Programmatic Environmental Assessment for Market
	

Authorization of “General Loose, General Dry Mint Portion 

Original Mini, General Portion Original Large, General Classic 

Blend Portion White Large – 12 CT, General Mint Portion White 

Large, General Nordic Mint Portion White Large – 12 CT, General 

Portion White Large, and General Wintergreen Portion White 

Large” Snus, Manufactured by Swedish Match North America, 

Inc.
	

Prepared by Center for Tobacco Products 

U.S. Food and Drug Administration 

October 8, 2015 
Table of Contents 

1 Name of Applicant 3
 

2 Address of Applicant 3
 

3 Name of Manufacturer 3
 

4 Background 3
 

5 Description of the Proposed Action 3
 

5.1	 Requested Action 4
 

5.2	 Need for Action 4
 

5.3	 Identification of the New Tobacco Products that are Subject of the Proposed Action 4
 

5.3.1 Type of tobacco product 4
 

5.3.2 Name of products 4
 

5.3.3 Package description of the new products 5
 

5.3.4 Location of manufacturing 5
 

5.3.5 Location of use 5
 

5.3.6 Location of disposal 5
 

5.4 Description of the New Products 5
 

6 Environmental Introduction Due to the Proposed Action 6
 

6.1	 Environmental Introduction as a Result of Manufacturing the New Products 6
 

6.1.1 Manufacturing conditions of smokeless tobacco products in the U.S. 6
 

6.1.2 Environmental consequences from manufacturing the new tobacco products 8
 

6.2	 Environmental Introduction as a Result of Use of the New Tobacco Products 9
 

6.2.1 Use of smokeless tobacco products in the U.S. 9
 

6.2.2 Environmental consequences from use of the new products 10
 

6.3	 Environmental Introduction as a Result of Disposal Following Use of the New Tobacco
 

Products 11
 

6.3.1 Disposal following use of smokeless tobacco products in the U.S 11
 

6.3.2 Environmental consequences from disposal following use of the new products 13
 

7 Cumulative Environmental Introduction Due to Past and Future Related Actions 14
 

8 Fate of New Materials Released into the Environment Due to the Proposed Action 15
 

9 Environmental Effects of New Materials Released into the Environment Due to the
 

Proposed Action 15
 

10 Use of Resources and Energy 15
 

11 Mitigation 15
 

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P a g e | 1 
12 Alternative Actions 15
 

13 List of Preparers 16
 

14 List of Appendix 16
 

15 List of Confidential Appendix 16
 

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P a g e | 2
 
This programmatic environmental assessment (PEA) is for market authorization orders for 

“General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General 

Classic Blend Portion White Large – 12 CT, General Mint Portion White Large, General Nordic 

Mint Portion White Large – 12 CT, General Portion White Large, and General Wintergreen 

Portion White Large” Snus. Information presented in the PEA is based on the submissions listed 

in Appendix 1, unless noted or referenced otherwise. This PEA has been prepared in 

accordance with 21 CFR 25.40 in support of the market authorization orders under section 

910(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

1 Name of Applicant 

Swedish Match North America, Inc. 

2 Address of Applicant 

Two James Center 

1021 East Cary Street, Suite 1600 

Richmond, VA 23219 

3 Name of Manufacturer 

Swedish Match North America, Inc. 

4 Background 

Swedish Match North America (SMNA) submitted eight premarket tobacco product applications 

(PMTAs) [PM00000010-PM00000017] for new snus products to FDA seeking authorization 

under Section 910(b) of the FD&C Act. The applicant submitted the PMTAs in connection with 

the June 10, 2014 modified risk tobacco product applications (MRTPAs) for the same eight snus 

products requesting risk modification orders under Section 911(g) of the FD&C Act to change 

the statutory mandated health warning on the package labels and advertisements. Additionally, 

the applicant also submitted Substantial Equivalence (SE) Reports for the same eight snus 

products requesting the market authorizations under section 910(a)(2) of FD&C Act. The 

agency has issued a finding of no significant impact (FONSI)”, dated August 20, 2015, for 

findings of substantial equivalence (SE) “General Loose, General Dry Mint Portion Original Mini, 

General Portion Original Large, General Portion White Large, and General Wintergreen Portion 

White Large” under section 910(a)(2) of FD&C Act. The FONSI is supported by a PEA issued 

on the same date. 

5 Description of the Proposed Action 

The proposed action is for FDA to issue market authorization orders under section 910(c)(1)(A)(i) 

of the FD&C Act prior to marketing the new products listed in Table 1 (See below). The agency 

has found the new snus products may be introduced or delivered for introduction into interstate 

commerce. The applicant has demonstrated that the products meet the criteria for marketing 

authorization under the PMTA pathway under section 910 of the FD&C Act.1 

1 FDA’s Draft Guidance for Industry on Applications for Premarket Review of New Tobacco Products 

P a g e | 3 
5.1 	 Requested A ction 

Orders find ing that the new products may be introduced or delivered for introduction into 

interstate commerce under Section 91 O(b) of the FD&C Act. 

5.2 	 Need for Action 

SMNA wishes to introduce eight new snus products into interstate commerce distribution in 

the United States (U.S.) and submitted to FDA the "Premarket Review of New Tobacco 

Products (PMT)" applications referenced in Appendix 1 to obtain market authorizations 

pursuant to Section 91 O(b) of the FD&C Act. 

Swedish Match North America, Inc. also identified currently marketed products (with the 

same names) that these new products wi ll replace (See Section 6.1.2 if the PEA ). 

5.3 	 Identification of the New Toba cco Products that are Subject of the Proposed 

Action 

5.3.1 Type oftobacco product 

Smokeless Tobacco -loose and portioned snus products 

5.3.2 Name ofproducts 

Product names are listed in Table 1. 

Table 1 List of Product Names, STNs and their Pa ckage Size 

STN Product Name Portion 

Size (g) 

Number of 

Portions per can 

Total Package 

Size (g) 

PM0000010 General Loose NA NA 45 

PM0000011 General Dry Mint Portion 

Original Mini 0.3 20 6 

PM0000012 General Portion Original 

Large 

1 24 24 

PM000001 3 General Classic Blend 

Portion White Large - 12 CT 0.9 12 10.8 

PM0000014 General Mint Portion White 

Large 

1 24 24 

PM0000015 General Nordic Mint Portion 

White Large - 12 CT 0.9 12 10.8 

issued in September 2011 . Avai lable at: 


http://www.fda.gov/dow nloads/TobaccoProducts/ GuidanceComplianceRegu latorylnformation/UCM27342 


S.pdf. Accessed August 6, 2015. 


Page 14 
STN Product Name Portion 

Size (g) 

Number of 

Portions per can 

Total Package 

Size (g) 

PM0000016 General Portion White Large 1 24 24 

PM0000017 General Wintergreen Portion 

White Large 

1 24 24 

5.3.3 Package description ofthe new products 

The packaging components of the fin ished products are similar to that of the snus 

products that are currently being marketed, except for the package size. The packaging 

components of the finished products consist of a can base and plasti c lid that are then 

wra pped in polypropylene plastic f ilm wrap. The can base for the loose product is made 

of card board paper but the can base for the pouched products is made of polypropylene 

plastic. The lid for the portioned products provides spaces designed for disposal of the 

used pouches. The can of the products is round shape but the can for the "General 

Classic Blend Portion White Large" and "General Nordic Mint Portion White Large" 

products is of rectangular shape. 

The package size of the fi nished products is listed in Table 1 and details of the package 

ingredients and weight of each packaging component are described in Confidential 

Appe ndix 1. 

5.3.4 Location of manufacturing 

Swedish Match North Europe 

Trollhi:Htegatan 1 

SE- 401 21 Goteborg, Swede 

5.3.5 Location of use 

Swedish Match North America intends to distribute and sell the new products to 

consumers in the U.S . for use as smokeless tobacco. 

5.3.6 Location of disposal 

The distribution of the generated waste due to disposal after use should correspond to 

the pattern of product use. Disposed packaging materials will either enter the recycling 

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

used tobacco is also disposed of in MSW or as litter. 

5.4 Description of the New Products 

Swedish snus is made mainly from air-dried tobacco varieties, various salts, flavoring, and 

moisture-preserving substances. According to the applications, the new products differ from 

other currently marketed smokeless tobacco products in several ways, including : 

• 

• 

Use of different quantities of tobacco blends 

Increase, decrease or replacement of certain ingredients 

Page 15 
	 

	 

Decrease or increase in quantity of certain harmful or potentially harmful constituents 

(HPHCs), such as the N’-Nitrosonornicotine (NNN), 4-(methylnitrosamino)-1-(3­

pyridyl)-1-butanone (NNK), acetaldehyde, crotonaldehyde, formaldehyde, and BaP 

Additional or tightened specifications for design features such as pH, pouch width 

decrease and tightened range limit for the ingredients and packaging components. 

Additionally, the plastic can design provides space for the used pouch receptacle in the lid of 

the can of pouched products. 

6 Environmental Introduction Due to the Proposed Action 

6.1 Environmental Introduction as a Result of Manufacturing the New Products 

6.1.1 Manufacturing conditions of smokeless tobacco products in the U.S. 

Smokeless tobacco products include: (i) chewing tobacco, which includes loose leaf, 

plug, or twist, and may come in flavors; (ii) snuff, which includes moist or dry and can be 

loose, or in packets; and (iii) dissolvables, which includes lozenges, sticks, strips, and 

orbs.2 3 Snus, also called spitless, is a moist snuff of finely ground tobacco and is 

available in either loose form or portioned form in sealed pouches.4 5 

Worldwide import of snuff into the U.S. has shown a 64-fold increase during the past 10 

years from 5 tons in 2005 to 319 tons in 2014. The U.S. import of snuff from Sweden 

also increased 33-fold, from 2.5 tons in 2005 to 165 tons in 2014 (Figure 1 and Figure 2). 

Products imported from Sweden comprise 50% and 27% of the worldwide import of snuff 

and smokeless tobacco, respectively, into the U.S.6 7 

2 World Health Organization. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. 

Volume 89: Smokeless Tobacco and Some Tobacco-Specific N-Nitrosamines. Lyon (France): W orld 

Health Organization, International Agency for Research on Cancer, 2007. Available at: 

http://monographs.iarc.fr/ENG/Monographs/vol89/mono89.pdf. Accessed June 20, 2015. 

3 U.S. Department of Health and Human Services. Preventing Tobacco Use Among Youth and Young 

Adults: A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services, 

Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health 

Promotion, Office on Smoking and Health, 2012. Available at: 

http://www.cdc.gov/tobacco/data_statistics/sgr/2012/index.htm. Accessed June 20, 2015 

4 Digard H, Errington G, Richter A and McAdam K. Patterns and behaviors of snus consumption in 

Sweden. Nicotine & Tobacco Research. 2009;11(10):1175-1181 

5 Hatsukami DK1, Ebbert JO, Feuer RM, Stepanov I, Hecht SS. Changing smokeless tobacco products 

new tobacco-delivery systems. Am J Prev Med. 2007;33(6 Suppl):S368-S378 

6 United States Department of Agriculture (USDA). Foreign Agricultural Service (FAS). Global Agricultural 

Trade System (GATS). Available at: http://apps.fas.usda.gov/gats/default.aspx. Accessed on April 29, 

2015 

7 Unit is defined by the United States International Trade Commission, available at: 

http://dataweb.usitc.gov/scripts/tariff_current.asp?Phase=List_items&lookfor=481310. Accessed on April 

29, 2015 

P a g e | 6 
Figure 1- U.S. Import of Smokeless Tobacco Products in 2005-2014 6 7 

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Page 17 
6.1.2	 Environmental consequences from manufacturing the new tobacco 

products 

The agency anticipates the waste generated as a result of manufacturing the new snus 

products to be released to the environment, transferred to publicly owned treatment 

works (POTW), and disposed of in landfills in the same manner as the waste generated 

from any other products manufactured in the same facility and in a similar manner to 

other smokeless tobacco products manufactured in Sweden. Therefore, the agency does 

not foresee the introduction of the new products to notably affect the current 

manufacturing waste generated as a result of manufacturing the new products. 

The new products will be manufactured in Sweden in two facilities that also manufacture 

other currently marketed snus products with the same names; one in Gothenburg and 

one in Kungalv. The applicant stated that both facilities comply with environmental 

legislation known as Miljobalken (1998:808) and are regulated by Gothenburg 

Environmental Agency and Kungalv Environmental Agency, respectively. According to 

the applicant, these agencies review the respective facilities on an annual basis for 

compliance with the environmental legislation to ensure efficient energy consumption 

and no environmental leakages. In addition, the new products are anticipated to replace 

the currently marketed snus products with same names, therefore, the agency does not 

anticipate any additional emissions to be released into the environment as a result of 

manufacturing the new products. 

No economic models are available to the agency to forecast the manufacturing of 

smokeless or snuff products in Sweden or their import into the U.S. To evaluate the 

environmental impact of the proposed action due to the manufacture of the new products 

in Sweden, the agency utilized historic data from 2009-2014 to forecast the amount of 

smokeless tobacco products imported to the U.S. from Sweden if the authorization 

orders are issued. This was achieved by using a best-fit trendline, which includes; 

exponential with an R2 value of 0.9683 for world smokeless import, exponential with an 

R2 value of 0.9348 for world snuff import, and power with an R2 value of 0.935 for 

Sweden snus import (See Appendix 2). A most accurate best-fit trendline is when the R2 

value is at or near 1. Accordingly, the forecast of future import of smokeless products 

was estimated using mathematical prediction (Appendix 2). 

The applicant also submitted SE Reports (SE0010524-SE0010533, listed in Appendix 1) 

to obtain market authorizations pursuant to section 910(a)(2) of the FD&C Act for the 

same new products.The applicant also submitted Modified Risk Tobacco Product 

Applications (MRTPA) (MR0000020-MR0000029 listed in Appendix 1) to obtain market 

authorizations pursuant to section 911(g) of the FD&C Act for the same new products 

but with the applicant’s proposed modifications of the package labels. The applicant 

indicated in the MRTPAs that the projected market volumes of the new products in the 

SE Reports and in the MRTPAs are the same. The applicant also indicated the lack of 

mathematical methods to forecast the difference in market volume projections due to the 

proposed changes to the package labels. As described in the SE Reports, the applicant 

indicated that these new products will replace currently marketed products with the same 

names. 

P a g e | 8 
The individual and cumulative projected market volumes of the new products in the 1st , 

5th, and 10th years of issuing the PMTA authorizations are anticipated to be a fraction of 

the forecasted worldwide import of smokeless products or snuff into the U.S. 

(Confidential Appendix 2 and Confidential Appendix 3). Additionally, the projected 

market volumes of the new products are a portion of the U.S. import forecast of snuff 

tobacco from Sweden. However, as discussed, the new products are expected to 

replace the currently marketed products with the same names. Any forecast of snuff 

import from Sweden would encompass the currently marketed products and therefore, 

the agency expects that the forecast of snuff imports from Sweden will likely be the same 

after authorization. 

It is worth noting that although the projected market volumes of all eight of these 

products are discussed in this PEA, the cumulative environmental effects due to the 

manufacturing of five of the eight were already evaluated and accounted for in the PEA 

for SE0010524-SE0010526 and SE0010532-SE0010533 reports. 

Consequently, the agency does not foresee any additional emissions to be released into 

the environment due to the manufacturing of the new products. Therefore, the 

introduction of released substances due to manufacturing the new products is negligible 

from the environmental viewpoint. 

6.2 Environmental Introduction as a Result of Use of the New Tobacco Products 

6.2.1 Use of smokeless tobacco products in the U.S. 

According to the statistical reports of the U.S. Department of Treasury’s Alcohol and 

Tobacco Tax and Trade Bureau (TTB), the use of snuff increased from 20,323 tons in 

1987 to 51,884 tons in 2014, whereas the use of chewing tobacco in the U.S. decreased 

from 36,029 tons in 1987 to 9,965 tons in 2014 (Figure 3A).8 While the combined use of 

smokeless tobacco products (snuff and chewing tobacco) in the U.S. remained relatively 

unchanged from 1987 to 2010, there seemed to be a gradual increase in use of 

smokeless products from 54,296 tons in 2009 to 61,849 tons in 2014 (Figure 3B). 

Three companies, U.S. Smokeless Tobacco Company, American Snuff, and Swedish 

Match, account for nearly 90% of U.S. sales of smokeless tobacco.9 

8 U.S. Department of Treasury Alcohol and Tobacco Tax and Trade Bureau (TTB). Tobacco Statistics. 

Available at: http://www.ttb.gov/tobacco/tobacco-stats.shtml. Accessed April 10, 2015. 

9 Centers for Disease Control and Prevention (CDC). Smoking and Tobacco Use – Economic Facts About 

U.S. Tobacco Production and Use. Available at: 

http://www.cdc.gov/tobacco/data_statistics/fact_sheets/economics/econ_facts/. Accessed April 20, 2015. 

P a g e | 9 
60 

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Figure 3A- Use of Smokeless Tobacco Products in t he U.S. in 1987- 2014 8 

Figure 38- Use of Smokeless Tobacco Products in the U.S. in 1987-20148 

6.2.2 Environmental consequences from use ofthe new products 

The new products are usually used in a manner similar to any other smokeless products 

that are currently on the market. The ingredients used in the new products are used in 

other smokeless products and the aim of the differences in the ingredients is to reduce 

the amount of certain HPHCs . Essentially, t he agency does not anticipate new 

substances to be re leased into the environment as a result of use of the new products, in 

Page 110 
comparison to the substances released by the smokeless products of the same name 

that are already on the market or all other smokeless tobacco. 

No economic models are available to the agency to predict the use of smokeless or snuff 

in the U.S. To evaluate the environmental impact of the proposed action due to use of 

the new products, the agency utilized the historic data for use in 2005-2014 to forecast 

the amount of use of smokeless tobacco products and snuff in the U.S. after issuance of 

the authorizations. This was achieved by using one best-fit exponential trendline with the 

R2 value of 0.9789 for snuff and another best-fit exponential trendline with the R2 value 

of 0.9802 for chewing tobacco (See Appendix 3). Accordingly, the forecast of future use 

of smokeless products was estimated using a mathematical prediction (Appendix 3). The 

individual projected market volumes in the 1st, 5th and 10th years of marketing the new 

products make up a fraction of the total forecasted use of smokeless products or snuff in 

the U.S during the same time frame (See Confidential Appendix 2 and Confidential 

Appendix 4). However, as discussed, the new products are expected to replace products 

that are already on the market. In addition, the environmental introduction due to use of 

five of the eight products were accounted for and evaluated in the PEA for SE0010524­

SE0010526 and SE0010532-SE0010533. 

Consequently, the amount of release of material mass into the environment as a result of 

use of the new products is negligible compared to that of all smokeless tobacco products 

or snuff being used in the U.S. Therefore, the introduction of released substances from 

use of the new products is negligible from the environment viewpoint. 

6.3	 Environmental Introduction as a Result of Disposal Following Use of the New 

Tobacco Products 

6.3.1 Disposal following use of smokeless tobacco products in the U.S. 

The environmental consequences of disposal following use of the smokeless tobacco 

products result from a) disposal of packaging material, b) discarding the used tobacco, 

and c) excretion of other ingredients in smokeless tobacco. 

a. Disposal of packaging material: 

Disposal of the packaging materials following use will either enter the recycling stream or 

be disposed of in MSW landfills or as litter. In 2012, the amount of waste generated in 

the U.S. was approximately 251 million tons and approximately 87 million tons of this 

material was recycled and composted, equivalent to a 34.5% recycling rate (Figure 4 

and Figure 5).10 Visual examination of the waste trend indicates that the annual amount 

of generated waste for the upcoming years will more likely remain approximately close to 

that in 2012. On average, 4.38 pounds per person per day of waste was generated, of 

which 1.51 pounds was recycled and composted in the U.S. in 2012. The recovery of 

10 EPA. Wastes - Non-Hazardous Waste - Municipal Solid Waste. Available at: 

http://www.epa.gov/waste/nonhaz/municipal/. Accessed April 20, 2015. 

P a g e | 11 
papers through recycling was about 70% and recovery for polypropylene waste was 

30.8%. 

Figure 4 – Municipal Solid Waste (MSW) Generation Rates in the U.S, 1960 – 2012 10

Figure 5 – MSW Recycling Rates in the U.S. 10

P a g e | 12 
b. Dis posal of used tobacco 

Used smokeless tobacco is usually disposed of in MSW landfi lls or as litter. When 

discarded as litter, the tobacco is likely to move by run-off to the ocean and eventually 

decompose. When discarded as MSW, the tobacco would enter landf ills. The agency 

utilized the historic data for use of smokeless tobacco products in the U.S. to forecast 

the f uture use of smokeless products and calculate the projected tobacco waste 

accordingly (Appendix 3). Assuming that all used smokeless or snuff products will be 

disposed of as MSW, the estimated waste of used smokeless or snuff products is a 

fraction of a percent of the total 251 million tons of projected MSW to be generated in the 

U.S (Table 2). 11 

Table 2 	Forecast of Waste of Used Smokeless Tobacco as Compared to Total MSW 

Forecast in the U.S.12 

Year 

Projected Use 

(Equivalent t o 

Pro jected 

Waste) o f 

Smokeless in 

the U.S. (To ns) a 

Percent of 

Project ed Waste 

of Smo keless t o 

Total MSW 

Fo recast in the 

u.s.(%) 

Projected Use 

(Equivalent t o 

Projected 

Waste) of Snuff 

in the U.S. 

(To ns) 

Percent of Proj ect ed 

Waste of Snuff t o 

Total MSW Fo recast 

in the U.S. (%) 

151 Year 65,736 0.026 57,512 0.023 

51 

" Year 73,522 0.029 67,357 0.027 

10m Year 86,366 0.034 82,064 0.033 

aSee Table 4 in Appendix 3 

c . Excretion of product ingredients: 

In addition to the disposal of the product in MSWs or as litter, there will also be excretion 

by the user of ingredients of the used smokeless products, which might enter the sewer 

system as components in human waste . The excreted waste is anticipated to be 

digested by microbial systems in the home's septic system or treated in POTW. 

6.3.2 Environmental consequences from disposal following use of the new 

products 

The agency believes that the disposal of the proposed products resembles the disposal 

cond itions of the snus products and any other smokeless tobacco products that are 

currently being marketed . The waste generated as a result of use of the products will be 

released to the environment, transf erred to POTWs, and disposed of in landfills in the 

same manner as the waste generated from any other smokeless tobacco products used 

11 Based on trend of MSW reported in the referenced EPA report. 

Page 113 
7 Cumulative Environmental Introduction Due to Past and Future Related 

Actions 

in the U.S. The projected tobacco waste due to use of the new products is a minute 

fraction of the forecasted tobacco waste generated due to use of the smokeless tobacco 

products (Confidential Appendix 5). 

In the worst case scenario, the agency assumes that all packaging material of the new 

products will be disposed of as MSW. However, paper components are more likely to be 

recycled. To determine the amount of waste due to disposal of paper and plastic 

packaging material, the agency used the projected market volumes in the 1st, 5 h and 10th 

years after issuance of the authorization orders for the new products (Confidential 

Appendix 6). The calculated waste of the cardboard packaging material of the can base 

of the loose product was accounted for and calculated in the PEA for SE0010524 and 

determined to be miniscule compared to the forecasted MSW to be generated in the 

U.S.; at least a portion of the waste is likely to be recycled. 

Likewise, the polypropylene waste generated from the can base of pouched products, 

can lids and film wrap of the new products, as well as pouch material is negligible 

compared to the amount of forecasted MSW to be generated in the U.S. (Confidential 

Appendix 6). Furthermore, the cumulative waste due to polypropylene packaging 

materials of the new loose and four of the pouched products (SE0010524-SE0010526 

and SE0010532-SE0010533) and the pouch components of the four pouched products 

(SE0010525, SE0010526, SE0010532 and SE0010533) is accounted for in the PEA for 

these SE Reports. The projected additional plastic and pouch material waste due to the 

remaining three products are anticipated to be negligible compared to the amount of 

forecasted MSW to be generated in the U.S (Confidential Appendix 6). 

Therefore, the introduction of released substances from disposal after use of the new 

products is negligible from the environmental viewpoint. 

As discussed, in addition to these eight PMT Applications, SMNA has also submitted ten SE 

Reports, SE0010524-SE0010533, listed in Appendix 1, to obtain market authorizations pursuant 

to section 910(a)(2) of the FD&C Act. In addition, concurrent with the SE Reports and PMT 

Applications, SMNA has submitted the MRTP Applications, MR0000020-MR0000029, also listed 

in Appendix 1, for the same snus products. The applicant also submitted SE Reports 

(SE00000138-SE00000145) to FDA for the eight provisional products that are currently 

marketed and will be replaced by the new products submitted in the SE Reports and the PMT 

Applications. Although the projected market volumes of all eight of the new products are 

discussed in this PEA, the cumulative environmental effects due to the manufacture, use and 

disposal after use of five of the eight were already evaluated and accounted for in the PEA for 

SE0010524-SE0010526 and SE0010532-SE0010533 reports. Consequently, the agency does 

not anticipate any additional emissions to be released into the environment as a result of its 

combined actions of issuing market authorizations for these five new products. 

P a g e | 14 
8	 Fate of New Materials Released into the Environment Due to the Proposed 

Action 

The introduction of released substances from manufacturing, use, and disposal after use of the 

new products is negligible from the environmental viewpoint. Therefore, no fate discussion is 

required. 

9	 Environmental Effects of New Materials Released into the Environment Due to 

the Proposed Action 

Because the amount of new materials anticipated to enter the environment due to the proposed 

action is negligible, the environmental effects of the materials released due to the 

manufacturing, use, and disposal following use of the new products are not substantial. 

10	 Use of Resources and Energy 

Swedish Match has two manufacturing facilities in Sweden one in Gothenburg and one in 

Kungalv. According to the applicant, both facilities comply with environmental legislation known 

as Miljobalken (1998:808). The facilities are regulated by the Gothenburg Environmental Agency 

and Kungalv Environmental Agency, respectively, which review the corresponding facilities on 

an annual basis for compliance with the environmental legislation and ensure efficient energy 

consumption. 

Based on information provided by the applicant, the projections of the market volume of the new 

products are a negligible fraction of the total smokeless tobacco products sold in the U.S. 

Furthermore, the new products will replace currently marketed products and the agency does 

not anticipate the market volume to be changed noticeably based on the provided information. 

Accordingly, the additional use of resources and energy due to the proposed action is negligible. 

11	 Mitigation 

During the review of the available data and information, the agency did not identify adverse 

environmental effects due to the manufacture, use, and disposal after use of the new products 

as proposed. Therefore, no mitigation measures are discussed. 

12	 Alternative Actions 

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

authorization orders. The environmental impact of this action would not noticeably change the 

existing condition of the manufacturing, use, and disposal from use of the smokeless products 

since snus products, as well as many other smokeless tobacco products, will continue to be 

marketed in the U.S. 

Alternative B (Proposed action): There are virtually no environmental effects due to the 

proposed action of issuing the market authorization orders and the associated manufacture, 

use, and disposal after use of the new tobacco products. Furthermore, the new products are 

intended to replace products that are being marketed and used in the U.S. To issue market 

authorization orders for the new products would not change the environment noticeably. The 

environmental effects from the proposed action are expected to be approximately the same as 

that related to the no action alternative. 

P a g e | 15 
Therefore, the difference between the environmental impacts of these two alternatives is 

negligible, or non-existent. 

13 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 this environmental assessment. 

Rudaina Alrefai-Kirkpatrick, Ph.D., Center for Tobacco Products 

Education: Ph.D. in Plant Molecular Biology and Virology 

Years of Experience: 22 years in various scientific activities 

Expertise: NEPA Analysis, Environmental Risk Assessment, Evidence-Based 

Assessment of Health Technologies 

14 List of Appendix 

Appendix 1 List of PMT Applications and Related Submissions and Amendments that are 

Covered Under this Programmatic Environmental Assessment (PEA) 

Appendix 2 Forecast of U.S. Import of Smokeless and Snuff Tobacco Products 

Appendix 3 Forecast of Use of Smokeless Tobacco Products in the U.S. 

15 List of Confidential Appendix 

Confidential Appendix I Detailed Description of Packaging Components of the New Products 

Confidential Appendix 2 Projected Market Volumes in the 1st, 5th and 10 h Years of Marketing 

the New Products 

Confidential Appendix 3 Projected Market Volumes of the New Products as Compared to the 

Forecasted Import of Smokeless and Snuff Tobacco Products to U.S. 

Confidential Appendix 4 Projected Market Volumes of the New Products as Compared to the 

Forecasted Use of Smokeless and Snuff Tobacco in the U.S. 

Confidential Appendix 5 Projected Waste Due to Use of the New Products 

Confidential Appendix 6 Projected Waste Due to Packaging Components of the New Products 

P a g e | 16 
APPENDIX 1 

List of PMT Applications and Related Submissions and Amendments that are 

Covered Under this Programmatic Environmental Assessment (PEA) 

Product Name STN Related 

MRTP Related SE Amendments 

General Loose PM0000010 MR0000020 SE0010524 PM0000018; PM0000026; 

PM0000027; MR0000030; 

MR0000031; MR0000032; 

MR0000033; MR0000035; 

MR0000036; MR0000038; 

MR0000039; MR0000041; 

MR0000042; MR0000044; 

MR0000045 

General Dry Mint 

Portion Original Mini 

PM0000011 MR0000021 SE0010525 PM0000019; PM0000026; 

PM0000027; PM0000029; 

MR0000030; MR0000031; 

MR0000032; MR0000033; 

MR0000035; MR0000036; 

MR0000038; MR0000039; 

MR0000041 ; MR0000042; 

MR0000044 ; MR0000045 

General Portion 

Original Large 

PM0000012 MR0000022 SE0010526 PM0000020; PM0000026; 

PM0000027; PM0000029; 

MR0000030; MR0000031 ; 

MR0000032; MR0000033; 

MR0000035; MR0000036; 

MR0000038; MR0000039; 

MR000004 1; MR0000042; 

MR0000044 ; MR0000045 

General Classic 

Blend Portion White 

Large - 12 CT 

PM0000013 MR0000024 SE0010528 PM000002 1; PM0000026; 

PM0000027; PM0000029; 

MR0000030; MR0000031; 

MR0000032; MR0000033; 

MR0000035; MR0000036; 

MR0000038; MR0000039; 

MR0000041 ; MR0000042; 

MR0000044 ; MR0000045 

General Mint Portion 

White Large 

PM0000014 MR0000025 SE0010529 PM0000022; PM0000026; 

PM0000027; PM0000029; 

MR0000030; MR0000031; 

MR0000032; MR0000033; 

Page l 17 
MR0000035; MR0000036; 

MR0000038; MR0000039; 

MR0000041; MR0000042; 

MR0000044; MR0000045 

General Nordic Mint 

Portion White Large – 

12 CT 

PM0000015 MR0000027 SE0010531 PM0000023; PM0000026; 

PM0000027; PM0000029; 

MR0000030; MR0000031; 

MR0000032; MR0000033; 

MR0000035; MR0000036; 

MR0000038; MR0000039; 

MR0000041; MR0000042; 

MR0000044; MR0000045 

General Portion 

White Large 

PM0000016 MR000028 SE0010532 PM0000024; PM0000026; 

PM0000027; PM0000029; 

MR0000030; MR0000031; 

MR0000032; MR0000033; 

MR0000035; MR0000036; 

MR0000038; MR0000039; 

MR0000041; MR0000042; 

MR0000044; MR0000045 

General Wintergreen 

Portion White Large 

PM0000017 MR0000029 SE0010533 PM0000025; PM0000026; 

PM0000027; PM0000029; 

MR0000030; MR0000031; 

MR0000032; MR0000033; 

MR0000035; MR0000036; 

MR0000038; MR0000039; 

MR0000041; MR0000042; 

MR0000044; MR0000045 

P a g e | 18 
Ill 

c 

0 

.... 

c 

0 

(J 

(J 

ns 

.c 

0 

.... 

Ill 


Ill 


Q) 

Q) 

~ 

0 

E 

rJ) 

.... 

0 

t:: 

0 

Q. 

E 

en 

::) 

2000 

1800 

1600 

1400 

1200 

1000 

800 

600 

400 

200 

0 

y =21.523x1·

099 

R

y =164.81 e 0.21 98x 

2 =0.9683 

2009 201 0 2011 2012 201 3 2014 

Year 

1!22.1 Snuff from Sweden - Snuff Fro m Wo rldw ide 


IS..'S..'S..'S3 Sm okeless From Wo rld --Power (Snuff from Sweden ) 


- Expo n. (Snuff From Wo rldwide) - Expo n. (Smo keless Fro m World) 


Appendix 2 

Forecast of U.S. Import of Smokeless Tobacco Products 

To evaluate the environmental impact of the proposed action due to manufacturing the new 

products in Sweden, t he agency ut ilized the historic data of U.S. import of smokeless 

products from Sweden and worldwide during 2009-2014 to forecast the futu re import of 

smokeless tobacco products. This was achieved by using a best-fit trendline of; exponential 

w it h an R2 va lue of 0.9683 for world smokeless import, exponential with an R2 value of 

0 .9348 fo r worl d snuff import, and power with an R2 value of 0.9348 for Sweden snus import. 

A most accurate best-fit trendl ine is when the R2 va lue is at or near 1 (Figure 6). 

Accordingly, the information f rom t hese best-fit trendlines were used to mathematically 

estimate the forecast of U.S . import of snuff and smokeless tobacco (T able 3). 

Figure 6 - Forecast of U.S. Import of Smo ke less Tobacco Products12 

Page 119 

12 Based on United States Department of Agriculture (USDA). Fore ign Agricultural Service (FAS ). Global 

Agricultural Trade System (GATS). Avai lable at: http://apps.fas.usda.gov/gats/default.aspx . Accessed on 

April 29, 20 
Table 3 Forecast of U.S. Import of Smokeless and Snuff Products from Worldwide and 

Sweden 1 3 

Year 

U.S. Import of 

Smokeless from 

Worldwide (Tons) 

U.S. Import of 

Snuff from 

Worldwide (Tons) 

U.S. Import of 

Snuff from Sweden 

(Tons) 

1st Year 956 518 212 

s tn Year 2,304 1,106 330 

10tn Year 6,915 2,851 484 

Page 120 
--------

70 

cri 60 ::) 

-

Q) 

J: 

.5 so 

.flU} 

CJ c 

:I 0 

"'C 1- 40 ~"'C Q.C 

1/) 1/) 1/) 

~ 

"' 

5 30 

Q) J: 

~toE 

(/) 20 .... 

0 

y =19.512e·

0 · 072" 

10 ___.re,;: 0.9802 

0 

Year - Snuff Tobacco l?22222.l Chewing Tobacco 

--Expon. (Snuff Tobacco) ---·Expon. (Chewing Tobacco) 

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 


Appendix 3 

Forecast of Use of Smokeless Tobacco Products in the U.S. 

To evaluate the environmental impact of the proposed action due to use of the new 

products, the agency utilized the historic data of use in 2005-2014 to forecast the use of 

smokeless tobacco products, chewing tobacco and snuff, in the U.S. This was achieved by 

using one best-fit exponential trendline with the R2 value of 0.9789 for snuff and another 

best-fit exponential trendline with the R2 value of 0.9802 for chewing tobacco (Figure 7). 

Utilizing trendlines, the forecast of use of smokeless products in the U.S. was estimated 

mathematically (Table 3). 

Figure 7 Forecast of Use of Smokeless Tobacco Products in the U.S.13 

13 Based on TIB data 

Page 121 
Table 4 Forecast of Use of Smokeless Products in the U.S. 14 

Year Snuff Use (Tons) Chewing Tobacco 

Use (Tons) 

Total Smokeless 

Use (Tons) 

15 

' Year 57,512 8,224 65,736 

sm Year 67,357 6,166 73,523 

10'" Year 82,064 4 ,302 86,366 

Page 122 
Confidential Appendix 1 


Detailed Des cription of the Packaging Components of the New Products 


Component PM0000010 PM0000011 PM0000012 PM000001 3 PM0000014 PM0000015 PM0000016 PM0000017 

Package Size 

(gram/Can) 

45 6 24 10.8 24 10.8 24 24 

Weight of 

Portion 

(gram/ pouch) 

Loose 0.3 1 0.9 1 0.9 1 1 

Number of 

Pouches/Can 

NA'" 20 24 12 24 12 24 24 

Weight of 

Pouch 

Material 

(gram/ Portion ) 

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

Weight of 

Pouch 

Material 

(gram/Can) 15 

14 NA= Not applicable 

1 5 The weight of pouch material in each can is calcu lated as follows: 

A= B x C, w here 

A= Weight of pouch material in each can (gram/can ) 

B= Weight of Pouch material for each portion (gm/pouch } 

C= Number of pouches in each can 

Page 123 
Component PM0000010 I PM0000011 I PM00000121 PM000001 3 1 PM00000141 PM00000151 PM00000161 PM0000017

We '{b}{'l) ight of Can 

Base 

(gram/Can) 

Weight of Lid 

(gram/Can) 

Weight of 

Plastic Film 

(gram/Can) I I I I I I I 

General Loose product (PM0000010) is contained in a waxed cardboa rd can base with a polypropylene plastic lid. The can base and 

lid materials of the pouched products are also made of polypropylene resin. The cans are wrapped in shrink wrap made of 

polypropylene resin. The pouched products; "General C lassic Blend Portion White Large - 12 CT and General Nordic Mint Portion 

Wh ite Large - 12 CT" are contained in a rectangu lar plastic can base, whereas all other pouched products are in round cans. The 

can lid of the pouched products also serves as a receptacle for the used tobacco waste. The white pouch fabric is made of 

b) 4 ) 

Page 124 
Confidential Appendix 2 

Projected Market Volumes in the 15 

\ 5th and 10th Years of Marketing the New Products 

The agency calculated the forecast of market volume of the new products after issuance of market authorizations as follows: 

A= B x C I D, where 


A= Foreca st market vo lume (Tons) 


B= Projected number of manufactured cans 


C= Weight of the new product (gram s/ can) 


D= 1 0~ (tons/gram) 


PM0000010 

PM0000011 

PM0000012 

PM0000013 

Projected Year of

Marketing the 

New Productsb 

1 Year 

5 Year 

10 Year 

1 Year 

5 Year 

10 Year 

1 Year 

5 Year 

10 Year 

1 Year 

5 Year 

Projected Market 

Volume 

(#of Cans) 

Weight of Product 

(gram/ Can) 

Projected Market 

Volume (Grams) 

Projected Market 

Volume (Tons) 

Pa g e 125 
PM0000014 

PM0000015 

PM000001 6 

PM0000017 

Projected Year of 

Marketing the 

New Productsb 

10 Year 

1 Year 

5 Year 

10 Year 

1 Year 

5 Year 

10 Year 

1 Year 

5 Year 

10 Year 

1 Year 

5 Year 

10 Year 

Projected Market 

Volume 

(# of Cans) 

Weight of Product 

(gram/ Can) 

Projected Market 

Volume (Grams) 

Projected Market 

Vo lume (To ns) 

aAlso see Append ix 1for the correspond ing MRTP STNs. These are the STNs that contained the market volume information . 

~he PMT Applications reference the EAs that are contained in the corresponding MRTP Application and amendments. In the 

EAs co ntained in the MRTP Application dated June 10, 2014, the applicant provided projections of market volumes in the 1st year 

and 2nd year of marketing the modified products after an order would be issued . So, the 1st year could be 2015. 

In response to an FDA request regarding theSE Reports, dated April 14, 2015 (S E0011687), the applicant provided proj ections 

of market volumes in the 1 5 

\ 5th and 1Oth years of marketi ng the products quoting the same volumes for the 1st year that were 

presented in the MRT P Application but specified the 5th yea r to be 20 19 and the 1Oth year to be 2024 . Back calcu lating using 

Page 126 
these years, that would mean the applicant is considiering 2015 as the 1st year of marketing .. However, the 1st year could be 

2016 as the submissions were received in 2015. 

In the applicant's response to another FDA request for information (MR0000042 dated May 22, 2015) to FDA, the applicant 

stated that the proj ected market volume provided for the SE Reports and the MRTP Aapplications correspond to years 5 and 10, 

2019 and 2024, respective ly. So, as discussed above, the 1st year could be 2015 because of the back calculation using 2019 and 

2024 as the 5th and 1Oth years, respectively . However, the 1st year could be 2016 because of the submission date being 2015. 

It is clear from the PMT Applications, MRTP Applications, and SE Reports, the applicant considers the 5th year to be 2019 and 

the 1oth year to be 2024. It appears that the years the applicant deems the 5th and 10 h years are dependent on when the 

applications were prepared, and the applicant's projections are based on the 1st year being 2015. However based on the timing 

of the receipt of the PMT Applications, the review of these submissions and the potential timing of any marketing authorizations, 

the f irst year of marketing the new products could be 2016. For the purpose of this PEA, the projected market volumes provided 

by the applicant were compared to the forecasted vo lumes of 2016, 2020, and 2025. 

The cumulative projected market volumes of the products that are covered in the PMT Applications and those covered in the SE 

Reports are presented in the table below. 

Cumulative Market Volume Projections of the New Products in Tons 

STN 

Projected market volume of 

all new products (Tons) from 

the table above in this 

Appendix 

Projected market volume of 

new products accounted for 

in the PEA of SE Reports 

SE001 0524- SE001 0526 and 

SE001 0532 - SE001 0533 

Projected market volume of 

the 3 remaining pouched new 

products (Tons) 

10 Year 

Page 127 
Confidential Appendix 3 


Projected Market Volumes of the New Products as Compared to the Forecasted U.S. Import of Smokeless and 


Snuff Tobacco Products 


STN8 

PM0000010 

Year 

Projected 

Market 

Volume of 

New 

Products 

(Tons) 

Forecast of

Worldwide 

Import of 

Smokeless 

to U.S. 

(Tons) 

Percent of 

Projected 

Market 

Volume to 

Forecasted 

Worldwide 

Import of 

Smokeless 

to U.S.(%) 

Forecast of

Worldwide 

Import of 

Snuff to 

u.s. 

(Tons) 

Percent of 

Projected 

Market 

Volume to 

Forecasted

Worldwide 

Import of 

Snuff to 

u.s.(%) 

Forecast of 

U.S. Import 

of Snuff 

from 

Sweden 

(Tons) 

Percent of 

Projected 

Market 

Volume to 

Forecasted

Import of 

Snuff from 

Sweden to 

u.s.(%) 

PM0000011 

PM0000012 

PM0000013 

5 Year 

10 Year 

15 1 Year 

5 Year 

10 Year 

15 Year 

5 Year 

10 Year 

10 Year 

15 Year 

Pa g e 128 
Percent of 

Projected 

Market 

Volume to 

Forecasted 

Worldwide 

Import of 

Smokeless 

to U.S. (%) 

Percent of 

Projected 

Market 

Volume to 

Forecasted 

Worldwide 

Import of 

Snuff to 

u.s.(%) 

Percent of 

Projected 

Market 

Volume to 

Forecasted 

Import of 

Snuff from 

Sweden to 

u.s. (%) 

Projected 

Market 

Volume of 

New 

Products 

(Tons) 

Forecast of 

Worldwide 

Import of 

Smokeless 

to U.S. 

(Tons) 

Forecast of 

Worldwide 

Import of 

Snuff to 

u .s. 

(Tons) 

Forecast of 

U.S. Import 

of Snuff 

from 

Sweden 

(Tons) 

STN8 Year 

PM0000014 15 Year 

5 Year 

10 Year 

PM0000015

10 Year 

PM0000016 1 Year 

PM0000017 

5 Year 

10 Year 

8 Aiso see Appendix 1for the corresponding MRTP STNs. These are the STNs that contained the market volume information. 

Based on these calculations, the projected market volume of each of the new products is a fraction of the forecasted market volume 

of all smokeless imported to the U.S, all snuf imported to the U.S., and all snuff imported to the U.S. from Sweden. 

Page 129 
Confidential Appendix 4 


Projected Market Volumes of the New Products as Compared to the Forecasted Use of Smokeless and Snuff 


Tobacco in the U.S. 


STN8 

PM0000010 

Year 

Projected Market 

Volume of the 

New Product 

(Tons) 

Forecast of 

Use of 

Smokeless in 

U.S. (Tons) 

Percent of 

Projected Market 

Volume to 

Forecasted 

Smokeless Use in 

u.s.(%) 

Forecast of Use 

of Snuff in U.S. 

(Tons) 

Percent of 

Projected Market 

Volume to 

Forecasted Snuff 

Use in U.S. (%) 

PM0000011 

PM0000012

PM0000013 

PM0000014 

5 Year 

10 Year 

15 Year 

5 Year 

10 Year 

15 Year 

5 Year 

10tn Year 

15 Year 

Page 130 
Percent of 

Projected Market 

Vo lume to 

Fo recasted 

Smokeless Use in 

u .s . (%) 

Percent of 

Projected Market 

Volume to 

Forecasted Snuff 

Use in U.S. (%) 

Projected Market 

Volume of the 

New Product 

(To ns) 

Forecast of 

Use of 

Smokeless in 

U.S. (Tons) 

Forecast of Use 

of Snuff in U.S. 

(Tons) 

STN Year 8 

PM0000015

PM000001 6 

5 Year 

10 Year 

151 Year 

5 Year 

10 Year 

PM0000017 

5 Year 

10 Year 

aAlso see Appendix 1for the corresponding MRTP STNs. These are the STNs that contained the market vo lume information . 

The total combined proj ected market volumes of b) 4) and b) 4) of the new products in the 15 

\ 5tn, and 1 otn years 

after issuance of the authorization orders, respective ly, are estimated to be a fraction of the ' @ 4) , an 6)@) 

(4 of the forecasted use of snuff in the U.S. within the same time frame. Additionally, the projected market volumes of f ive of the 

eight products were already accounted for, and their environmental impact was evaluated, in the PEA for SE001 0524-SE001 0526 

and SE0010532-SE00 10533 . 

Page 131 
Based on these calculations, the projected market volume of each of the new products is a fraction of the forecasted smokeless and 

snuff use in the U.S. in the 1st, 5th, and 10th years after issuances of the marketing authorizations. 

P a g e | 32
 
Confidential Appendix 5 

Projected Waste Due to Use of the New Products 

The projected waste due to use of the finished product is the weight of the products used by the consumers (i.e, total package size ). 

Assuming that t he entire product is disposed of in the worst case scenario, the agency estimated the waste in tons of used products 

as follows: 

A= B X C X D, where 

A= Projected waste of disposed tobacco (tons) 

B= Projected market volume (number of manufactured cans) 

C= Weight of tobacco product in each can (i.e., total package size; grams/can) 

D= 1 0~ (tons/gram) 

1s Year 

5 Year 

1s Year 

Percent of 

Projected Waste to

Total Forecasted 

Waste of Smokeless

in U.S. (%)b 

Percent of 

Projected Waste to

Total Forecasted 

Waste of Snuff in 


the U.S.(%) 


Projected Market 

Volume 

(#of cans) 

Projected Waste 

of Used Product 

(Tons) 


Product Size 

(gm/can) Year

PM000001 0

PM0000011 

PM0000012

5 Year 

10 Year

Page 133 
Year 

PM0000013 1s Year

5 Year 

PM0000014 

PM0000015 1s Year 

5 Year 

10 Year 

PM0000016 1s Year 

5 Year

10 Year

PM0000017 1s Year 

5 Year 

10 Year 

Projected Market 

Volume 

(#of cans) 

Product Size

(gm/can) 

Projected Waste 

of Used Product 

(Tons) 

Percent of 

Projected Waste to 

Total Forecasted 

Waste of Smokeless

in U.S. (%)b 

Percent of 

Projected Waste to 

Total Forecasted 

Waste of Snuff in 

the U.S.(%) 

aAlso see Append ix 1for the correspond ing MRTP STNs. These are the STNs that contained the market volume informat ion. 

bsee Table 4, Appen dix 3, assuming that the entire product is disposed of in the worst case scenario 

Page 134 
The cumulative projected waste disposed of as litter after use of all of the new products in the 1st year, sth year, and 1Oth year of 

marketing is summarized in the table below. 

Cumulative Projected Waste Due to Use of the New Products in Tons 

Projected waste of all new 

products (Tons) from the 

table above in this Appendix

Projected waste of new 

products accounted for in the 

PEA of SE Reports 

SE001 0524- SE001 0526 and 

SE001 0532 - SE001 0533 

Projected waste of the 3 

remaining pouched new 

products (Tons) 

15 Year Projected 

Waste 

5 Year Projected 

Product Waste 

10 Year Projected 

Product Waste 

The cumulative projected waste of snuff products in the 1st year, 5th year and 1Oth year of issuance of the orders is a minute fraction 

of the forecasted 251 million tons of waste to be generated in the U.S. 

Page 135 
Confidential Appendix 6 

Projected Waste Due to Packaging Components of the New Products 

The agency calculated the forecast of waste (in tons ) of packaging components generated from disposa l after use of the new 

products as follows: 

A= B X C X D, where 


A= Projected waste of the packaging component (tons ) 


B= Projected market volume (numbe r of manufactured cans ) 


C= Weight of the packaging component (grams/can ) (base , lid, film, can or pouch ) 


D= 1 0~ (tons/gram) 


STN8 Year 

Proj ect ed 

Market 

Vo lume 

(Number o f 

Cans) 

Weight of 

Cardboard 

Can Base 

(gm/Can) 

Projected 

Cardb oard 

Waste 

(To ns) 

Weight of 

Plasti c Lid 

(gm/Can) 

Project ed 

Plastic 

Waste 

(To ns) 

Weight of 

Plastic 

film 

(gm/Can) 

Projected 

Waste of 

Plasti c 

Film 

PM00 00010 15

{ Yea r (b) (4) sm Year 

10m Year 

Page 136 
Project ed 

Market 

Vo lume 

(# of Cans) 

Weight of 

Plastic Can 

(Base & Lid) 

(gm/Can) 

Projected 

Pl astic 

Waste 

(To ns) 

Weight of 

Pl astic 

Shrink film 

(gram/Can) 

Proj ected 

Film 

Waste 

(To ns) 

Weight of 

Fabri c 

Po uc h 

(gram/Can) 

Projected 

Po uc h Fabric 

Waste (To ns) STN Year
 8 


5 Year 

15 Yea r 

15
 PM0000011 Yea r 

PM0000012 

PM0000013 

5 Year 

10 Year 

15
 PM0000014 Yea r 

5 Year 

10 Year 

15
 PM0000015 Yea r 

5 Year 

10 Year 

15
 PM000001 6 Yea r 


5 Year 


10 Year 


15
 PM0000017 Yea r 

Page 137 

Projected 

Market 

Vo lume 

(# of Cans)

Weight of 

Plastic Can 

(Base & Lid) 

(gm/Can) -

Projected 

Plastic 

Waste 

(Tons) 

Weight of 

Plastic 

Shrink film 

(gram/Can) 

Projected 

Film 

Waste 

(To ns) 

Weight of 

Fabric 

Po uch 

(gram/Can) 

Projected 

Pouch Fabric 

Waste (To ns) STN8 Year 

sm Year 

10m Year (b) (4) 

a Also see Appendix 1for the corresponding MRTP STNs. These are the STNs that contained the market volume information. 

The cumulative projected waste of the packaging components is presented in the table below. 

Cumulative Projected Waste Due to Packaging Components of the New Products 

Year Waste of Cardboard (To ns) 1 Waste o f Plastic (Tons) 1 Waste of Fabric Pouc h (To ns) 

1st year 

All productsa /b' I , 4' I Products Evaluated in SE 

Reports ~ J ~ J 

sm Year 

All productsa (b) (4) Products Evaluated in SE 

Reports 

10m Year 

All productsa (b) (4) Products Evaluated in SE

Reports

alnformation relevant to all new products in this PEA is obtained from the table above in this appendix. 

Page 138 
Assuming that the entire packaging material is disposed of as waste in the worst case scenario, the cumulative projected waste of 

cardboard paper and fabric pouch material in the 1st, 5th and 10th years of issuing the PMT orders is a fraction of the 251 million tons 

of the forecasted waste based on the EPA 2012 trend report of waste in the U.S. Furthermore, a portion of the generated paper 

waste is likely to be recycled. Likewise, the cumulative projected waste of polypropylene plastic packaging components is a small 

fraction of the forecasted MSW in the U.S. 

Additionally, the projected waste of the cardboard packaging material of the new loose product was already accounted for and 

evaluated in the PEA for SE0010524, whereas the projected waste of polypropylene waste and pouch material due to use of the 

loose and four pouched products in the 1st year, 5th year, and 10th of issuance of the authorization orders were already accounted for 

in EAs for SE0010524-SE0010526 and SE0010532-SE0010533. 

P a g e | 39