[Federal Register Volume 62, Number 187 (Friday, September 26, 1997)]
[Notices]
[Pages 50617-50619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25588]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96F-0493]


Gerard T. O'Brien; Denial Without Prejudice of Food Additive 
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying a petition 
(FAP 7A4530) 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. The petitioner 
did not provide sufficient data and information for the agency to 
conclude that the proposed use of the food additive is safe, or that it 
will have its intended technical effect.

DATES: Written objections and request for a hearing by October 27, 
1997.

ADDRESSES: Submit written objections 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-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204-0001, 202-418-3078.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register on January 2, 1997 (62 FR 101), FDA announced that a food 
additive petition (FAP 7A4530) had been filed by Gerard T. O'Brien, 
2162 Skyline Dr., Gainesville, GA 30501. The petitioner requested that 
FDA 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.
    In acting on any food additive petition, FDA must determine whether 
the proposed use of the additive under the conditions of use to be 
specified in the regulation is safe (section 409(c)(3)(A) of the 
Federal Food, Drug,

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and Cosmetic Act (the act) (21 U.S.C. 348(c)(3)(A))). The burden is on 
the petitioner to submit to FDA data and information that are adequate 
to provide the basis for such a determination. The data and information 
must include all studies, whether favorable or adverse, relevant to the 
safety of the food additive and relevant to whether the food additive 
will achieve its intended physical or technical effect.
    FAP 7A4530 was submitted to the agency on September 24, 1987, as 
FAP 7A4045. The agency found that the petition did not meet the minimum 
requirements for filing in accordance with Sec. 171.1(c) (21 CFR 
171.1(c)). Despite FDA requests to petitioner for data and information 
to correct the deficiencies (Refs. 1, 2, and 3), the petitioner failed 
to submit such data and information to demonstrate that the food 
additive will achieve its intended technical effect, and that it is 
safe for the intended use. Specifically, the petitioner failed to 
provide data and information to demonstrate that the hydrogen peroxide 
and sodium bicarbonate mixture would significantly reduce pathogenic 
bacterial contamination on the surface of fresh poultry, e.g. 
Salmonella, Escherichia coli, and psychrophiles. In addition, the 
petitioner failed to provide data and information on whether oxidative 
effects of hydrogen peroxide occur on poultry as a result of the 
proposed use.
    Consequently, FDA requested that the petitioner submit laboratory 
data to demonstrate that there is reduced bacterial contamination on 
poultry processed with hydrogen peroxide and sodium bicarbonate, to 
provide TBA (2-thiobarbituric acid, a representative measure of lipid 
oxidation) values in skin/fat and meat from processed poultry, and to 
provide the basis to estimate the amount of hydrogen peroxide that 
reacts with poultry during the proposed treatment. FDA requested this 
information to: (1) Determine the bacteriocidal effectiveness of the 
petitioned use of the additive, (2) assess the degree of oxidation of 
poultry lipids by hydrogen peroxide, and (3) estimate the human dietary 
exposure to oxidation products that might be formed in the chicken 
during processing and might remain until consumption. The petitioner 
failed to submit this information that the agency had requested in 
several letters. Without this information the agency is not able to 
determine the microbiological efficacy and safety of treating fresh 
poultry with a mixture of hydrogen peroxide and sodium bicarbonate. 
This information is essential for the agency to determine whether the 
proposed use of this food additive is safe, and whether it will achieve 
its intended technical effect.
    FDA has several safety concerns regarding the petitioned use of the 
mixture of hydrogen peroxide and sodium bicarbonate that would be 
addressed by the data and information that FDA requested from the 
petitioner. One concern is that this mixture may not kill significant 
numbers of the pathogenic microbes on the surface of the chicken skin. 
Thus, human exposure to these pathogens could be higher with the use of 
the mixture of hydrogen peroxide and sodium bicarbonate than human 
exposure to these pathogens from currently used methods for killing 
bacteria on the surface of chicken skin, for example processing poultry 
in chlorinated water. In addition, it is possible that the mixture of 
hydrogen peroxide and sodium bicarbonate will kill off nonpathogenic 
microbes, giving a competitive advantage to the pathogens, so that they 
may reproduce to higher numbers. Another safety concern is that 
hydrogen peroxide is a strong oxidant that could interact with lipids 
and other biological constituents in the skin of chicken to form 
oxidation products. These oxidation products could potentially be 
mutagenic and represent a hazard to consumers.
    Thus, on March 9, 1992, because the petitioner failed to correct 
the deficiencies in the petition as previously described, FDA notified 
the petitioner that it would not continue to evaluate this submitted 
petition (Ref. 4).
    Although the petitioner continued to correspond with the agency, at 
no time did he submit 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, on 
December 6, 1995, the petitioner filed, in the U.S. District Court for 
the Northern District of Georgia, Gainesville Division, a pro se 
complaint against FDA and others alleging patent and copyright 
infringement, antitrust violations, Racketeer Influenced and Corrupt 
Organizations Act violations, fraud, and various torts. The Court 
dismissed the complaints without prejudice on March 20, 1996.
    In a letter dated October 16, 1996, the agency responded to the 
petitioner's earlier question on whether the petitioner had exhausted 
his administrative remedies. In that letter, the agency stated 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). The petitioner responded in a November 4, 1996, 
letter indicating that he wanted FDA to approve the proposed use of the 
additive and did not intend to supplement the petition. Therefore, on 
December 10, 1996, FDA filed the petition as submitted in accordance 
with Sec. 171.1(i)(1) (62 FR 101, January 2, 1997).
    The filed petition (FAP 7A4530) proposed 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. After reviewing the petition, which the petitioner did 
not supplement in order to correct previously identified deficiencies, 
the agency concluded that the petition does not contain data and 
information that would allow the agency to conclude that the food 
additive is safe and that it will achieve its intended technical 
effect. Therefore, FDA is denying FAP 7A4530 in accordance with 21 CFR 
171.100(a).

References

     The following information has been placed on display in the 
Dockets Management Branch (address above) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Letter dated January 6, 1988, from FDA to the petitioner.
    2. Letter dated April 14, 1988, from FDA to the petitioner.
    3. Letter dated June 15, 1989, from FDA to the petitioner.
    4. Letter dated March 9, 1992, from FDA to the petitioner.
    Any person who will be adversely affected by the foregoing order 
may at any time on or before October 27, 1997, file with the Dockets 
Management Branch (address above) written objections thereto. Each 
objection shall be separately numbered. Each numbered objection shall 
show wherein the person filing will be adversely affected by the order, 
specify with particularity the provisions of the order to which 
objection is made, and state the grounds for the objection. Each 
numbered objection on which a hearing is requested shall specifically 
so state. Failure to request a hearing for any particular objection 
shall constitute a waiver of the right to a hearing on that objection. 
Each numbered objection for which a hearing is requested shall include 
a detailed description and analysis of the specific factual information 
intended to be presented in support of the objection in the event that 
a hearing is held. Failure to include

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such a description and analysis for any particular objection shall 
constitute a waiver of the right to a hearing on the objection. Three 
copies of all documents shall be submitted and shall be identified with 
the docket number found in brackets in the heading of this document. 
Any objections received in response to the order may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: September 17, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-25588 Filed 9-25-97; 8:45 am]
BILLING CODE 4160-01-F