[Federal Register Volume 69, Number 115 (Wednesday, June 16, 2004)]
[Rules and Regulations]
[Pages 33572-33574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13404]


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DEPARTMENT OF THE TREASURY

Alcohol and Tobacco Tax and Trade Bureau

27 CFR Parts 4, 5, and 7

[T.D. TTB-12]
RIN 1513-AA93


Removal of Requirement To Disclose Saccharin in the Labeling of 
Wine, Distilled Spirits, and Malt Beverages (2003R-575P)

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

ACTION: Final rule; Treasury decision.

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SUMMARY: This document amends the Alcohol and Tobacco Tax and Trade 
Bureau's labeling regulations to remove the requirement for bottlers of 
wine, distilled spirits, and malt beverages to show a warning on 
products containing saccharin. The regulatory amendments

[[Page 33573]]

in this document reflect the National Toxicology Program's revised 
findings about saccharin and the removal of the statutory requirement 
for the warning.

DATES: This rule is effective on June 16, 2004.

FOR FURTHER INFORMATION CONTACT: Lisa M. Gesser, Regulations and 
Procedures Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 
128, Morganza, Maryland 20660; (301-290-1460) or e-mail 
[email protected].

SUPPLEMENTARY INFORMATION: 

Background

    The Federal Alcohol Administration Act, 27 U.S.C. 205(e)(2), 
authorizes the Administrator of the Alcohol and Tobacco Tax and Trade 
Bureau (TTB), as a delegate of the Secretary of the Treasury, to 
prescribe regulations which will provide the consumer with ``adequate 
information'' as to the identity and quality of alcohol beverage 
products. Under this authority, parts 4, 5, and 7 of title 27 of the 
Code of Federal Regulations (27 CFR 4, 5, and 7) prescribe the labeling 
requirements for wines, distilled spirits, and malt beverages, 
respectively. Prior to January 24, 2003, the Secretary of the Treasury 
had delegated this responsibility to the Administrator's predecessor, 
the Director of the former Bureau of Alcohol, Tobacco and Firearms, 
Department of the Treasury (ATF-Treasury). The regulations requiring 
basic mandatory labeling information for alcohol beverage products have 
been in effect for over 50 years.
    On November 23, 1977, President Carter signed into law the 
Saccharin Study and Labeling Act, Public Law 95-203, 91 Stat. 1451. 
Section 4(a)(1) of the Saccharin Study and Labeling Act added paragraph 
(o) to 21 U.S.C. 343, requiring the following statement on the labels 
of all food and beverage products that contained saccharin:

    Use of this product may be hazardous to your health. This 
product contains saccharin which has been determined to cause cancer 
in laboratory animals.

    In 1984 and 1985, ATF-Treasury began receiving petitions from 
industry members requesting to use saccharin as a sugar substitute in 
alcohol beverage manufacturing. The Food and Drug Administration 
regulations, 21 CFR 180.37 (21 U.S.C. 348, 371), did not and still do 
not preclude the use of saccharin in the production of alcohol 
beverages. In recognition of the congressional mandate as expressed in 
the Saccharin Study and Labeling Act and pursuant to section 205(e)(2) 
of the Federal Alcohol Administration Act, ATF-Treasury published 
Treasury Decision ATF-220 on December 20, 1985 at 50 FR 51851 (as 
corrected in 51 FR 4338, published February 4, 1986).
    Treasury Decision ATF-220 amended the regulations in 27 CFR parts 
4, 5, and 7 to require bottlers of alcohol beverage products containing 
saccharin (including sodium saccharin, calcium saccharin and ammonium 
saccharin) to label their products with a health warning statement 
identical to that set forth in the Saccharin Study and Labeling Act.
    On May 15, 2000, the U.S. Department of Health and Human Services, 
Public Health Service, National Toxicology Program published the 9th 
Report on Carcinogens. The Report delisted saccharin, which had been 
listed in the Report as ``reasonably anticipated to be a human 
carcinogen'' since 1981. The Report explained that saccharin was 
removed from the list after a review of the carcinogenicity data for 
saccharin. The Report concluded:

    Saccharin will be removed from the Report on Carcinogens, 
because the rodent cancer data are not sufficient to meet the 
current criteria to list this chemical as reasonably anticipated to 
be a human carcinogen. This is based on the perception that the 
observed bladder tumors in rats arise by mechanisms not relevant to 
humans, and the lack of data in humans suggesting a carcinogenic 
hazard.

    Section 517, Title V, Appendix A, Consolidated Appropriations Act 
of 2001 (Pub. L. 106-554, 114 Stat. 2763), repealed 21 U.S.C. 343(o), 
the saccharin warning statement requirement, as well as subsections (c) 
and (d) of section 4 of the Saccharin Study and Labeling Act. 
Accordingly, we are amending 27 CFR parts 4, 5, and 7 by removing the 
saccharin warning statement requirement for the labeling of wine, 
distilled spirits, and malt beverages. These regulatory changes are 
made solely to reflect the statutory change noted above, and are in no 
way intended to reflect or prejudice our review of a recent petition we 
have received, proposing a number of new and broader labeling 
requirements.

Inapplicability of Notice and Delayed Effective Date Requirements

    Because the regulatory changes in this document remove a 
requirement imposed by the Saccharin Study and Labeling Act, which was 
repealed, TTB has determined it is impractical and unnecessary to issue 
these regulations with prior public notice and comment procedures under 
5 U.S.C. 553(b) or subject to the effective date limitation in section 
553(d).

Executive Order 12866

    This final rule does not meet the criteria for a ``significant 
regulatory action'' as specified in Executive Order 12866. Accordingly, 
this final rule is not subject to the analysis required by this 
Executive Order.

Regulatory Flexibility Act

    The provisions of the Regulatory Flexibility Act relating to an 
initial and final regulatory flexibility analysis (5 U.S.C. 603, 604) 
do not apply to this final rule because no notice of proposed 
rulemaking is required by 5 U.S.C. 553(b).

Paperwork Reduction Act

    The provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(j)) and its implementing regulations, 5 CFR part 1320, do not 
apply to this final rule because no requirement to collect information 
is imposed.

Drafting Information

    The principal author of this document is Lisa M. Gesser, 
Regulations and Procedures Division, Alcohol and Tobacco Tax and Trade 
Bureau.

List of Subjects

27 CFR Part 4

    Advertising, Consumer protection, Customs duties and inspection, 
Imports, Labeling, Packaging and containers, Reporting and 
recordkeeping requirements, Trade practices, Wine.

27 CFR Part 5

    Advertising, Consumer protection, Customs duties and inspection, 
Imports, Labeling, Liquors, Packaging and containers, Reporting and 
recordkeeping requirements, Trade practices.

27 CFR Part 7

    Advertising, Beer, Consumer protection, Customs duties and 
inspection, Imports, and Labeling.

Authority and Issuance

0
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 part 4 continues to read as follows:

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


Sec.  4.32  [Amended]

0
2. Amend Sec.  4.32 by removing and reserving paragraph (d).

[[Page 33574]]

PART 5--LABELING AND ADVERTISING OF DISTILLED SPIRITS

0
3. The authority citation for part 5 continues to read as follows:

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


Sec.  5.32  [Amended]

0
4. Amend Sec.  5.32 by removing and reserving paragraph (b)(6).

PART 7--LABELING AND ADVERTISING OF MALT BEVERAGES

0
5. The authority citation for part 7 continues to read as follows:

    Authority: 27 U.S.C. 205.


Sec.  7.22  [Amended]

0
6. Amend Sec.  7.22 by removing and reserving paragraph (b)(5).

    Signed: March 8, 2004.
Arthur J. Libertucci,
Administrator.
    Approved: April 9, 2004.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and Tariff Policy).
[FR Doc. 04-13404 Filed 6-15-04; 8:45 am]
BILLING CODE 4810-31-P