[Federal Register Volume 63, Number 28 (Wednesday, February 11, 1998)]
[Rules and Regulations]
[Pages 6852-6854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3357]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 97F-0181]
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 change the melting point range for propylene
homopolymers, intended for use in contact with food, from 160-180
deg.C to 150-180 deg.C. This action is in response to a petition filed
by Exxon Chemical Co.
DATES: The regulation is effective February 11, 1998; written
objections and requests for a hearing by March 13, 1998.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Mark A. Hepp, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3098.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of May 16, 1997 (62 FR 27060), FDA announced that a food
additive petition (FAP 7B4544) had been filed by Exxon Chemical Co.,
P.O. Box 3272, Houston, TX 77253-3272. The petition proposed to amend
the food additive regulations in Sec. 177.1520 Olefin polymers (21 CFR
177.1520), to change the melting point range for propylene polymers,
intended for use in contact with food, from 160-180 deg.C to 150-180
deg.C. However, the petitioner submitted data and information to
support a proposed change in the melting point range from 160-180
deg.C to 150-180 deg.C for propylene homopolymers prepared from
metallocene catalysts. Therefore, FDA considered a change in the
melting point only for propylene homopolymers prepared from metallocene
catalysts.
In the Federal Register of May 16, 1997 (62 FR 27060), the filing
notice for the petition stated that the action resulting from the
petition qualified for a categorical exclusion under previous 21 CFR
25.24(9). This was a misprint and should have cited 21 CFR 25.24(a)(9).
Upon further review, the agency determined that such a
[[Page 6853]]
categorical exclusion, which is based on a technical change in a
regulation, is not appropriate for this action because the proposed
amendment is not simply a technical change. Consequently, the agency
considered the environmental effects of this action.
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency determined that the petitioner
has adequately demonstrated that propylene homopolymers manufactured by
the catalytic polymerization of propylene with a metallocene catalyst,
and with a melting point range between 150 deg.C and 180 deg.C,
conform to the identity and specifications for polypropylene under
Sec. 177.1520, in item 1.1(a) in the table in paragraph (c) (previously
item 1.1), except for the melting point range specification. Thus, the
agency concludes that: (1) The proposed use of the additive is safe,
(2) the additive will achieve its intended technical effect, and (3)
the regulations in Sec. 177.1520 should be amended as set forth in this
document.
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 previously. 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.
Any person who will be adversely affected by this regulation may at
any time on or before March 13, 1998, 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 by redesignating paragraph (a)(1) as
paragraph (a)(1)(i), by adding paragraph (a)(1)(ii), and in the table
in paragraph (c) by redesignating item 1.1 as item 1.1a, and by
revising newly redesignated item 1.1a, and by adding item 1.1b to read
as follows:
Sec. 177.1520 Olefin polymers.
* * * * *
(a) * * *
(1) * * *
(ii) Propylene homopolymer consists of basic polymers manufactured
by the catalytic polymerization of propylene with a metallocene
catalyst.
* * * * *
(c) * * *
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Maximum
extractable Maximum soluble
fraction fraction
Melting Point (MP) (expressed as (expressed as
or softening point percent by percent by weight
Olefin polymers Density (SP) (Degrees weight of the of polymer) in
Centigrade) polymer) in N- xylene at
hexane at specified
specified temperatures
temperatures
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1.1a Polypropylene described in 0.880-0.913 MP: 160-180 C..... 6.4 pct at 9.8 pct at 25 C
paragraph (a)(1)(i) of this reflux
section temperature.
1.1b Propylene homopolymer 0.880-0.913 MP: 150-180 C..... 6.4 pct at 9.8 pct at 25 C
described in paragraph (a)(1)(ii) reflux
of this section temperature.
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[[Page 6854]]
* * * * *
Dated: January 30, 1998.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and
Applied Nutrition.
[FR Doc. 98-3357 Filed 2-10-98; 8:45 am]
BILLING CODE 4160-01-F
