[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]


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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.

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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) * * *

 
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             Substances                          Limitations
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  *                    *                    *                    *
                   *                    *                    *
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.
  *                    *                    *                    *
                   *                    *                    *
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* * * * *

    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