[Federal Register Volume 70, Number 29 (Monday, February 14, 2005)]
[Rules and Regulations]
[Pages 7394-7396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 2003F-0535]


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 permit the manufacture of chlorine dioxide by 
electrolysis of an aqueous solution of sodium chlorite. This action is 
in response to a petition filed by Vulcan Chemicals.

DATES: This rule is effective February 14, 2005. Submit written or 
electronic objections and requests for a hearing by March 16, 2005. See 
section VI of this document for information on the filing of 
objections. The Director of the Office of the Federal Register approves 
the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51 of certain publications in Sec.  173.300 (21 CFR 173.300) 
as of February 14, 2005.

ADDRESSES: You may submit written objections and requests for a 
hearing, identified by Docket No. 2003F-0535, by any of the following 
methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: [email protected]. Include Docket No. 2003F-
0535 in the subject line of your e-mail message.

[[Page 7395]]

     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All objections received will be 
posted without change to http://www.fda.gov/ohrms/dockets/default.htm, 
including any personal information provided. For detailed instructions 
on submitting objections, see the ``Objections'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul C. DeLeo, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1302.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of December 1, 2003 
(68 FR 67195), FDA announced that a food additive petition (FAP 4A4751) 
had been filed by Vulcan Chemicals, P.O. Box 385015, Birmingham, AL 
35238-5015. The petition proposed to amend the food additive 
regulations in Sec.  173.300 Chlorine dioxide (21 CFR 173.300) to 
provide for an additional method for producing the additive, 
specifically, treating an aqueous solution of sodium chlorite by 
electrolysis.
    In the notice of filing, the agency announced that it was placing 
the environmental assessment on display at the Division of Dockets 
Management for public review and comment. FDA did not receive any 
comments addressing the potential environmental effects of the proposed 
change to the regulation. As discussed below, the agency has determined 
that this action will not have a significant impact on the human 
environment and that an environmental impact statement is not required.

II. Conclusion

    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that chlorine dioxide 
generated by electrolysis of an aqueous solution of sodium chlorite is 
equivalent to the chlorine dioxide generated by the currently-approved 
methods as described in Sec.  173.300 (Ref. 1). In addition, the 
chlorine dioxide generated by the electrolytic process will have the 
same intended technical effect and use as the chlorine dioxide produced 
by the currently-approved methods. Consequently, there will be no 
change in the exposure to chlorine dioxide from the petitioned use. 
Therefore, FDA concludes that Sec.  173.300 should be amended as set 
forth below.
    Based on a request by the petitioner, the FDA is also updating 
Sec.  173.300 by citing the 20th edition of the method that is 
incorporated by reference rather than the 18th edition. Section 173.300 
currently incorporates by reference Method 4500-ClO2 E in 
the ``Standard Methods for the Examination of Water and Wastewater,'' 
18th ed., 1992. The agency compared the 18th and 20th editions of this 
method and found them to be identical. Therefore, the agency is making 
this requested editorial change.

III. Public Disclosure

    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 in this document. 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.

IV. Environmental Impact

    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 Division 
of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Paperwork Reduction Act of 1995

    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.

VI. Objection and Hearing Requests

    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (see ADDRESSES) written 
objections by (see DATES). 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 Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

VII. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Memorandum from H. Lee, FDA Division of Petition Review, 
Chemistry Review Group, to P. DeLeo, FDA, Division of Petition 
Review, Regulatory Group I, March 17, 2004.

List of Subjects in 21 CFR Part 173

    Food additives, Incorporation by reference.

0
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

0
1. The authority citation for 21 CFR part 173 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348.

[[Page 7396]]


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2. Section 173.300 is amended by revising paragraphs (a) and (b) to 
read as follows:


Sec.  173.300  Chlorine dioxide.

* * * * *
    (a)(1) The additive is generated by one of the following methods:
    (i) Treating an aqueous solution of sodium chlorite with either 
chlorine gas or a mixture of sodium hypochlorite and hydrochloric acid.
    (ii) Treating an aqueous solution of sodium chlorate with hydrogen 
peroxide in the presence of sulfuric acid.
    (iii) Treating an aqueous solution of sodium chlorite by 
electrolysis.
    (2) The generator effluent contains at least 90 percent (by weight) 
of chlorine dioxide with respect to all chlorine species as determined 
by Method 4500-ClO2 E in the ``Standard Methods for the 
Examination of Water and Wastewater,'' 20th ed., 1998, or an equivalent 
method. Method 4500-ClO2 E (``Amperometric Method II'') is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. You may obtain a copy from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or the American Public Health 
Association, 800 I St. NW., Washington, DC 20001-3750. You may inspect 
a copy at the Center for Food Safety and Applied Nutrition's Library, 
5100 Paint Branch Pkwy., College Park, MD, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (b)(1) The additive may be used as an antimicrobial agent in water 
used in poultry processing in an amount not to exceed 3 parts per 
million (ppm) residual chlorine dioxide as determined by Method 4500-
ClO2 E, referenced in paragraph (a)(2) of this section, or 
an equivalent method.
    (2) The additive may be used as an antimicrobial agent in water 
used to wash fruits and vegetables that are not raw agricultural 
commodities in an amount not to exceed 3 ppm residual chlorine dioxide 
as determined by Method 4500-ClO2 E, referenced in paragraph 
(a)(2) of this section, or an equivalent method. Treatment of the 
fruits and vegetables with chlorine dioxide shall be followed by a 
potable water rinse or by blanching, cooking, or canning.

    Dated: January 28, 2005.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 05-2808 Filed 2-11-05; 8:45 am]
BILLING CODE 4160-01-S