[Federal Register Volume 63, Number 44 (Friday, March 6, 1998)]
[Rules and Regulations]
[Pages 11118-11119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5073]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. 97F-0038]
Secondary Direct Food Additives Permitted in Food for Human
Consumption
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of acidified solutions
of sodium chlorite as an antimicrobial agent in the processing of red
meat. This action is in response to a petition filed by Alcide Corp.
DATES: This regulation is effective March 6, 1998; written objections
and requests for a hearing by April 6, 1998. The Director of the Office
of the Federal Register approves the incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain
publications in Sec. 173.325(d) (21 CFR 173.325(d)), effective March 6,
1998.
ADDRESSES: Written objections may be sent to the Dockets Management
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420
Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Robert L. Martin, Center for Food
Safety and Applied Nutrition (HFS-217), Food and Drug Administration,
200 C St. SW., Washington, DC 20204-0001, 202-418-3074.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of February 5, 1997 (62 FR 5428), FDA announced that a food
additive petition (FAP 7A4532) had been filed by Alcide Corp., Inc.,
8561 154th Ave. NE., Redmond, WA 98052, proposing that the food
additive regulations be amended to provide for the safe use of
acidified sodium chlorite solutions for red meat disinfection in
processing plants. In its evaluation of the petition, the agency has
concluded that red meat is not disinfected, but that the microbial
contamination of the meat is reduced. Therefore, the agency is
approving this additive as an antimicrobial agent in red meat
processing.
FDA has evaluated data in the petition and other relevant material.
The agency has also consulted with scientists from the Food Safety and
Inspection Service, U. S. Department of Agriculture, concerning the
technological and practical aspects of the proposed use of acidified
sodium chlorite solutions. Based upon this information and
consultation, the agency concludes that the proposed use of the
additive is safe, and the additive will have the intended technical
effect of reducing microbial contamination on red meat. Therefore,
Sec. 173.325 is being amended as set forth below. Additionally, the
agency is revising Sec. 173.325 to eliminate redundancy. This revision
is strictly editorial and is not a substantive change in the
regulation.
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person
[[Page 11119]]
listed above. As provided in Sec. 171.1(h), the agency will delete from
the documents any materials that are not available for public
disclosure before making the documents available for inspection.
In the notice of filing, FDA gave interested parties an opportunity
to submit comments on the petitioner's environmental assessment. FDA
received no comments in response to that notice.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
Any person who will be adversely affected by this regulation may at
any time on or before April 6, 1998, file with the Dockets Management
Branch (address above) written objections thereto. Each objection shall
be separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and 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 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 regulation may be seen in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 173
Food additives, Incorporation by reference.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 173 is amended as follows:
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION
1. The authority citation for 21 CFR part 173 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348.
2. Section 173.325 is amended by revising paragraph (b) and adding
paragraphs (c) and (d) to read as follows:
Sec. 173.325 Acidified sodium chlorite solutions.
* * * * *
(b) The additive is used as an antimicrobial agent in poultry
processing water as a component of a carcass spray or dip solution
prior to immersion of the carcass in a prechiller or chiller tank, or
in a prechiller or chiller solution in accordance with current industry
practice for use of poultry process water.
(1) When used in a carcass spray or dip solution, the additive is
used at levels that result in sodium chlorite concentrations between
500 and 1,200 parts per million (ppm), in combination with any GRAS
acid at levels sufficient to achieve a solution pH of 2.5 to 2.9.
(2) When used in a prechiller or chiller tank, the additive is used
at levels that result in sodium chlorite concentrations between 50 and
150 ppm, in combination with any GRAS acid at levels sufficient to
achieve a solution pH of 2.8 to 3.2.
(c) The additive is used as an antimicrobial agent in the
processing of red meat as a component of a carcass spray in accordance
with current industry practice. In the carcass spray, the additive is
used at levels that result in sodium chlorite concentrations between
500 and 1,200 parts per million (ppm) in combination with any GRAS acid
at levels sufficient to achieve a solution pH of 2.5 to 2.9.
(d) The concentration of sodium chlorite is determined by a method
entitled ``Determination of Sodium Chlorite: 50 ppm to 1500 ppm
Concentration,'' September 13, 1995, developed by Alcide Corp.,
Redmond, WA, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Division
of Petition Control (HFS-215), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC
20204-0001, or may be examined at the Center for Food Safety and
Applied Nutrition's Library, 200 C St. SW., rm. 3321, Washington, DC
20204-0001, or the Office of the Federal Register, 800 North Capitol
St. NW., suite 700, Washington, DC.
Dated: February 27, 1998
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-5073 Filed 3-5-98; 8:45 am]
BILLING CODE 4160-01-F
