[Federal Register Volume 65, Number 8 (Wednesday, January 12, 2000)]
[Rules and Regulations]
[Page 1776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-691]



[[Page 1776]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 99F-2907]


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 sodium 
chlorite solutions as an antimicrobial agent on red meat parts and 
organs. This action is in response to a petition filed by Alcide Corp.

DATES: This rule is effective January 12, 2000; written objections and 
requests for a hearing by February 11, 2000.

ADDRESSES: Written objections may be sent 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 August 30, 1999 (64 FR 47193), FDA announced that a food 
additive petition (FAP 9A4692) had been filed by Alcide Corp., 8561 
154th Ave. NE., Redmond, WA 98052. The petition proposed to amend the 
food additive regulation in 21 CFR 173.325 (Sec. 173.325) to provide 
for the safe use of acidified sodium chlorite solutions as an 
antimicrobial agent on red meat parts and organs.
     FDA has evaluated data in the petition and other relevant 
material. Based on this information, the agency concludes that the 
proposed use of the additive is safe, that the additive will achieve 
its intended technical effect, and therefore, that 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 on or before February 11, 2000, 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 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 in 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 (c) to read as 
follows:


Sec.  173.325   Acidified sodium chlorite solutions.

* * * * *
     (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.
* * * * *

    Dated: December 30, 1999.
Janice F. Oliver,
Deputy Director for Operations, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-691 Filed 1-11-00; 8:45 am]
BILLING CODE 4160-01-F