[Federal Register Volume 64, Number 44 (Monday, March 8, 1999)]
[Rules and Regulations]
[Pages 10943-10944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5520]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 97F-0412]
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/propylene
copolymers that contain up to 20 mole-percent of polymer units derived
from propylene, with the remainder of the polymer consisting of
ethylene, and having a minimum viscosity-average molecular weight of
95,000 and a minimum Mooney viscosity of 13, at up to 30 percent in
blends with regulated polyolefins intended for contact with foods. This
action responds to a petition filed by Mitsui Petrochemical Industries,
Ltd.
DATES: The regulation is effective March 8, 1999; written objections
and requests for a hearing by April 7, 1999.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Hortense S. Macon, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3086.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of October 6, 1997 (62 FR 52136), FDA announced that a food
additive petition (FAP 7B4549) had been filed by Mitsui Petrochemical
Industries, Ltd., c/o Keller and Heckman LLP, 1001 G St. NW., suite 500
West, Washington, DC 20001. The petition proposed to amend the food
additive regulations in Sec. 177.1520 Olefin polymers (21 CFR 177.1520)
to provide for the safe use of ethylene/propylene copolymers that
contain up to 20 mole-percent of polymer units derived from propylene,
with the remainder of the polymer consisting of ethylene, and having a
minimum viscosity-average molecular weight of 95,000 and a minimum
Mooney viscosity of 13, at up to 30 percent of other regulated polymer
blends intended for contact with food.
FDA has evaluated data in the petition and other relevant
material. Based on this information, the agency concludes that: (1) The
proposed use of the additive is safe, (2) the additive will achieve its
intended technical effect, and therefore, (3) 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 Sec. 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.
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
Any person who will be adversely affected by this regulation may at
any time on or before April 7, 1999, 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: 21 U.S.C. 321, 342, 348, 379e.
2. Section 177.1520 is amended in the table in paragraph (c) by
adding an item 3.7 to read as follows:
Sec. 177.1520 Olefin polymers.
* * * * *
(c)* * *
[[Page 10944]]
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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 the polymer) in N- of polymer) in
(Degrees Centigrade) hexane at specified xylene at specified
temperatures temperatures
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* * * * *
3.7 Ethylene/ Not less than 0.86
propylene
copolymers, meeting
the identity
described in
paragraph (a)(3)(i)
of this section,
containing not less
than 80 mole-percent
of polymer units
derived from
ethylene and having
a minimum viscosity
average molecular
weight of 95,000 as
determined by the
method described in
paragraph (d)(5) of
this section, and a
minimum Mooney
viscosity of 13 as
determined by the
method described in
paragraph (d)(6) of
this section.
Ethylene/propylene
copolymers described
in this item 3.7 are
to be used only in
blends with other
olefin polymers
complying with this
section, at levels
not to exceed 30
percent by weight of
the total polymer
blend, and in
contact with food
only of types
identified in Sec.
176.170(c) of this
chapter, Table 1,
under Types I, II,
III, IV-B, VI, VII,
VIII, and IX.
Additionally,
optional adjuvants
permitted for use in
olefin copolymers
complying with item
3.4 of this table
may be used in the
production of this
copolymer.
* * * * *
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* * * * *
Dated: February 23, 1999.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and
Applied Nutrition.
[FR Doc. 99-5520 Filed 3-5-99; 8:45 am]
BILLING CODE 4160-01-F