[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,
[[Page 50618]]
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
[[Page 50619]]
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