TABLE OF CONTENTS 

ENVIRONMENTAL ASSESSMENT TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION FOR

LOGIC® PRO RECHARGEABLE ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) PRODUCTS................. 3

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

2. NAME OF APPLICANT/SUBMITTER .............................................................................................................................. 4

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. E-liquid ........................................................................................................................................................................ 8

6.3.1.2 Capsule/Cartomizer (excluding e-liquid) and Cartomizer Case ...................................................................................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 ................................................................................................................................................................... 13

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 Nicotine ............................................................................................................................................ 13

7.1.1.2. Manufacture of Flavors .............................................................................................................................................. 15

7.1.1.3. Manufacture of Bulk E-Liquid .................................................................................................................................. 16

7.1.1.4. Manufacture of Battery Unit, Device Kits and Refills .............................................................................................. 17

7.1.1.5. 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. Atomospheric ............................................................................................................................................................. 26

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

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

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

1

l
7.1.3.2. Disposal of Packaging Following Use ....................................................................................................................... 35

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

7.2.1. Nicotine ......................................................................................................................................................................... 36

7.2.1.1. Physical Chemical Properties .................................................................................................................................... 36

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

7.3. Environmental Effects of Released Products ................................................................................................................... 37

7.3.1. Nicotine ......................................................................................................................................................................... 38

7.4. Use of Resources and Energy .......................................................................................................................................... 39

7.4.1. Use of Resources .......................................................................................................................................................... 39

7.4.2. Use of Energy ............................................................................................................................................................... 39

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

7.5.1. Compliance with ESA and CITES ................................................................................................................................ 41

7.5.2. Environmental Sustainability ........................................................................................................................................ 43

8. MITIGATION MEASURES .............................................................................................................................................. 44

9. ALTERNATIVES TO THE PROPOSED ACTION .......................................................................................................... 44

10. LIST OF PREPARERS .................................................................................................................................................... 45

11. REFERENCES ................................................................................................................................................................. 48

12. APPENDICES .................................................................................................................................................................. 51

LIST OF TABLES 

Table 1. Logic® Pro Rechargeable Manufacturer Information ................................................................................................ 5

Table 2a. Characterization of the Product – Capsule Tank System .......................................................................................... 7

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

Table 2c. Characterization of the Product – Tobacco ............................................................................................................... 7

Table 2d. Characterization of the Product – Cherry ................................................................................................................. 7

Table 2e. Characterization of the Product – Berry Mint ........................................................................................................... 8

Table 3. Formulation of E-Liquid – Maximum Ingredient Weight for Menthol, Tobacco, Cherry, and Berry Mint Products 8

Table 4. Characterization and Weight of Packaging Materials for the Products. .....................................................................12

Table 5. Maximum Calculated Aquatic EIC Values for Ingredients of the Product’s E-Liquid and HPHCs in the Vapor

(Menthol, Tobacco, Cherry, and Berry Mint).......................................................................................................................... 23

Table 6. Energy Conservation Standards for External Power Supplies ................................................................................. 40

LIST OF APPENDICES

APPENDIX 1. ADDITIONAL INFORMATION ON THE COMPONENTS AND PACKAGING OF THE LOGIC®

PRO RECHARGEABLE ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) PRODUCTS............................... 53

APPENDIX 2. DATA SUMMARY LIST FOR THE LOGIC® PRO RECHARGEABLE ELECTRONIC NICOTINE

DELIVERY SYSTEMS (ENDS) PRODUCTS...................................................................................................................... 62

APPENDIX 3. FDA CITATIONS FOR THE LOGIC® PRO RECHARGEABLE ELECTRONIC NICOTINE

DELIVERY SYSTEMS (ENDS) PRODUCTS......................................................................................................................459

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ENVIRONMENTAL ASSESSMENT 

TRADE SECRET/CONFIDENTIAL COMMERCIAL INFORMATION 

FOR LOGIC® PRO RECHARGEABLE ELECTRONIC NICOTINE 

DELIVERY SYSTEMS (ENDS) PRODUCTS 

Memorandum 

To: Logic Technology Development, LLC 

From: Environmental Resources Management, Inc. 

Date: October 29, 2018 

Subject: Environmental Assessment for the Logic® Pro 

Rechargeable Electronic Nicotine Delivery Systems 

(ENDS) Products 

Environmental 

Resources 

Management 

919 East Main Street

Suite 1701

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

Richmond, VA 23219

(fax)

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 

Absent a categorical exclusion for electronic nicotine delivery systems 

(ENDS), Environmental Resources Management, Inc. (ERM) respectfully 

submits the following environmental assessment in support of the Premarket 

Tobacco Applications (PMTAs) for the Logic® Pro Rechargeable ENDS 

Products (“New 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 

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

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

1 21 CFR 25.15(a) 

3

A member of the Environmental 

Resources Management Group 
 

 

 

 

 

 

 

 

 

 

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 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 

October 29, 2018 

2. NAME OF APPLICANT/SUBMITTER 

Logic Technology Development, LLC 

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

proposed action of authorizing the New Products and the associated manufacture, use, 

and disposal from use of the New Products. 

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. 

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 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, 

Toxic Substances Control Act (TSCA) compliance, and product 

stewardship and sustainability. 

 ERM, Inc. 

(b)(6)

Education: B.S. in Environmental, Safety and Occupational Health 

Management; M.S. in Environmental and Industrial Hygiene 

Years of Experience: 12 years in global product regulatory affairs 

Qualifications: Environmental assessments, chemical control regulation, 

hazard communication, downstream product regulation, 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. 

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______________________ 

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(b)(6)

ERM, Inc. 

(b)(6)

ERM, Inc. 

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11. REFERENCES 

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Pascual J, Saltó E, Fernández E.. Cigarettes vs. e-cigarettes: Passive exposure at home 

measured by means of airborne marker and biomarkers. Environmental Research, 135 (76–

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Bradley et al. (2007); Bradley, Barber, Kolpin, McMahon, & Chapelle. Biotransformation 

of Caffeine, Cotinine and Nicotine in Stream Sediments. Environmental Toxicology and 

Chemistry, 26(6), 1116-1121. 

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

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

435. 

Chang (2014); Chang, H. Research gaps related to the environmental impacts of 

electronic cigarettes. Tobacco Control. 23, ii54-ii58. 

Czogala et al. (2014); Czogala, J., Goniewicz, M., Fidelus, B., Zielinska-Danch, W., 

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

Nicotine & Tobacco Research, Volume 16 (6), 655–662. 

Gaidajis et al. (2010); Gaidajis, G., Angelakoglou, K., Aktsoglou, D. E-waste: 

Environmental problems and current management. Journal of Engineering Science and 

Technology Review. 3(1), 193-199. 

Gallart-Mateu et al. (2016); Gallart-Mateu D, Elbal L, Armenta S, Guardia M. Passive 

exposure to nicotine from e-cigarettes. Department of Analytical Chemistry, 

University of Valencia, Valencia, Spain. Talanta 2016 May 15; Vol. 152:329-334. 

Geiss et al. (2015); Geiss, O., Bianchi, I., Barahona, F., Barrero-Moreno, J. 

Characterisation of mainstream and passive vapours emitted by selected electronic 

cigarettes. International Journal of Hygiene and Environmental Health, 218, 169-180. 

FEMA (2014); FEMA. Electronic Cigarette Fires and Explosions. U.S. Fire 

Administration, October 2014. 

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Fernández et al. (2015); Fernández, E., Ballbè, M., Sureda, X., et al. Particulate Matter 

from Electronic Cigarettes and Conventional Cigarettes: a Systematic Review and 

Observational Study Current Environmental Health Report 2:423–429. 

Hansch et al. (1995); Hansch, C., Hoekman, D.,Leo, A., Zhang, L., &Li, P. The expanding 

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

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

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

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

Helman (2013); Helman, C. How Much Electricity Do Your Gadgets Really Use? Forbes. 

Retrieved from: http://www.forbes.com/sites/christopherhelman/2013/09/07/howmuch-energy-does-your-iphone-and-other-devices-use-and-what-to-do-aboutit/#15771530228e 

Hochstein et al. (1959); Hochstein, & Rittenberg. The Bacterial Oxidation of Nicotine: 

Nicotine Oxidation by Cell Free Preparations. The Journal of Biological Chemistry, 234(1), 

151-155.

Jaccard et al. (2017); Jaccard G, Tafin Djoko D, Moennikes O, Jeannet C, Kondylis A, 

Belushkin M. Comparative assessment of HPHC yields in the Tobacco Heating System 

THS2.2 and commercial cigarettes. Regul Toxicol Pharmacol. 2017 Nov; 90:1-8. 

Johnson et al. (2018); Johnson J, Naeher L, Yu X, Rathbun S, Muilenburg J, Wang J. Air 

monitoring at large public electronic cigarette events. International Journal of Hygiene 

and Environmental Health. Online: https://doi.org/10.1016/j.ijheh.2018.02.003 

Kang et al. (2013); Kang, D.H.P., Chen, M., Ogunseitan, O.A. Potential environmental 

and human health impacts of rechargeable lithium batteries in electronic waste. 

Environmental Science and Technology. 47, 5495-5503. 

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

Nostrand Reinhold. 

Lincoln et al. (2007); Lincoln, J.D., Ogunseitan, O.A., Shapiro, A.A., Saphores, J.D.M. 

Leaching assessments of hazardous materials in cellular telephones. Environmental 

Science and Technology. 41, 2572-2578. 

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Long (2014); Long, G.A. Comparison of select analytes in exhaled aerosol from ecigarettes with exhaled smoke from a conventional cigarette and exhaled breaths. 

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P. D., Patskan, G. J., Shafer, K. H., Sarkar, M. A. Insights from two industrial hygiene

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PRO RECHARGEABLE ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) 

PRODUCTS 

P A G E 4 9

cigarettes) impairs indoor air quality and increases FeNO levels of e-cigarette 

consumers. Int J Hyg Environ Health. 2S1438-4639(13), 00153-3. 

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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 (cartomizer, cartomizer 

case, 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 

51
 

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PRO RECHARGEABLE ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) 

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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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