[Federal Register Volume 64, Number 226 (Wednesday, November 24, 1999)]
[Rules and Regulations]
[Pages 66103-66104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30569]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F-1170]


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 2-methyl-4,6-bis-
[(octylthio)methyl] phenol as a stabilizer for repeat use rubber 
articles. This action is in response to a petition filed by Ciba 
Specialty Chemicals Corp.

DATES: This regulation is effective November 24, 1999. Submit written 
objections and requests for a hearing by December 27, 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: Mark A. Hepp, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3098.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of May 6, 1999 (64 FR 24407), FDA announced that a food 
additive petition (FAP 9B4660) 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. 178.2010 Antioxidants and/or stabilizers for 
polymers (21 CFR 178.2010) to provide for the safe use of 2-methyl-4,6-
bis-[(octylthio)methyl] phenol as a stabilizer for repeat use rubber 
articles.
    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 as a stabilizer for repeat use rubber articles 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 9B4660 (64 FR 
24407, May 6, 1999). 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 December 27, 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

[[Page 66104]]

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 178.2010 is amended in the table in paragraph (b) by 
revising the entry for ``2-methyl-4,6-bis-[(octylthio)methyl] phenol'' 
in item ``4.'' under the heading ``Limitations'' to read as follows:

Sec. 178.2010   Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

 
------------------------------------------------------------------------
             Substances                          Limitations
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
2-Methyl-4,6-bis-                    For use only:
 [(octylthio)methyl] phenol (CAS     * * *
 Reg. No. 110553-27-0)               4. At levels not to exceed 1.7
                                      percent by weight of the finished
                                      rubber products complying with
                                      Sec.  177.2600 of this chapter.
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------


    Dated: October 22, 1999.
L. Robert Lake,
Director, Office of Policy, Planning, and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-30569 Filed 11-23-99; 8:45 am]
BILLING CODE 4160-01-F