[Federal Register Volume 62, Number 17 (Monday, January 27, 1997)]
[Rules and Regulations]
[Pages 3791-3792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1853]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 95P-0337]


Food Labeling: Saccharin and Its Salts; Retail Establishment 
Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revoking the food 
labeling regulation that prescribes conditions for the display by a 
retail establishment of a notice concerning the sale of products 
containing saccharin and its salts. This action is being taken in 
response to an act to repeal the saccharin notice requirement and a 
citizen petition submitted by the Calorie Control Council. This action 
is intended to reduce the burden on small businesses.

EFFECTIVE DATE: January 27, 1997.

FOR FURTHER INFORMATION CONTACT: Gerad L. McCowin, Center for Food 
Safety and Applied Nutrition (HFS-151), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4561.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 27, 
1996 (61 FR 50770), FDA published a proposal to amend its food labeling 
regulations by revoking Sec. 101.11 Saccharin and its salts; retail 
establishment notice (21 CFR 101.11). The agency had issued this 
proposal partly in response to enactment on April 1, 1996, of Pub. L. 
104-124, which amended the Federal Food, Drug, and Cosmetic Act (the 
act) by repealing section 403(p) (21 U.S.C. 343(p)), and partly in 
response to a citizen petition that it received on October 11, 1995, 
from the Calorie Control Council requesting that the agency revoke this 
provision. No comments were received in response to the proposal.
    Having received no comments, FDA concludes that, for the reasons 
set forth in the proposal, it is appropriate to amend its food labeling 
regulations by revoking Sec. 101.11. In view of the revocation of 
section 403(p) of the act by Pub. L. 104-124 and the fact that section 
403(o) of the act requires that all food products containing saccharin 
include on their labeling a warning statement (see Statement of final 
guidelines for labeling of food products containing saccharin (42 FR 
62209, December 9, 1977)), the agency finds that Sec. 101.11 is no 
longer necessary. This action is also consistent with the 
Administration's ``Reinventing Government'' initiative which seeks to 
ease burdens on regulated industry and consumers.
    FDA has determined that this final rule is not a significant 
regulatory action for the purposes of Executive Order 12866. This final 
rule is expected to reduce the burden on small businesses. Therefore, 
the agency certifies that this final rule will not have a significant 
adverse impact on a substantial number of small entities within the 
meaning of the Regulatory Flexibility Act (5 U.S.C. 601-612).
    The agency has determined under 21 CFR 25.24(a)(11) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment

[[Page 3792]]

nor an environmental impact statement is required.
    This final rule contains no information collection requirements 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.).

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).


Sec. 101.11  [Removed]

    2. Section 101.11 Saccharin and its salts; retail establishment 
notice is removed from subpart A.

    Dated: January 17, 1997.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 97-1853 Filed 1-24-97; 8:45 am]
BILLING CODE 4160-01-F