[Federal Register Volume 60, Number 149 (Thursday, August 3, 1995)]
[Rules and Regulations]
[Page 39645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19152]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 94F-0090]


Indirect Food Additives: Adhesives and Components of Coatings

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 broadened specifications for congealing 
point and oil content for synthetic paraffinic waxes produced by the 
Fischer-Tropsch process so that the specifications for synthetic 
paraffin waxes more closely resemble specifications for other synthetic 
waxes permitted for use in food packaging under other regulations. This 
action is in response to a petition filed by Shell Oil Co.

DATES: Effective August 3, 1995; written objections and requests for a 
hearing September 5, 1995.

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: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-216), 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 18, 1994 (59 FR 18412), FDA announced that a food 
additive petition (FAP 4B4416) had been filed by Shell Oil Co., One 
Shell Plaza, P.O. Box 4320, Houston, TX 77210. The petition proposed to 
amend the food additive regulations in Sec. 175.250 Paraffin 
(synthetic) (21 CFR 175.250) to incorporate broadened specifications 
for congealing point and oil content for synthetic paraffinic waxes 
produced by the Fischer-Tropsch process, so that the specifications for 
synthetic paraffin waxes more closely resemble specifications for other 
synthetic paraffin waxes permitted for use in food packaging under 
other regulations.
     FDA has evaluated data in the petition and other relevant 
material. The agency concludes that the proposed use of the additive is 
safe and that Sec. 175.250 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 September 5, 1995, 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 175

    Adhesives, 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 175 is amended as follows:

PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF 
COATINGS

     1. The authority citation for 21 CFR part 175 continues to read as 
follows:

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

Sec. 175.250  [Amended]

    2. Section 175.250 Paraffin (synthetic) is amended in paragraph (a) 
in the third sentence by adding the words ``may be'' after the word 
``and'', in paragraph (b)(1) in the first sentence by removing ``93 
deg.C'' and adding in its place ``50  deg.C'', and in paragraph (b)(2) 
in the first sentence by removing ``0.5 percent'' and adding in its 
place ``2.5 percent.''

    Dated: July 22, 1995.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 95-19152 Filed 8-2-95; 8:45 am]
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