[Federal Register: August 24, 1999 (Volume 64, Number 163)] [Rules and Regulations] [Page 46129-46130] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr24au99-8] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 176 [Docket No. 96F-0145] Indirect Food Additives: Paper and Paperboard Components 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 tetrakis(hydroxymethyl)phosphonium sulfate (CAS Reg. No. 55566-30-8) as a slimicide for use in the manufacture of paper and paperboard that contact food. This action responds to a petition filed by Albright & Wilson, Ltd. DATES: This regulation is effective August 24, 1999; submit written objections and requests for a hearing by September 23, 1999. 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: Vivian M. Gilliam, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3094. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of May 20, 1996 (61 FR 25228), FDA announced that a food additive petition (FAP 5B4472) had been filed by Albright & Wilson, Ltd., c/o Delta Analytical Corp., 7910 Woodmont Ave., suite 1000, Bethesda, MD 20814. The petition proposed to amend the food additive regulations in Sec. 176.300 Slimicides (21 CFR 176.300) to provide for the safe use of tetrakis(hydroxymethyl)phosphonium sulfate as a slimicide in the manufacture of paper and paperboard intended to contact food. Albright and Wilson, Ltd. is currently represented by Lewis & Harrison, 122 C St. NW., suite 740, Washington, DC 20001. (Formerly represented by Delta Analytical Corp., 7910 Woodmont Ave., suite 1000, Bethesda, MD 20814.) When the petition was filed on May 20, 1996, it contained an environmental assessment (EA). In the notice of filing, the agency announced that it was placing the EA on display at the Dockets Management Branch for public review and comment (61 FR 25228). No comments were received. On July 29, 1997 (62 FR 40569), FDA published revised regulations under part 25 (21 CFR part 25), which became effective on August 28, 1997. On January 7, 1999, the petitioner submitted a claim of categorical exclusion under new Sec. 25.32(q), in accordance with the procedures in Sec. 25.15(a) and (d). Because the agency had not completed its review of the earlier submitted EA, the agency reviewed the claim of categorical exclusion under Sec. 25.32(q) for the final rule and has determined that this action is a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an EA nor an environmental impact statement is required. FDA has evaluated data in the petition and other relevant material. Based on this information, the agency concludes that: (1) The proposed use of tetrakis(hydroxymethyl)phosphonium sulfate as a slimicide in the manufacture of paper and paperboard that contact food is safe; (2) the additive will achieve its intended technical effect; and therefore,(3) the regulation in Sec. 176.300(c) 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. This final rule contains no collections 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 September 23, 1999, 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 [[Page 46130]] 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 shall be submitted and shall 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 176 Food additives, Food packaging. 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 176 is amended as follows: PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS 1. The authority citation for 21 CFR part 176 continues to read as follows: Authority: 21 U.S.C. 321, 342, 346, 348, 379e. 2. Section 176.300 is amended by alphabetically adding an entry to the table in paragraph (c) to read as follows: Sec. 176.300 Slimicides. * * * * * (c) * * * ------------------------------------------------------------------------ List of Substances Limitations ------------------------------------------------------------------------ * * * * * * * Tetrakis(hydroxymethyl)phosphonium Maximum use level of 84 mg/kg in sulfate (CAS Reg. No. 55566-30-8) the pulp slurry. The additive may also be added to water, which when introduced into the pulp slurry, results in a concentration in the pulp slurry not to exceed 84 mg/ kg. * * * * * * * ------------------------------------------------------------------------ * * * * * Dated: August 12, 1999. L. Robert Lake, Director, Office of Policy, Planning and Strategic Initiatives, Center for Food Safety and Applied Nutrition. [FR Doc. 99-21851 Filed 8-23-99; 8:45 am] BILLING CODE 4160-01-F