National Environmental Policy 
Act; Environmental 
Assessments for Tobacco 
Products; Categorical 
Exclusions 
 
 
Small Entity Compliance Guide   
 
Guidance for Industry 
 
 
Comments may be submitted at any time for Agency consideration.  Electronic comments may 
be submitted to http://www.regulations.gov.  Alternatively, submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, Rockville, MD 20852.  All comments should be identified with Docket No. 
FDA-2013-N-1282.  
 
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-877-
CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m.  4 p.m. EDT. 
 
Additional copies are available online at 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.  
You may send an e-mail request to SmallBiz.Tobacco@fda.hhs.gov to receive an electronic copy 
of this guidance. You may send a request for hard copies to U.S. Food and Drug Administration, 
Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control 
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000. 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
 
October 2015  Contains Nonbinding Recommendations 
 
Table of Contents 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 1 
III.  QUESTIONS AND ANSWERS ....................................................................................... 2 
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National Environmental Policy Act; 
1 
Environmental Assessments for Tobacco 
2 
Products; Categorical Exclusions 
3 
 
4 
 
5   
1
Guidance for Industry  
6 
7   
8   
9  This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
10  this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
11  can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
12  To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the 
13  title page. 
14   
15   
16   
17   
18  I.  INTRODUCTION  
19   
20  This guidance is intended to help small businesses understand and comply with FDAs 
21  implementation of the National Environmental Policy Act (NEPA) and the Council on 
22  Environmental Quality (CEQ) regulations for classes of actions for tobacco products as amended 
23  by this final rule.   FDA has prepared this Small Entity Compliance Guide in accordance with 
24  section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). 
25   
26  FDAs guidance documents, including this guidance, do not establish legally enforceable 
27  responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and should 
28  be viewed only as recommendations, unless specific regulatory or statutory requirements are 
29  cited.  The use of the word should in Agency guidances means that something is suggested or 
30  recommended, but not required.  
31   
32  II.  BACKGROUND 
33   
34  NEPA and the CEQ Regulations require each Federal Agency to assess, as an integral part of its 
35  decision-making process, the environmental impacts of any proposed Federal action to ascertain 
36  the environmental consequences of that action on the quality of the human environment and to 
37  ensure that the interested and affected public is appropriately informed (42 U.S.C. 4332(2); 40 
                                                 
1 This guidance was prepared by the Office of Science and Office of Regulations in the Center for Tobacco Products 
at FDA. 
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38  CFR 1506.6).  FDA regulations governing its responsibilities under NEPA are codified at 21 
39  CFR part 25, and the CEQ regulations are codified at 40 CFR parts 1500 to 1508.   
40   
41  CEQ oversees FDAs compliance with NEPA.  For major Federal actions that may have a 
42  significant environmental impact, FDA can prepare either an environmental impact statement 
43  (EIS) or an environmental assessment (EA).  An EA provides sufficient information and analysis 
44  for FDA to determine whether to prepare an EIS or issue a finding of no significant impact 
45  (FONSI) (21 CFR 25.20; 40 CFR 1501.4).  FDA is responsible for the scope and content of an 
46  EA and generally requires an applicant to prepare an EA and make necessary corrections to it (21 
47  CFR 25.40(b)).  
48   
49  Categorically excluded actions refer to a category of actions that have been found not to 
50  individually or cumulatively have a significant effect on the quality of the human environment 
51  and which do not normally require the preparation of an EA or EIS (40 CFR 1508.4).  However, 
52  as required under 21 CFR 25.21 and 40 CFR 1508.4, FDA will require preparation of at least an 
53  EA for any specific action that normally would be excluded if extraordinary circumstances are 
54  present such that the specific proposed action may have the potential to significantly affect the 
55  quality of the human environment. 
56   
57  In the Federal Register of January 23, 2014 (79 FR 3742), FDA issued a notice of proposed 
58  rulemaking (NPRM) to amend 21 CFR part 25 to provide categorical exclusions for certain 
59  actions related to substantial equivalence (SE) reports, SE exemption requests, and tobacco 
60  product applications, and the rescission (order withdrawing an order) or suspension of orders 
61  regarding the marketing of tobacco products under the Family Smoking Prevention and Tobacco 
62  Control Act (Tobacco Control Act). FDA also proposed to amend its NEPA-implementing 
63  regulations to include tobacco products, where appropriate, in light of its new authority under the 
64  Tobacco Control Act.  In the Federal Register of September, 24, 2015 (80 FR 57531), FDA 
65  published the final rule, codified at 21 CFR part 25. 
66   
67  III.  QUESTIONS AND ANSWERS     
68   
69  A.  What are the specific sections of the Code of Federal Regulations (CFR) 
70  which are impacted by this rule?  
71   
72  This rule amends  25.15, 25.20, 25.30, 25.35, 25.50, and 25.52 of title 21 of the CFR. 
73   
74  B.  How does this rule affect part 25 of title 21 of the CFR? 
75   
76  Part 25 of title 21 provides that all applications or petitions requesting agency action require the 
77  submission of an EA or a claim of categorical exclusion.  It also clarifies that FDA may refuse to 
78  file or approve an application or petition if an applicant provides an insufficient EA.  This final 
79  rule (1) expands the list of actions that ordinarily require at least the preparation of an EA, to 
80  include certain orders relating to tobacco product applications; (2) creates categorical exclusions 
81  for certain classes of actions involving tobacco products; and (3) requires applicants to submit an 
82  EA or claim of categorical exclusion with their tobacco product applications.  
83   
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84  C.  What classes of actions for tobacco products ordinarily require at least the 
85  preparation of an EA?  
86   
87  Section 25.20 lists the following classes of actions that ordinarily require at least the preparation 
88  of an EA, unless categorically excluded under  25.35 (see III. D. for those classes of actions for 
89  tobacco products that are categorically excluded):  
90   
91    Issuance of an order finding a tobacco product substantially equivalent under the 
92  Federal Food, Drug, and Cosmetic Act, or granting of a request for an exemption 
93  under 21 CFR part 1107 from the requirement of demonstrating substantial 
94  equivalence. 
95    Issuance of an order authorizing marketing of a new tobacco product under 
96  section 910 of the Federal Food, Drug, and Cosmetic Act or an order authorizing 
97  marketing of a modified risk tobacco product under section 911 of the Federal 
98  Food, Drug, and Cosmetic Act. 
99   
100  D.  What classes of actions for tobacco products qualify for a categorical 
101  exclusion? 
102   
103  Section 25.35 lists the following classes of actions that are categorically excluded and, therefore, 
104  normally do not require the preparation of an EA or an EIS: 
105   
106    Issuance of an order finding a tobacco product substantially equivalent under 
107  section 910(a)(2)(B) of the FD&C Act (provisional SE order); 
108    Denial of a request for an exemption under 21 CFR part 1107 from the 
109  requirement of demonstrating substantial equivalence; 
110    Issuance of a not substantially equivalent (NSE) order under section 910(a) of the 
111  FD&C Act; 
112    Issuance of an order finding that a product may not be introduced or delivered for 
113  introduction into interstate commerce under section 910(c) of the FD&C Act; 
114    Issuance of an order finding that a modified risk tobacco product may not be 
115  introduced or delivered for introduction into interstate commerce under section 
116  911 of the FD&C Act; 
117    Rescission (order withdrawing an order) or temporary suspension of an order 
118  authorizing the marketing of a new tobacco product; 
119    Rescission of a modified risk tobacco product (MRTP) authorization order; and 
120    Rescission of an order granting an exemption from the requirement of 
121  demonstrating substantial equivalence. 
122   
123  E.  What information must be provided to FDA to request a categorical 
124  exclusion?  
125   
126  A claim of categorical exclusion must be submitted in accordance with 21 CFR 25.15.  Section 
127  25.15 requires that the claim of categorical exclusion include:  (1) A statement of compliance 
128  with the categorical exclusion criteria and (2) a statement that, to the submitter's knowledge, no 
129  extraordinary circumstances exist.   
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130   
131  F.  What if I qualify for a categorical exclusion but I have already submitted my 
132  application and CTP has not yet made a determination? 
133   
134  You may amend your application.  Contact the assigned regulatory health project manager for 
135  your application for further details. 
136   
137  G.  Under what circumstances is an application prohibited from requesting 
138  categorical exclusion? 
139   
140  If extraordinary circumstances exist, such that the specific proposed action may have the 
141  potential to significantly affect the quality of the human environment, an EA must be submitted 
142  for that particular application. To learn more about what qualifies as an extraordinary 
143  circumstance, refer to CEQs, "Final Guidance for Federal Departments and Agencies on 
144  Establishing, Applying, and Revising Categorical Exclusions Under the National Environmental 
145  Policy Act," 76 FR 3843, January 21, 2011. 
146   
147  H.  When will applicants have to submit an EA 
148   
149  Section 25.15 requires that all applications or petitions requesting agency action include the 
150  submission of an EA or a claim of categorical exclusion. Thus, applicants must include an EA in 
151  their applications seeking the actions listed in III.C or a claim of categorical exclusion. The EA 
152  must be prepared in accordance with 21 CFR 25.40, unless the action qualifies for a categorical 
153  exclusion. Under  25.15, an applicants failure to submit an adequate EA for an application or 
154  petition requesting agency action of a type specified in  25.20, unless the agency can determine 
155  that the action qualifies for exclusion under  25.35, is sufficient grounds for FDA to refuse to 
156  file or approve the application or petition. Per  25.15, an EA adequate for filing is one that 
157  addresses the relevant environmental issues and an EA adequate for approval is one that contains 
158  sufficient information to enable the agency to determine whether the proposed action may 
159  significantly affect the quality of the human environment.  More information on environmental 
160  assessments can be found in 21 CFR part 25. 
161   
162  I.  Will FDA provide assistance for small businesses seeking additional 
163  information regarding this rule?  
164   
165  FDAs Center for Tobacco Products (CTP) has established an Office of Small Business 
166  Assistance in an effort to help small businesses access up-to-date information and comply with 
167  the requirements of the Tobacco Control Act. CTPs Office of Small Business Assistance can be 
168  reached at SmallBiz.Tobacco@fda.hhs.gov or at 1-877-CTP-1373 (1-877-287-1373) Monday 
169  Friday, 9:00 a.m.  4:00 p.m. EDT. 
170   
171  J.  When does this rule become effective? 
172   
173  This rule becomes effective on October 26, 2015, which is 30 days after the rule published in the 
174  Federal Register. See 80 FR 57531. 
175   
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