Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acid-catalyzed condensation reaction products of branched 4-nonylphenol, formaldehyde, and 1-dodecanethiol for use as an antioxidant in adhesives, pressure-sensitive adhesives, and repeated-use rubber articles intended for use in contact with food. This action is in response to a petition filed by Goodyear Tire & Rubber Co.
This rule is effective May 5, 2000. Submit written objections and requests for a hearing by June 5, 2000.
Submit written objections to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Vir D. Anand, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3081.End Further Info End Preamble Start Supplemental Information
In a notice published in the Federal Register of December 2, 1999 (64 FR 67575), FDA announced that a food additive petition (FAP 0B4703) had been filed by Goodyear Tire & Rubber Co., 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 § 178.2010 Antioxidants and/or stabilizers for polymers (21 CFR 178.2010) to provide for the safe use of acid-catalyzed condensation reaction products of branched 4-nonylphenol, formaldehyde, and 1-dodecanethiol for use as an antioxidant in adhesives, pressure-sensitive adhesives, and repeated-use rubber articles intended for use in contact with food.
FDA has evaluated the data in the petition and other relevant material. Based on this information, the agency concludes that: (1) The proposed use of the additive is safe, (2) the additive will achieve its intended technical effect, and (3) that the regulations in § 178.2010 should be amended as set forth below.
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 above. 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.
The agency has previously considered the environmental effects of this rule as announced in the notice of filing for FAP 0B4703 (64 FR 67575). No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.
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 June 5, 2000, file with the Dockets Management Branch (address above) written objection 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 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.Start List of Subjects
List of Subjects in 21 CFR Part 178End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. Section 178.2010 is amended in the table in paragraph (b) by revising the entry for “Alkylthiophenolics” to read as follows:End Amendment Part
(b) * * * Start Printed Page 26130
|* * * * * * *|
|Alkylthiophenolics:||For use only:|
|1. Acid-catalyzed condensation reaction products of 4-nonylphenol, formaldehyde, and 1-dodecanethiol (CAS Reg. No. 164907-73-7).||1. At levels not to exceed 2 percent by weight of adhesives complying with § 175.105 of this chapter, of pressure-sensitive adhesives complying with § 175.125 of this chapter, and of rubber articles complying with § 177.2600 of this chapter.|
|2. Acid-catalyzed condensation reaction products of branched 4-nonylphenol, formaldehyde, and 1-dodecanethiol (CAS Reg. No. 203742-97-6).||2. Do.|
|* * * * * * *|
Dated: April 25, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied Nutrition.
[FR Doc. 00-11201 Filed 5-4-00; 8:45 am]
BILLING CODE 4160-01-F