1 

Environmental Assessment for a Modified Risk Order for a 

Loose Moist Snuff Product 

Manufactured by U.S. Smokeless Tobacco Company LLC

Prepared by the Center for Tobacco Products

U.S. Food and Drug Administration

October 24, 2022
2 

Table of Contents

1. Introduction .............................................................................................................................3

1.1 Background ......................................................................................................................................... 3

1.2 Applicant and Manufacturer Information........................................................................................... 3

1.3 Product Information............................................................................................................................ 3

1.4 Product Identification ......................................................................................................................... 3

2. The Purpose and Need for the Proposed Action.........................................................................4

3. Proposed Action and the Alternative.........................................................................................4

4. Potential Environmental Impacts of the Proposed Action and Alternative – New Product 

Manufacturing..........................................................................................................................4

4.1 Affected Environment......................................................................................................................... 4

4.2 Analysis of Potential Environmental Impacts...................................................................................... 5

4.3 Impacts from the No-Action Alternative............................................................................................. 7

5. Potential Environmental Impacts of the Proposed Action and Alternative - New Product Use .....7

5.1 Affected Environment......................................................................................................................... 7

5.2 Analysis of Potential Environmental Impacts...................................................................................... 8

5.3 Impacts from the No-Action Alternative............................................................................................. 9

6. Potential Environmental Impacts of the Proposed Action and Alternative - New Product Disposal

.................................................................................................................................................9

6.1 Affected Environment......................................................................................................................... 9

6.2 Analysis of Potential Environmental Impacts...................................................................................... 9

6.3 Impacts from the No-Action Alternative...........................................................................................10

7. List of Preparers......................................................................................................................10

8. List of Agencies and Persons Consulted....................................................................................10

Confidential Appendix 1: First- and Fifth-Year Market Volume Projections for the New Product ........12
3 

1. Introduction

1.1 Background

On March 20, 2018, U.S. Smokeless Tobacco Company LLC (USSTC) submitted to the Food and Drug 

Administration (FDA) a modified risk tobacco product application (MRTPA) seeking marketing 

authorization for a loose moist snuff product under the provisions of Section 911(g) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act). On March 26, 2021, FDA completed its review of the MRTPA. FDA 

determined that the application in its current form did not provide sufficient evidence to meet the 

standards of 911(g)(1), but they could be amended in a way that would support the issuance of a modified 

risk order. Accordingly, FDA issued a Response Letter, which included eight deficiencies. On September 29, 

2021, USSTC submitted an amendment to address the FDA Response Letter. The applicant amended their 

applications by proposing a product name change to the revised MRTPA. 

FDA prepared this environmental assessment (EA) to evaluate the potential environmental impacts from 

marketing a “loose moist snuff with a modified risk claim” (referred to as the “new product”) in the 

United States and from the no-action alternative of not issuing marketing orders for the product. This EA 

is prepared in accordance with the Council on Environmental Quality’s (CEQ’s) regulations (40 CFR 1500 

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

Part 25.40).

1.2 Applicant and Manufacturer Information

Applicant Name: Altria Client Services LLC

Applicant Address: 2325 Bells Road 

Richmond, VA 23234

Manufacturer Name: U.S. Smokeless Tobacco Company LLC

Product Manufacturing 

Locations:

800 Harrison Street

Nashville, TN 37203

1.3 Product Information

Submission Tracking Number (STN) and Name of the New Product

New Product STN New Product

MR0000108 Copenhagen Classic Snuff

1.4 Product Identification

Product Category Smokeless

Product Subcategory Loose Moist Snuff

Product Quantity per Retail 

Unit 1.2 oz.(34.02 grams) of loose moist snuff per can.

Product Package

The packaging materials consist of a fiberboard can with a metal lid, a 

Coated one-Side (C1S) paper label on the side and bottom, and a 

polypropylene shrink wrap. 
4 

2. The Purpose and Need for the Proposed Action

Purpose: USSTC submitted to the FDA a MRTPA for a loose, moist snuff product to obtain a modified risk 

order under Section 911(g) of the FD&C Act to change the statutory mandated health warnings on the 

package labels and advertisements of a previously found grandfathered product [GF1200194]. USSTC

wishes to introduce the tobacco product with the proposed modified risk claim (the new product) into 

interstate commerce for commercial distribution in the United States with the following proposed claim 

to the product’s advertising label: "IF YOU SMOKE, CONSIDER THIS: Switching completely to this product 

from cigarettes reduces risk of lung cancer."Upon receipt of an MRTPA, FDA considers the submission, 

using criteria detailed in section 911(g) of the FD&C Act, and issues a risk modification order that either 

allows or denies the proposed risk modification claim for a commercially marketed tobacco product. The 

purpose of FDA’s MRTPA review is to determine whether an applicant has shown that the tobacco 

product sold or distributed with the proposed modified risk information will (A) significantly reduce 

harm and the risk of tobacco related disease to individual tobacco users and (B) benefit the health of the 

population as a whole taking into account both users of tobacco products and persons who do not 

currently use tobacco products.

Need: FDA is responsible for reviewing an MRTPA, making a finding as described in the previous 

paragraph, and subsequently determining whether or not to issue a marketing order for the proposed new

product. 

3. Proposed Action and the Alternative 

Proposed action: The proposed action is for the FDA to issue a modified risk granted order under the 

provisions of 911(g)(1) authorizing the marketing of Copenhagen Classic Snuff tobacco with the following 

claim to the advertising label: "IF YOU SMOKE, CONSIDER THIS: Switching completely to this product 

from cigarettes reduces risk of lung cancer."

Alternative: The no-action alternative is the FDA does not issue a modified risk order for marketing the 

new product in the United States.

4. Potential Environmental Impacts of the Proposed Action and Alternative – Manufacturing the 

New Product

The Agency considered potential impacts to resources in the environment that may be affected by 

manufacturing the new product and found no significant impacts based on Agency-gathered information 

and the following applicant-submitted information:

• Ingredients in the new product are commonly used in other smokeless tobacco products. 

• The new product would not require additional resources or equipment to produce. 

• No facility expansion or new construction is expected due to manufacture of the new product. 

• Based on the applicant’s submitted information, the new product will replace the currently 

marketed grandfathered product.

4.1 Affected Environment 

The new product would be manufactured at the address listed in section 1.2 (Figure 1). 
5 

The manufacturing facility is in a mixed-use industrial, commercial and residential area just west of the 

the Cumberland River and east of interstates 40 and 65. The facility is located in the Lower CumberlandSycamore Watershed (U.S. EPA Waters GeoViewer, 2022). 

Figure 1. Location of the Manufacturing Facility1

4.2 Analysis of Potential Environmental Impacts

The Agency does not anticipate that the proposed action will significantly increase or change chemicals 

released to the environment from tobacco manufacturing at the USSTC facility. 

Environmental 

Resource Analysis of Potential Impacts

Air quality The applicant stated that manufacturing the new product would have the same or 

similar air emissions as those associated with current smokeless tobacco products 

manufactured at the facility and would not require a new or revised permit. 

A search in the U.S. Environmental Protection Agency (EPA)’s Toxic Release 

Inventory (TRI) database showed that in 2021, USSTC manufacturing facility in 

Nashville, TN released 439.6 pounds of nicotine and nicotine salts to air and 

1 Google Maps. (2022). Map for 800 Harrison Street, Nashville, TN 37203. Retrieved from www.google.com/maps. Accessed 

May 19, 2022. 
6 

Environmental 

Resource Analysis of Potential Impacts

transferred 57,686 pounds of nicotine and nicotine salts offsite. The TRI database 

search did not show that the USSTC manufacturing facility released into the 

environment any other reportable toxicants associated with manufacturing. No 

other hazardous air pollutants were reported. (U.S. EPA TRI, 2022) The Agency does 

not anticipate that manufacturing the new products would cause the release of any 

new chemicals into the environment. 

Water 

resources

The applicant stated that manufacturing the new product would have the same or 

similar wastewater discharges as products currently manufactured at the facility and 

would not require a new or revised permit. The Agency verified that no TRIreportable chemicals were released to water from the manufacturing facility. (U.S. 

EPA TRI, 2022)

Land use and 

zoning

The applicant stated that manufacturing the new product would not involve 

manufacturing facility expansion. Therefore, no changes in land use or zoning would 

occur as a direct impact of the proposed action. The Agency verified that no TRIreportable chemicals were released to the land from the manufacturing facility. 

(U.S. EPA TRI, 2022)

Biological 

resources

No effects to biological resources would occur as a direct impact of manufacturing 

the new product because no facility expansion or change in chemical emissions are

expected. The applicant reviewed the U.S. Fish and Wildlife Service’s (U.S. FWS) 

critical habitat and endangered species maps. The U.S. FWS’s list of species by 

county shows that the Nashville area (Davidson County) may have eleven 

endangered species (six types of clams, one crayfish , two flowering plants, and two 

ian bat species) and two threatened species (one flowering plant and one bat 

species) (U.S. FWS ECOS, 2022a; 2022b). However, the applicant stated that none of 

these species are found near the manufacturing facility. The Agency searched the 

U.S. FWS maps and verified the accuracy of the listed species.

Geological 

features and 

soils

No facility expansion would be expected due to manufacturing the new product . 

Therefore, no effects to geological features or soils would occur as a direct impact of

manufacturing the new product manufacture. 

Socioeconomic 

conditions

No impacts would be expected on employment, state or municipal revenue and 

taxes, or on police force and fire department resources because there would be no 

facility expansion due to manufacturing the new product. 

Environmental 

justice 

No new chemicals would be released from manufacturing the new product. 

Therefore, no disproportionate impacts to minority and low-income populations 

near the manufacturing facilities are anticipated.

Solid waste 

and hazardous 

materials

The applicant stated that the new product would not change solid waste generation 

at the manufacturing facility and waste would be disposed of in the same manner as 

waste generated by other smokeless tobacco products manufactured at the same 

facility. Therefore, no effects to solid waste or hazardous materials would occur as a 

direct impact from manufacturing the new product.

Floodplains, 

wetlands, and 

coastal zones

The applicant stated that no facility expansion would be expected due to 

manufacturing the new product. Therefore, no effects to floodplains, wetlands, or 

coastal zones are anticipated.
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Environmental 

Resource Analysis of Potential Impacts

Regulatory 

compliance

The applicant stated that the manufacturing facility complies with all federal, state, 

and local environmental regulations. The applicant provided information for the 

following air emission and wastewater permits:

(1) Air permits: 

Synthetic Minor Air Pollutant Source Operating Permits (permit numbers 81-2 

through 81-4, 81-6, 81-8, 81-9 through 81-10) issued by the Metropolitan 

Government of Nashville and Davidson County, Public Health Department. These air 

permits place limits on air emissions and production capacities and require 

submittal of compliance data to the local agency.

(2) Wastewater permits: 

Industrial User Wastewater Discharge Permit (permit number CP-0286), issued in 

accordance with applicable Metropolitan Government of Nashville and Davidson 

County regulations. The permit requires compliance with the relevant effluent 

limitations (40 CFR 400-699) to ensure the wastewater is of a certain quality for 

effective treatment at the POTW facility. The applicant stated that the facility 

submits regular discharge monitoring reports to the County.

The Agency’s search of U.S. EPA’s Enforcement and Compliance History Online did 

not reveal any violations of the federal environmental laws and regulations (U.S. 

EPA ECHO, 2022). The applicant also stated that the facility complies with the 

Endangered Species Act.

4.3 Impacts from the No-Action Alternative

The no-action alternative would not change existing manufacturing of other smokeless tobacco products 

at USSTC manufacturing facility because manufacture of similar smokeless tobacco products would

continue at this facility. 

5. Potential Environmental Impacts of the Proposed Action and Alternative – Use of the New 

Product

The Agency evaluated potential environmental impacts that may be caused by use of the new product 

with the modified risk claim and found no significant impacts.

5.1 Affected Environment 

The affected environment includes human and natural environments in the United States because the 

marketing order would allow for the new modified risk product to be sold to consumers in the United 

States with the advertising claim nationwide. 
8 

5.2 Analysis of Potential Environmental Impacts

The proposed action was evaluated for potential environmental impacts from use of the new product

based on Agency-gathered information and the applicant’s submitted information. Included in the 

information the Agency considered were the projected market volumes for the new products as proxy 

for use (Confidential Appendix 1).

Data from the tobacco products monthly statistical release reports from U.S. Alcohol and Tobacco Tax 

and Trade Bureau (TTB) show that since 1997, snuff tobacco sale as a proxy for consumption in the 

United States has increased overall but leveled off in recent years (Figure 2; U.S. TTB, 2022).

2

Figure 2. Use of Smokeless Tobacco in the United States, 1997 – 2020

The applicant stated that the new product will replace the currently marketed grandfathered product.

The Agency does not expect the new product to significantly increase snuff use in the United States

because (1) the new tobacco products are expected to compete with, or replace, other currently 

marketed snuff, and (2) the ingredients in the new tobacco products are used in other currently 

marketed tobacco products.

Environmental 

Resource Analysis of Potential Impacts

Environmental 

justice 

The new product is likely to be used by consumers that use existing smokeless 

tobacco products, competing for the same market share. Therefore, no change 

in impacts to minority and low-income populations would be expected.

2 Sales data reported by TTB are used as a proxy for consumption. 

0

20

40

60

80

100

120

140

199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020

Sm

okeless T

obacco

Use in the United States

(Million P

ounds)

Year
9 

5.3 Impacts from the No-Action Alternative

The no-action alternative would not change existing use of other smokeless tobacco products because

use of many similar smokeless tobacco products would continue in the United States. 

6. Potential Environmental Impacts of the Proposed Action and Alternative – Disposal of the 

New Product

The Agency evaluated potential environmental impacts that may be caused by disposal of the new 

product and found no significant impacts based on Agency-gathered information and the applicant’s 

submitted information. 

6.1 Affected Environment 

The affected environment includes human and natural environments in the United States because the 

marketing order would allow for the new product to be sold to consumers nationwide who would

dispose of used new product and packaging as municipal solid waste (MSW), recycled material, or litter.

6.2 Analysis of Potential Environmental Impacts

Environmental 

Resource Analysis of Potential Impacts

Biological 

resources

Proper disposal of the used new product and packaging in the MSW stream would 

not adversely affect biological resources. Improper disposal (littering) could lead to 

direct terrestrial wildlife exposure and hazardous substances leaching to aquatic 

environments and soil. However, no net litter increases are expected because the 

new product would compete for the same market share occupied by currently 

marketed smokeless tobacco products. Therefore, these impacts are not considered 

significant.

Environmental 

justice 

No significant environmental impacts associated with disposal of the used new

product and packaging were identified. The new product is likely to be used, and 

thereof disposed, by consumers that use existing smokeless tobacco products, 

competing for the same market share. Therefore, no disproportionate impacts to 

minority and low-income populations are anticipated.

Water 

resources

Proper disposal of the used new product and packaging in the MSW stream would 

not affect water resources. Improper disposal (littering) could result in hazardous 

substances leaching to water systems. However, no net litter increases are 

expected because the new product would compete for the same market share 

occupied by currently marketed smokeless tobacco products. Therefore, these 

impacts are not considered significant.

Solid waste 

and hazardous 

materials

Distribution of waste generated from disposal of the used new product and 

packaging is anticipated to correspond to U.S. product use patterns. However, 

introducing the new product into the U.S. market is not expected to increase 

nationwide use and disposal. Therefore, no net increase in littering would be 

expected.
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Environmental 

Resource Analysis of Potential Impacts

Regulatory 

compliance

The new product has no features that would lead to a different used product litter 

rate compared to currently marketed smokeless tobacco products. Despite state 

and local ordinances, it is assumed that noncompliance (littering) would occur at

the same rate for the new and currently marketed smokeless products. Therefore, 

these impacts are not considered significant.

6.3 Impacts from the No-Action Alternative

The no-action alternative would not change existing smokeless tobacco product and packaging material

disposal because disposal of similar products would continue in the United States. 

7. List of Preparers

The following individuals were primarily responsible for preparing and reviewing this environmental 

assessment: 

Preparers:

William E. Brenner, B.S., Center for Tobacco Products

Education: B.S. in Biology

Experience: Eight years in various scientific activities 

Expertise: NEPA analysis, environmental risk assessment, air quality analysis, archaeological and

archival preservation

Reviewer:

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

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

Experience: Forty-three years in various scientific activities including ten years in NEPA practice

Expertise: NEPA analysis, environmental risk assessment, evidence-based assessment of health 

technologies, NEPA Implementation

8. List of Agencies and Persons Consulted

None. 

9. References

U.S. EPA Enforcement and Compliance History Online (ECHO). (2022). Facility Search. Available at: 

https://echo.epa.gov/. Accessed September 8, 2022. 

U.S. EPA Toxic Release Inventory Database (TRI). (2022). TRI Facility Release Reports. Available at: 

https://www3.epa.gov/enviro/facts/tri/form_ra_download.html. Searched September 9, 2022. 
11

U.S. EPA WATERS GeoViewer. (2022). Available at: 

https://epa.maps.arcgis.com/apps/webappviewer/index.html?id=ada349b90c26496ea52aab66a092593

b. Accessed on September 8, 2022.

U.S. Fish and Wildlife Services (U.S. FWS) Environmental Conservation Online System (ECOS). (2022a).

Endangered Species Online Mapper: Listed species believed to or known to occur in Davidson, 

Tennessee. Available at: https://ecos.fws.gov/ecp/report/species-listings-by-current-rangecounty?fips=47037. Accessed September 8, 2022. 

U.S. FWS ECOS. (2022b). Critical Habitat for Threatened & Endangered Species Online Mapper. Available

at: 

https://fws.maps.arcgis.com/home/webmap/viewer.html?webmap=9d8de5e265ad4fe09893cf75b8dbf

b77. Search for Davidson County, TN. Accessed September 8, 2022. 

U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB). (2022). Tobacco statistics. U.S. Department of the 

Treasury.statistical data aAvailable at: https://www.ttb.gov/tobacco/tobacco-stats.shtml. Accessed April 

22, 2021. 
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Confidential Appendix 1: First- and Fifth-Year Market Volume Projections for the New Product

First- and fifth-year market volume projections of the new product were compared to the total 

forecasted use of snuff tobacco in the United States.3 The projected use of the new product in the first 

and fifth year of marketing after a modified risk order is issued account for about % and %

respectively of the forecasted snuff tobacco use in the United States.4

 

STN Unit

Market Volume

First-Year 

(Projected)

New Product

% Of Total Snuff 

Tobacco Used5

Fifth-Year 

(Projected)

New Product

% Of Total Snuff 

Tobacco Used6

MR0000108

Cans

Metric 

Tons

3 The Agency used historical data regarding total use of snuff from 1997 to 2020 to mathematically estimate the total number 

of snuff tobacco used in the United States. Using the best-fit trend line with an R2 value of 0.9459, the forecasted amount of 

snuff tobacco that will be used in the United States is estimated at 126,903,000 pounds in the first year and 133,705,000 

pounds in the fifth year of marketing the new product.

4 Market volumes are used as proxy for use, assuming that all produced products will be consumed or used in the United States. 

5 Projected Market Occupation of the New Product in the United States (%)= 

Projected Market Volume of the New Product (Metric TTTTTTTT) xx 2204.62 PPPPPPPPPPPP

MMMMMMMMMMMM TTPPPP

Projected Use of snuff tobacco in United States (pounds) xx 100

6 ibid

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