[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.325]

[Page 134-135]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION--Table of Contents
 
                   Subpart D--Specific Usage Additives
 
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)(1) The additive is used as an antimicrobial agent in poultry 
processing water in accordance with current industry practice under the 
following conditions:
    (i) As a component of a carcass spray or dip solution prior to 
immersion of the intact carcass in a prechiller or chiller tank;
    (ii) In a prechiller or chiller solution for application to the 
intact carcass;
    (iii) As a component of a spray or dip solution for application to 
poultry carcass parts;
    (iv) In a prechiller or chiller solution for application to poultry 
carcass parts; or
    (v) As a component of a post-chill carcass spray or dip solution 
when applied to poultry meat, organs, or related parts or trim.
    (2) When used in a 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 a 
level sufficient to achieve a solution pH of 2.3 to 2.9.
    (3) When used in a prechiller or chiller solution, 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 accordance 
with current industry practice in the processing of red meat, red meat 
parts, and organs as a component of a spray or in the processing of red 
meat parts and organs as a component of a dip. Applied as a dip or 
spray, the additive is used at levels that result in sodium chlorite 
concentrations between 500 and 1,200 ppm in combination with any GRAS 
acid at levels sufficient to achieve a solution pH of 2.5 to 2.9.
    (d) The additive is used as an antimicrobial agent in water and ice 
that are used to rinse, wash, thaw, transport, or store seafood in 
accordance with current industry standards of good manufacturing 
practice. The additive is produced by mixing an aqueous solution of 
sodium chlorite with any GRAS acid to achieve a pH in the range of 2.5 
to 2.9 and diluting this solution with water to achieve an actual use 
concentration of 40 to 50 parts per million (ppm) sodium chlorite. Any 
seafood that is intended to be consumed raw shall be subjected to a 
potable water rinse prior to consumption.
    (e) The additive is used as an antimicrobial agent on raw 
agricultural commodities in the preparing, packing, or holding of the 
food for commercial purposes, consistent with section 201(q)(1)(B)(i) of 
the act, and not applied for use under section 201(q)(1)(B)(i)(I), 
(q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act, in accordance with 
current industry standards of good manufacturing practice. Applied as a 
dip or a spray, the additive is used at levels that result in chlorite 
concentrations of 500 to 1200 parts per million (ppm), in combination 
with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9. 
Treatment of the raw agricultural commodities with acidified sodium 
chlorite solutions shall be followed by a potable water

[[Page 135]]

rinse, or by blanching, cooking, or canning.
    (f) The additive is used as an antimicrobial agent on processed, 
comminuted or formed meat food products (unless precluded by standards 
of identity in 9 CFR part 319) prior to packaging of the food for 
commercial purposes, in accordance with current industry standards of 
good manufacturing practice. Applied as a dip or spray, the additive is 
used at levels that result in sodium chlorite concentrations of 500 to 
1200 ppm, in combination with any GRAS acid at levels sufficient to 
achieve a pH of 2.5 to 2.9.
    (g) 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, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, 200 C St. SW., Washington, DC 20204-
0001, or the Office of the Federal Register, 800 North Capitol St. NW., 
Suite 700, Washington, DC.

[61 FR 17829, Apr. 23, 1996, as amended at 63 FR 11119, Mar. 6, 1998; 64 
FR 44123, Aug. 13, 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, Jan. 
12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR 22922, May 7, 2001; 66 FR 
31841, June 13, 2001]