[Federal Register Volume 75, Number 212 (Wednesday, November 3, 2010)]
[Proposed Rules]
[Pages 67669-67672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27733]


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DEPARTMENT OF THE TREASURY

Alcohol and Tobacco Tax and Trade Bureau

27 CFR Parts 4, 5, and 7

[Docket No. TTB-2010-0008; Notice No. 111]
RIN 1513-AB79


Disclosure of Cochineal Extract and Carmine in the Labeling of 
Wines, Distilled Spirits, and Malt Beverages

AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau is proposing to 
revise its regulations to require the disclosure of the presence of 
cochineal extract and carmine on the labels of any alcohol beverage 
product containing one or both of these color additives. This proposed 
rule responds to a recent final rule issued by the Food and Drug 
Administration as well as reports of severe allergic reaction, 
including anaphylaxis, to cochineal extract and carmine-containing 
foods. This proposal would allow consumers who are allergic to 
cochineal extract or carmine to identify and thus avoid alcohol 
beverage products that contain these color additives.

DATES: Comments must be received on or before January 3, 2011.

ADDRESSES: You may send comments on this notice to one of the following 
addresses:
    <bullet> http://www.regulations.gov: Use the online comment form 
for this notice as posted within Docket No. TTB-2010-0008 at 
``Regulations.gov,'' the Federal e-rulemaking portal, to submit 
comments via the Internet;
    <bullet> Mail: Director, Regulations and Rulings Division, Alcohol 
and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-
4412; or
    <bullet> Hand Delivery/Courier in Lieu of Mail: Alcohol and Tobacco 
Tax and Trade Bureau, 1310 G Street, NW., Suite 200-E, Washington, DC 
20005.
    See the Public Participation section of this notice for specific 
instructions and requirements for submitting comments, and for 
information on how to request a public hearing.
    You may view copies of this notice and any comments we receive 
about it within Docket No. TTB-2010-0008 at http://www.regulations.gov. 
A direct link to this docket is posted under Notice No. 111 on the TTB 
Web site at http://www.ttb.gov/regulations_laws/all_rulemaking.shtml. 
You also may view copies of this notice and the comments we receive 
about it by appointment at the TTB Information Resource Center, 1310 G 
Street, NW., Washington, DC 20220. Please call 202-453-2270 to make an 
appointment.

FOR FURTHER INFORMATION CONTACT: Lisa M. Gesser, Regulations and 
Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 
128, Morganza, MD 20660; telephone (301) 290-1460; or Joanne C. Brady, 
Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade 
Bureau, P.O. Box 45797, Philadelphia, PA 19149; telephone (215) 333-
7050.

SUPPLEMENTARY INFORMATION:

I. TTB's Authority To Prescribe Alcohol Beverage Labeling Regulations

    Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 
codified at 27 U.S.C. 205(e), sets forth standards for regulation of 
the labeling of wine (containing at least 7 percent alcohol by volume), 
distilled spirits, and malt beverages, generally referred to as 
``alcohol beverage products'' throughout this notice. This section 
gives the Secretary of the Treasury the authority to issue regulations 
to prevent deception of the consumer, to provide the consumer with 
``adequate information'' as to the identity and quality of the product, 
to prohibit false or misleading statements, and to provide information 
as to the alcohol content of the product. Section 105(e) of the FAA Act 
also

[[Page 67670]]

requires that a person obtain a certificate of label approval for all 
distilled spirits, wine, or malt beverages introduced into interstate 
or foreign commerce before bottling the product or removing the product 
from customs custody, in accordance with regulations prescribed by the 
Secretary.
    The labeling provisions of the FAA Act also give the Secretary the 
authority to prohibit, irrespective of falsity, statements relating to 
age, manufacturing processes, analyses, guarantees, and scientific or 
irrelevant matters that are likely to mislead the consumer. In the case 
of malt beverages, the labeling provisions of the FAA Act apply only if 
the laws of the State into which the malt beverages are to be shipped 
impose similar requirements. TTB is responsible for the administration 
of the FAA Act and the regulations promulgated under it.

II. Background on Cochineal Extract and Carmine

    Cochineal extract is an insect-derived color additive that is 
permitted for use in foods, including alcohol beverage products, and 
drugs in the United States. The related color additive carmine is 
permitted for use in foods, including alcohol beverage products, drugs, 
and cosmetics. The Food and Drug Administration (FDA) has listed these 
color additives, and conditions for their safe use in foods, in Sec.  
73.100 of title 21 of the Code of Federal Regulations (21 CFR 73.100).
    On January 30, 2006, FDA published a proposed rule in the Federal 
Register (71 FR 4839) to amend its requirements for cochineal extract 
and carmine by requiring their declaration on the labels of all food 
and cosmetic products that contain these color additives. More 
specifically, for food products, FDA proposed to amend the color 
additive regulations that permit the use of cochineal extract or 
carmine in foods (21 CFR 73.100) by adding a new requirement that all 
foods which contain cochineal extract or carmine specifically declare 
that fact in the ingredient statement of the food label by using its 
respective common or usual name, ``cochineal extract'' or ``carmine.''
    FDA explained that the proposal was issued in response to reports 
of severe allergic reactions, including anaphylaxis, to cochineal 
extract and carmine-containing foods and cosmetics. The proposal was 
also in response to a 1998 citizen petition from the Center for Science 
in the Public Interest, which asked the FDA to take action to protect 
consumers who are allergic to cochineal extract and carmine.
    The preamble to FDA's proposed rule describes, in detail, several 
instances and studies in which allergic reactions occurred. One of the 
referenced articles described allergic reactions (including 
anaphylaxis) experienced by five patients after ingesting the alcohol 
beverage product Campari, which, according to FDA's preamble, contained 
carmine. All five patients were women; three had a history of allergic 
respiratory disease, one had only non-clinical sensitivity to mugwort, 
and one was nonatopic (had no history of allergy). The time period 
between ingestion and onset of allergic reaction was given for four 
patients and varied from 15 minutes to 30 minutes. Two of the five 
patients reportedly experienced ``severe'' anaphylactic reactions. Of 
these two, one required hospitalization while the other was treated 
with inhalers and intravenous antihistamine. The remaining three 
experienced angioedema (tissue swelling). See 71 FR 4842.
    The preamble to FDA's proposed rule further explains as follows: 
``Allergic reactions to cochineal extract and/or carmine in a variety 
of foods (grapefruit juice, the alcohol beverage Campari, a popsicle, 
candy, yogurt, and artificial crabmeat) and [certain] cosmetics * * * 
have been reported in scientific and medical literature since 1961.'' 
71 FR 4839-4840. Since 1994, FDA has received 11 adverse event reports 
of allergic reactions, including anaphylaxis, experienced by 
individuals after eating food or drinking a beverage containing 
cochineal extract or carmine, or using cosmetics colored with carmine.
    FDA solicited comments from all interested parties in response to 
their proposal to require the listing of these color additives. As a 
result, FDA received a total of 159 responses.
    On January 5, 2009, FDA published a final rule in the Federal 
Register (74 FR 207) which addressed the comments submitted and 
finalized the regulatory changes as proposed by adding a new 
requirement that all foods containing cochineal extract or carmine 
specifically declare that fact in the ingredient statement of the food 
label by using its respective common or usual name, ``cochineal 
extract'' or ``carmine.'' The final rule takes effect on January 5, 
2011.
    In light of FDA's official recognition of evidence linking the 
presence of cochineal extract and carmine in foods and beverages to a 
health risk for a small percentage of consumers, TTB believes that it 
is appropriate to require the disclosure of cochineal extract and 
carmine on the labels of the alcohol beverage products that it 
regulates. While TTB believes that the use of these color additives in 
the manufacture of alcohol beverage products is relatively rare, at 
least one such alcohol product contained the color additive carmine, as 
evidenced by the FDA's rulemaking record.
    We also note that similar action has been taken in the past. On 
October 6, 1983, TTB's predecessor agency, the Bureau of Alcohol 
Tobacco and Firearms (ATF) published a final rule (T.D. ATF-150, 48 FR 
45549), rescinding the ingredient labeling regulations for alcohol 
beverage products. However, mandatory label disclosure was required for 
alcoholic beverages containing the color additive FD&C Yellow No. 5. 
The Bureau found, as a result of its rulemaking effort, that there was 
evidence establishing that consumers of the few alcohol beverage 
products containing that color additive could have adverse reactions to 
the ingredient. Pursuant to T.D. ATF-150, the Bureau specifically 
stated that it ``will look at the necessity of mandatory labeling of 
other ingredients on a case-by-case basis through its own rulemaking 
initiative, or on the basis of petitions for rulemaking under 5 U.S.C. 
553(e) and 27 CFR 71.41(c).''
    In that regard, ATF published a final rule in the Federal Register 
requiring mandatory label disclosure of saccharin for alcoholic 
beverages containing that artificial sweetener (T.D. ATF-220; December 
20, 1985, 50 FR 51851), which was subsequently removed as a requirement 
by TTB in 2004 (T.D. TTB-12; June 16, 2004, 69 FR 33572). ATF also 
published a final rule requiring label disclosure of sulfites when 
present in alcoholic beverages at a level of ten or more parts per 
million (T.D. ATF-236; September 30, 1986, 51 FR 34706).
    In determining whether there is a need to require label disclosure 
of specific ingredients in alcoholic beverages, ATF traditionally 
utilized the expertise of the Food and Drug Administration (FDA). In 
1987, FDA and ATF entered into a memorandum of understanding (52 FR 
45502, November 30, 1987), to clarify the enforcement responsibilities 
of each agency with respect to alcohol beverages. ATF agreed that 
``when FDA has determined that the presence of an ingredient in food 
products, including alcoholic beverages, poses a recognized public 
health problem, and that the ingredient or substance must be identified 
on a food product label, ATF would initiate rulemaking proceedings to 
promulgate labeling regulations for alcoholic beverages consistent with 
ATF's health policy with respect to alcoholic

[[Page 67671]]

beverages.'' TTB operates under the same memorandum of understanding 
with FDA.
    Accordingly, TTB proposes to amend the TTB regulations to require 
that each alcohol beverage product containing the color additive 
cochineal extract or carmine disclose that information on the product's 
label.

III. Format and Placement of Disclosure

    TTB proposes that all alcohol beverage products that contain the 
color additive cochineal extract or carmine must declare the presence 
of the additive on the brand label or on a back label, prominently and 
conspicuously, using its respective common or usual name ``cochineal 
extract'' or ``carmine''. (For example: ``Contains: Cochineal Extract'' 
or ``Contains carmine as a color additive.'').

IV. Implementation Date

    TTB believes that this proposed new regulatory requirement will 
require revisions to the labels of very few alcohol beverage products. 
Accordingly, TTB proposes an implementation date of 90 days after the 
date the final rule is published in the Federal Register. Upon 
implementation of the final rule, the label of an alcohol beverage 
product subject to the requirement for disclosure of cochineal extract 
and carmine would have to bear the mandatory statement at the time of 
its removal from bond or from customs custody in bottles. TTB seeks 
comments from affected industry members as to whether 90 days is a 
sufficient amount of time to incorporate these changes.

V. Public Participation

A. Comments Invited

    We invite comments from interested members of the public on this 
proposed rulemaking.

B. Submitting Comments

    You may submit comments on this notice by using one of the 
following three methods:
    <bullet> Federal e-Rulemaking Portal: You may send comments via the 
online comment form linked to this notice in Docket No. TTB-2010-0008 
on ``Regulations.gov,'' the Federal e-rulemaking portal, at http://www.regulations.gov. Direct links to the comment form and docket are 
available under Notice No. 111 on the TTB Web site at http://www.ttb.gov/regulations_laws/all_rulemaking.shtml. Supplemental files 
may be attached to comments submitted via Regulations.gov. For 
information on how to use Regulations.gov, click on the site's Help or 
FAQ tabs.
    <bullet> U.S. Mail: You may send comments via postal mail to the 
Director, Regulations and Rulings Division, Alcohol and Tobacco Tax and 
Trade Bureau, P.O. Box 14412, Washington, DC 20044-4412.
    <bullet> Hand Delivery/Courier: You may hand-carry your comments or 
have them hand-carried to the Alcohol and Tobacco Tax and Trade Bureau, 
1310 G Street, NW., Suite 200-E, Washington, DC 20005.
    Please submit your comments by the closing date shown above in this 
notice. Your comments must reference Notice No. 111 and include your 
name and mailing address. Your comments also must be made in English, 
be legible, and be written in language acceptable for public 
disclosure. We do not acknowledge receipt of comments, and we consider 
all comments as originals.
    If you are commenting on behalf of an association, business, or 
other entity, your comment must include the entity's name as well as 
your name and position title. If you comment via Regulations.gov, 
please include the entity's name in the ``Organization'' blank of the 
comment form. If you comment via postal mail, please submit your 
entity's comment on letterhead.
    You may also write to the Administrator before the comment closing 
date to ask for a public hearing. The Administrator reserves the right 
to determine whether to hold a public hearing.

C. Confidentiality

    All submitted comments and attachments are part of the public 
record and subject to disclosure. Do not enclose any material in your 
comments that you consider to be confidential or that is inappropriate 
for public disclosure.

D. Public Disclosure

    On the Federal e-rulemaking portal, Regulations.gov, we will post, 
and the public may view, copies of this notice, selected supporting 
materials, and any electronic or mailed comments we receive about this 
proposal. A direct link to the Regulations.gov docket containing this 
notice and the posted comments received on it is available on the TTB 
Web site at http://www.ttb.gov/regulations_laws/all_rulemaking.shtml 
under Notice No. 111. You may also reach the docket containing this 
notice and the posted comments received on it through the 
Regulations.gov search page at http://www.regulations.gov.
    All posted comments will display the commenter's name, organization 
(if any), city, and State, and, in the case of mailed comments, all 
address information, including e-mail addresses. We may omit voluminous 
attachments or material that we consider unsuitable for posting.
    You and other members of the public may view copies of this notice, 
all related petitions, maps and other supporting materials, and any 
electronic or mailed comments we receive about this proposal by 
appointment at the TTB Information Resource Center, 1310 G Street, NW., 
Washington, DC 20220. You may also obtain copies at 20 cents per 8.5- x 
11-inch page. Contact our information specialist at the above address 
or by telephone at 202-453-2270 to schedule an appointment or to 
request copies of comments or other materials.

VI. Regulatory Analysis and Notices

A. Regulatory Flexibility Act

    We certify under the provisions of the Regulatory Flexibility Act 
(5 U.S.C. 601 et seq.) that this proposed rule, if adopted, would not 
have a significant economic impact on a substantial number of small 
entities. We believe that the proposed rule, if adopted, will not 
impose, or otherwise cause, a significant increase in reporting, 
recordkeeping, or other compliance burdens on a substantial number of 
small entities as very few alcohol beverages are made using cochineal 
extract or carmine as color additives. We specifically solicit comments 
on the number of small producers, bottlers, and importers of alcohol 
beverages that may be affected by this proposed rule and the impact of 
this rule on those small businesses. We ask any small business that 
believes that it would be significantly affected by this proposed rule 
to submit a comment and explain how the rule would affect it.

B. Executive Order 12866

    We have determined that this proposed rule is not a significant 
regulatory action as defined in Executive Order 12866. Therefore, a 
regulatory assessment is not required.

C. Paperwork Reduction Act

    The revisions to collections of information contained in this 
notice of proposed rulemaking have been submitted to the Office of 
Management and Budget (OMB) for review in accordance with the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3507(d)). Comments on the collection 
of information may be sent by e-mail to <a href="/cdn-cgi/l/email-protection#c695aea7a1b3a0b2a79987aeaba3a286a9aba4e8a3a9b6e8a1a9b0"><span class="__cf_email__" data-cfemail="6132090006140715003e20090c0405210e0c034f040e114f060e17">[email protected]</span></a> or 
by postal mail to Shagufta Ahmed, Office of Management and Budget, 
Attention: Desk Officer for the Department of the

[[Page 67672]]

Treasury, Office of Information and Regulatory Affairs, Room 10235, 
Washington, DC 20503. A copy should also be sent to the Alcohol and 
Tobacco Tax and Trade Bureau by any of the methods previously 
described. Because OMB must complete its review of the collection of 
information between 30 and 60 days after publication, comments on the 
information collection should be submitted not later than December 3, 
2010. Comments are specifically requested concerning:
    <bullet> Whether the proposed collections of information are 
necessary for the proper performance of the functions of the Alcohol 
and Tobacco Tax and Trade Bureau, including whether the information 
will have practical utility;
    <bullet> The accuracy of the estimated burden associated with the 
proposed revision of the collection of information (see below);
    <bullet> How to enhance the quality, utility, and clarity of the 
information to be collected;
    <bullet> How to minimize the burden of complying with the proposed 
revision of the collection of information, including the application of 
automated collection techniques or other forms of information 
technology; and
    <bullet> Estimates of capital or start-up costs and costs of 
operation, maintenance, and purchase of services to provide 
information.
    The collection of information in this proposed regulation is in 27 
CFR Sections 4.32, 5.32, and 7.22, and involves mandatory disclosures 
of information on labels. This information is required to prevent 
deception of the consumer and to provide the consumer with adequate 
information as to the identity and quality of the alcohol beverage 
product. The likely respondents are businesses or other for-profit 
institutions, including partnerships, associations, and corporations.
    This information constitutes only a portion of the labeling 
information on alcohol beverages required under authority of the 
Federal Alcohol Administration Act (FAA Act). OMB has previously 
approved a collection of information for Labeling and Advertising 
Requirements Under the FAA Act, under control number 1513-0087. The 
current burdens of this existing collection are:
    <bullet> Estimated Number of Respondents: 7,071.
    <bullet> Estimated Total Annual Burden Hours: 7,071.
    Because the proposed disclosure required under this regulation 
would affect an extremely small number of respondents, the burden 
estimate associated with this collection of information, in light of 
the collective burden, is minimal and is expected to contribute only a 
negligible additional burden beyond that already accounted for under 
control number 1513-0087.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a valid 
control number assigned by OMB.

VII. Drafting Information

    The principal authors of this document are Lisa M. Gesser and 
Joanne C. Brady, Regulations and Rulings Division, Alcohol and Tobacco 
Tax and Trade Bureau.

List of Subjects

27 CFR Part 4

    Administrative practice and procedure, Advertising, Customs duties 
and inspection, Imports, Labeling, Packaging and containers, Reporting 
and recordkeeping requirements, Trade practices, Wine.

27 CFR Part 5

    Administrative practice and procedure, Advertising, Customs duties 
and inspection, Distilled spirits, Imports, Labeling, Packaging and 
containers, Reporting and recordkeeping requirements, Trade practices.

27 CFR Part 7

    Administrative practice and procedure, Advertising, Customs duties 
and inspection, Imports, Labeling, Malt beverages, Reporting and 
recordkeeping requirements, Trade practices.

    For the reasons discussed in the preamble, TTB proposes to amend 27 
CFR, chapter 1, parts 4, 5, and 7, as set forth below:

PART 4--LABELING AND ADVERTISING OF WINE

    1. The authority citation for 27 CFR part 4 continues to read as 
follows:


    Authority:  27 U.S.C. 205, unless otherwise noted.

    2. In Sec.  4.32, paragraph (d) is added to read as follows:


Sec.  4.32  Mandatory label information.

* * * * *
    (d) Declaration of cochineal extract or carmine. There shall be 
stated on the brand label or on a back label a statement that the 
product contains the color additive cochineal extract or carmine, 
prominently and conspicuously, using its respective common or usual 
name ``cochineal extract'' or ``carmine,'' where that coloring material 
is used in a product removed on or after February 1, 2011. (For 
example: ``Contains: Cochineal Extract'' or ``Contains carmine as a 
color additive'' or, if applicable, ``Contains: Cochineal Extract and 
Carmine.'').
* * * * *

PART 5--LABELING AND ADVERTISING OF DISTILLED SPIRITS

    3. The authority citation for 27 CFR part 5 continues to read as 
follows:

    Authority: 26 U.S.C. 5301, 7805, 27 U.S.C. 205.

    4. In Sec.  5.32, paragraph (b)(6) is added to read as follows:


Sec.  5.32  Mandatory label information.

* * * * *
    (b) * * *
    (6) A statement that the product contains the color additive 
cochineal extract or carmine, prominently and conspicuously, using its 
respective common or usual name ``cochineal extract'' or ``carmine,'' 
where that coloring material is used in a product removed on or after 
February 1, 2011. (For example: ``Contains: Cochineal Extract'' or 
``Contains carmine as a color additive'' or, if applicable, ``Contains: 
Cochineal Extract and Carmine.'').
* * * * *

PART 7--LABELING AND ADVERTISING OF MALT BEVERAGES

    5. The authority citation for 27 CFR part 7 continues to read as 
follows:

    Authority:  27 U.S.C. 205.

    6. In Sec.  7.22, paragraph (b)(8) is added to read as follows:


Sec.  7.22  Mandatory label information.

* * * * *
    (b) * * *
    (8) A statement that the product contains the color additive 
cochineal extract or carmine, prominently and conspicuously, using its 
respective common or usual name ``cochineal extract'' or ``carmine,'' 
where that coloring material is used in a product removed on or after 
February 1, 2011. (For example: ``Contains: Cochineal Extract'' or 
``Contains carmine as a color additive'' or, if applicable, ``Contains: 
Cochineal Extract and Carmine.'').

    Signed: August 24, 2010.
John J. Manfreda,
Administrator.
    Approved: August 30, 2010.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and Tariff Policy).
[FR Doc. 2010-27733 Filed 11-2-10; 8:45 am]
BILLING CODE 4810-31-P


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