[Federal Register Volume 66, Number 114 (Wednesday, June 13, 2001)]
[Rules and Regulations]
[Pages 31840-31841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14811]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 00F-1488]


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 processed, comminuted 
or formed meat food products (unless precluded by United States 
Department of Agriculture's standards of identity) prior to packaging 
of the food for commercial purposes in accordance with current industry 
standards of good manufacturing practice. This action is in response to 
a petition filed by Alcide Corp.

DATES: This rule is effective June 13, 2001. Submit written objections 
and requests for a hearing by July 13, 2001.

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, 
Washington, DC 20204-0001, 202-418-3074.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of September 11, 2000 (65 FR 54855), FDA announced that a food 
additive petition (FAP 0A4724 ) had been filed by Alcide Corp., 8561 
154th Ave. NE., Redmond, WA 98052. The petition proposed to amend the 
food additive regulations in Sec. 173.325 Acidified sodium chlorite 
solutions (21 CFR 173.325) to provide for the safe use of acidified 
sodium chlorite solutions as an antimicrobial agent on processed, 
comminuted, or formed meat food products prior to packaging of the 
food.
    FDA has evaluated data in the petition and other relevant material. 
FDA is approving the use of acidified sodium chlorite solutions on 
processed, comminuted or formed meat food products, unless such use is 
precluded by standards of identity in 9 CFR part 319, prior to 
packaging of the food for commercial purposes. For example, this 
acidified sodium chlorite solution is not permitted to be added to 
ground beef under 9 CFR 319.15. 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 file with the Dockets Management Branch (address above) 
written objections by July 13, 2001. 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:

[[Page 31841]]

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 redesignating paragraph (f) as 
paragraph (g) and by adding new paragraph (f) to read as follows:


Sec. 173.325  Acidified sodium chlorite solutions.

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

    Dated: June 5, 2001.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 01-14811 Filed 6-12-01; 8:45 am]
BILLING CODE 4160-01-S