[Federal Register Volume 64, Number 171 (Friday, September 3, 1999)]
[Rules and Regulations]
[Pages 48292-48293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23000]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 98F-0893]


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 siloxanes and 
silicones, methyl hydrogen, reaction products with 2,2,6,6-tetramethyl-
4-(2-propenyloxy)piperidine as an ultraviolet (UV) stabilizer for 
polypropylene intended for use in contact with food. This action 
responds to a petition filed by Great Lakes Chemical Corp.

DATES: This regulation is effective September 3, 1999. Submit written 
objections and requests for a hearing by October 4, 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 October 21, 1998 (63 FR 56197), FDA announced that a food 
additive petition (FAP 8B4633) had been filed by Great Lakes Chemical 
Corp., c/o Keller and Heckman LLP, 1001 G St. NW., suite 500 West, 
Washington, DC 20001. 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 siloxanes and 
silicones, methyl hydrogen, reaction products with 2,2,6,6-tetramethyl-
4-(2-propenyloxy)piperidine as a UV stabilizer for high density 
polyethylene and polypropylene intended for use in contact with food.
    The petition was subsequently amended to request the use of the 
additive only in polypropylene, at a maximum level of use of 0.33 
percent by weight of the polymer. Because the request to amend the 
petition is for a use that is within the scope of the filing notice of 
October 21, 1998, the agency determined that an amended filing notice 
was not required. Accordingly, the regulation in this document provides 
for the amended clearance sought by the petitioner.
    FDA has evaluated the 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. 178.2010 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 8B4633 (63 FR 
56197). 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 4, 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

[[Page 48293]]

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 
alphabetically adding an entry under the headings ``Substances'' and 
``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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  *                    *                    *                    *
                   *                    *                    *
Siloxanes and silicones, methyl      For use as an ultraviolet (UV)
 hydrogen, reaction products with     stabilizer only at levels not to
 2,2,6,6-tetramethyl-4-(2-            exceed 0.33 percent by weight of
 propenyloxy)piperidine (CAS Reg.     polypropylene complying with Sec.
 No. 182635-99-0).                    177.1520(c) of this chapter, items
                                      1.1a, 1.1b, 1.2, and 1.3, under
                                      conditions of use D, E, F, and G,
                                      as described in Table 2 of Sec.
                                      176.170 of this chapter.
  *                    *                    *                    *
                   *                    *                    *
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    Dated: August 26, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-23000 Filed 9-2-99; 8:45 am]
BILLING CODE 4160-01-F