[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