Source: https://www.federalregister.gov/documents/2005/02/14/05-2808/secondary-direct-food-additives-permitted-in-food-for-human-consumption
Timestamp: 2018-02-25 00:46:54
Document Index: 766634488

Matched Legal Cases: ['art 51', 'art 51', '§\u2009173', '§\u2009173', '§\u2009173', '§\u2009173', '§\u2009173', '§\u2009171', '§\u2009171', 'art\n2', '§\u2009173', 'art 51']

A Rule by the Food and Drug Administration on 02/14/2005
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.
7394-7396 (3 pages)
Docket No. 2003F-0535
VI. Objection and Hearing Requests
https://www.federalregister.gov/d/05-2808 https://www.federalregister.gov/d/05-2808
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.
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 § 173.300 (21 CFR 173.300) as of February 14, 2005.
You may submit written objections and requests for a hearing, identified by Docket No. 2003F-0535, by any of the following methods:
E-mail: fdadockets@oc.fda.gov. Include Docket No. 2003F-0535 in the subject line of your e-mail message.
Start Printed Page 7395
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 § 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.
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 § 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 § 173.300 should be amended as set forth below.
Based on a request by the petitioner, the FDA is also updating § 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.
In accordance with § 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 § 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.
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.
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.
End Authority Start Printed Page 7396 Start Amendment Part
2. Section 173.300 is amended by revising paragraphs (a) and (b) to read as follows:
§ 173.300
(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.
[FR Doc. 05-2808 Filed 2-11-05; 8:45 am]