[Federal Register Volume 59, Number 245 (Thursday, December 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31510]
[[Page Unknown]]
[Federal Register: December 22, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 182
[Docket No. 81N-0314]
Sulfiting Agents; Withdrawal of Regulation Revoking Gras Status
for Use on ``Fresh'' Potatoes Served or Sold Unpackaged and Unlabeled
to Consumers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing a final
rule that revoked the generally recognized as safe (GRAS) listing of
sulfiting agents (i.e., sulfur dioxide, sodium sulfite, sodium and
potassium bisulfite, and sodium and potassium metabisulfite) on
``fresh'' potatoes that are intended to be served or sold unpackaged
and unlabeled to the consumer. The agency is revising its regulations
in accordance with the withdrawal. This action is being taken in
response to a court ruling.
EFFECTIVE DATE: December 22, 1994. Insofar as it prohibits the use of
sulfiting agents on ``fresh'' potatoes that are intended to be served
or sold unpackaged and unlabeled to consumers, the final rule being
withdrawn has been null and void since a court ruling to that effect on
August 3, 1990.
FOR FURTHER INFORMATION CONTACT:
JoAnn Ziyad, Center for Food Safety and Applied Nutrition (HFS-207),
Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-
418-3116.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 15, 1990
(55 FR 9826), FDA published a final rule that amended the GRAS
regulations to revoke GRAS status for the use of sulfiting agents on
``fresh'' potatoes. The rule was challenged by the ``fresh'' potato
industry and invalidated by the U.S. District Court for the Middle
District of Pennsylvania on procedural grounds; subsequently, the U.S.
Court of Appeals for the Third Circuit, sitting en banc, i.e., the full
court, heard the case and, by an equally divided vote, let the district
court's decision stand. In accordance with the court's ruling, the
agency is withdrawing the revocation of GRAS status for the use of
sulfiting agents on ``fresh'' potatoes and is revising Secs. 182.3616,
182.3637, 182.3739, 182.3766, 182.3798, and 182.3862 (21 U.S.C.
182.3616, 182.3637, 182.3639, 182.3766, 182.3798, and 182.3862)
accordingly.
Because the issuance of this document is in response to a court
order, FDA finds that providing notice and public comment prior to the
publication of this final rule is unnecessary and may therefore be
dispensed with for good cause under 5 U.S.C. 553(b)(3)(B). Therefore,
publication of this rule withdrawing the revocation of GRAS status for
use of sulfiting agents on ``fresh'' potatoes constitutes final action.
The agency advises, however, that it has continuing concerns about the
safety of this use of sulfiting agents and is considering further
action.
List of Subjects in 21 CFR Part 182
Food ingredients, Food packaging, Spices and flavorings.
Therefore, under the Federal Food, Drug, and Cosmetic Act, part 182
is amended as follows:
PART 182--SUBSTANCES GENERALLY RECOGNIZED AS SAFE
1. The authority citation for 21 CFR part 182 continues to read as
follows:
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
2. In Sec. 182.3616, by revising paragraph (c) to read as follows:
Sec. 182.3616 Potassium bisulfite.
* * * * *
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits and vegetables
intended to be served raw to consumers or sold raw to consumers, or to
be presented to consumers as fresh.
3. In Sec. 182.3637, by revising paragraph (c) to read as follows:
Sec. 182.3637 Potassium metabisulfite.
* * * * *
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits and vegetables
intended to be served raw to consumers or sold raw to consumers, or to
be presented to consumers as fresh.
4. In Sec. 182.3739, by revising paragraph (c) to read as follows:
Sec. 182.3739 Sodium bisulfite.
* * * * *
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits or vegetables
intended to be served raw to consumers or sold raw to consumers, or to
be presented to the consumer as fresh.
5. In Sec. 182.3766, by revising paragraph (c) to read as follows:
Sec. 182.3766 Sodium metabisulfite.
* * * * *
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits or vegetables
intended to be served raw to consumers or sold raw to consumers, or to
be presented to consumers as fresh.
6. In Sec. 182.3798, by revising paragraph (c) to read as follows:
Sec. 182.3798 Sodium sulfite.
* * * * *
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits or vegetables
intended to be served raw to consumers or sold raw to consumers, or to
be presented to consumers as fresh.
7. In Sec. 182.3862, by revising paragraph (c) to read as follows:
Sec. 182.3862 Sulfur dioxide.
* * * * *
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits or vegetables
intended to be served raw to consumers or sold raw to consumers, or to
be presented to consumers as fresh.
Dated: December 15, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-31510 Filed 12-21-94; 8:45 am]
BILLING CODE 4160-01-P
