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