[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