[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withdrawn has been null and void since a court ruling to that effect on 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