[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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