[Federal Register Volume 66, Number 99 (Tuesday, May 22, 2001)]
[Proposed Rules]
[Pages 28135-28137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12802]



[[Page 28135]]

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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.

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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: <a href="/cdn-cgi/l/email-protection#d6b8a6a4bb96b7a2b0bea7f8b7a2b0f8a2a4b3b7a5f8b1b9a0"><span class="__cf_email__" data-cfemail="c6a8b6b4ab86a7b2a0aeb7e8a7b2a0e8b2b4a3a7b5e8a1a9b0">[email protected]</span></a>. 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 8\1/2\"  x  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

[[Page 28136]]

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 lower-case 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:
[GRAPHIC] [TIFF OMITTED] TP22MY01.017

    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 
eye-movements 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 alcoholic-beverage 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.

[[Page 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:
    <bullet> Be legible;
    <bullet> Reference this notice number;
    <bullet> Be 8\1/2\"  x  11" in size;
    <bullet> Contain a legible written signature; and
    <bullet> 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


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