[Federal Register Volume 61, Number 79 (Tuesday, April 23, 1996)]
[Rules and Regulations]
[Pages 17828-17829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9783]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 94F-0358]


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 in poultry processing water. This action is in 
response to a petition filed by Alcide Corp.

DATES: Effective April 23, 1996; written objections and requests for a 
hearing by May 23, 1996. 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 listed in new 
Sec. 173.325, effective April 23, 1996.

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: 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 November 1, 1994 (59 FR 54609), FDA announced that a food 
additive petition (FAP 4A4433) 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 solutions of sodium chlorite/chlorous acid in poultry 
processing water.
    FDA has evaluated data in the petition and other relevant material 
and has consulted with scientists in the Food Safety and Inspection 
Service in the U.S. Department of Agriculture concerning the 
technological and practical aspects of the proposed use of acidified 
solutions of sodium chlorite. The agency concludes that the proposed 
use of the additive is safe and will have the intended technical effect 
of reducing microbial contamination on poultry. The agency also 
concludes that the regulation approving the additive should be entitled 
``acidified sodium chlorite solutions.'' Acidification of sodium 
chlorite results in partial conversion of chlorite to chlorous acid. 
Also, in the notice of filing, FDA announced that the petition proposed 
to allow the use of any of the following acids to prepare acidified 
sodium chlorite solutions: Phosphoric acid, citric acid, hydrochloric 
acid, lactic acid, malic acid, or sulfuric acid. These acids are all 
generally recognized as safe (GRAS) acids. The agency has concluded 
that the use of any GRAS acid is appropriate, and is codifying this 
conclusion in the regulation. Therefore, 21 CFR part 173 is amended as 
set forth below.
    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

[[Page 17829]]

approve the petition are available for inspection at the Center for 
Food Safety and Applied Nutrition by appointment with the information 
contact person 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 for this petition 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 May 23, 1996, 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, 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: Secs. 201, 402, 409 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348).

    2. New Sec. 173.325 is added to subpart D to read as follows:


Sec. 173.325  Acidified sodium chlorite solutions.

    Acidified sodium chlorite solutions may be safely used in 
accordance with the following prescribed conditions:
    (a) The additive is produced by mixing an aqueous solution of 
sodium chlorite (CAS Reg. No. 7758-19-2) with any generally recognized 
as safe (GRAS) acid.
    (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 processing 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. The 
concentration of sodium chlorite is determined by a method entitled 
``Determination of Sodium Chlorite: 50 ppm to 1500 ppm Concentration,'' 
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, Food and Drug Administration, 200 C St. SW., rm. 3321, 
Washington, DC, or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC.
    (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. The concentration of sodium 
chlorite is determined by a method entitled ``Determination of Sodium 
Chlorite: 50 ppm to 1500 ppm Concentration,'' which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The 
availability of this method is listed in paragraph (b)(1) of this 
section.

    Dated: April 11, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-9783 Filed 4-22-96; 8:45 am]
BILLING CODE 4160-01-F