introduction of Products into the Environment .................................................................................................... 13 

7.1.1. As a Result of Manufacture .............................................................................................................................. 13 

7.1.1.1. Manufacture of E-liquid ................................................................................................................................. 13 

7.1.1.2. Manufacture of Tobacco Capsule .................................................................................................................. 14 

7.1.1.3. Manufacture of Battery Unity, Cartirduge, Device Kits (Battery Unit & USB Charger) .............................. 16 

7.1.1.4. U.S. Import and Warehousing ........................................................................................................................ 18 

7.1.2. As a Result of Use ............................................................................................................................................. 20 

7.1.2.1. Aquatic ........................................................................................................................................................... 21 

7.1.2.2. Atmospheric ................................................................................................................................................... 26 

7.1.2.3. Terrestrial ....................................................................................................................................................... 30 

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7.1.3. As a Result of Disposal ..................................................................................................................................... 31 

7.1.3.1. Disposal of the Products Following Use ........................................................................................................ 31 

7.1.3.2. Disposal of Packaging Following Use ........................................................................................................... 36 

7.2. Fate of Products Released into the Environment ................................................................................................. 36 

7.2.1. Nicotine ............................................................................................................................................................. 37 

7.2.1.1. Physical Chemical Properties ......................................................................................................................... 37 

7.2.1.2. Degradation .................................................................................................................................................... 37 

7.3. Environmental Effects of Released Products ....................................................................................................... 38 

7.3.1. Nicotine ............................................................................................................................................................. 39 

7.4. Use of Resources and Energy .............................................................................................................................. 40 

7.4.1. Use of Resources ............................................................................................................................................... 40 

7.4.2. Use of Energy .................................................................................................................................................... 40 

7.5. Compliance with Environmental Laws and Regulations ..................................................................................... 41 

7.5.1. Compliance with ESA and CITES .................................................................................................................... 42 

7.5.2. Environmental Sustainability ............................................................................................................................ 44 

8. MITIGATION MEASURES .................................................................................................................................. 45 

9. ALTERNATIVES TO THE PROPOSED ACTION .............................................................................................. 45 

10. LIST OF PREPARERS ......................................................................................................................................... 46 

11. REFERENCES ...................................................................................................................................................... 49 

12. APPENDICES ...................................................................................................................................................... 53 

LIST OF TABLES

Table 1. Logic Vapeleaf Manufacturer Information ..................................................................................................... 5 

Table 2a. Characterization of the Product – Tobacco Vapor System ........................................................................... 7 

Table 2b. Characterization of the Product – Regular .................................................................................................... 7 

Table 2c. Characterization of the Product – Menthol Green ........................................................................................ 7 

Table 2d. Characterization of the Product – Menthol Purple ....................................................................................... 7 

Table 3. Formulation of Tobacco Capsules for Use in the New Products (Menthol Purple, Menthol Green, and

Regular).......................................................................................................................................................................... 9 

Table 4. Ingredients of Tobacco Granules (excluding Nicotine) for Use in the New Products (Menthol Purple,

Menthol Green, and Regular)......................................................................................................................................... 9 

Table 5. Characterization and Weight of Packaging Materials for the Products. .........................................................12 

Table 6. Maximum Calculated Aquatic EIC Values for Ingredients (and HPHCs) of the New Product’s E-Liquid

and Tobacco Granules (Menthol Purple, Menthol Green, and Regular)..................................................................... 23 

Table 7. Energy Conservation Standards for External Power Supplies ...................................................................... 41 

LIST OF APPENDICES

Confidential Appendix 1. Additional Information on the Components and Packaging of the Logic Vapeleaf

Electronic Nicotine Delivery Systems (ENDS) Products............................................................................................ 54 

Confidential Appendix 2. Data Summary List for the Logic Vapeleaf Rechargeables Electronic Nicotine Delivery

Systems (ENDS) Products........................................................................................................................................... 61 

Confidential Appendix 3. FDA Citations for the Logic Vapeleaf Electronic Nicotine Delivery Systems (ENDS)

Products...................................................................................................................................................................... 290

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To: Logic Technology Development, LLC 

From: Environmental Resources Management, Inc. 

Date: November 17, 2018 

Subject: Environmental Assessment for the Logic® 

VapeleafTM Electronic Nicotine Delivery Systems 

(ENDS) Products 

This environmental assessment was prepared in accordance with 21 CFR 25.20 

and 21 CFR 25.40, the Food and Drug Administration’s (FDA’s or Agency’s)

regulation implementing the National Environmental Policy Act of 1969 

(NEPA). Under NEPA, “all applications or petitions requesting Agency action

require the submission of an environmental assessment or a claim of 

categorical exclusion”.1 

The Logic® VapeleafTM Products (“New Products”) are novel electronic

nicotine delivery systems (ENDS) products with a tobacco component. Absent 

a categorical exclusion for ENDS or tobacco products, Environmental 

Resources Management, Inc. (ERM) respectfully submits the following 

environmental assessment in support of the Premarket Tobacco Applications 

(PMTAs) for the Logic Vapeleaf Products pursuant to 21 CFR 25.20. The 

environmental assessment was prepared in accordance with 21 CFR 25.40 and 

relevant aspects of FDA guidance 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); 

 Environmental Considerations for Premarket Tobacco Product Applications 

Submitted to CTP, presented at “The Premarket Tobacco Product Application

for Electronic Nicotine Delivery Systems (ENDS): A Public Seminar” by 

1 21 CFR 25.15(a) 

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Gregory Gagliano, M.S., Toxicologist, Division of Nonclinical Science, Office 

of Science, CTP, FDA (October, 17 2016); 

 Draft guidance: Premarket Tobacco Product Applications for Electronic Nicotine 

Delivery Systems. Presented by: Paul Hart, J.D. Ii-Lun Chen, M.D. Center for Tobacco 

Products Food and Drug Administration; 

 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). 

This environmental assessment was prepared at the request of Logic Technology 

Development, LLC (Logic). The potential aquatic, atmospheric, and terrestrial 

environmental effects of marketing the New Products were considered using a 

conservative set of assumptions. The assessment identified no significant environmental 

impacts, and a Finding of No Significant Impact by FDA is warranted for this 

environmental assessment of the New Products. 

Confidentiality Statement 

This memorandum contains trade secret and confidential commercial information that 

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

disclosure under the Food, Drug and Cosmetic Act §§ 301(j) (21 U.S.C. §§ 331(j)), 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 and Part 40. If FDA receives a request 

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

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

to any disclosure in accordance with 21 CFR 20.47 and 21 CFR 20.61. Logic 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 

November 17, 2018 

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Under either scenario, we expect that the number of ENDS products sold in the United 

States will be similar. The difference between the environmental impacts of these two 

alternatives is considered negligible, or non-existent. 

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 ERM and Logic were consulted. 

 ERM, Inc. 

(b)(6)

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. 

 ERM, Inc. 

(b)(6)

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. 

 ERM, Inc. 

(b)(6)

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, 

46
 

 

Toxic Substances Control Act (TSCA) compliance, and product 

stewardship and sustainability. 

 ERM, Inc. 

(b)(6)

Education: B.S. in Environmental Toxicology; Registered Environmental 

Assessor 

Years of Experience: 22 years in risk assessment and toxicology 

Qualifications: Environmental exposure assessments, human and 

environmental risk assessments, toxicological research, fate and transport 

assessments, data evaluations, and risk communication. 

47
______________________ 

___________________ 

(b)(6)

ERM, Inc. 

(b)(6)

ERM, Inc. 

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Travers, M.J., Sobczak, A. Secondhand Exposure to Vapors From Electronic Cigarettes. 

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12. APPENDICES

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

the use of the New Products, ERM has included the following Confidential Appendices. 

Additional information on the components of the New Products (cartridge, tobacco 

capsule, battery unit, and USB charger) and the packaging materials is included within 

Confidential Appendix 1. 

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

properties, toxicology and ecotoxicology data for the e-liquid ingredients and are 

included in Confidential Appendix 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 the e-liquid ingredients in 

order to further substantiate FDA’s acceptance of these substances from an

environmental perspective are provided in Confidential Appendix 3. 

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