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 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

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

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

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

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

PART 5—LABELING AND ADVERTISING OF DISTILLED SPIRITS

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

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

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

PART 7—LABELING AND ADVERTISING OF MALT BEVERAGES

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

Authority: 27 U.S.C. 205.

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