[Federal Register Volume 63, Number 202 (Tuesday, October 20, 1998)]
[Rules and Regulations]
[Pages 55944-55945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27992]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 98F-0292]


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 expanded safe use of 2-methyl-
4,6-bis[(octylthio)methyl]phenol intended for use in food-contact 
applications. This action is in response to a petition filed by Ciba 
Specialty Chemicals Corp.

DATES: The regulation is effective October 20, 1998; submit written 
objections and requests for a hearing by November 19, 1998.

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 May 11, 1998 (63 FR 25864), FDA announced that a food 
additive petition (FAP 8B4594) had been filed by Ciba Specialty 
Chemicals Corp., 540 White Plains Rd., 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 expanded safe use of 2-methyl-4,6-bis-
[(octylthio)methyl]phenol as a stabilizer for rubber-modified 
polystyrene complying with 21 CFR 177.1640 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 the 
proposed use of the additive is safe, that the additive will achieve 
its intended technical effect, and therefore, that 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 potential 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 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 November 19, 1998, 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 178.2010 is amended in the table in paragraph (b) by 
revising the entry for ``2-methyl-4,6-bis[(octylthio)methyl]phenol'' in 
item ``5.'' under the heading ``Limitations'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

[[Page 55945]]



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                       Substances                                              Limitations
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  *                    *                    *                    *                    *                    *
                                                             *
2-Methyl-4,6-bis[(octylthio)methyl]phenol (CAS Reg. No.  For use only:
 110553-27-0).                                           * * *
                                                         5. At levels not to exceed 0.1 percent by weight of
                                                          petroleum alicyclic hydrocarbon resins complying with
                                                          Sec.  175.320 of this chapter; rubber-modified
                                                          polystyrene complying with Sec.  177.1640 of this
                                                          chapter; and petroleum hydrocarbon resins and rosins
                                                          and rosin derivatives complying with Sec.  178.3800 of
                                                          this chapter.
  *                    *                    *                    *                    *                    *
                                                             *
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    Dated: October 9, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-27992 Filed 10-19-98; 8:45 am]
BILLING CODE 4160-01-F