[Federal Register Volume 63, Number 172 (Friday, September 4, 1998)]
[Notices]
[Pages 47300-47301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23837]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 92F-0397]
Great Lakes Chemical Corp.; Withdrawal of Food Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal, without prejudice to a future filing, of a food additive
petition (FAP 2B4343) proposing that the food additive regulations be
amended to provide for the safe use of an aqueous solution of 1-bromo-
3-chloro-5,5-dimethylhydantoin as a sanitizing solution to be used on
food processing equipment and utensils and on food-contact surfaces in
public eating places.
FOR FURTHER INFORMATION CONTACT: Julius Smith, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3091.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of December 7, 1992 (57 FR 57838), FDA announced that a food
additive petition (FAP 2B4343) had been filed by Great Lakes Chemical
Corp., P.O. Box 2200, West Lafayette, IN 47906. The petition proposed
to amend the food additive regulations in Sec. 178.1010 Sanitizing
solutions (21 CFR 178.1010) to provide for the safe use of an aqueous
solution of 1-bromo-3-chloro-5,5-dimethylhydantoin as a sanitizing
solution to be used on food processing equipment and utensils and on
food-contact surfaces in public eating places.
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170),
which was enacted on August 3, 1996, amended the Federal Food, Drug,
and Cosmetic Act (the act) and provided the Environmental Protection
Agency (EPA) with the regulatory authority over the petitioned use of
this substance. Under FQPA, the petitioned use of this
[[Page 47301]]
substance is regulated as a pesticide chemical under section 408 of the
act (21 U.S.C. 346a). Thus, post-FQPA, the petitioned use of this
substance is no longer subject to FDA's regulatory authority as a food
additive under section 409 of the act (21 U.S.C. 348).
In response to a request by the petitioner, which was prompted by
the change in regulatory authority over the antimicrobial substance
that is the subject of this petition, FDA transferred the records for
FAP 2B4343, including all of FDA's reviews of information in the
petition, to EPA. Great Lakes Chemical Corp. has now withdrawn the
petition without prejudice to a future filing (21 CFR 171.7).
Dated: July 15, 1998.
George H. Pauli,
Acting Director, Office of Premarket Approval, Center for Food Safety
and Applied Nutrition.
[FR Doc. 98-23837 Filed 9-3-98; 8:45 am]
BILLING CODE 4160-01-F
