[Federal Register Volume 62, Number 193 (Monday, October 6, 1997)]
[Notices]
[Page 52136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95F-0040]
Chemie Research and Manufacturing Co., Inc.; 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 filed by Chemie Research and Manufacturing Co., Inc.,
proposing that the food additive regulations be amended to provide for
the safe use of a glycerin extract of dried grapefruit seeds and pulp
as an antimicrobial agent in the processing of fresh or frozen poultry,
fish, and shellfish.
FOR FURTHER INFORMATION CONTACT: Valerie M. Davis, Center for Food
Safety and Applied Nutrition (HFS-206), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3181.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of March 16, 1995 (60 FR 14286), FDA announced that a food
additive petition (FAP 2A4336) had been filed by Chemie Research and
Manufacturing Co., Inc., 160 Concord Dr., P.O. Box 181279, Casselberry,
FL 32718-1279. The petition proposed that the food additive regulations
be amended to provide for the safe use of a glycerin extract of dried
grapefruit seeds and pulp as an antimicrobial agent in the processing
of fresh or frozen poultry, fish, and shellfish.
By letter dated May 10, 1995, the agency notified the petitioner
that consideration of the petitioned use for the glycerin extract of
dried grapefruit seed and pulp would require the submission and
evaluation of specific additional data. By letter of June 1, 1995, the
petitioner provided a partial response to the agency's request for
information and stated an intent to provide a complete response within
180 days. However, no further information was submitted within the 180-
day time period.
By letter of July 24, 1996, FDA again requested that the necessary
data be submitted within 30 days and stated that a failure to respond
would be considered to be an agreement by the petitioner to withdraw
the petition. Because FDA has received no response from the petitioner,
and the required information has not been submitted, the petition is
now withdrawn without prejudice to a future filing (21 CFR 171.7(b)).
Future consideration of the use of a glycerin extract of dried
grapefruit seeds and pulp as an antimicrobial agent in the processing
of fresh or frozen poultry, fish, and shellfish will require submission
of a new food additive petition.
Dated: September 22, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-26413 Filed 10-3-97; 8:45 am]
BILLING CODE 4160-01-F