[Federal Register Volume 65, Number 105 (Wednesday, May 31, 2000)]
[Rules and Regulations]
[Pages 34587-34588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13477]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 00F-0786]


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 chlorine dioxide 
produced by treating an aqueous solution of sodium chlorite with 
hydrogen peroxide in the presence of sulfuric acid. This action is in 
response to a petition filed by Eka Chemicals, Inc.

DATES: This rule is effective May 31, 2000. Submit written objections 
and requests for a hearing by June 30, 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 March 2, 2000 (65 FR 11319), FDA announced that a food 
additive petition (FAP 0A4716) had been filed by Eka Chemicals, Inc., 
c/o Keller and Heckman LLP, 1001 G St. NW., suite 500 West, Washington, 
DC 20001. The petition proposed to amend the food additive regulations 
in Sec. 173.300 Chlorine dioxide (21 CFR 173.300) to provide for the 
safe use of chlorine dioxide produced by treating an aqueous solution 
of sodium chlorite with hydrogen peroxide in the presence of sulfuric 
acid.
    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. 173.300 
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 June 30, 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 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 173.300 is amended by revising paragraph (a) to read as 
follows:


Sec. 173.300  Chlorine dioxide.

* * * * *
    (a) The additive is generated by one of the following methods: 
Treating an aqueous solution of sodium chlorite with either chlorine 
gas or a mixture of sodium hypochlorite and hydrochloric acid, or 
treating an aqueous solution of sodium chlorate with hydrogen peroxide 
in the presence of sulfuric acid. In either case, the generator 
effluent contains at least 90 percent (by weight) of chlorine dioxide 
with respect to all chlorine species as determined by Method 4500-
ClO<INF>2</INF> E in the ``Standard Methods for the Examination of 
Water and Wastewater,'' 18th ed., 1992, or an equivalent method. Method 
4500-ClO<INF>2</INF> E is incorporated by reference in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center 
for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204-0001, and the 
American Public Health Association, 1015 Fifteenth St. NW., Washington, 
DC 20005, or may be examined at the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC.
* * * * *


[[Page 34588]]


    Dated: May 19, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-13477 Filed 5-30-00; 8:45 am]
BILLING CODE 4160-01-F