[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Proposed Rules]
[Pages 3742-3750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01224]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 25

[Docket No. FDA-2013-N-1282]


National Environmental Policy Act; Environmental Assessments for 
Tobacco Products; Categorical Exclusions

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: In accordance with the National Environmental Policy Act of 
1969 (NEPA) and the Council on Environmental Quality (CEQ) Regulations 
Implementing NEPA (CEQ Regulations), the Food and Drug Administration 
(FDA) is proposing to revise its NEPA implementing regulations to 
provide categorical exclusions for certain actions related to 
substantial equivalence (SE) reports, SE exemption requests, and 
tobacco product applications, and the rescission (order withdrawing an 
order) or suspension of orders regarding the marketing of tobacco 
products under the Family Smoking Prevention and Tobacco Control Act 
(Tobacco Control Act). FDA is also proposing to amend its NEPA 
implementing regulations to include tobacco products, where 
appropriate, in light of its new authority under the Tobacco Control 
Act.

DATES: Submit either electronic or written comments on the proposed 
rule by April 8, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-1282, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions):

[[Page 3743]]

Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2013-N-1282 for this rulemaking. All comments 
received may be posted without change to http://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gerie A. Voss, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 1-877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background and Legal Authority
II. Overview of the Proposed Rule
    A. Classes of Tobacco Product-Related Actions Subject to 
Proposed Categorical Exclusions
    B. Extraordinary Circumstances for Tobacco Product-Related 
Actions
    C. Proposed Categorical Exclusions Would Benefit the Public 
Interest
III. Description of the Proposed Rule
    A. General Procedures (Sec.  25.15)
    B. Actions Requiring Preparation of an Environmental Assessment 
(Sec.  25.20)
    C. General (Sec.  25.30)
    D. Tobacco Product Applications (Sec.  25.35)
    E. Environmental Assessments (Sec.  25.40)
    F. General Information (Sec.  25.50)
    G. Environmental Impact Statements (Sec.  25.52)
IV. Paperwork Reduction Act of 1995
V. Federalism
VI. Environmental Impact
VII. Analysis of Impacts
VIII. Comments
IX. References

I. Background and Legal Authority

    NEPA and the CEQ Regulations require each Federal Agency to assess, 
as an integral part of its decisionmaking process, the environmental 
impacts of any proposed Federal action to ascertain the environmental 
consequences of that action on the quality of the human environment and 
to ensure that the interested and affected public is appropriately 
informed (42 U.S.C. 4332(2); 40 CFR 1506.6). The CEQ is responsible for 
the CEQ Regulations and for overseeing Federal efforts to comply with 
NEPA. Both FDA and CEQ have issued regulations governing Agency 
obligations and responsibilities under NEPA. The FDA regulations are 
included at 21 CFR part 25 and the CEQ regulations are at 40 CFR parts 
1500 to 1508.
    The CEQ regulations, which are binding on all Federal executive 
Agencies, establish procedures for implementing NEPA. Agencies may 
adopt procedures to supplement CEQ's regulations. In adopting NEPA-
implementing procedures, Federal Agencies are directed by CEQ to reduce 
paperwork (40 CFR 1500.4 and 1500.2(b)) and to reduce delay (40 CFR 
1500.5) by using several means, including the use of categorical 
exclusions. The CEQ regulations also state that Agencies shall continue 
to review their policies and procedures and, in consultation with CEQ, 
revise them as necessary to ensure full compliance with the purpose and 
provisions of NEPA (40 CFR 1507.3).
    The FDA regulations state that for major Federal actions that may 
``significantly affect the quality of the human environment,'' FDA must 
prepare an environmental impact statement (EIS) (21 CFR 25.22; see also 
40 CFR 1501.4). The term ``significantly,'' as used in NEPA, requires 
considerations of both ``context'' (i.e., analyzed in several contexts) 
and ``intensity'' (i.e., severity of impact) (40 CFR 1508.27(a), (b)). 
If the action may have a significant environmental impact, FDA can 
either prepare an EIS or prepare an Environmental Assessment (EA). An 
EA provides sufficient information and analysis for FDA to determine 
whether to prepare an EIS or issue a finding of no significant impact 
(FONSI) (21 CFR 25.20; 40 CFR 1501.3). FDA is responsible for the scope 
and content of an EA and generally requires an applicant to prepare an 
EA and make necessary corrections to it (21 CFR 25.40(b)).
    Categorically excluded actions refer to a category of actions that 
have been found not to individually or cumulatively have a significant 
effect on the quality of the human environment and which do not 
ordinarily require the preparation of an EA or EIS (40 CFR 1508.4). 
However, as required under 21 CFR 25.21 and 40 CFR 1508.4, FDA will 
require at least an EA for any specific action that ordinarily would be 
excluded if extraordinary circumstances indicate that the specific 
proposed action may significantly affect the quality of the human 
environment.
    If a submitter elects to request a categorical exclusion for a 
proposed action, a claim of categorical exclusion must be submitted in 
accordance with 21 CFR 25.15. Section 25.15 requires that the claim of 
categorical exclusion include: (1) A statement of compliance with the 
categorical exclusion criteria and (2) a statement that, to the 
submitter's knowledge, no extraordinary circumstances exist.
    In November 2010, CEQ issued a final guidance on categorical 
exclusions including the process Agencies should use to establish new 
categorical exclusions. The guidance states that Agencies can establish 
new categorical exclusions to reduce paperwork and delay where the 
Agency has developed a record illustrating that the proposed 
categorical exclusion covers a category of action that, on the basis of 
past experience, does not normally have the potential to cause 
significant environmental effects (Ref. 1 at pp. 2 and 16). In 
addition, ``[w]hen agencies acquire new responsibilities through 
legislation or administrative restructuring, they should propose new 
categorical exclusions after they, or other agencies, gain sufficient 
experience with the new activities to make a reasoned determination 
that any resulting environmental impacts are not significant'' (Ref. 1 
at p. 18).
    FDA is proposing new categorical exclusions in accordance with 
NEPA, FDA, and CEQ regulations, and the CEQ November 2010 categorical 
exclusion guidance.

II. Overview of the Proposed Rule

    Since FDA's NEPA policies and supplemental procedures were 
published in 1985 and prior to Congress giving FDA authority to 
regulate tobacco products in 2009, the Agency has prepared EAs for many 
Agency-initiated actions and has reviewed hundreds of EAs for a variety 
of industry requests for Agency action on foods, drugs, and medical 
devices for human consumption and use, and foods and drugs given to 
animals. In accordance with Sec.  25.40(a) (21 CFR 25.40(a)), these EAs 
have focused on the potential environmental effects related to the use 
and disposal from use of the FDA-regulated articles. Based on FDA's 
experience reviewing EAs for actions involving foods, drugs, and 
medical devices for human consumption and use, and food and drugs given 
to animals, and its evaluation and knowledge of other relevant 
environmental science, FDA has determined that certain classes of

[[Page 3744]]

actions related to tobacco products normally do not cause significant 
environmental effects and, therefore, should be added to the list of 
actions that are excluded from the requirement to prepare an EA or an 
EIS. In addition, FDA has gained sufficient experience from its 
responsibilities under the Tobacco Control Act to determine that 
certain actions on tobacco-related applications do not result in 
significant environmental impacts to the quality of the human 
environment. Accordingly, FDA is proposing several new categorical 
exclusions for tobacco product-related actions. See the ``Statement of 
RADM David Ashley, Ph.D. and Hoshing Chang, Ph.D.'' (Ref. 2).

A. Classes of Tobacco Product-Related Actions Subject to Proposed 
Categorical Exclusions

    FDA is proposing that the following classes of tobacco product-
related actions qualify for categorical exclusions: (1) Issuance of an 
order finding a tobacco product substantially equivalent to a tobacco 
product commercially marketed in the United States as of February 15, 
2007, under section 910(a)(2)(B) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 387j(a)(2)(B)); (2) issuance of 
an order finding a tobacco product not substantially equivalent under 
section 910(a) of the FD&C Act, an order under section 910(c) of the 
FD&C Act that a new tobacco product may not be introduced or delivered 
for introduction into interstate commerce, or an order under section 
911 of the FD&C Act (21 U.S.C. 387k) that a modified risk tobacco 
product (MRTP) may not be introduced or delivered for introduction into 
interstate commerce (a modified risk tobacco product is any tobacco 
product that is sold or distributed for use to reduce harm or the risk 
of tobacco-related disease associated with commercially marketed 
tobacco products); (3) rescission (order withdrawing an order) or 
temporary suspension of an order authorizing the marketing of a new 
tobacco product under section 910 of the FD&C Act; (4) rescission of an 
order authorizing the marketing of a MRTP under section 911 of the FD&C 
Act; and (5) rescission of an order granting an exemption request under 
21 CFR 1107.1.
    For each proposed categorical exclusion, the environmental effect 
from the use and disposal from use of the tobacco product is 
negligible, if any, and would not individually or cumulatively have a 
significant effect on the quality of the human environment. Therefore, 
FDA believes that absent extraordinary circumstances, such actions 
should not require the preparation of any further analysis such as an 
EIS or an EA, which is intended to focus on ``relevant environmental 
issues relating to the use and disposal from use of FDA-regulated 
articles'' (Sec.  25.40(a)).
    FDA also is proposing to amend several paragraphs of its existing 
environmental impact regulations in order to include tobacco products, 
where appropriate, in light of its new authority under the Tobacco 
Control Act.
1. SE Order Under Section 910(a)(2)(B) of the FD&C Act
    FDA proposes that the Agency's issuance of an order finding a 
product to be substantially equivalent under section 910(a)(2)(B) of 
the FD&C Act qualifies for a categorical exclusion. Section 
910(a)(2)(B) allows manufacturers of tobacco products that were first 
introduced or delivered for introduction into interstate commerce after 
February 15, 2007, and before March 22, 2011, and who submit a report 
by March 22, 2011, to continue to market the tobacco product unless the 
Agency issues an order that the tobacco product is not substantially 
equivalent and therefore must be removed from the market.
    The estimated environmental effects that encompass all FDA-
regulated tobacco products on the market, including products marketed 
after February 15, 2007, and before March 22, 2011, and grandfathered 
products (defined here as those products on the market as of February 
15, 2007), are as follows:
    a. Effects due to the manufacture of the tobacco products:
    According to the 2011 Toxics Release Inventory (TRI) National 
Analysis, FDA estimates that 46,308 pounds of toxic chemicals (ammonia) 
were released to the land in the United States in 2011 without recycle 
and treatment; 3,702 pounds of toxic chemicals (including ammonia, 
nicotine and salts, and nitrate compounds) to the water; 719,451 pounds 
of toxic chemicals (including ammonia, chlorine, lead compounds, as 
well as nicotine and salts) to the air; 252,931 pounds of toxic 
chemicals (including ammonia, lead compounds, as well as nicotine and 
salts) recycled; and 1,563,193 pounds of toxic chemicals (including 
ammonia, nitrate compounds, as well as nicotine and salts) treated 
(Ref. 3). Compared to toxic waste released due to other manufacture 
activities estimated by the Environmental Protection Agency (EPA) using 
the same EPA database, the amount of waste released, recycled, and 
treated due to the manufacture of all tobacco products on the market is 
a fraction of the total toxic waste released from and managed in 
industrial facilities in the United States (as reported in 2011 TRI 
National Analysis Report).

[[Page 3745]]



                                       Table 1--Release of Toxic Chemicals
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                                   Chemicals in Pounds Released Due to Manufacture    Total Toxic Released from
                                    of Tobacco Products in 2011 (Derived from 2011  and Managed in Industrial
                                          TRI National Analysis Report, EPA)        Facilities in the United
                                                                                    States in 2011 (2011 TRI
                                                                                    National Analysis Report,
                                                                                    EPA) in Pounds
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Land Total Release..............  Ammonia...........                        46,308                 1,255,558,266
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Water Total Release.............  Ammonia...........                           185                   212,990,079
                                  Nicotine and Salts                           285
                                  Nitrate compounds.                         3,232
                                 --------------------------------------------------
                                     Subtotal.......                         3,702
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Air Total Release...............  Ammonia...........                       467,181                   799,250,733
                                  Chlorine..........                           294
                                  Lead Compounds....                            38
                                  Nicotine and Salts                       251,938
                                 --------------------------------------------------
                                     Subtotal.......                       719,451
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Total Recycled..................  Ammonia...........                           775                 8,601,489,350
                                  Lead Compounds....                           621
                                  Nicotine and Salts                       251,535
                                 --------------------------------------------------
                                     Subtotal.......                       252,931
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Total Treated...................  Ammonia...........                        30,385                 7,397,857,287
                                  Nicotine and Salts                       369,130
                                  Nitrate compounds.                     1,163,678
                                 --------------------------------------------------
                                     Subtotal.......                     1,563,193
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    b. Effects due to use of the tobacco products:
    As reported in the U.S. Department of Agriculture's 2007 Tobacco 
Outlook, the United States consumed 2.9 pounds of cigarettes per capita 
and 0.38 pounds of snuff per capita (adults age 18 and over) (Ref. 4). 
From 1996 to 2006, tobacco product consumption dropped by about 24 
percent, chewing tobacco use decreased 41 percent, snuff use increased 
23 percent, and cigarette smoking decreased 29 percent (Ref. 4).
    The existing environmental impact resulting from cigarette and 
roll-your-own use is tobacco smoke, which is one of the causes of poor 
indoor air quality (Ref. 5). Environmental Tobacco Smoke (secondhand 
smoke) is classified as a Class A carcinogen by EPA (Ref. 6). Studies 
on outdoor tobacco smoke have shown that during periods of active 
smoking, peak and average outdoor tobacco smoke levels near smokers are 
equivalent to indoor tobacco smoke concentrations levels. However, 
outdoor tobacco smoke levels approached zero at distances greater than 
approximately 2 meters from a single cigarette and dropped almost 
instantly after smoking activity ceased (Ref. 7). The existing 
environmental impact resulting from use of smokeless tobacco products 
is not as substantial as that for cigarettes or roll-your-own tobacco. 
FDA expects that any new tobacco products that receive marketing 
authorization through the available pathways would have less or no more 
environmental impact than that of tobacco products currently on the 
market.
    c. Effects due to the disposal from use of the tobacco products:
    The existing environmental consequence resulting from disposal from 
use of cigarettes is from the discarded cigarette filters. Cigarette 
filters are primarily composed of cellulose acetate (Ref. 8) and may 
persist under normal environmental conditions for 18 months to 10 years 
(Ref. 9). As much as 766,571 metric tons of cigarette filters are 
discarded as litter worldwide each year (Ref. 10). Discarded cigarette 
filters are carried as runoff from streets to drains and rivers and, 
ultimately, to the ocean and its beaches and are found to be the most 
collected item in beach clean-ups and litter surveys (Ref. 10). 
Evidence has shown that cigarette butts are the most prevalent items 
discarded in urban areas (Ref. 11). Cigarette filters were found to be 
a point source for metal contamination litter, based on a study 
performed to assess the gradual release of multiple metals from the 
cigarette filter over the 34-day study period (Ref. 12). Scientists 
evaluating the ecotoxicity of discarded cigarette filters also have 
shown the potential existing environmental consequences that result 
from disposal of cigarette filters. Scientists found that the solution 
made as a result of soaking smoked cigarette butts (smoked filter + 
tobacco) in water was toxic to both marine and fresh water fish used in 
the study (Ref. 13).
    The existing environmental consequence resulting from disposal from 
use of smokeless tobacco is the impact on landfills. About 126 million 
pounds of smokeless tobacco were consumed in the United States in 2006, 
which resulted in an approximately equal amount of spent smokeless 
tobacco in the country's landfills (Ref. 14).\1\
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    \1\ The consumption of smokeless tobacco in 2006 is estimated as 
follows: 225,662,922 (U.S. population for age 18 years old and over 
in 2006) x 0.38 (snuff consumption per capita 18 years and over in 
pounds, 2007) + 109,777,445 (U.S. population for male age 18 years 
old and over in 2006) x 0.37 (chewing tobacco consumption per capita 
male 18 years and over in pounds, 2007) = 126,369,565 pounds.
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    The Agency estimates that there are currently about 5,000 brands 
and subbrands of tobacco products on the market that are subject to 
FDA's tobacco product authorities. The majority of them are on the 
market under section 910(a)(2)(B) of the FD&C Act. The effects of 
keeping tobacco products on the market are individually and 
cumulatively trivial compared to the existing environmental effects due 
to toxic waste released from and managed

[[Page 3746]]

in industrial facilities in the United States and the existing 
environmental effects due to the use and disposal from use of the 
tobacco products in the country. Therefore, the action should qualify 
for a categorical exclusion under proposed Sec.  25.35(a).
2. Orders Under Sections 910(a), 910(c), and 911 of the FD&C Act
    FDA proposes that the Agency's issuance of any of the following 
orders qualifies for a categorical exclusion: (1) An order finding a 
tobacco product not substantially equivalent under section 910(a) of 
the FD&C Act; (2) an order finding that a new tobacco product may not 
be introduced or delivered for introduction into interstate commerce 
under section 910(c) of the FD&C Act; or (3) an order finding that a 
modified risk tobacco product may not be introduced or delivered for 
introduction into interstate commerce under section 911. No use or 
disposal from use exists as a result of these actions. Generally, the 
effect of a denial for a new product application is to prevent the 
entry or continued entry of a product into the market. With regard to 
products that entered the market after February 15, 2007, and before 
March 22, 2011, and for which a report was submitted by March 22, 2011, 
the effect of a finding of not substantially equivalent would be to 
remove that product from the market. Such a removal would not result in 
the production or distribution of any substances and, therefore, would 
not result in the introduction of any substance into the environment. 
Therefore, FDA believes these actions would not individually or 
cumulatively have an effect on the quality of the human environment and 
should qualify for categorical exclusions under proposed Sec.  
25.35(b).
3. Rescission or Temporary Suspension of an Order Issued Under Section 
910 of the FD&C Act
    FDA proposes that the Agency's rescission or temporary suspension 
of an order authorizing the marketing of a new tobacco product under 
section 910 of the FD&C Act qualifies for a categorical exclusion. This 
action stops or suspends the use of a new tobacco product under section 
910. The Agency is proposing that these rescissions or temporary 
suspensions of authorization, whether requested by industry or 
initiated by the Agency, be categorically excluded because these types 
of actions would not result in the production or distribution of any 
substances and, therefore, would not result in the introduction of any 
substance into the environment. Furthermore, assuming that users of the 
product continued to use tobacco, they would be expected to continue 
use by changing their use to products already on the market. These 
products would have been part of the baseline market that existed prior 
to passage of the Tobacco Control Act or would have already been 
subject to a categorical exclusion or an EA. The discontinuation of use 
and disposal from use of the tobacco product would not individually or 
cumulatively have a significant impact on the quality of the human 
environment. Therefore, the action should qualify for a categorical 
exclusion under proposed Sec.  25.35(c).
4. Rescission of an Order Issued Under Section 911 of the FD&C Act
    FDA proposes that the Agency's rescission of an order authorizing 
the marketing of an MRTP under section 911 of the FD&C Act qualifies 
for a categorical exclusion. This action would prohibit a tobacco 
product manufacturer from the use of advertisements, labels, or 
labeling indicating that the product somehow reduces harm or the risk 
of tobacco-related diseases associated with other tobacco products. The 
Agency is proposing that these rescissions of authorization, whether 
requested by industry or initiated by the Agency, be categorically 
excluded because these types of actions would not result in the 
production or distribution of any substances and, therefore, would not 
result in the introduction of any substance into the environment. 
Accordingly, FDA believes the action would not individually or 
cumulatively have a significant effect on the quality of the human 
environment and should qualify for a categorical exclusion under 
proposed Sec.  25.35(d).
5. Rescission of an Order Issued Under Section 905(j)(1)(A)(ii) of the 
FD&C Act and Sec.  1107.1
    FDA proposes that the Agency's rescission of an order authorizing 
the marketing of a new tobacco product under section 905(j)(1)(A)(ii) 
of the FD&C Act (21 U.S.C. 387e(j)(1)(A)(ii)) and Sec.  1107.1 
qualifies for a categorical exclusion. Section 1107.1 allows the Agency 
to rescind an exemption from the requirements relating to the 
demonstration of substantial equivalence where the tobacco product is 
modified by adding or deleting a tobacco additive, or increasing or 
decreasing the quantity of an existing tobacco additive, if it finds 
that the exemption is not appropriate for the protection of public 
health (Sec.  1107.1(d)). The action stops the use of a new tobacco 
product under these provisions. The Agency is proposing that these 
rescissions of authorization, whether requested by industry or 
initiated by the Agency, be categorically excluded because these types 
of actions would not result in the production or distribution of any 
substances and, therefore, would not result in the introduction of any 
substance into the environment. The discontinuation of use and disposal 
from use of the tobacco product would not individually or cumulatively 
have a significant effect on the quality of the human environment. 
Therefore, the action should qualify for a categorical exclusion under 
proposed Sec.  25.35(e).

B. Extraordinary Circumstances for Tobacco Product-Related Actions

    The current regulations state that FDA will require further 
analysis, at least an EA, for any specific action that ordinarily would 
be categorically excluded if extraordinary circumstances indicate that 
the specific proposed action may significantly affect the quality of 
the human environment (Sec.  25.21). The regulations also state that 
examples of actions where extraordinary circumstances would preclude 
using a categorical exclusion include ``[a]ctions for which available 
data establish that, at the expected level of exposure, there is the 
potential for serious harm to the environment'' and ``[a]ctions that 
adversely affect a species or the critical habitat of a [protected] 
species'' (Sec.  25.21(a) and (b)).
    These examples are applicable to tobacco products. If any tobacco 
product submission indicates that the action could result in the 
exposure of substances harmful to some biological mechanisms or systems 
in the environment or that the action may cause harm to a protected or 
endangered species, this would be considered an extraordinary 
circumstance that would warrant at least the preparation of an EA. FDA 
will continue to rely upon considerations of the intensity and context 
as set out at 40 CFR 1508.27 for determining whether an extraordinary 
circumstance will result in the potential for a proposed action to 
significantly affect the environment.

C. Proposed Categorical Exclusions Would Benefit the Public Interest

    FDA believes that this proposal would benefit FDA, regulated 
industry, and the public as a whole. The proposal would substantially 
reduce the numbers of EAs required to be submitted by industry and 
reviewed by FDA and, consequently, reduce the number of FONSIs the 
Agency would be required to prepare for such applications. This would 
enable FDA to focus its

[[Page 3747]]

environmental resources on situations likely to have an effect on the 
environment--a key goal of NEPA and CEQ (see 40 CFR 1500.4(b), 
1500.5(k)). As CEQ noted in 2010, the ``use of categorical exclusions 
can reduce paperwork and delay, so that EAs and EISs are targeted 
toward proposed actions that truly have the potential to cause 
significant environmental effects'' (Ref. 1 at p. 16). The proposal 
also would allow tobacco product manufacturers to focus on other key 
portions of their applications, which is particularly necessary given 
that this industry has not been previously subject to Federal 
regulations. In addition, the proposal would benefit the tobacco 
product industry by alleviating otherwise necessary burdens given that 
``[g]enerally, FDA requires an applicant to prepare an EA and make 
necessary corrections to it'' (21 CFR 25.40(b)). Furthermore, this rule 
would benefit the public health by allowing both FDA and industry to 
better focus their resources on other matters that could have a direct 
impact on the public health. Finally, Sec.  25.21 provides a safeguard 
that allows the Agency to prepare or require industry to prepare an EA 
if there are extraordinary circumstances such that an action that 
ordinarily would be categorically excluded may significantly affect the 
quality of the human environment.

III. Description of the Proposed Rule

    FDA proposes to amend Title 21 of the Code of Federal Regulations 
in order to:
     Clarify that part 25 applies to tobacco products subject 
to FDA's authority under Chapter IX of the FD&C Act (U.S.C. 387 through 
U.S.C. 387u); and
     Establish categorical exclusions specific to tobacco 
products.
    Specifically, the proposed regulations would: (1) Amend Sec.  
25.15(a), (c), and (d) to indicate the availability of categorical 
exclusions under Sec.  25.35; (2) amend Sec.  25.20 by adding language 
to the introductory paragraph and adding paragraphs (p) and (q) to 
identify the tobacco-related actions that normally would require at 
least the preparation of an EA, unless the specific classes of actions 
are categorically excluded by the proposed exclusions in Sec.  25.35; 
(3) revise the introductory paragraph of Sec.  25.30 to reflect the new 
proposed categorical exclusions in Sec.  25.35; (4) add Sec.  25.35 to 
outline the categorical exclusions that apply solely to certain actions 
on tobacco product applications; (5) amend Sec.  25.40(a) to indicate 
the availability of categorical exclusions under Sec.  25.35; and (6) 
amend Sec. Sec.  25.50(b) and 25.52(a), (b), and (c) to ensure that the 
public has an opportunity to participate in the development of 
environmental documents regarding tobacco products and that it receives 
notification of these documents.

A. General Procedures (Sec.  25.15)

    The proposed rule would revise paragraphs (a), (c), and (d) of 
Sec.  25.15 to add a reference to new proposed Sec.  25.35, which would 
provide categorical exclusions for actions associated with various 
tobacco product submissions. Specifically, the addition to Sec.  
25.15(a) would explain that failure to submit an adequate EA with a 
tobacco application constitutes sufficient grounds for FDA to refuse to 
file or approve the application or petition, unless the action 
qualifies for a categorical exclusion under proposed Sec.  25.35. The 
addition to Sec.  25.15(c) would add the categorical exclusions under 
proposed Sec.  25.35 to the classes of actions that qualify for 
categorical exclusions. Finally, the addition to Sec.  25.15(d) would 
provide that a person submitting a tobacco application or petition 
identified in proposed Sec.  25.35 would not be required to submit an 
EA if the person's application states that: (1) The action requested 
qualifies for a categorical exclusion and (2) no extraordinary 
circumstances exist that would prevent the use of the categorical 
exclusion. For the purposes of tobacco products, the term 
``application'' includes any application or submission to FDA 
(including SE reports and exemption requests) related to the marketing 
of tobacco products.

B. Actions Requiring Preparation of an Environmental Assessment (Sec.  
25.20)

    FDA proposes to revise Sec.  25.20 to change the introductory 
paragraph to indicate the existence of tobacco-specific categorical 
exclusions under proposed Sec.  25.35. In addition, FDA proposes to add 
to Sec.  25.20 paragraphs (p) and (q) to state that the following 
Agency actions on tobacco applications require the preparation of an EA 
unless it is an action in a specific class that is categorically 
excluded: (1) Issuance of an order finding a tobacco product to be 
substantially equivalent under the FD&C Act, unless categorically 
excluded in Sec.  25.35 and (2) issuance of an order authorizing the 
marketing of a new tobacco product under section 910 or an MRTP under 
section 911 of the FD&C Act, unless categorically excluded in Sec.  
25.35.
    These revisions are necessary to make clear that certain types of 
actions on tobacco-related submissions could result in the requirement 
to prepare an EA, but manufacturers may be exempted from this 
requirement for certain classes of actions if the action qualifies for 
the use of a categorical exclusion.

C. General (Sec.  25.30)

    The proposed rule would revise the introductory sentence to reflect 
the fact that we are proposing to add categorical exclusions in Sec.  
25.35. Therefore, those actions listed in Sec.  25.30 and in Sec. Sec.  
25.30 through 25.35 would not ordinarily require the preparation of an 
EA or EIS.

D. Tobacco Product Applications (Sec.  25.35)

    The proposed rule would add new Sec.  25.35, which would provide 
additional categorical exclusions from the requirement to prepare at 
least an EA for certain actions on tobacco product submissions.
    Specifically, proposed Sec.  25.35(a) would provide for a 
categorical exclusion from preparing an EA for the issuance of an order 
finding that a product is substantially equivalent to a predicate 
product under section 910(a)(2)(B) of the FD&C Act.
    Proposed Sec.  25.35(b) would provide for a categorical exclusion 
regarding FDA's issuance of orders stating that: (1) A tobacco product 
is not substantially equivalent under section 910(a) of the FD&C Act; 
(2) a new tobacco product may not be introduced or delivered for 
introduction into interstate commerce under section 910(c) of the FD&C 
Act; or (3) a modified risk tobacco product may not be introduced or 
delivered into interstate commerce under section 911 of the FD&C Act.
    Proposed Sec.  25.35(c) would allow for a categorical exclusion 
where FDA rescinds or temporarily suspends an order authorizing the 
marketing of a new tobacco product under section 910 of the FD&C Act. 
Proposed Sec.  25.35(d) would provide a categorical exclusion where FDA 
rescinds an order authorizing the marketing of a modified risk tobacco 
product under section 911 of the FD&C Act. Similarly, proposed Sec.  
25.35(e) would provide a categorical exclusion where FDA rescinds an 
order authorizing the marketing of a new tobacco product under section 
905(j)(1)(A)(ii) of the FD&C Act and under Sec.  1107.1. The term ``new 
tobacco product'' is defined in section 910(a)(1)(A) and (a)(1)(B) of 
the FD&C Act.

E. Environmental Assessments (Sec.  25.40)

    The proposed rule would amend Sec.  25.40(a), which currently 
indicates that an EA shall be prepared for each action not 
categorically excluded in Sec.  25.30, 25.31, 25.32, 25.33, or 25.34.

[[Page 3748]]

The proposed rule would delete ``or 25.34'' and replace with it with 
``25.34, or 25.35'' to indicate the availability of additional 
categorical exclusions in proposed Sec.  25.35.

F. General Information (Sec.  25.50)

    The proposed rule would amend Sec.  25.50(b), which relates to 
information protected from disclosure by law. By adding tobacco 
products to this regulation, FDA seeks to make clear that any 
environmental impact documentation regarding tobacco product 
applications (including SE reports and requests for exemptions from the 
requirements to demonstrate substantial equivalence) would not be 
released prior to issuance of an FDA order, unless the existence of 
such application has been made publicly available.

G. Environmental Impact Statements (Sec.  25.52)

    Section 25.52 explains the process and requirements for public 
participation and notification regarding the preparation of an EIS for 
FDA-regulated products. Similar to other FDA-regulated products, FDA 
may determine that forthcoming actions involving tobacco products 
should require the preparation of an EIS. Therefore, the proposed rule 
would add ``tobacco products'' to paragraphs (a), (b), and (c) of Sec.  
25.52, where the regulation refers to actions on other FDA-regulated 
products that may require preparation of an EIS.
    Specifically, the proposed rule would amend Sec.  25.52(a) to 
explain that if an EIS is necessary for an action involving tobacco 
products, it would become available for review by the public only at 
the time of the issuance of an order authorizing commercial marketing 
of the product in the United States. In addition, the proposed rule 
would amend Sec.  25.52(b) to indicate that comments on the EIS may be 
submitted after the issuance of an order authorizing commercial 
marketing of the tobacco product in the United States and that these 
comments can form the basis for beginning the process of rescinding the 
marketing authorization. The proposed rule also would amend Sec.  
25.52(c) to state that where the existence of an application for a 
tobacco product has been disclosed before the Agency action, FDA will 
involve the public in preparing an EA or an EIS while continuing to 
adhere to the Agency's disclosure regulations with regard to 
confidential commercial information that has not been disclosed.
    Further, the proposed rule would amend Sec.  25.52(a) and (b) to 
add references to ``market authorizations.'' As currently written, 
Sec.  25.52(a) and (b) do not identify all the types of actions that 
could be taken with regard to tobacco products, including market 
authorizations. Not only can FDA engage in review and assessment of 
investigations with respect to tobacco products, but the Agency also 
may provide market authorizations in response to applications regarding 
tobacco products (see, e.g., section 911(g)(1) of the FD&C Act).

IV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

V. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the Agency tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive Order and, consequently, a federalism summary impact 
statement is not required.

VI. Environmental Impact

    The proposed amendment of the FDA NEPA Regulations (21 CFR part 25) 
concerns NEPA documentation for certain actions on tobacco product 
submission. CEQ does not direct Agencies to prepare a NEPA analysis or 
document before establishing Agency procedures that supplement the CEQ 
regulations for implementing NEPA. Agencies are required to adopt NEPA 
procedures that establish specific criteria for, and identification of, 
three classes of actions: Those that require preparation of an EIS; 
those that require preparation of an EA; and those that are 
categorically excluded from further NEPA review (40 CFR 1507.3(b)). 
Categorical exclusions are one part of those Agency procedures, and 
therefore establishing categorical exclusions does not require 
preparation of a NEPA analysis or document. Agency NEPA procedures, 
such as the FDA NEPA regulations assist FDA in the fulfillment of 
Agency responsibilities under NEPA, but are not FDA's final 
determination of what level of NEPA analysis is required for a 
particular proposed action on a tobacco product submission. The 
requirements for establishing Agency NEPA procedures are set forth at 
40 CFR 1505.1 and 1507.3. Furthermore, the Agency has also determined 
under 21 CFR 25.30(h) that this rulemaking does not individually or 
cumulatively have a significant effect on the quality of the human 
environment.

VII. Analysis of Impacts

    The analysis of economic impacts is available as Reference 15 in 
Docket No. FDA-2013-N-1282 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VIII. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). As noted previously, if 
you have comments on specific provisions of the proposed regulation, we 
request that you identify these provisions in your comments. In 
addition, if you have concerns that would be addressed by alternative 
text for the regulation, we request that you provide this alternative 
text in your comments. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

IX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m. Monday through Friday, and 
are available electronically at http://www.regulations.gov. (FDA has 
verified all the Web site addresses in this reference section, but FDA 
is not responsible for any subsequent changes to the Web sites after 
this document publishes in the Federal Register.)

    1. Council on Environmental Quality, ``Final Guidance for 
Federal Departments and Agencies on Establishing, Applying, and 
Revising Categorical Exclusions Under the National Environmental 
Policy Act,'' 76 FR 3843, January 21, 2011.
    2. Statement of RADM David Ashley, Ph.D. and Hoshing Chang, 
Ph.D., ``Impact of Tobacco Products on the Environment.''
    3. 2011 Toxic Release Inventory (TRI) National Analysis. 
Available at http://

[[Page 3749]]

www.epa.gov/tri/tridata/tri11/nationalanalysis/overview/2011_TRI_
NA_Overview.pdf.
    4. U.S. Department of Agriculture. ``Tobacco Outlook Report,'' 
Economic Research Service, 2007. http://usda01.library.cornell.edu/usda/ers/TBS//2000s/2007/TBS-10-24-2007.pdf. Accessed on August 29, 
2012.
    5. Poor Air Quality, available at http://www.epa.gov/iaq/pubs/insidestory.html.
    6. U.S. Environmental Protection Agency, ``Respiratory Health 
Effects of Passive Smoking: Lung Cancer and Other Disorders,'' EPA/
600/6-90/006F, December 1992.
    7. Klepeis, NE., W.R. Ott, and P. Switzer, ``Real-Time 
Measurement of Outdoor Tobacco Smoke Particles,'' Journal of the Air 
& Waste Management Association, 57:5, 522-534, 2007.
    8. U.S. Department of Health and Human Services, ``Reducing the 
Health Consequences of Smoking: 25 Years of Progress.'' A Report of 
the Surgeon General, 1989. Rockville, MD: Public Health Service, 
Centers for Disease Control, Office on Smoking and Health, 1989. 
(DHHS Publication No (CDC) 89-8411.)
    9. Ach, A. Biodegradable Plastics Based on Cellulose Acetate. 
Journal of Macromolecular Science: Pure and Applied Chemistry. 
A30:733-740, 1993.
    10. Smith, E.A. and T.E. Novotny, ``Whose Butt Is It? Tobacco 
Industry Research About Smokers and Cigarette Butt Waste.'' Tobacco 
Control, 20:I2-I9, 2011. DOI: 10.1136/tc.2010.040105.
    11. Department for the Environment, Food and Rural Affairs of 
the U.K. ``Preventing Cigarette Litter in England: Guidelines for 
Local Authorities,'' DEFRA 2007.
    12. Moerman, J.W. and G.E. Potts, ``Analysis of Metals Leached 
From Smoked Cigarette Litter.'' Tobacco Control, 20:I30-I35, 2011. 
DOI: 10.1136/tc.2010.040196.
    13. Slaughter, E.; R.M. Gersberg, K. Watanabe, et al., 
``Toxicity of Cigarette Butts, and Their Chemical Components, to 
Marine and Freshwater Fish,'' Tobacco Control, 20: I25-I29 2011.
    14. United States Census Bureau, Vintage 2006: National Tables, 
available at http://www.census.gov/popest/data/historical/2000s/vintage_2006/index.html; accessed October 20, 2012.
    15. Preliminary Regulatory Impact Analysis.

List of Subjects in 21 CFR Part 25

    Environmental impact statements, Foreign relations, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR Chapter I be amended as follows:

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

0
1. The authority citation for part 25 continues to read as follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 
4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 
1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 
1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 
Comp., p. 356-360.


Sec.  25.15  [Amended]

0
2. Amend Sec.  25.15 as follows:
0
a. Remove from paragraph (a) ``or 25.34,'' and add in its place 
``25.34, or 25.35,'';
0
b. Remove from paragraph (c) ``or 25.34''and add in its place ``25.34, 
or 25.35''; and
0
c. Remove from paragraph (d) ``or 25.34,'' and add in its place 
``25.34, or 25.35,''.
0
3. Amend Sec.  25.20 by revising the introductory text and by adding 
paragraphs (p) and (q) to read as follows:


Sec.  25.20  Actions requiring preparation of an environmental 
assessment.

    Any proposed action of a type specified in this section ordinarily 
requires at least the preparation of an EA, unless it is an action in a 
specific class that qualifies for exclusion under Sec. Sec.  25.30, 
25.31, 25.32, 25.33, 25.34, or 25.35:
* * * * *
    (p) Issuance of an order finding a tobacco product substantially 
equivalent under Federal Food, Drug, and Cosmetic Act, unless 
categorically excluded under Sec.  25.35.
    (q) Issuance of an order authorizing marketing of a new tobacco 
product under section 910 of the Federal Food, Drug, and Cosmetic Act 
or an order authorizing marketing of a modified risk tobacco product 
under section 911 of the Federal Food, Drug, and Cosmetic Act, unless 
categorically excluded under Sec.  25.35.
0
4. Amend the introductory text of Sec.  25.30 by removing ``25.34'' and 
adding in its place ``25.35''.
0
5. Add new Sec.  25.35 to subpart C to read as follows:


Sec.  25.35  Tobacco product applications.

    The classes of actions listed in this section are categorically 
excluded and, therefore, ordinarily do not require the preparation of 
an EA or an EIS:
    (a) Issuance of an order finding a tobacco product substantially 
equivalent under section 910(a)(2)(B) of the Federal Food, Drug, and 
Cosmetic Act;
    (b) Issuance of an order finding a tobacco product not 
substantially equivalent under section 910(a) of the Federal Food, 
Drug, and Cosmetic Act, issuance of an order under section 910(c) of 
the Federal Food, Drug, and Cosmetic Act that a new tobacco product may 
not be introduced or delivered for introduction into interstate 
commerce, or issuance of an order under section 911 of the Federal 
Food, Drug, and Cosmetic Act that a modified risk tobacco product may 
not be introduced or delivered for introduction into interstate 
commerce;
    (c) Rescission or temporary suspension of an order authorizing the 
marketing of a new tobacco product under section 910 of the Federal 
Food, Drug, and Cosmetic Act;
    (d) Rescission of an order authorizing the marketing of a modified 
risk tobacco product under section 911 of the Federal Food, Drug, and 
Cosmetic Act; and
    (e) Rescission of an order granting an exemption request under 
Sec.  1107.1 of this chapter.
0
6. Amend Sec.  25.40 by removing from paragraph (a) ``or Sec.  25.34'' 
and adding in its place, ``Sec.  25.34, or Sec.  25.35.''
0
7. Amend Sec.  25.50 by revising the first, third, fourth, and fifth 
sentences of paragraph (b) to read as follows:


Sec.  25.50  General information.

* * * * *
    (b) Many FDA actions involving investigations, review, and approval 
or market authorization of applications, and premarket notifications 
for human drugs, animal drugs, biologic products, devices, and tobacco 
products are protected from disclosure under the Trade Secret Act, 18 
U.S.C. 1905, and section 301(j) of the Federal Food, Drug, and Cosmetic 
Act. * * * Even the existence of applications for human drugs, animal 
drugs, biologic products, devices, and tobacco products is protected 
from disclosure under these regulations. Therefore, unless the 
existence of applications for human drugs, animal drugs, biologic 
products, tobacco products, or premarket notification for devices has 
been made publicly available, the release of the environmental document 
before approval or authorization of human drugs, animal drugs, biologic 
products, devices and tobacco products is inconsistent with statutory 
requirements imposed on FDA. Appropriate environmental documents, 
comments, and responses will be included in the administrative record 
to the extent allowed by applicable laws.
0
8. Amend Sec.  25.52 by revising the first sentence of paragraph (a), 
and paragraphs (b) and (c) to read as follows:


Sec.  25.52  Environmental impact statements.

    (a) If FDA determines that an EIS is necessary for an action 
involving investigations, approvals, or market authorizations for 
drugs, animal drugs, biologic products, devices, or tobacco products, 
an EIS will be prepared but

[[Page 3750]]

will become available only at the time of the approval or market 
authorization of the product. * * *
    (b) Comments on the EIS may be submitted after the approval or 
market authorization of the drug, animal drug, biologic product, 
device, or tobacco product. Those comments can form the basis for the 
Agency to consider beginning an action to withdraw the approval or 
market authorization of applications for a drug, animal drug, biologic 
product, or tobacco product, or to withdraw premarket notifications or 
premarket approval applications for devices.
    (c) In those cases where the existence of applications and 
premarket notifications for drugs, animal drugs, biologic products, 
devices, or tobacco products has already been disclosed before the 
Agency approves the action, the Agency will ensure appropriate public 
involvement consistent with 40 CFR 1506.6 and part 1503 in preparing 
and implementing the NEPA procedures related to preparing EIS's while 
following its own disclosure requirements including those listed in 
part 20 and Sec. Sec.  312.130(b), 314.430(d), 514.11(d), 514.12(b), 
601.51(d), 807.95(e), 812.38(b), and 814.9(d) of this chapter.
* * * * *

    Dated: January 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01224 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P