[Federal Register Volume 62, Number 1 (Thursday, January 2, 1997)]
[Notices]
[Page 101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-33380]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96F-0493]
Gerard T. O'Brien; Filing 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 that
Gerard T. O'Brien has filed a petition proposing that the food additive
regulations be amended to provide for the safe use of a mixture of
hydrogen peroxide and sodium bicarbonate as an antimicrobial agent on
fresh poultry.
DATES: Written comments on the petitioner's environmental assessment by
February 3, 1997.
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: James C. Wallwork, Center for Food
Safety and Applied Nutrition (HFS-217), Food and Drug Administration,
200 C St. SW., Washington, DC 20204-0001, 202-418-3078.
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food
additive petition (FAP 7A4530) has been filed by Gerard T. O'Brien,
2162 Skyline Dr., Gainesville, GA 30501. The petition proposes to amend
the food additive regulations to provide for the safe use of a mixture
of hydrogen peroxide and sodium bicarbonate as an antimicrobial agent
on fresh poultry.
FAP 7A4530 was submitted to the agency on September 24, 1987, as
FAP 7A4045. On March 9, 1992, because of continued deficiencies in the
petition, which the agency had not filed, FDA notified the petitioner
that it would not continue its review of this petition. Information
concerning microbiological and chemical studies, which the agency had
requested in several letters to the petitioner, had not been submitted.
These studies were needed to demonstrate the bactericidal effectiveness
of the petitioned use of the additive and the dietary exposure to
oxidation products that might be formed on the chicken during
processing. Therefore, FDA planned no further review.
Since that time, the agency has been corresponding with the
petitioner and has still not received the requested information. In a
September 18, 1995, letter to FDA the petitioner asked whether he had
exhausted his administrative remedies. Before receiving a response from
FDA, the petitioner filed a lawsuit against the agency. After the
dismissal of this lawsuit, the agency responded to the petitioner's
original question in an October 16, 1996, letter saying that the
petitioner had not exhausted his administrative remedies and that he
could either file a new petition that would include the supplemental
information requested by the agency or send a written request to FDA
asking the agency to file the petition as submitted in accordance with
Sec. 171.1(i)(1) (21 CFR 171.1(i)(1)). The petitioner responded in a
November 4, 1996, letter indicating that he wants FDA to approve the
proposed use of this additive and does not intend to supplement the
petition. Therefore, FDA is filing the petition as submitted, in
accordance with Sec. 171.1(i)(1). The agency has assigned a new number
(FAP 7A4530) to this petition for administrative purposes.
The potential environmental impact of this action is being
reviewed. To encourage public participation consistent with regulations
promulgated under the National Environmental Policy Act (40 CFR
1501.4(b)), the agency is placing the environmental assessment
submitted with the original petition that is the subject of this notice
on public display at the Dockets Management Branch (address above) for
public review and comment. Interested persons may, on or before
February 3, 1997 submit to the Dockets Management Branch (address
above) written comments. 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. FDA will also place
on public display any amendments to, or comments on, the petitioner's
environmental assessment without further announcement in the Federal
Register. If, based on its review, the agency finds that an
environmental impact statement is not required and this petition
results in a regulation, the notice of availability of the agency's
finding of no significant impact and the evidence supporting that
finding will be published with the regulation in the Federal Register
in accordance with 21 CFR 25.40(c).
Dated: December 12, 1996.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and
Applied Nutrition.
[FR Doc. 96-33380 Filed 12-31-96; 8:45 am]
BILLING CODE 4160-01-F
