Food additives: Imidazolium compounds,
[Federal Register: June 12, 2000 (Volume 65, Number 113)]
[Rules and Regulations]
[Page 36786-36787]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jn00-4]
[[Page 36786]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 176
[Docket No. 99F-1581]
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 imidazolium compounds, 2-(C17and C17-unsaturated alkyl)-1-
[2-(C18and C18-unsaturated amido)ethyl] -4,5- dihydro-1-methyl, methyl sulfates as a debonding agent in the manufacture of paper and paperboard intended for use in contact with aqueous and fatty food and in contact with dry food. This action is in response to a petition filedby Witco Corp.
DATES: This rule is effective June 12, 2000. Submit written objections and requests for a hearing by July 12, 2000.
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: 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.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of June 4, 1999 (64 FR 30038), FDA announced that a food additive petition (FAP 9B4669) had been filedby Witco Corp., One American Lane, Greenwich, CT 06831-2559. The petition proposed to amend the food additive regulations in Sec. 176.170 Components of paper and paperboard in contact with aqueous and fatty foods (21 CFR 176.170) and Sec. 176.180 Components of paper and paperboard in contact with dry food (21 CFR 176.180) to provide for the safe use of imidazolium compounds, 2-(C17and C17-unsaturated alkyl)-[2- (C18and C18-unsaturated amido)ethyl]-4,5- dihydro-1-methyl, methyl sulfates as a debonding agent in the manufacture of paper intended for use in contact with food. The name of the additive was incorrect in the June 4, 1999, notice, but is being used correctly as imidazolium compounds, 2-(C17and C17-unsaturated alkyl)-1-[2-(C18and C18-unsaturated amido)ethyl]-4,5-dihydro-1-methyl, methyl sulfates in this document.
FDA has evaluated data in the petition and other relevant material. Based on this information, the agency concludes that the proposed use of the additive is safe, that the additive will achieve its intended technical effect, and therefore, that the regulations in Secs. 176.170 and 176.180 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 carefully considered the environmental effects of this rule as announced in the notice of filing for the petition. 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 file with the Dockets Management Branch (address above) written objections by July 12, 2000. 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.
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
-
The authority citation for 21 CFR part 176 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 346, 348, 379e.
-
Section 176.170 is amended in the table in paragraph (a)(5) by alphabetically adding an entry under the headings ``List of substances'' and ``Limitations'' to read as follows:
Sec. 176.170 Components of paper and paperboard in contact with aqueous and fatty foods.
* * * * *
(a) * * *
(5) * * *
List of substances
Limitations
*
*
*
* *
*
* Imidazolium compounds, 2-(C17and For use only at a level not to C17-unsaturated alkyl)-1-[2-(C18exceed 0.5 percent by weight of and C18-unsaturated amido)ethyl]- the dry paper and paperboard. 4,5-dihydro-1-methyl, methyl sulfates (CAS Reg. No. 72749-55- 4).
*
*
*
* *
*
*
[[Page 36787]]
* * * * *
-
Section 176.180 is amended in the table in paragraph (b)(2) by alphabetically adding an entry under the headings ``List of substances'' and ``Limitations'' to read as follows:
Sec. 176.180 Components of paper and paperboard in contact with dry food.
* * * * *
(b) * * *
(2) * * *
List of substances
Limitations
*
*
*
* *
*
* Imidazolium compounds, 2-(C17and For use only at levels not to C17-unsaturated alkyl)-1-[2-(C18exceed 0.5 percent by weight of and C18-unsaturated amido)ethyl]- the dry paper and paperboard. 4,5-dihydro-1-methyl, methyl sulfates (CAS Reg. No. 72749-55- 4).
*
*
*
* *
*
*
Dated: May 31, 2000. L. Robert Lake, Director of Regulations and Policy, Center for Food Safety and Applied Nutrition.
[FR Doc. 00-14700Filed6-9-00; 8:45 am]
BILLING CODE 4160-01-F
