[Federal Register Volume 64, Number 153 (Tuesday, August 10, 1999)]
[Notices]
[Pages 43387-43388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20487]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Gerard T. O'Brien; Denial, Response to Objections

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; order denying objection.

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SUMMARY: The Food and Drug Administration (FDA) is denying an objection 
to the agency's denial of 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 objector did not request a hearing, and 
thus waives the right to such a hearing.

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 of 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 the Federal Register of 
September 26, 1997 (62 FR 50617), FDA published an order denying this 
petition, in accordance with Sec. 171.100(a) (21 CFR 171.100(a)), 
because FDA concluded that the petition did not contain sufficient data 
and information to allow the agency to determine either that the food 
additive is safe for its proposed use or that the additive will have 
its intended technical effect.
    In its denial, the agency explained that the petitioner had 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, and that the 
petitioner had failed to provide data and information on whether 
oxidative effects of hydrogen peroxide would occur on poultry as a 
result of the proposed use. FDA noted that the agency had requested 
certain data from the petitioner on several occasions during its review 
of the petition, including laboratory data to demonstrate that there is 
reduced bacterial contamination on poultry processed with hydrogen 
peroxide and sodium bicarbonate, TBA (2-thiobarbituric acid) values (an 
indicator of oxidation) in skin/fat and meat from processed poultry, 
and a basis to estimate the amount of hydrogen peroxide that reacts 
with poultry during the proposed treatment. Because the petitioner 
failed to provide these data and information, FDA did not have a 
sufficient basis to determine whether the food additive would achieve 
its intended technical effect or was safe for the intended use. 
Accordingly, FDA denied the petition.
    Under Sec. 171.110 of the food additive regulations, objections and 
requests for a hearing are governed by part 12 (21 CFR part 12) of 
FDA's regulations. Section 12.22(a) sets forth the conditions that each 
objection must meet for filing. Section 12.22(a) provides that each 
objection must: (1) Be submitted on or before the 30th day after the 
date of publication of the final rule; (2) be separately numbered; (3) 
specify with particularity the provision of the order objected to; (4) 
state whether a hearing is requested; and (5) for each objection for 
which a hearing is requested, include a detailed description of the 
factual information to be presented in support of the objection. 
Failure to include a description and analysis for an objection 
constitutes a waiver of the right to a hearing on that objection.
    In response to the agency's denial of FAP 7A4530, the petitioner, 
on October 22, 1997, submitted material within the 30-day objection 
period challenging the denial. The petitioner submitted, as its 
objection, references to three complaints filed in various legal 
proceedings in Federal court. Such complaints were filed before the 
date of the agency's denial of the petition, and therefore, were not 
written in response to the agency's denial, but were submitted as 
``objections.'' A copy of one of the referenced complaints, filed on 
August 25, 1997, in the U.S. District Court for the Northern District 
of Georgia, was included in the submission. In addition,

[[Page 43388]]

the petitioner submitted a copy of the agency's September 26, 1997, 
order that had been annotated (apparently by the petitioner) with words 
and statements that asserted that FDA's findings were wrong. The 
petitioner provided no explanation for its assertions.
    FDA has reviewed the material submitted by the petitioner. The 
submitted material is not in the form that is required for the filing 
of objections under Sec. 12.22(a). Although the petitioner submitted 
material that he characterized as ``objections,'' he failed to identify 
the specific provisions of the agency's order to which he objected. 
Further, the petitioner did not request a hearing for any ``objection'' 
and therefore, waived the right to a hearing under Sec. 12.22(a)(4). 
Even if the agency assumed that the petitioner, in his submission, made 
an implicit request for a hearing, the petitioner did not provide a 
detailed description and analysis of the factual information to be 
presented in support of each of his objections, as required under 
Sec. 12.22(a)(5). Therefore, the material submitted did not meet the 
conditions for filing objections under Sec. 12.22(a).
    Moreover, even if the petitioner's submission is assumed to be an 
objection that meets the requirements of filing and contains an 
implicit request for a hearing, the petitioner has not met the 
requirements for the grant of a request for a hearing under 
Sec. 12.24(b). Specifically, the petitioner has not identified any 
genuine and substantial issue of fact for resolution at a hearing 
(Sec. 12.24(b)(1)). The petitioner has not provided a factual basis for 
why the data and information that FDA requested, but that were not 
provided in the petition, are not necessary in order for the agency to 
determine whether the proposed use of the food additive is safe, or to 
determine that the proposed use of the additive will achieve its 
intended technical effect. The petitioner merely asserted that the 
agency's determination was wrong, but failed to provide a basis for 
this assertion. Furthermore, because the petitioner did not provide a 
detailed description and analysis of the specific factual information 
intended to be presented in support of any objection, the agency will 
not use its discretion under Sec. 12.30(b) to order a hearing.
    In summary, the petitioner alleges no misapplication of the law by 
FDA in the agency's order of denial. Moreover, the petitioner has 
provided the agency with no genuine or substantial issue of fact that 
could form the basis for FDA to reconsider its decision denying FAP 
7A4530. Furthermore, the petitioner's submission provides no basis for 
granting a hearing because no such request was made, and even if such a 
request is implied, the petitioner did not include specifically 
identified reliable evidence that could lead to resolution of any 
factual issue in dispute. A hearing will not be granted on the basis of 
mere allegations or denials, or general descriptions of positions and 
contentions (Sec. 12.24(b)(2)). Therefore, in accordance with 
Secs. 12.28 and 12.30(b), FDA is denying in its entirety the 
petitioner's objection to the agency's order denying FAP 7A4530.

    Dated: August 3, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-20487 Filed 8-9-99; 8:45 am]
BILLING CODE 4160-01-F