[Federal Register Volume 61, Number 227 (Friday, November 22, 1996)]
[Rules and Regulations]
[Pages 59330-59331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29874]
[[Page 59330]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 95F-0365]
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/pentene-1
copolymers containing not less than 90 percent of polymer units derived
from ethylene as components of articles intended for use in contact
with food. This action is in response to a petition filed by Sasol
Alpha Olefins.
DATES: Effective November 22, 1996; written objections and requests for
a hearing by December 23, 1996.
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: Daniel N. Harrison, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3084.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of November 15, 1995 (60 FR 57434), FDA announced that a food
additive petition (FAP 5B4482) had been filed by Sasol Alpha Olefins,
P.O. Box 5486, Johannesburg 2000, Republic of South Africa. 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/pentene-1 copolymers containing not less than 90
percent of polymer units derived from ethylene as components of
articles intended for use in contact with food.
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that the proposed food
additive use is safe, that it will achieve its intended technical
effect, and therefore, 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 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 December 23, 1996, 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)(a)(3), and in the table in paragraph (c) by revising item
3.1a and by adding a new item 3.1c to read as follows:
Sec. 177.1520 Olefin polymers.
* * * * *
(a) * * *
(3) * * *
(i) * * *
(a) * * *
(3) Olefin basic copolymers manufactured by the catalytic
copolymerization of ethylene and pentene-1 shall contain not less than
90 weight-percent of polymer units derived from ethylene.
* * * * *
(c) * * *
[[Page 59331]]
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Maximum
extractable Maximum soluble
fraction fraction
Melting point (expressed as (expressed as
Olefin (MP) or percent by percent by
polymers Density softening point weight of weight of
(SP) (Degrees polymer) in N- polymer) in
Centigrade) hexane at xylene at
specified specified
temperatures temperatures
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* * * *
* * *
3.1a Olefin 0.85-1.0 ........... 5.5 pct at 50 C 30 pct at 25 C
copolymers 0
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)(
a)(3) of
this
section
and listed
in item
3.1c of
this table
and olefin
copolymers
described
in
paragraph
(a)(3)(i)(
e) of this
section
and listed
in item
3.1b of
this
table.
* * * *
* * *
3.1c Olefin Not less ........... ...........
copolymers than
described 0.92
in
paragraph
(a)(3)(i)(
a)(3) of
this
section
for use in
contact
with food
only under
conditions
of use B,
C, D, E,
F, G, and
H
described
in Sec.
176.170(c)
of this
chapter,
Table 2;
except
that such
copolymers
when used
in contact
with food
of the
types
identified
in Sec.
176.170(c)
, Table 1,
under
types III,
IVA, V,
VIIA, and
IX, shall
be used
only under
conditions
of use D,
E, F, and
G
described
in Sec.
176.170(c)
of this
chapter,
Table 2.
* * * *
* * *
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* * * * *
Dated: November 18, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-29874 Filed 11-21-96; 8:45 am]
BILLING CODE 4160-01-F