[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that: (1) ``[T]he language of the notice is outdated and appears to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
