[Federal Register Volume 64, Number 169 (Wednesday, September 1, 1999)]
[Rules and Regulations]
[Pages 47669-47670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22679]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 99F-0994]
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 provide for the safe use of phosphorothioic
acid, O,O,O-triphenyl ester, tert-butyl derivatives, as extreme
pressure-antiwear adjuvants for lubricants intended for incidental
contact with food. This action responds to a petition filed by Ciba
Specialty Chemicals Corp.
DATES: This regulation is effective September 1, 1999; submit written
objections and requests for a hearing by October 1, 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: 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 April 27, 1999 (64 FR 22615), FDA announced that a food
additive petition (FAP 9B4657) had been filed by Ciba Specialty
Chemical 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 phosphorothioic acid,
O,O,O-triphenyl ester, tert-butyl derivatives, as extreme pressure-
antiwear adjuvants for lubricants intended for incidental contact with
food.
[[Page 47670]]
The filing notice for the petition (64 FR 22615) stated that the
action resulting from the petition qualified for a categorical
exclusion under 21 CFR 25.32(i). This was a misprint. The correct
citation is 21 CFR 25.32(j). The agency reviewed the claim and
concluded that the exclusion listed in 21 CFR 25.32(j) applies.
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 final rule under 21 CFR 25.32(j), as stated above. 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 October 1, 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 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) * * *
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
* * * *
* * *
Phosphorothioic acid, O,O,O- For use only as an extreme pressure-
triphenyl ester, tert-butyl antiwear adjuvant at a level not
derivatives (CAS Reg. No. 192268- to exceed 0.5 percent by weight of
65-8). the lubricant.
* * * *
* * *
------------------------------------------------------------------------
* * * * *
Dated: August 20, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 99-22679 Filed 8-31-99; 8:45 am]
BILLING CODE 4160-01-F
