[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