[Federal Register Volume 59, Number 46 (Wednesday, March 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5321]


[[Page Unknown]]

[Federal Register: March 9, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 85F-0176]

 

Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Synthetic Petroleum Wax

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 synthetic petroleum 
wax prepared by copolymerization of ethylene with linear (C3 to 
C12) alpha-olefins in or on food. This action is in response to a 
petition filed by Petrolite Corp.

DATES: Effective March 9, 1994; written objections and requests for a 
hearing by April 8, 1994.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Aydin Orstan, Center for Food Safety 
and Applied Nutrition (HFS-217), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-254-9515.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of May 17, 1985 (50 FR 20625), FDA announced that a food 
additive petition (FAP 5A3849) had been filed by Petrolite Corp., 369 
Marshall Ave., St. Louis, MO 63119-1897, proposing that Sec. 172.888 
Synthetic petroleum wax (21 CFR 172.888) be amended to provide for the 
safe use in or on food of synthetic petroleum wax prepared by 
copolymerization of ethylene with higher alpha olefins.
    FDA has evaluated the data in the petition and other relevant 
material and concludes that the proposed food additive is more 
accurately described as synthetic petroleum wax prepared by 
copolymerization of ethylene with linear (C3 to C12) alpha-
olefins. The agency also concludes that the proposed food use of this 
additive is safe and that Sec. 172.888 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 21 CFR 
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 carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    Any person who will be adversely affected by this regulation may at 
any time on or before April 8, 1994, 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 172

    Food additives, Reporting and recordkeeping requirements.

    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 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

    1. The authority citation for 21 CFR part 172 continues to read as 
follows:

    Authority: Secs. 201, 401, 402, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 
379e).

    2. Section 172.888 is amended by revising paragraph (a) to read as 
follows:


Sec. 172.888  Synthetic petroleum wax.

* * * * *
    (a) Synthetic petroleum wax is a mixture of solid hydrocarbons, 
paraffinic in nature, prepared by either catalytic polymerization of 
ethylene or copolymerization of ethylene with linear (C3 to 
C12) alpha-olefins, and refined to meet the specifications 
prescribed in this section.
* * * * *

    Dated: February 25, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-5321 Filed 3-8-94; 8:45 am]
BILLING CODE 4160-01-F