[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]
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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.
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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) * * *
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Substances Limitations
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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.
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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