Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Proposed Rules 28135

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and

Firearms

27 CFR Part 16

[Notice No. 917]

RIN 1512–AC12

Alcohol Beverage Health Warning

Statement (99R–507P)

AGENCY: Bureau of Alcohol, Tobacco

and Firearms (ATF), Department of the

Treasury.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Bureau of Alcohol,

Tobacco and Firearms (ATF) is

considering amending the regulations

concerning the placement, legibility,

and noticeability of the congressionally

mandated health warning statement

required to appear on the labels of all

containers of alcohol beverages. Based

on a petition we have received, we wish

to gather information by inviting

comments from the public and industry

as to whether the existing regulations

should be revised.

DATES: Comments must be received on

or before August 20, 2001.

ADDRESSES: Send written comments to:

Chief, Regulations Division; Bureau of

Alcohol, Tobacco and Firearms; P.O.

Box 50221; Washington, DC 20091–

0221; ATTN: Notice No. 917. Written

comments must be signed, and may be

of any length.

E-mail comments may be submitted

to: nprm@atfhq.atf.treas.gov. E-mail

comments must contain your name,

mailing address, and e-mail address.

They must also reference this notice

number and be legible when printed on

not more than three pages 81⁄2′′ × 11′′ in

size. We will treat e-mail as originals

and we will not acknowledge receipt of

e-mail. See the Public Participation

section at the end of this advance notice

for requirements for submitting written

comments by facsimile.

FOR FURTHER INFORMATION CONTACT:

James P. Ficaretta, Regulations Division,

Bureau of Alcohol, Tobacco and

Firearms, 650 Massachusetts Avenue,

NW., Washington, DC 20226 (202–927–

8210).

SUPPLEMENTARY INFORMATION:

Background

Title VIII of the Anti-Drug Abuse Act

of 1988, Public Law 100–690 (enacted

November 18, 1988), amended the

Federal Alcohol Administration Act

(FAA Act) by designating the existing

sections of the FAA Act as ‘‘Title I,’’ and

by adding at the end a new title, ‘‘Title

II—Alcoholic Beverage Labeling.’’ This

title, cited as the ‘‘Alcoholic Beverage

Labeling Act of 1988’’ (ABLA), requires

that the following health warning

statement appear on the labels of all

containers of alcohol beverages for sale

or distribution in the United States:

GOVERNMENT WARNING: (1) According

to the Surgeon General, women should not

drink alcoholic beverages during pregnancy

because of the risk of birth defects. (2)

Consumption of alcoholic beverages impairs

your ability to drive a car or operate

machinery, and may cause health problems.

The health warning statement

requirement applies to alcohol

beverages bottled on or after November

18, 1989, and applies both to interstate

and intrastate sale and distribution of

alcohol beverages. In addition, the

health warning statement must appear

on containers of alcohol beverages that

are sold, distributed, or shipped to

members or units of the U.S. Armed

Forces, including those located outside

the United States. For purposes of the

ABLA, the term ‘‘alcoholic beverage’’

includes any beverage in liquid form

which contains not less than one-half of

one percent (.5%) of alcohol by volume

and is intended for human

consumption.

The law specifies that the health

warning statement ‘‘shall be located in

a conspicuous and prominent place on

the container of such beverage, as

determined by the Secretary [of the

Treasury], shall be in type of a size

determined by the Secretary, and shall

appear on a contrasting background.’’

On February 14, 1990, we issued final

regulations in 27 CFR Part 16

implementing the provisions of the

ABLA (T.D. ATF–294; 55 FR 5414).

These regulations became effective on

November 14, 1990. The final rule was

preceded by a notice of proposed

rulemaking (Notice No. 678, February

16, 1989; 54 FR 7164), which solicited

comments on our temporary regulations

(T.D. ATF–282, February 16, 1989; 54

FR 7160). The temporary regulations

applied to products bottled between

November 18, 1989, and November 13,

1990.

The final regulations provide that the

health warning statement must appear

on the brand label or separate front

label, or on a back or side label, separate

and apart from all other information. It

must be readily legible under ordinary

conditions, and must appear on a

contrasting background. Furthermore,

labels bearing the health warning

statement must be firmly affixed to the

container. In order to ensure that the

consumer’s attention is drawn to the

health warning statement, the

regulations require that the words

‘‘GOVERNMENT WARNING’’ appear in

capital letters and in bold type. The

remainder of the warning statement may

not appear in bold type.

The regulations specify the maximum

number of characters (i.e., letters,

numbers, marks) permitted per inch in

which the health warning statement

may appear. This requirement is

intended to ensure that the warning

statement is more easily read by the

average consumer. Additionally, the

regulations prescribe minimum type

size requirements for the health warning

statement.

Petition

We have received a petition, dated

November 17, 1999, filed on behalf of

the Center for Science in the Public

Interest (CSPI), four members of

Congress, the National Council on

Alcoholism and Drug Dependence, Inc.

(NCADD), and 119 other organizations,

requesting an amendment of the

regulations regarding the legibility,

clarity, and noticeability of the health

warning statement. The petitioners

included citations to research to support

their proposed amendments.

Specifically, the petitioners request that

the regulations in Part 16 be amended

to require the following:

1. The health warning statement must

appear in a prominent place on the

front of the container in a horizontal

position. The petitioners contend that

many alcohol producers position the

warning statement vertically on the

margin of the label, thus making the

label difficult to read when the

container is placed on a shelf. The

petitioners also allege that the warning

statement often appears crowded and is

embedded in the surrounding

information, making it hard to locate

and read. According to the petitioners,

warnings that contain fewer characters

per inch, occupy a larger area on the

label, and appear less embedded in

surrounding information tend to be

noticed more readily. The petitioners

further state that for maximum

effectiveness the warning information

should be easy to locate and should

appear in the same relative position on

all labels. Finally, the petitioners claim

that label messages appearing

horizontally are significantly more

noticeable than warnings that are

printed in a vertical position.

2. The health warning statement must

appear in red or black type on a white

background, and be surrounded by a

lined border. In addition to placement

on the front of the container, the

petitioners claim that the research

suggests two other elements that would

28136 Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Proposed Rules

dramatically improve consumer

awareness of the alcohol warning

statement, i.e., a clear, lined border

surrounding the statement and text in a

highly contrasting color. The petitioners

refer to one study that found that

graphic devices such as boxes help

consumers recognize and process a

warning message. They refer to another

study that found that color helps

immensely to increase awareness of

warning labels; in fact, the higher the

contrast between text and background,

the more likely consumers are to notice

them.

3. The first two words of the health

warning statement, i.e.,

‘‘GOVERNMENT WARNING,’’ must

appear in capital letters and boldface

type that is at least 15 percent larger

than the remaining text of the

statement. The text of the remaining

portion of the warning statement must

be in upper and lower-case lettering. A

particular type font should be required

to maximize legibility. According to the

petitioners, one researcher found that

the degree to which the phrase

‘‘GOVERNMENT WARNING’’ stood out

from the rest of the label was a

significant predictor of the consumer

response time. In this regard, the

petitioners note that in both the statute

and the regulations the words

‘‘GOVERNMENT WARNING’’ appear in

capital letters while the text of the

statement appears in upper and lowercase letters. However, the regulations do

not specify that the text of the warning

statement must appear in upper and

lower-case letters. The petitioners

maintain that it is harder to read the

warning when the entire statement

appears in capital letters.

4. The warning statement must

appear together with a red pictorial

device or icon that is a triangle with an

exclamation mark inside. As proposed

by the petitioners, the warning

statement would appear as follows:

According to the petitioners, several

studies have shown that the inclusion of

an icon or pictorial element

substantially heightens consumer

recognition of a warning label. In

studies of the way consumer eyemovements track warning labels, the

petitioners state that one researcher

specifically studied a triangular icon

with an exclamation mark inside it and

found that this icon produced

significantly faster response times than

warnings without the icon.

With the above modifications, the

petitioners believe that the health

warning statement will be ‘‘more

noticeable, more effective, and will help

insure that the labels on alcoholicbeverage containers meet the standards

for the warning statement as originally

set out by Congress.’’

Review of Petition by Other Federal

Agencies and the Surgeon General

By letters dated December 3, 1999,

ATF asked the Food and Drug

Administration (FDA), the National

Institute on Alcohol Abuse and

Alcoholism, the Surgeon General, and

the Federal Trade Commission (FTC) to

review the petition and provide us with

their comments. We also asked for

available information regarding the

latest scientific studies dealing with the

design of alcohol warning labels, as well

as any research on warning labels in

general.

In his letter of February 15, 2000, the

Surgeon General (on behalf of the Food

and Drug Administration, the Centers

for Disease Control and Prevention, the

National Institutes of Health, and the

Substance Abuse and Mental Health

Services Administration) noted that it

has been more than a decade since the

alcohol health warning statement and

implementing regulations were adopted.

As such, revisiting this issue would be

a valuable contribution to the public

health as the abuse of alcohol beverages

continues to represent a serious public

health problem. The Surgeon General

stated the following:

If the current mandatory health warning is

to serve a public function of informing

consumers, it is important that periodic

efforts be made to evaluate the placement of

the label, its legibility, the extent to which

manufacturers are complying with current

label requirements, and the level of consumer

awareness of the label, particularly under

expected conditions of use.

In addition, the Surgeon General

indicated that over the last 10 years

there has been an abundance of

practical experience and science about

ways to design and disseminate health

information on product packaging. For

example, he notes that in Canada and

Australia much work has been done to

assess the most effective placement of

health warnings on tobacco products.

He also notes that the FDA has unique

and relevant experience in this area

through the development and

evaluation of food label and nutrient

requirements.

By letter dated March 13, 2000, the

FTC advised us that it has experience

with respect to health warnings,

including the ‘‘Surgeon General’s’’

warnings required on cigarettes and the

warnings required on smokeless tobacco

products. In addition, the FTC recently

recommended to Congress that cigar

manufacturers and marketers be

required to comply with a system of

multiple rotating warnings, similar to

those now in place for cigarettes and

smokeless tobacco. The FTC also

provided us with citations to some of

the relevant research on warning labels

with respect to size, placement,

pictorials, borders, etc. If ATF decides

to explore modifying the requirements

with respect to the health warning

statement, the FTC recommends that we

conduct consumer testing of any

proposed changes. Based on its

experience, the FTC states that such

research is often useful in assessing the

prominence, noticeability, and

understandability of warnings.

Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Proposed Rules 28137

Discussion

ATF is requesting information from

consumers, consumer groups, interest

groups, associations, and industry

members on the desirability of

amending the regulations with regard to

the legibility and noticeability of the

mandated Government health warning

statement. Although we are soliciting

comments on the following specific

questions, we are also requesting any

relevant information on the subject.

1. Are consumers aware that the

health warning statement must appear

on the labels of all alcohol beverages

sold in the U.S.?

2. Do consumers look for the warning

statement on alcohol beverage

containers?

3. Do consumers notice the health

warning statement on alcohol beverage

containers? Explain.

4. Do consumers read the warning

statement on labels of alcohol

beverages? Why or why not?

5. Are consumers familiar with the

information contained in the alcohol

health warning statement?

6. Do consumers find the warning

statement on alcohol beverages difficult

to read? Explain.

7. Do consumers have examples of

alcohol beverages where the warning

statement is legible and noticeable?

What makes the warning statement

legible and noticeable?

8. Do consumers believe the

regulations need to be amended to make

the warning statement more legible?

Explain.

9. What would be the costs associated

with adopting any or all of the changes

recommended by the petitioners, to the

industry and, ultimately, the consumer?

As indicated by the Surgeon General,

over the last 10 years there has been an

abundance of practical experience and

science about ways to design and

disseminate health information on

product packaging. Accordingly, we are

requesting scientific information, i.e.,

scientific studies, reports, consumer

surveys, research literature, etc., that

might be useful in assessing the changes

suggested by the petitioners concerning

the legibility of the health warning

statement. As mentioned in the FTC’s

letter to us, the question of whether any

particular warning is clear and

prominent is an empirical one.

Information submitted should not be

limited to that completed within the last

few years. Although we believe that

such information may be more valid, we

are seeking any pertinent information

on the subject.

We are also interested in studies that

are currently in progress and, if

available, any interim findings. We

would also like to be advised of any

studies currently underway which may

not be completed within the 90-day

comment period, along with a projected

target date for completion.

Executive Order 12866

It has been determined that this

advance notice is not a significant

regulatory action as defined by

Executive Order 12866. Accordingly,

this advance notice is not subject to the

analysis required by this Executive

Order.

Public Participation

We are requesting comments on the

petition from all interested persons. We

are specifically requesting comments on

the clarity of this advance notice and

how it may be made easier to

understand.

Comments received on or before the

closing date will be carefully

considered. Comments received after

that date will be given the same

consideration if it is practical to do so,

but assurance of consideration cannot

be given except as to comments received

on or before the closing date.

ATF will not recognize any material

in comments as confidential. Comments

may be disclosed to the public. Any

material that the commenter considers

to be confidential or inappropriate for

disclosure to the public should not be

included in the comment. The name of

the person submitting a comment is not

exempt from disclosure.

You may submit written comments by

facsimile transmission to (202) 927–

8602. Facsimile comments must:

• Be legible;

• Reference this notice number;

• Be 81⁄2′′ × 11′′ in size;

• Contain a legible written signature;

and

• Be not more than three pages long.

We will not acknowledge receipt of

facsimile transmissions. We will treat

facsimile transmissions as originals.

Disclosure

Copies of the petition, this notice, and

the comments received will be available

for public inspection during normal

business hours at: ATF Public Reading

Room, Room 6480, 650 Massachusetts

Avenue, NW, Washington, DC.

Drafting Information

The author of this document is James

P. Ficaretta, Regulations Division,

Bureau of Alcohol, Tobacco and

Firearms.

List of Subjects in 27 CFR Part 16

Alcohol and alcoholic beverages,

Consumer protection, Health, Labeling,

Panalties.

Authority and Issuance

This notice is issued under the

authority of 27 U.S.C. 205 and 215.

Dated: April 25, 2001.

Bradley A. Buckles,

Director.

Approved: April 25, 2001.

Timothy E. Skud,

Acting Deputy Assistant Secretary,

(Regulatory, Tariff and Trade Enforcement).

[FR Doc. 01–12802 Filed 5–21–01; 8:45 am]

BILLING CODE 4810–31–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[MD116–3067b; FRL–6979–5]

Approval and Promulgation of Air

Quality Implementation Plans; State of

Maryland; Repeal of Petroleum

Refinery Regulations

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to approve

a State Implementation Plan (SIP)

revision submitted by the State of

Maryland. This action proposes to

approve Maryland’s repeal of its

petroleum refinery regulation. EPA is

approving the State’s SIP submittal as a

direct final rule without prior proposal

because the Agency views this as a

noncontroversial submittal and

anticipates no adverse comments. A

detailed rationale for the approval is set

forth in the direct final rule. If no

adverse comments are received in

response to this action, no further

activity is contemplated. If EPA receives

adverse comments, the direct final rule

will be withdrawn and all public

comments received will be addressed in

a subsequent final rule based on this

proposed rule. EPA will not institute a

second comment period. Any parties

interested in commenting on this action

should do so at this time. Please note

that if EPA receives adverse comment

on an amendment, paragraph, or section

of this rule and if that provision may be

severed from the remainder of the rule,

EPA may adopt as final those provisions

of the rule that are not the subject of an

adverse comment.

DATES: Comments must be received in

writing by June 21, 2001.