[Federal Register Volume 59, Number 164 (Thursday, August 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20984]
[[Page Unknown]]
[Federal Register: August 25, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 92F-0327]
Indirect Food Additives: Polymers
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 an aromatic
petroleum hydrocarbon resin, hydrogenated, as a component of
polypropylene intended for food-contact use. This action is in response
to a petition filed by Arakawa Chemical Industries, Ltd.
DATES: Effective August 25, 1994; written objections and requests for a
hearing by September 26, 1994. The Director of the Office of the
Federal Register approves the incorporations by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in 21
CFR 177.1520(b), effective August 25, 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: Julius Smith, 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 September 22, 1992 (57 FR 43740), FDA announced that a food
additive petition (FAP 2B4338) had been filed by Arakawa Chemical
Industries, Ltd., c/o 1001 G St. NW., suite 500 West, Washington, DC
20001. The petition proposed that the food additive regulations be
amended to provide for the safe use of an aromatic petroleum
hydrocarbon resin, hydrogenated, as a component of polypropylene
intended for food-contact use.
FDA has evaluated the data in the petition and other relevant
material and concludes that the proposed use of the food additive in
polypropylene articles in contact with food is safe. The agency has
also concluded that the additive will have the intended technical
effect, and that, therefore, Sec. 177.1520 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 26, 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 177
Food additives, Food packaging, Incorporation by reference.
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 177 is amended as follows:
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS
1. The authority citation for 21 CFR part 177 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).
2. Section 177.1520 is amended in the table in paragraph (b) by
alphabetically adding a new entry under the headings ``Substance'' and
``Limitations'' to read as follows:
Sec. 177.1520 Olefin polymers.
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(b) * * *
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Substance Limitations
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Aromatic petroleum hydrocarbon resin, For use only as an adjuvant at
hydrogenated (CAS Reg. No. 88526-47- levels not to exceed 25 percent
0), produced by the catalytic by weight in blends with
polymerization of aromatic- polypropylene complying with
substituted olefins from distillates paragraph (c), item 1.1 of this
of cracked petroleum stocks with a section. The finished polymer
boiling point no greater than 220 may be used in contact with food
deg.C (428 deg.F), and the Types I, II, IV-B, VI-A through
subsequent catalytic hydrogenation VI-C, VII-B, and VIII identified
of the resulting aromatic petroleum in Table 1 of Sec. 176.170(c) of
hydrocarbon resin, having a minimum this chapter and under
softening point of 110 deg.C (230 conditions of use B through H
deg.F), as determined by ASTM Method described in Table 2 of Sec.
E 28-67 (Reapproved 1982), 176.170(c) of this chapter; and
``Standard Test Method for Softening with food Types III, IV-A, V,
Point by Ring-and-Ball Apparatus,'' VII-A, and IX identified in
and a minimum aniline point of 107 Table 1 of Sec. 176.170(c) of
deg.C (225 deg.F), as determined by this chapter and under
ASTM Method D 611-82, ``Standard conditions of use D through G
Test Methods for Aniline Point and described in Table 2 of Sec.
Mixed Aniline Point of Petroleum 176.170(c) of this chapter.
Products and Hydrocarbon Solvents,''
both of which are incorporated by
reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51.
Copies are available from the
American Society for Testing and
Materials, 1916 Race St.,
Philadelphia, PA 19103, or from the
Division of Petition Control, Center
for Food Safety and Applied
Nutrition (HFS-216), Food and Drug
Administration, 200 C St. SW.,
Washington, DC 20204, or may be
examined at the Office of the
Federal Register, 800 North Capitol
St. NW., suite 700, Washington, DC.
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Dated: August 18, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-20984 Filed 8-24-94; 8:45 am]
BILLING CODE 4160-01-F