[Federal Register Volume 64, Number 245 (Wednesday, December 22, 1999)]
[Rules and Regulations]
[Pages 71639-71640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33095]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F-2534]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of di(n-
octyl)phosphite as an extreme pressure-antiwear adjuvant for lubricants 
intended for incidental contact with food. This action responds to a 
petition filed by Ciba Specialty Chemicals Corp.

DATES: Effective December 22, 1999. Submit written objections and 
requests for a hearing by January 21, 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 August 9, 1999 (64 FR 43190), FDA announced that a food 
additive petition (FAP 9B4683) had been filed by Ciba Specialty 
Chemicals Corp., 540 White Plains Rd., P.O. Box 2005, Tarrytown, NY 
10591-9005. The petition proposed to amend the food additive 
regulations in Sec. 178.3570 Lubricants with incidental food contact 
(21 CFR 178.3570) to provide for the safe use of di(n-octyl)phosphite 
as an extreme pressure-antiwear adjuvant for lubricants intended for 
incidental contact with food.
     FDA has evaluated 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. 178.3570 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 9B4683 (64 FR 
43190). 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 collection 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 January 21, 2000, 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.
     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.

     1. The authority citation for 21 CFR part 178 continues to read as 
follows:
    Authority: 21 U.S.C. 321, 342, 348, 379e.
     2. Section 178.3570 is amended in the table in paragraph (a)(3) by 
alphabetically adding an entry under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 178.3570   Lubricants with incidental food contact.

* * * * *
     (a) * * *
     (3) * * *

 
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             Substances                          Limitations
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  *                    *                    *                    *
                   *                    *                    *
 Di (n-octyl) phosphite (CAS Reg.     For use only as an extreme
 No. 1809-14-9).                      pressure-antiwear adjuvant at a
                                      level not to exceed 0.5 percent by
                                      weight of the lubricant.
  *                    *                    *                    *
                   *                    *                    *
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[[Page 71640]]

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    Dated: December 8, 1999.
L. Robert Lake,
Director, Office of Policy, Planning, and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-33095 Filed 12-21-99; 8:45 am]
BILLING CODE 4160-01-F