[Federal Register Volume 59, Number 10 (Friday, January 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-897]
[[Page Unknown]]
[Federal Register: January 14, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 176
[Docket No. 92F-0056]
Indirect Food Additives: Paper and Paperboard Components
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 expand the safe use of aromatic petroleum
hydrocarbon resin hydrogenated, as a component of wax polymer blend
coatings for paper and paperboard in contact with fatty foods. This
action responds to a food additive petition filed by Arakawa Chemical
Industries, Ltd.
DATES: Effective on January 14, 1994; written objections and requests
for a hearing by February 14, 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: Andrew J. Zajac, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-254-9500.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of March 17, 1992 (57 FR 9260), FDA announced that a food
additive petition (FAP 2B4315) had been filed by Arakawa Chemical
Industries, Ltd., c/o 1001 G St. NW., suite 500 West, Washington, DC
20001. The petition proposed that Sec. 176.170 Components of paper and
paperboard in contact with aqueous and fatty foods (21 CFR 176.170) be
amended to provide for the safe use of hydrogenated aromatic petroleum
hydrocarbon resin in coatings on paper and paperboard in contact with
fatty foods.
FDA has evaluated data in the petition and other relevant material
and concludes that the proposed expanded use of the additive is safe.
The agency further concludes that Sec. 176.170 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 February 14, 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 176
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 176 is amended as follows:
PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
1. The authority citation for 21 CFR part 176 continues to read as
follows:
Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).
2. Section 176.170 is amended in the table in paragraph (a)(5) by
revising the entry for ``Aromatic petroleum hydrocarbon resin,
hydrogenated (CAS Reg. No. 88526-47-0)'' to read as follows:
Sec. 176.170 Components of paper and paperboard in contact with
aqueous and fatty foods.
* * * * *
(a) * * *
(5) * * *
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List of Substances Limitations
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Aromatic petroleum hydrocarbon For use only as modifiers in wax
resin, hydrogenated (CAS Reg. No. polymer blend coatings for paper
88526-47-0), produced by the and paperboard at a level not to
catalytic polymerization of exceed 50 weight-percent of the
aromatic substituted olefins from coating solids under conditions
low boiling distillates of cracked of use E, F, and G identified in
petroleum stocks with a boiling Table 2 of paragraph (c) of this
point no greater than 220 deg.C section.
(428 deg.F), and the subsequent
catalytic reduction of the
resulting aromatic petroleum
hydrocarbon resin. The resin meets
the following specifications:
softening point 85 deg.C (185
deg.F) minimum, as determined by
ASTM Method E 28-67 (Reapproved
1982), ``Standard Test Method for
Softening Point by Ring-and-Ball
Apparatus,'' and aniline point 70
deg.C (158 deg.F) minimum, as
determined by ASTM Method D 611-82,
``Standard Test Methods for Aniline
Point and Mixed Aniline Point of
Petroleum Products and Hydrocarbon
Solvents,'' which are incorporated
by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51.
Copies may be obtained from the
American Society for Testing and
Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be
examined at the Office of the
Federal Register, 800 North Capitol
Street, NW., suite 700, Washington,
DC.
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Dated: January 4, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-897 Filed 1-13-94; 8:45 am]
BILLING CODE 4160-01-F
