[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Rules and Regulations]
[Pages 57531-57536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24219]


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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: Final 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 or the Agency) is issuing a final rule 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 amending its NEPA 
implementing regulations to include tobacco products, where 
appropriate, in light of its new authority under the Tobacco Control 
Act.

DATES: This rule is effective October 26, 2015.

FOR FURTHER INFORMATION CONTACT: Gerie Voss or Katherine Collins, 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 877-287-1373; [email protected] or 
[email protected].

Executive Summary

Purpose of the Final Rule

    This final rule will allow certain classes of actions on tobacco 
product marketing applications to be excluded from the requirements to 
prepare an environmental assessment (EA) or an environmental impact 
statement (EIS). FDA is also amending its NEPA implementing regulations 
to include tobacco products, where appropriate, in light of its new 
authority under the Tobacco Control Act (Pub. L. 111-31).

Legal Authority

    FDA is issuing this final rule under NEPA and CEQ regulations (42 
U.S.C. 4332(2); 40 CFR parts 1500 to 1508) requiring FDA 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. FDA regulations governing its responsibilities under NEPA are 
codified at part 25 (21 CFR part 25), and CEQ regulations are codified 
at 40 CFR parts 1500 to 1508.

Summary of the Major Provisions

    This final rule applies to certain classes of tobacco product-
related actions including: (1) Issuance of an order finding a tobacco 
product substantially equivalent 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, denial 
of a request for an exemption under 21 CFR part 1107 (part 1107) from 
the requirement of demonstrating substantial equivalence, issuance of 
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 issuance of 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; (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 
Sec.  1107.1 (21 CFR 1107.1).
    This final rule provides that certain classes of actions are 
categorically excluded from the requirement to prepare an EA or EIS 
unless extraordinary circumstances are present such that the specific 
proposed action may have the potential to significantly affect the 
quality of the human environment. The rule also amends FDA's NEPA 
implementing regulations to include tobacco products in sections 
dealing with statements about disclosure regarding certain FDA actions 
and preparation of an EIS.

I. Background and Legal Authority

    NEPA and 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). CEQ is responsible for 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. FDA regulations are codified at part 
25 and CEQ regulations are codified at 40 CFR parts 1500 to 1508.
    CEQ regulations, which are binding on all Federal Agencies, 
establish

[[Page 57532]]

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. 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).
    FDA regulations state that for major Federal actions that may 
``significantly affect the quality of the human environment,'' FDA must 
prepare an EIS (Sec.  25.22 (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 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 (Sec.  25.20; 40 CFR 1501.4). 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 (Sec.  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 
normally require the preparation of an EA or EIS (40 CFR 1508.4). 
However, as required under Sec.  25.21 and 40 CFR 1508.4, FDA will 
require preparation of at least an EA for any specific action that 
normally would be excluded if extraordinary circumstances are present 
such that the specific proposed action may have the potential to 
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 Sec.  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 Federal 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; 40 CFR 
1508.4). In addition, when 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 issuing new categorical exclusions in accordance with NEPA, 
FDA, and CEQ regulations, and the CEQ November 2010 categorical 
exclusion guidance. In the Federal Register of January 23, 2014 (79 FR 
3742), FDA issued a notice of proposed rulemaking (NPRM) to 
categorically exclude certain tobacco product application actions from 
the requirement to conduct an EA or EIS unless extraordinary 
circumstances are present such that the specific proposed action may 
have the potential to significantly affect the quality of the human 
environment. The NPRM also sought to amend FDA's NEPA implementing 
regulations to include tobacco products. This final rule includes these 
categorical exclusions and amends FDA's NEPA implementing regulations.
    The final rule is issued under 42 U.S.C. 4332(2) and 40 CFR 1507.3, 
which requires FDA 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).

II. Overview of the Final Rule

    FDA considered all of the comments it received regarding the 
proposed rule and is finalizing it with three changes. We have changed 
the text of Sec.  25.20(o) in the final rule to clarify that granting a 
request for an exemption under part 1107 from the requirement of 
demonstrating substantial equivalence normally requires the preparation 
of an EA, unless it is subject to a categorical exclusion. Similarly, 
we have changed the text of Sec.  25.35(b) to clarify that denial of a 
request for an exemption under part 1107 from the requirement of 
demonstrating substantial equivalence is categorically excluded and, 
therefore, normally does not require the preparation of an EA or an 
EIS. We have also made a technical change by replacing the term 
``ordinarily'' with ``normally'' in Sec. Sec.  25.20 and 25.35 to 
conform with 40 CFR 1508.4. The Agency considers these terms, as used 
in these regulations, to be synonymous. FDA will continue to evaluate 
the need for this conforming amendment to other FDA regulations in part 
25 as the FDA regulations are updated.
    In addition, Sec.  25.20(o) in the final rule replaces proposed 
Sec.  25.20(p) (Issuance of an order finding a tobacco product 
substantially equivalent under the FD&C Act, unless categorically 
excluded under Sec.  25.35) andSec.  25.20(p) replaces Sec.  25.20(q) 
(Issuance of an order authorizing marketing of a new tobacco product 
under section 910 of the FD&C Act or an order authorizing marketing of 
a modified risk tobacco product under section 911 of the FD&C Act, 
unless categorically excluded under Sec.  25.35).
    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), these EAs have focused on the potential 
environmental effects related to the use and disposal from use of 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 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 adding several new categorical 
exclusions for tobacco product-related actions.
    With this final rule, FDA is adding the following classes of 
tobacco product-related actions that qualify for categorical 
exclusions: (1) Issuance of an order finding a tobacco product 
substantially equivalent to a tobacco

[[Page 57533]]

product commercially marketed in the United States as of February 15, 
2007, under section 910(a)(2)(B) of the FD&C Act; (2) issuance of an 
order finding a tobacco product not substantially equivalent under 
section 910(a) of the FD&C Act, denial of a request for an exemption 
under part 1107 from the requirement of demonstrating substantial 
equivalence, issuance of 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 issuance of an order under 
section 911 of the FD&C Act that a MRTP may not be introduced or 
delivered for introduction into interstate commerce (a MRTP 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 
Sec.  1107.1.

III. Comments on the Proposed Rule

    FDA received 10 comments on the proposed rule. Comments were 
received from tobacco product manufacturers, environmental groups, and 
individuals. To make it easier to identify comments and our responses, 
the word ``Comment,'' in parentheses, will appear before each comment, 
and the word ``Response,'' in parentheses, will appear before each 
response. We have numbered the comments to make it easier to 
distinguish between comments; the numbers are for organizational 
purposes only and do not reflect the order in which we received the 
comments or any value associated with them. We have combined similar 
comments under one numbered comment. In addition to the comments 
specific to this rulemaking that we address in the following 
paragraphs, we received five general comments: (1) One expressing a 
view that all tobacco products should be prohibited; (2) another 
providing reasons why FDA should regulate tobacco products and tobacco 
marketing; (3) one opposing any regulation that decreases FDA 
authority; (4) one supporting another comment; and (5) one that stated 
general disagreement with FDA proposing rules for this policy. These 
comments express broad policy views and do not address specific points 
related to this rulemaking. Because these general comments fall outside 
the scope of the proposed rule, we do not address them here. The 
remaining comments and FDA's responses follow.
    (Comment 1) Multiple comments addressed the classes of tobacco 
actions FDA proposed to qualify for categorical exclusions. Several 
comments did not want FDA to categorically exclude any class of actions 
from the requirement to prepare an EA or EIS. These comments stated 
that the tobacco industry has misrepresented facts and relevant 
information regarding adverse impacts of its tobacco products and 
cannot be trusted to determine whether extraordinary circumstances are 
present such that the specific proposed action may have the potential 
to significantly affect the quality of the human environment.
    (Response) We disagree with these comments. FDA is categorically 
excluding those actions that FDA has determined, based on experience, 
will not significantly affect the quality of the human environment. 
Additionally, this final rule will require a person submitting a 
tobacco product application to certify that the application qualifies 
for a categorical exclusion. FDA may deny the application if the 
submitter makes a false certification. In addition, under section 1001 
of title 18 of the United States Code, anyone who makes a materially 
false, fictitious, or fraudulent statement to the Government of the 
United States is subject to criminal penalties. FDA, therefore, will 
continue to have appropriate oversight of the environmental impacts of 
tobacco product applications that are the subject of this final rule.
    (Comment 2) Other comments expressed support for the rule and 
recommended that FDA add additional categorical exclusions for 
marketing authorizations for products that are the subject of SE 
reports under section 910(a)(2)(A) (nonprovisional SE reports) and SE 
exemption requests under section 905(j)(3) of the FD&C Act (21 U.S.C. 
387e(j)(3)). These comments stated that FDA's analysis in support of 
the proposed rule should apply to these actions as well.
    (Response) We disagree. As we stated in the proposed rule, FDA 
expects that any new tobacco product that receives marketing 
authorization through any of the available premarket pathways will have 
less--or no more--environmental impact than do tobacco products 
currently on the market. However, FDA does not yet have data to 
determine whether these actions, in the aggregate, will significantly 
impact the environment. Actions on provisional SE reports, by contrast, 
will relate only to products already on the market. Therefore, FDA is 
not proposing to add such categorical exclusions at this time.
    (Comment 3) Comments provided several reasons why they believe 
categorically excluding nonprovisional SE reports and SE exemption 
requests from the requirement to develop an EA or EIS for tobacco 
products will not significantly affect the quality of the human 
environment. First, comments stated that marketing authorizations for 
products that are the subject of nonprovisional SE reports and SE 
exemption requests will not lead to a larger overall tobacco product 
market or expand tobacco product consumption; and tobacco products 
found SE or exempt from SE will compete with or replace tobacco 
products currently on the market. In addition, comments estimated that 
the number of new tobacco products for which FDA issues SE orders (for 
nonprovisional SE reports under section 910(a)(2)(A) of the FD&C Act) 
or grants SE exemptions would be relatively small.
    Second, comments urged FDA to categorically exclude the granting of 
SE exemption requests because they believe the foreseeable 
environmental effects are even less significant for SE exemptions than 
for nonprovisional SE reports, based upon the more limited 
circumstances in which a product would be eligible for a request for an 
SE exemption.
    Third, comments stated that authorizing categorical exclusions for 
marketing authorizations for products that are the subject of 
nonprovisional SE reports and SE exemption requests would be consistent 
with FDA's regulatory approach to premarket clearances and approvals 
for other product categories regulated by the Agency. Comments also 
maintained that the tobacco industry's previous experience with EAs for 
tobacco product applications demonstrates that these tobacco products 
are unlikely to significantly affect environment.
    Fourth, a comment suggested that the extraordinary circumstances 
provision of the proposed rule supports inclusion of other classes of 
tobacco actions because it provides a mechanism by which to prevent any 
SE report or SE exemption request from resulting in the exposure of 
substances harmful to some biological mechanisms or systems in the 
environment or cause harm to a protected or endangered species.
    (Response) We disagree with these comments. CEQ has provided 
guidance to Federal Agencies for substantiating a new or revised 
categorical exclusion. In this guidance, CEQ explains that

[[Page 57534]]

Federal Agencies should propose new categorical exclusions after they, 
or other Agencies, ``gain sufficient experience with new activities to 
make a reasoned determination that any resulting environmental impacts 
are not significant.'' At this time, FDA is not yet able to effectively 
evaluate whether these classes of actions will lead to a larger overall 
tobacco product market or expand tobacco product consumption. A finding 
of SE for products that are the subject of a nonprovisional SE report, 
while comparing one tobacco product to another for characteristics and 
public health impact, does not account for the environmental impact of 
many determinations in the aggregate. FDA will continue to monitor 
submissions and will consider issuing a new proposed rule if the Agency 
determines that additional tobacco product actions should be 
categorically excluded, in the absence of extraordinary circumstances, 
from further analysis in an EA or EIS.
    (Comment 4) One comment stated that FDA should revise the examples 
provided in the preamble of the proposed rule regarding circumstances 
where a categorical exclusion would not be appropriate for tobacco 
products. This comment stated that FDA paraphrases two extraordinary 
circumstances examples provided in the regulations (at Sec.  25.21(a) 
and (b)) and unnecessarily expands the scope of these provisions.
    (Response) We disagree with this comment's characterization of 
FDA's discussion of extraordinary circumstances. FDA's description in 
the preamble provided circumstances for which EA or EIS preparation may 
be required for tobacco product applications. The descriptions were not 
intended to expand the existing regulations on extraordinary 
circumstances (Sec.  25.21 Extraordinary circumstances) but, rather, to 
apply them to tobacco product applications. As set forth in Sec.  
25.21, FDA will require preparation of at least an EA for an action 
that would normally be categorically excluded if extraordinary 
circumstances are present such that the proposed Agency action may have 
the potential to ``significantly'' affect the quality of the human 
environment. The ``protected or endangered species'' mentioned in the 
preamble to the proposed rule will continue to be those determined 
under the Endangered Species Act or the Convention on International 
Trade in Endangered Species of Wild Flora and Fauna to be endangered or 
threatened or wild flora or fauna that are entitled to special 
protection under some other Federal law, as stipulated at Sec.  
25.21(b). As stated in the preamble of the proposed rule, FDA will 
continue to rely upon consideration of the intensity and context as set 
out at 40 CFR 1508.27 for determining whether an extraordinary 
circumstance is present and a proposed action may have the potential to 
significantly affect the environment (79 FR 3742 at 3746).
    (Comment 5) Two comments questioned FDA's assertion that tobacco 
product waste is ``individually and cumulatively trivial'' and asserted 
that FDA did not review a sufficient number of studies. These comments 
urged FDA to not finalize the proposed rule based on the environmental 
impact of tobacco product waste. They noted that the growing of tobacco 
and manufacturing of cigarettes may result in a variety of pesticides, 
herbicides, insecticides, fungicides, and rodenticides being deposited 
into the environment, and 4,000 chemicals may be introduced to the 
environment via tobacco product waste, thirdhand, and secondhand smoke. 
One comment stated that the environmental impacts of tobacco product 
manufacture and disposal are best addressed by having FDA retain the 
lead role in preparing any necessary EISs or EAs.
    (Response) FDA disagrees with comments stating that it did not 
adequately consider the environmental impact of tobacco product waste. 
FDA reviewed the 2011 Toxics Release Inventory National Analysis to 
determine that the amount of waste released, recycled, and treated due 
to the manufacturer of all tobacco products currently on the market is 
a fraction of the total toxic waste released from and managed by 
industrial facilities in the United States. The classes of actions that 
FDA proposed for categorical exclusions do not result in additional 
tobacco products being marketed because those exclusions represent 
either the marketing authorization of tobacco products already on the 
market (provisional SE reports), or the rescission, suspension, or 
denial of authorization for a new tobacco product. As mentioned in the 
proposed rule, FDA also reviewed the effect on the environment due to 
the use (including secondhand and thirdhand smoke) and disposal of 
tobacco products (including cigarette butts) currently on the market. 
FDA acknowledged that currently marketed tobacco products contribute to 
pollution on beaches and streets and affect wildlife and marine and 
freshwater fish. FDA concluded from its review that 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 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 (79 FR 
3742 at 3745). FDA has carefully considered the information available 
in order to conclude that these tobacco product actions qualify for 
categorical exclusion under NEPA.

V. Environmental Impact

    The amendment of FDA's NEPA regulations (part 25) concerns NEPA 
documentation for certain actions on tobacco product submission. CEQ 
does not direct Federal Agencies to prepare a NEPA analysis or document 
before establishing Agency procedures that supplement CEQ regulations 
for implementing NEPA. Agencies are required to adopt NEPA procedures 
that establish specific criteria for, and identification of, three 
classes of actions: (1) Those that require preparation of an EIS; (2) 
those that require preparation of an EA; (3) and those that are 
categorically excluded from further NEPA review (40 CFR 1507.3(b)). 
Categorical exclusions are one part of those Agency procedures; 
therefore, establishing categorical exclusions does not require 
preparation of a NEPA analysis or document. Agency NEPA procedures, 
such as FDA's EPA 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 Sec.  
25.30(h) that this rulemaking does not individually or cumulatively 
have a significant effect on the quality of the human environment.

VI. Analysis of Impacts

    The final regulatory impact analysis is available as Reference 2 in 
Docket No. FDA-2013-N-1282 (Ref. 2) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 is not required.

[[Page 57535]]

VIII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the final 
rule does not contain policies that 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 has concluded 
that the 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.

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.

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.''

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, 21 CFR part 
25 is amended as follows:

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

0
1. The authority citation for 21 CFR 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. In paragraph (a), remove ``or 25.34,'' and add in its place ``25.34, 
or 25.35,'';
0
b. In paragraph (c), remove ``or 25.34'' and add in its place ``25.34, 
or 25.35''; and
0
c. In paragraph (d), remove ``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 (o) and (p) to read as follows:


Sec.  25.20  Actions requiring preparation of an environmental 
assessment.

    Any proposed action of a type specified in this section normally 
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:
* * * * *
    (o) Issuance of an order finding a tobacco product substantially 
equivalent under the Federal Food, Drug, and Cosmetic Act, or granting 
of a request for an exemption under 21 CFR part 1107 from the 
requirement of demonstrating substantial equivalence, unless 
categorically excluded under Sec.  25.35.
    (p) 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.


Sec.  25.30  [Amended]

0
4. Amend the introductory text of Sec.  25.30 by removing ``25.34'' and 
adding in its place ``25.35''.

0
5. Add 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, normally 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, denial of a request for an exemption under 21 
CFR part 1107 from the requirement of demonstrating substantial 
equivalence, 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.


Sec.  25.40  [Amended]

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 will become available only at the time

[[Page 57536]]

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 EISs 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: September 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24219 Filed 9-23-15; 8:45 am]
BILLING CODE 4164-01-P