[Federal Register Volume 65, Number 60 (Tuesday, March 28, 2000)]
[Rules and Regulations]
[Page 16312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7536]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 99F-5523]


Secondary Direct Food Additives Permitted in Food for Human 
Consumption

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of acidified sodium 
chlorite solutions as an antimicrobial agent on poultry carcass parts. 
This action is in response to a petition filed by Alcide Corp.

DATES: This rule is effective March 28, 2000. Submit written objections 
and requests for a hearing by April 27, 2000.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert L. Martin, Center for Food 
Safety and Applied Nutrition (HFS-215), 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 January 6, 2000 (65 FR 782), FDA announced that a food 
additive petition (FAP 0A4705) had been filed by Alcide Corp., 8561 
154th Ave. NE., Redmond, WA 98052. The petition proposed to amend the 
food additive regulation in Sec. 173.325 (21 CFR 173.325) to provide 
for the safe use of acidified sodium chlorite solutions as an 
antimicrobial agent on poultry carcass parts.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that: (1) The proposed 
use of the additive is safe, (2) the additive will achieve its intended 
technical effect, and, therefore, (3) the regulation in Sec. 173.325 
should be 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 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, 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.
    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (address above) 
written objections by April 27, 2000. 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 are to be 
submitted and are to 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 21 CFR Part 173

    Food additives.

    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) to read as 
follows:


Sec. 173.325  Acidified sodium chlorite solutions.

* * * * *
    (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; or
    (iv) In a prechiller or chiller solution for application to poultry 
carcass parts.
    (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.
* * * * *

    Dated: March 20, 2000.
L. Robert Lake
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-7536 Filed 3-27-00; 8:45 am]
BILLING CODE 4160-01-F