[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
