Food additives: Adjuvants, production aids, and sanitizers undecane,
[Federal Register: November 23, 1999 (Volume 64, Number 225)]
[Rules and Regulations]
[Page 65657-65658]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no99-3]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98F-0825]
Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the food additive regulations to expand the safe use of 3,9-bis[2,4-bis(1- methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9- diphosphaspiro[5.5]undecane, which may contain not more than 2 percent by weight of triisopropanolamine, as an antioxidant and/or stabilizer for polymers intended for use in contact with food. This action responds to a petition filedby Dover Chemical Corp.
DATES: This regulation is effective November 23, 1999. Submit written objections and requests for a hearing by December 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: Andrew J. Zajac, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3095.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of October 6, 1998 (63 FR 53679), FDA announced that a food additive petition (FAP 8B4627) had been filedby Dover Chemical Corp., 3676 Davis Rd. NW., Dover, OH 44622. The petition proposed to amend the food additive regulations in Sec. 178.2010 Antioxidants and/or stabilizer for polymers (21 CFR 178.2010) to expand the safe use of 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9- diphosphaspiro[5.5]undecane, which may contain not more than 2 percent by weight of triisopropanolamine, as an antioxidant and/or stabilizer for polymers 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 therefore, (3) the regulations in Sec. 178.2010 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. The agency has previously considered the environmental effects of this rule as announced in the notice of filing for FAP 8B4627 (63 FR 53679). 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 December 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 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 178
Food additives, Food packaging.
[[Page 65658]]
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 178 is amended as follows:
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
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The authority citation for 21 CFR part 178 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348, 379e. 2. Section 178.2010 is amended in the table in paragraph (b) by revising the entry for ``3,9-bis[2,4-bis(1-methyl-1- phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9- diphosphaspiro[5.5]undecane'' under the headings ``Substances'' and ``Limitations'' to read as follows:
Sec. 178.2010 Antioxidants and/or stabilizers for polymers.
* * * * * (b) * * *
Substances
Limitations
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* 3,9-Bis[2,4-bis(1-methyl-1-
For use only: phenylethyl)phenoxy]-2,4,8,10- 1. At levels not to exceed 0.15 tetraoxa-3,9-
percent by weight of all polymers, diphosphaspiro[5.5]undecane (CAS except as specified below. Reg. No. 154862-43-8), which may 2. At levels not to exceed 0.2 contain not more than 2 percent by percent by weight of polycarbonate weight of triisopropanolamine (CAS resins complying with Sec. Reg. No. 122-20-3).
177.1580 of this chapter. 3. At levels not to exceed 0.3 percent by weight of polyetherimide resins complying with Sec. 177.1595 of this chapter.
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Dated: October 28, 1999. L. Robert Lake, Director, Office of Policy, Planning and Strategic Initiatives, Center for Food Safety and Applied Nutrition.
[FR Doc. 99-30523Filed11-22-99; 8:45 am]
BILLING CODE 4160-01-F
