[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: 94-5320]
[[Page Unknown]]
[Federal Register: March 9, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 177
[Docket No. 88F-0199]
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 ethylene-octene
copolymers, ethylene-octene-hexene copolymers, ethylene-octene-butene
copolymers, ethylene-octene-propylene copolymers, and ethylene-octene-
4-methylpentene-1 copolymers, which contain not less than 80 weight
percent of polymer units derived from ethylene, as articles or
components of articles for use in contact with food. This action is in
response to a petition filed by the Dow Chemical Co.
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.
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, 202-254-9500.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of June 24, 1988 (53 FR 23798), FDA announced that a food
additive petition (FAP 8B4091) had been filed by the Dow Chemical Co.,
1803 Bldg., Door 7, Midland, MI 48674, proposing that the food additive
regulations be amended in Sec. 177.1520 Olefin polymers (21 CFR
177.1520) to provide for the safe use of ethylene-octene copolymers,
ethylene-octene-hexene copolymers, ethylene-octene-butene copolymers,
ethylene-octene-propylene copolymers, and ethylene-octene-4-
methylpentene-1 copolymers, which contain not less than 75 weight
percent of polymer units derived from ethylene, as articles or
components of articles for use in contact with food.
The notice stated that the copolymers, which are the subject of
this action, would contain not less than 75 weight percent of polymer
units derived from ethylene. Upon review of the data presented in the
petition and subsequent amendments, FDA determines that the subject
copolymers should contain not less than 80 weight percent of polymer
units derived from ethylene. The attached order reflects this change.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that the proposed use of the additives is safe and
that the regulations in 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 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 177
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 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 by adding a new paragraph
(a)(3)(i)(e), and in the table in paragraph (c) by redesignating
item``3.1'' in the first column as item ``3.1a'' and revising it, and
by adding a new item ``3.1b'' to read as follows:
Sec. 177.1520 Olefin polymers.
* * * * *
(a) * * *
(3) * * *
(i) * * *
(e) Olefin basic copolymers manufactured by the catalytic
polymerization of ethylene and octene-1, or ethylene, octene-1, and
either hexene-1, butene-1, propylene, or 4-methylpentene-1 shall
contain not less than 80 weight percent of polymer units derived from
ethylene.
* * * * *
(c) * * *
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Maximum extractable Maximum soluble
fraction (expressed fraction (expressed
Melting point (MP) or as percent by weight as percent by weight
Olefin Polymers Density softening point (SP) of polymer) in N- of polymer) in
(Degrees Centigrade) hexane at specified xylene at specified
temperatures temperatures
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*******
3.1a Olefin 0.85-1.00............ ..................... 5.5 pct at 50 deg. C. 30 pct at 25 deg. C
copolymers described
in paragraph
(a)(3)(i) of this
section for use in
articles that
contact food except
for articles used
for packing or
holding food during
cooking; except
olefin copolymers
described in
paragraph
(a)(3)(i)(e) of this
section and listed
in item 3.1b of this
table.
3.1b Olefin 0.9-1.00............. ..................... Do................... Do.
copolymers described
in paragraph
(a)(3)(i)(e) of this
section for use in
contact with food
only under
conditions of use D,
E, F, G, and H
described in Sec.
176.170(c) of this
chapter, Table 2.
*******
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* * * * *
Dated: February 28, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-5320 Filed 3-8-94; 8:45 am]
BILLING CODE 4160-01-F