[Federal Register Volume 77, Number 73 (Monday, April 16, 2012)]
[Rules and Regulations]
[Pages 22485-22488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9101]
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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; T.D. TTB-103; Ref: 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: Final rule; Treasury decision.
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SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau is revising 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 rule responds to
a final rule issued by the Food and Drug Administration. Consumers who
are allergic to cochineal extract or carmine will now be able to
identify and thus avoid alcohol beverage products that contain these
color additives.
DATES: Effective Date: May 16, 2012. Transitional rules are provided
which will require compliance by April 16, 2013. Voluntary compliance
with this final rule, including making any required labeling changes,
may begin immediately.
FOR FURTHER INFORMATION CONTACT: Lisa M. Gesser, telephone 202-453-
1039, ext. 292 or Joanne C. Brady, telephone 202-453-1039, ext. 291;
Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade
Bureau, 1310 G Street NW., Box 12, Washington, DC 20005.
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 final rule. 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.
[[Page 22486]]
Section 105(e) of the FAA Act also requires that a person obtain a
certificate of label approval (COLA) for all wines, distilled spirits,
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.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the
FAA Act pursuant to section 1111(d) of the Homeland Security Act of
2002, codified at 6 U.S.C. 531(d). The Secretary has delegated various
authorities through Treasury Department Order 120-01 (Revised), dated
January 21, 2003, to the TTB Administrator to perform the functions and
duties in the administration and enforcement of this law.
II. Background
In 1987, the Food and Drug Administration (FDA) and the Bureau of
Alcohol, Tobacco and Firearms (ATF), TTB's predecessor agency, entered
into a memorandum of understanding (published in the Federal Register
at 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
beverages.'' TTB operates under the same memorandum of understanding
with FDA.
Cochineal extract and carmine are color additives that are
permitted for use in foods, including alcohol beverage products, in the
United States. The FDA has listed these color additives, and the
conditions for their safe use in foods, in Sec. 73.100 of the FDA
regulations (21 CFR 73.100). On January 5, 2009, FDA published a final
rule in the Federal Register (74 FR 207) requiring cochineal extract
and carmine to be declared by name on the labels of all food and
cosmetic products containing one or both of these color additives. FDA
explained that this requirement was adopted in response to reports of
severe allergic reactions, including anaphylaxis, to foods containing
these color additives. The FDA final rule does not require food or
cosmetics labels to disclose that these color additives are derived
from insects.
Accordingly, on November 3, 2010, TTB published in the Federal
Register a Notice of Proposed Rulemaking, Notice No. 111, (75 FR 67669)
which proposed to require cochineal extract and carmine to be listed on
the labels of any alcohol beverage product containing one or both of
these color additives. Specifically, TTB proposed amending Sec. Sec.
4.32, 5.32, and 7.22 of Title 27 Code of Federal Regulations to require
that all alcohol beverage products containing cochineal extract or
carmine list the additive(s) prominently and conspicuously on the brand
label or on a back label using its respective common or usual name
``cochineal extract'' or ``carmine.'' Beginning on the implementation
date, an alcohol beverage product containing cochineal extract or
carmine would have to bear the mandatory statement on its label at the
time of its removal from bond or from customs custody. TTB sought
comments on the proposal as outlined in Notice No. 111. TTB
specifically sought comments from affected industry members as to
whether an implementation date beginning 90 days from the date of the
final rule would provide a sufficient amount of time to incorporate
these changes. Commenters had until January 3, 2011, to respond to the
proposed rule.
During the comment period, TTB received a request from the
Distilled Spirits Council of the United States, Inc. (DISCUS), a
national trade association that represents producers and marketers of
distilled spirits and importers of wines sold in the United States, to
extend the comment period for 60 days to allow more time to collect and
review data from domestic and foreign companies regarding the issues
raised in the proposed rule.
In response to this request, on December 29, 2010, TTB published in
the Federal Register Notice No. 114 (75 FR 81949) which extended the
comment period for Notice No. 111 an additional 60 days. Accordingly,
the comment period for the proposal outlined in Notice No. 111 closed
on March 4, 2011.
III. Discussion of Comments and Agency Responses
TTB received a total of six responses to TTB Notice No. 111, in
addition to the request to extend the comment period discussed above.
The commenters include three individuals, two trade associations
(DISCUS and the International Association of Color Manufacturers
(IACM)), and one alcohol beverage importer. Two of the individual
commenters commented in support of TTB's proposal to require the
disclosure of these color additives, which they characterize as known
allergens, on alcohol beverage labels. Furthermore, none of the other
commenters opposed TTB's proposal to require the disclosure of
cochineal extract or carmine on alcohol beverage labels.
With regard to the number of products that would be affected by the
proposed rule, the comments did not provide specific numbers. However,
DISCUS stated that it believed that ``several'' alcohol beverage
products would be affected, and the IACM stated that ``few alcohol
beverage products'' contained cochineal extract. Based on the comments,
TTB has no reason to believe that a substantial number of industry
members would be affected by the proposed rule. Nonetheless, several
commenters suggested modifications to the proposed rule. The following
is a summary of those comments and TTB's responses.
Comments Concerning Disclosure of the Origin of the Color Additives
One individual commenter supported the requirement to list
cochineal extract and carmine on alcohol beverage labels, but suggested
that the TTB rule should go further and require statements on labels
that disclose that the additives are animal products derived from an
insect. The commenter stated that while industry groups may not want to
list the source of the dye for fear that consumers would find the
thought of insect derivatives unappealing, vegetarians or people of
certain faiths may be interested in this information so they can avoid
consuming products that conflict with their beliefs.
IACM stated that it did not oppose the disclosure of cochineal
extract and carmine on alcohol beverage labels. However, IACM opposed
any requirement to disclose that the additives are derived from
insects. IACM noted that FDA (in its proposed rule published in the
Federal Register at 71 FR 4839 on January 30, 2006) specifically stated
it saw no need to require the declaration of insect origin
[[Page 22487]]
for cochineal extract and carmine, as information on the origin of the
additives was readily available to those who wanted it.
TTB Response
As previously noted, the FDA final rule does not require that food
or cosmetics labels disclose that these color additives are derived
from insects. In the preamble to its final rule, which was published in
the Federal Register on January 5, 2009 (74 FR 207), FDA explained that
it did not agree with the commenters who suggested that declaring these
color additives by name would provide insufficient information to
consumers who choose to avoid products containing these additives.
Similarly, TTB does not believe that the source of the color additives
needs to be listed on the alcohol beverage label in order for consumers
to have adequate information about the product. The purpose of the rule
is to allow persons with sensitivities to cochineal extract or carmine
the opportunity to avoid ingestion of or contact with these additives.
Providing the common name of the color additives on the label will
provide sufficient information to all consumers, including those with
sensitivities to the additives as well as those who for other reasons
wish to avoid these additives. Accordingly, TTB is not adopting this
requested change in the final rule.
Comments Concerning the Implementation Period
In their respective comments, the two trade associations and the
alcohol beverage importer suggested that TTB extend the proposed 90-day
implementation period in order to lessen the burden on affected
industry members. IACM commented that while it does not anticipate that
the proposed rule would have a substantial economic impact on color
additive manufacturers, TTB should consider extending the
implementation date from 90 days to 180 days after the date the final
rule is published in order to reduce the burden on small companies that
are already facing limited financial resources due to the sluggish
economy.
DISCUS stated in its comment that the proposed 90-day
implementation period would not provide sufficient time to comply with
the proposed labeling requirement. DISCUS suggested that TTB adopt a
phased-in approach similar to the one which implemented the sulfite
labeling disclosure. For that rule, TTB's predecessor agency, ATF,
provided a one year transition period to fully implement the new
requirement.
The alcohol beverage importer stated in his comment that he
currently imports a product that contains cochineal extract, and that
he currently uses a TTB-approved label for this product that states
that the product contains artificial color. He stated that although he
does not oppose TTB's proposal, he is concerned about the
implementation date, as he has a large supply of labels for this
product. The commenter requested that the proposed labeling
requirements be implemented no less than one year after the date the
final rule is published, to allow more time to use up the labels.
Alternatively, he requests that TTB grant him permission to use up the
rest of his previously approved labels, as he believes the ``artificial
color'' statement on the label will prevent consumers from being
misled.
TTB Response
After careful consideration of the comments concerning the
implementation period, TTB agrees that a longer transition period is
appropriate. A longer implementation period will allow more time for
bottlers and importers to exhaust their label stocks before the new
requirements become effective. Accordingly, the requirement to disclose
the presence of cochineal extract and carmine by name on the labels of
any alcohol beverage product containing one or both of these color
additives will become mandatory for products that are removed on or
after one year from the publication of this final rule in the Federal
Register. TTB believes this longer implementation period will provide
sufficient time for industry members to comply with the new labeling
requirement, and is the most appropriate alternative to address the
concerns expressed by commenters regarding the implementation date.
Bottlers and importers may begin voluntarily complying with the
requirements immediately upon publication of this final rule.
Comments Concerning COLA Requirements for New Label Disclosure
In its comment, DISCUS also requested that TTB consider permitting
industry members with existing approved COLAs covering affected
products to revise the labels solely to include the mandatory
declaration without applying for and receiving new label approvals.
DISCUS also suggested that TTB allow the addition of a separate strip
or neck label that shows the mandatory declaration, instead of having
to apply for and receive a new label approval.
TTB Response
TTB agrees with the suggestion by DISCUS that if a label is merely
being changed to include the new label disclosure, without altering
existing information on the label, an application for a new COLA would
be unnecessary. Accordingly, by publication of this document in the
Federal Register, TTB is adopting the policy that labels covered by
existing approved COLAs which are revised solely to include the
mandatory cochineal or carmine declaration are considered approved by
TTB and do not require further approval. Bottlers and importers also do
not require a new COLA to add a new neck or strip label solely to
comply with the mandatory cochineal or carmine declaration. Any other
changes to the label, other than those permitted in accordance with the
instructions listed on the COLA application (TTB F 5100.31 or the
electronic COLA submission through COLAS Online) will require the
submission of a new COLA for approval.
IV. Changes to TTB Regulations
As proposed in TTB Notice No. 111, this final rule amends
Sec. Sec. 4.32, 5.32(b), and 7.22(b) of the TTB 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. With regard to Sec. 7.22(b), TTB is incorporating the
amendment in paragraph (b)(5) instead of (b)(8) as originally proposed,
and, for clarity, TTB has made some changes from the language
originally proposed in the amendments to Sec. Sec. 4.32, 5.32(b)(6),
and 7.22(b). The regulations permit the disclosure to appear on the
front, back, neck, or strip label and require that the disclosure be
displayed prominently and conspicuously.
V. Regulatory Analysis and Notices
A. Regulatory Flexibility Act
TTB certifies under the provisions of the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.) that the final rule will not have a
significant economic impact on a substantial number of small entities.
The final rule will not impose, or otherwise cause, a significant
increase in reporting, recordkeeping, or other compliance burdens on a
substantial number of small entities, because relatively few alcohol
beverages are made using cochineal extract or carmine as color
additives. Furthermore, in response to comments about allowing
sufficient time to use up existing inventories of labels, the final
rule provides for a one-year implementation
[[Page 22488]]
period. Accordingly, a regulatory flexibility analysis is not required.
B. Executive Order 12866
This rule is not a significant regulatory action as defined by
Executive Order 12866. Therefore, a regulatory assessment is not
required.
C. Paperwork Reduction Act
The collection of information contained in this final regulation
has been reviewed and approved by the Office of Management and Budget
(OMB) in accordance with the requirements of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3507(d)) under control number 1513-0087.
The collection of information in this regulation is in 27 CFR 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 entities, including
partnerships, associations, and corporations.
This information constitutes only a portion of the labeling
information on alcohol beverages required under authority of the FAA
Act and approved 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.
VI. 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.
Amendments to the Regulations
For the reasons discussed in the preamble, TTB amends 27 CFR,
chapter I, parts 4, 5, and 7, as set forth below:
PART 4--LABELING AND ADVERTISING OF WINE
0
1. The authority citation for 27 CFR part 4 continues to read as
follows:
Authority: 27 U.S.C. 205, unless otherwise noted.
0
2. In Sec. 4.32, add a new paragraph (d) to read as follows:
Sec. 4.32 Mandatory label information.
* * * * *
(d) Declaration of cochineal extract or carmine. There shall be
stated on a front label, back label, strip label, or neck label a
statement that the product contains the color additive cochineal
extract or the color additive carmine, prominently and conspicuously,
using the respective common or usual name (``cochineal extract'' or
``carmine''), where either of the coloring materials is used in a
product that is removed on or after April 16, 2013. (For example:
``Contains Cochineal Extract'' or ``Contains Carmine'' or, if
applicable, ``Contains Cochineal Extract and Carmine'').
* * * * *
PART 5--LABELING AND ADVERTISING OF DISTILLED SPIRITS
0
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.
0
4. In Sec. 5.32, add a new paragraph (b)(6) to read as follows:
Sec. 5.32 Mandatory label information.
* * * * *
(b) * * *
(6) A statement that the product contains the color additive
cochineal extract or the color additive carmine, prominently and
conspicuously, using the respective common or usual name (``cochineal
extract'' or ``carmine''), where either of the coloring materials is
used in a product that is removed on or after April 16, 2013. (For
example: ``Contains Cochineal Extract'' or ``Contains Carmine'' or, if
applicable, ``Contains Cochineal Extract and Carmine''). The statement
that the product contains the color additive cochineal extract or the
color additive carmine may appear on a strip label or a neck label in
lieu of appearing on the brand label or back label.
* * * * *
PART 7--LABELING AND ADVERTISING OF MALT BEVERAGES
0
5. The authority citation for 27 CFR part 7 continues to read as
follows:
Authority: 27 U.S.C. 205.
0
6. In Sec. 7.22, a new paragraph (b)(5) is added to read as follows:
Sec. 7.22 Mandatory label information.
* * * * *
(b) * * *
(5) A statement that the product contains the color additive
cochineal extract or the color additive carmine, prominently and
conspicuously, using the respective common or usual name (``cochineal
extract'' or ``carmine''), where either of the coloring materials is
used in a product that is removed on or after April 16, 2013. (For
example: ``Contains Cochineal Extract'' or ``Contains Carmine'' or, if
applicable, ``Contains Cochineal Extract and Carmine''). The statement
that the product contains the color additive cochineal extract or the
color additive carmine may appear on a strip label or a neck label in
lieu of appearing on the brand label or back label.
* * * * *
Signed: March 12, 2012.
John J. Manfreda,
Administrator.
Approved: March 12, 2012.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and Tariff Policy).
[FR Doc. 2012-9101 Filed 4-13-12; 8:45 am]
BILLING CODE 4810-31-P