Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Proposed Rules 44485 

regulation, require restrictions on the 

sale and distribution of a tobacco 

product (section 906(d)(1) of the FD&C 

Act (21 U.S.C. 387f(d)(1))). The 

restrictions on sale and distribution of a 

tobacco product may include 

restrictions on the access to, and the 

advertising and promotion of, the 

tobacco product, if the Secretary of HHS 

determines such regulation would be 

appropriate for the public health. 

FDA intends to use the information 

submitted in response to this Federal 

Register document, FDA’s preliminary 

independent scientific evaluation, and 

other appropriate information to inform 

its thinking about options for regulating 

menthol in cigarettes. 

II. Request for Comments and 

Information 

FDA is seeking comments, including 

comments on its preliminary evaluation, 

and data, research (e.g., published or 

unpublished studies, case studies), and 

any other information related to the 

following questions. Please explain your 

responses and provide any evidence or 

other information supporting your 

responses to the following questions: 

A. Tobacco Product Standards 

1. Should FDA consider establishing 

a tobacco product standard for menthol 

in menthol cigarettes? If so, what 

allowable level of menthol (e.g., 

maximum or minimum) would be 

appropriate for the protection of the 

public health? 

2. Rather than a tobacco product 

standard for menthol in menthol 

cigarettes, should FDA consider a 

tobacco product standard for any 

additive, constituent, artificial or 

natural flavor, or other ingredient that 

produces a characterizing flavor of 

menthol in the tobacco product or its 

smoke? 

3. If a tobacco product standard for 

menthol in menthol cigarettes were to 

be established, should FDA consider 

issuing regulations to address menthol 

in other tobacco products besides 

cigarettes? If so, what other tobacco 

products with menthol should be 

regulated: All tobacco products, just all 

combusted tobacco products, or some 

other category or group of tobacco 

products? If not, what distinctions 

should be made between products? 

4. If a product standard prohibiting or 

limiting menthol were to be established, 

what length of time should 

manufacturers be provided to achieve 

compliance with the standard? If a 

product standard prohibiting or limiting 

menthol were to be established, would 

a stepped approach in which the level 

of menthol was gradually reduced be 

appropriate for the protection of the 

public health? 

5. If a product standard limiting 

menthol were to be established, are 

there alternatives that could be 

substituted by manufacturers to 

maintain the effect or appeal of menthol 

to menthol cigarette smokers and 

potential initiators? If so, what are these 

substitutes? Should they be regulated if 

menthol is regulated; and if so, how 

should they be regulated? If not, what 

distinctions should be made between 

menthol and potential substitutes? 

B. Sale and Distribution Restrictions 

1. Should FDA consider establishing 

restrictions on the sale and/or 

distribution of menthol cigarettes? If so, 

what restrictions would be appropriate 

and what would be the impact on youth 

or adult smoking behavior, initiation, 

and cessation? 

2. Should FDA consider establishing 

restrictions on the advertising and 

promotion of menthol cigarettes? If so, 

what restrictions would be appropriate 

and what would be the impact on youth 

or adult smoking behavior, initiation, 

and cessation? 

C. Other Actions and Considerations 

1. Are there other tobacco product 

standards, regulatory, or other actions 

that FDA could implement that would 

more effectively reduce the harms 

caused by menthol cigarette smoking 

and better protect the public health than 

the tobacco product standards or 

regulatory actions discussed in the 

preceding questions? 

2. To the extent that you have 

identified a tobacco product standard or 

other regulatory action in response to 

the prior questions, please provide 

additional information and comments 

on: 

2.1 Is compliance with the tobacco 

product standard or other regulatory 

action you identified technically 

achievable? 

2.2 How FDA would structure a 

corresponding rule to maximize 

compliance, facilitate enforcement, and 

otherwise maximize public health 

benefits? 

3. If menthol cigarettes could no 

longer be legally sold, is there evidence 

that illicit trade in menthol cigarettes 

would become a significant problem? If 

so what would be the impact of any 

such illicit trade on public health? How 

would any such illicit trade compare to 

the existing illicit trade in cigarettes? 

4. What additional information and 

research beyond that described in the 

evaluation is there on the potential 

impact of sale and distribution 

restrictions of menthol cigarettes on 

specific subpopulations, such as those 

based on racial, ethnic, socioeconomic 

status, and sexuality/gender identity? 

5. To what extent are you aware of 

current (within the past 5 years) 

advertising and/or promotion of 

menthol cigarettes that have targeted 

specific communities, subpopulations, 

and locations, beyond that described in 

the evaluation? 

6. Might any current advertising or 

other marketing or public statements 

concerning menthol cigarettes, or 

menthol in other tobacco products, 

constitute reduced risk claims? 

III. 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). 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. 

IV. 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. CTP, Preliminary Scientific Evaluation of 

the Possible Public Health Effects of 

Menthol Versus Nonmenthol Cigarettes. 

2. CTP, Reference Addendum to the 

‘‘Preliminary Scientific Evaluation of the 

Possible Public Health Effects of Menthol 

versus Nonmenthol Cigarettes, 2013.’’ 

Dated: July 19, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–17805 Filed 7–23–13; 8:45 am] 

BILLING CODE 4160–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 50, 51, 70 and 71 

[EPA–HQ–OAR–2010–0885, FRL–9836–5] 

Implementation of the 2008 National 

Ambient Air Quality Standards for 

Ozone: State Implementation Plan 

Requirements 

AGENCY: Environmental Protection 

Agency (EPA). 


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44486 Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Proposed Rules 

ACTION: Notice of extension of comment 

period. 

SUMMARY: The EPA is announcing an 

extension of the public comment period 

on the Proposed Rule Regarding 

‘‘Implementation of the 2008 National 

Ambient Air Quality Standards for 

Ozone: State Implementation Plan 

Requirements’’ (June 6, 2013). The EPA 

is extending the comment period that 

originally was scheduled to end on 

August 5, 2013. The extended comment 

period will close on September 4, 2013. 

The EPA is extending the comment 

period because of a request we received 

in a timely manner. 

DATES: Comments. Comments must be 

received on or before September 4, 

2013. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

OAR–2010–0885, by one of the 

following methods: 

• www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

• Email: a-and-r-docket@epa.gov. 

• Mail: Air and Radiation Docket and 

Information Center, Attention Docket ID 

No. EPA–HQ–OAR–2010–0885, 

Environmental Protection Agency, 1301 

Constitution Ave. NW., Washington, DC 

20460. Mail Code: 2822T. Please 

include two copies if possible. In 

addition, please mail a copy of your 

comments on the information collection 

provisions to the Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB), Attn: 

Desk Officer for EPA, 725 17th Street 

NW., Washington, DC 20503. 

• Hand Delivery: Air and Radiation 

Docket and Information Center, 

Attention Docket ID No. EPA–HQ– 

OAR–2010–0885, Environmental 

Protection Agency in the EPA 

Headquarters Library, Room Number 

3334 in the EPA West Building, located 

at 1301 Constitution Ave. NW., 

Washington, DC. The EPA/DC Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m. Eastern Standard Time (EST), 

Monday through Friday. 

Instructions: Direct your comments to 

Docket ID No. EPA–HQ–OAR–2010– 

0885. The EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available on-line at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be confidential business 

information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or email. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means the EPA will not know 

your identity or contact information 

unless you provide it in the body of 

your comment. If you send an email 

comment directly to the EPA without 

going through www.regulations.gov, 

your email address will be 

automatically captured and included as 

part of the comment that is placed in the 

public docket and made available on the 

Internet. If you submit an electronic 

comment, the EPA recommends that 

you include your name and other 

contact information in the body of your 

comment and with any CD you submit. 

If the EPA cannot read your comment 

due to technical difficulties and cannot 

contact you for clarification, the EPA 

may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters and any 

form of encryption and be free of any 

defects or viruses. For additional 

information about the EPA’s public 

docket, visit the EPA Docket Center 

homepage at http://www.epa.gov/ 

epahome/dockets.htm. For additional 

instructions on submitting comments, 

go to the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: All documents in the docket 

are listed in www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

i.e., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically in 

www.regulations.gov or in hard copy at 

the Air and Radiation Docket and 

Information Center in the EPA 

Headquarters Library, Room Number 

3334 in the EPA West Building, located 

at 1301 Constitution Ave. NW., 

Washington, DC. The Public Reading 

Room is open from 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number 

for the Public Reading Room is (202) 

566–1744. 

FOR FURTHER INFORMATION CONTACT: For 

further general information on this 

rulemaking, contact Dr. Karl Pepple, 

Office of Air Quality Planning and 

Standards, U.S. Environmental 

Protection Agency, by phone at (206) 

553–1778, or by email at 

pepple.karl@epa.gov; or Mr. Butch 

Stackhouse, Office of Air Quality 

Planning and Standards, U.S. 

Environmental Protection Agency, by 

phone at (919) 541-5208, or by email at 

stackhouse.butch@epa.gov. For 

information on the public hearings, 

contact Ms. Pamela S. Long by phone at 

(919) 541–0641 or by email at 

long.pam@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

Entities potentially affected directly 

by this proposal include state, local and 

tribal governments. Entities potentially 

affected indirectly by this proposal 

include owners and operators of sources 

of emissions (volatile organic 

compounds (VOCs) and nitrogen oxides 

(NOX)) that contribute to ground-level 

ozone formation. 

B. What should I consider as I prepare 

my comments for the EPA? 

1. Submitting CBI. Do not submit CBI 

information to the EPA through 

www.regulations.gov or email. Clearly 

mark the part or all of the information 

that you claim to be CBI. For CBI 

information on a disk or CD ROM that 

you mail to the EPA, mark the outside 

of the disk or CD ROM as CBI and then 

identify electronically within the disk or 

CD ROM the specific information that is 

claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed to be 

CBI must be submitted for inclusion in 

the public docket. Information marked 

CBI will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for Preparing Your Comments. 

When submitting comments, remember 

to: 

• Identify the rulemaking by docket 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

• Follow directions—The agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

• Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

• Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

• If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

• Provide specific examples to 

illustrate your concerns, and suggest 

alternatives. 


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Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Proposed Rules 44487 

• Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

• Make sure to submit your 

comments by the comment period 

deadline identified. 

C. Where can I get a copy of this 

document and other related 

information? 

In addition to being available in the 

docket, an electronic copy of this notice 

will be posted at http://www.epa.gov/ 

air/ozonepollution/actions.html#impl. 

Dated: July 17, 2013. 

Mary E. Henigin, 

Acting Director, Office of Air Quality Planning 

and Standards. 

[FR Doc. 2013–17830 Filed 7–23–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 52 and 81 

[EPA–R03–OAR–2012–0368; FRL–9836–1] 

Approval and Promulgation of Air 

Quality Implementation Plans; West 

Virginia; Redesignation of the West 

Virginia Portion of the Wheeling, WV– 

OH 1997 Annual Fine Particulate Matter 

Nonattainment Area to Attainment and 

Approval of the Associated 

Maintenance Plan 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule; supplemental. 

SUMMARY: EPA is issuing a supplement 

to its proposed approval of the State of 

West Virginia’s request to redesignate 

the West Virginia portion of the 

Wheeling, WV–OH fine particulate 

matter (PM2.5) nonattainment area 

(Wheeling Area or Area) to attainment 

for the 1997 annual PM2.5 national 

ambient air quality standard (NAAQS). 

This supplemental proposal revises and 

expands the basis for proposing 

approval of the State’s request in light 

of developments since EPA issued its 

initial proposal on December 11, 2012. 

This supplemental proposal addresses 

the effects of the decision of the United 

States Court of Appeals for the District 

of Columbia (D.C. Circuit Court) on 

January 4, 2013 to remand to EPA two 

final rules implementing the PM2.5

NAAQS. EPA is seeking comment only 

on the issues raised in this 

supplemental proposal and is not 

reopening for comment other issues 

raised in its prior proposal. 

DATES: Written comments must be 

received on or before August 23, 2013. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2012–0368 by one of the 

following methods: 

A. www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

B. Email: fernandez.cristina@epa.gov. 

C. Mail: EPA–R03–OAR–2012–0368, 

Cristina Fernandez, Associate Director, 

Office of Air Program Planning, 

Mailcode 3AP30, U.S. Environmental 

Protection Agency, Region III, 1650 

Arch Street, Philadelphia, Pennsylvania 

19103. 

D. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–R03–OAR–2012– 

0368. EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or email. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an email 

comment directly to EPA without going 

through www.regulations.gov, your 

email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the 

electronic docket are listed in the 

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in www.regulations.gov or 

in hard copy during normal business 

hours at the Air Protection Division, 

U.S. Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

Copies of the State submittal are 

available at the West Virginia 

Department of Environmental 

Protection, Division of Air Quality, 601 

57th Street SE., Charleston, West 

Virginia 25304. 

FOR FURTHER INFORMATION CONTACT: Rose 

Quinto, (215) 814–2182, or by email at 

quinto.rose@epa.gov. 

Table of Contents 

I. Background 

II. Effect of the January 4, 2013 D.C. Circuit 

Decision Regarding the PM2.5

Implementation Under Subpart 4 

A. Background 

B. Supplemental Proposal on This Issue 

1. Applicable Requirements for Purposes of 

Evaluating the Redesignation Request 

2. Subpart 4 Requirements and Wheeling 

Area’s Redesignation Request 

3. Subpart 4 and Control of PM2.5

Precursors 

4. Maintenance Plan and Evaluation of 

Precursors 

III. Ammonia and VOC Comprehensive 

Emissions Inventory 

IV. Summary of Proposed Action 

V. Statutory and Executive Order Reviews 

I. Background 

On March 8, 2012, the State of West 

Virginia through the West Virginia 

Department of Environmental Protection 

(WVDEP) formally submitted a request 

to redesignate the West Virginia portion 

of the Wheeling Area from 

nonattainment to attainment of the 1997 

annual PM2.5 NAAQS. Concurrently, 

West Virginia submitted a maintenance 

plan for the Area as a SIP revision to 

ensure continued attainment throughout 

the Area over the next 10 years. 

On December 11, 2012 (77 FR 73575), 

EPA published a notice of proposed 

rulemaking (NPR) determining that the 

Wheeling Area has attained the 1997 

annual PM2.5 NAAQS and that the Area 

has met the requirements for 

redesignation under section 107(d)(3)(E) 

of the Clean Air Act (CAA). In the 

December 11, 2012 NPR, EPA proposed 

several actions related to the 

redesignation of the Area to attainment 

for the 1997 annual PM2.5 NAAQS. First, 

EPA proposed to approve West 

Virginia’s request to change the legal 

definition of the West Virginia portion 

of the Wheeling Area from 

nonattainment to attainment for the 


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