[Federal Register Volume 61, Number 189 (Friday, September 27, 1996)]
[Proposed Rules]
[Pages 50770-50771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24754]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 95P-0337/CP1]


Food Labeling: Saccharin and Its Salts; Retail Establishment 
Notice; Revocation

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to revoke 
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 the enactment of Pub. L. 104-124, which amended the Federal 
Food, Drug, and Cosmetic Act (the act), and a citizen petition 
submitted by the Calorie Control Council. This action is intended to 
reduce the burden on small businesses.

DATES: Comments by December 11, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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: FDA is proposing to amend its food labeling 
regulations by revoking Sec. 101.11 Saccharin and its salts; retail 
establishment notice (21 CFR 101.11). In the Federal Register of March 
3, 1978 (43 FR 8793), FDA adopted Sec. 101.11 to implement a provision 
of the Saccharin Study and Labeling Act (Pub. L. 95-203) (hereinafter 
referred to as the SSLA). Among other things, the SSLA amended the act 
by adding section 403(p) (21 U.S.C. 343(p)), which provided that a food 
would be misbranded if it contained saccharin and was offered for sale, 
but not for immediate consumption, at a retail establishment unless the 
retail establishment displayed specific information relative to 
saccharin and its salts.
    On October 11, 1995, FDA received a citizen petition from the 
Calorie Control Council requesting that the agency revoke Sec. 101.11. 
The petition claimed

[[Page 50771]]

that: (1) ``[T]he language of the notice is outdated and appears to 
have been intended for a labeling transition that took place during 
1977-1978,'' (2) ``specific requirements of the regulation are 
outdated,'' and (3) ``the regulation is one that should be deleted per 
President Clinton's request for a list of regulations that the agency 
plans to eliminate.''
    Subsequently, on April 1, 1996, the President signed into law Pub. 
L. 104-124 to amend the act by repealing section 403(p) of the act. In 
discussing the provisions of H. R. 1787, which was enacted as Pub. L. 
104-124, the House report reflected on the intent of the SSLA provision 
for a store placard and the intent of Pub. L. 104-124 that the placard 
no longer be required:

    The redundant store notice warning requirement was included as a 
stop-gap measure to provide the warning prior to the time that 
warning labels would begin to appear on foods containing saccharin. 
Now that warning labels appear on all products, this requirement is 
no longer necessary. Eliminating the store warning notice will 
reduce a burden on retail establishments including ``mom and pop'' 
grocery stores, neighborhood supermarkets, pharmacies, and 
convenience stores.

H. Rept. 104-386, page 2 (December 6, 1995).
    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, which was also 
added to the act by the SSLA, 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 tentatively 
finds that Sec. 101.11 is no longer necessary and should be revoked. 
This action responds to the request in the Calorie Control Council's 
citizen petition. 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 proposed rule is not a significant 
regulatory action for the purposes of Executive Order 12866. This 
proposed rule is expected to reduce the burden on small businesses. 
Therefore, the agency certifies that this proposed 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 et 
seq.)
    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 nor an environmental impact statement is 
required.
    The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) is 
intended to minimize the reporting and recordkeeping burden on the 
regulated community, as well as to minimize the cost of Federal 
information collection and dissemination. In general, the Paperwork 
Reduction Act of 1995 requires that information requests and 
recordkeeping requirements affecting 10 or more non-Federal respondents 
be approved by the Office of Management and Budget. Because this 
proposed rule would remove an existing regulation and would not 
establish or modify any information or recordkeeping requirements, it 
is not subject to the requirements of the Paperwork Reduction Act of 
1995.
    Interested persons may, on or before December 11, 1996 submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

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, it is 
proposed that 21 CFR part 101 be 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: September 19, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-24754 Filed 9-26-96; 8:45 am]
BILLING CODE 4160-01-F