[Federal Register Volume 63, Number 102 (Thursday, May 28, 1998)]
[Rules and Regulations]
[Pages 29135-29136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14104]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 96F-0489]
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 5,7-bis(1,1-
dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, reaction products with o-
xylene, as an antioxidant and/or stabilizer for olefin polymers
intended for use in contact with food. This action responds to a
petition filed by Ciba Specialty Chemicals Corp.
DATES: The regulation is effective May 28, 1998. Submit written
objections and request for a hearing by June 29, 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: Hortense S. Macon, Center for Food
Safety and Applied Nutrition (HFS-206), 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 January 2, 1997 (62 FR 100), FDA announced that a food
additive petition (FAP 7B4529) had been filed by Ciba Specialty
Chemicals Corp., 540 White Plains Rd., Tarrytown, NY 10591-9005. The
petition proposed to amend the food additive regulations in
Sec. 178.2010 Antioxidants and/or stabilizers for polymers (21 CFR
178.2010) to provide for the safe use of 5,7-bis(1,1-dimethylethyl-3-
hydroxy-2(3H)-benzofuranone, reaction products with o-xylene as an
antioxidant and/or stabilizer for olefin polymers 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: (1) The proposed
use of the additive is safe, (2) the food additive will achieve its
intended technical effect, and therefore, (3) the regulations in
Sec. 178.2010 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 June 29, 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 178
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 178 is amended as follows:
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
1. The authority citation for 21 CFR part 178 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
2. Section 178.2010 is amended in the table in paragraph (b) by
alphabetically adding an entry to read as follows:
Sec. 178.2010 Antioxidants and/or stabilizers for polymers.
* * * * *
(b) * * *
[[Page 29136]]
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Substances Limitations
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5,7-bis(1,1-dimethylethyl)-3-hydroxy- For use only:
2(3H)-benzofuranone, reaction products 1. At levels not to exceed 0.1
with o-xylene (CAS Reg. No. 181314-48- percent by weight of olefin
7). polymers complying with Sec.
177.1520(c) of this chapter.
The finished polymers may only
be used in contact with food
of the types identified in
Sec. 176.170(c) of this
chapter, Table 1, under
Categories I, II, IV-B, VI-A,
VI-B, VII-B, and VIII, and
under conditions of use B
through H described in Table 2
of Sec. 176.170(c) of this
chapter.
2. At levels not to exceed 0.02
percent by weight of propylene
polymers and copolymers
complying with Sec.
177.1520(c) of this chapter,
items 1.1, 1.2, 3.1a, 3.2a,
3.2b, 3.4, or 3.5, and
ethylene polymers and
copolymers complying with Sec.
177.1520(c) of this chapter,
items 2.1, 2.2, 2.3, 3.1a,
3.1b, 3.2a, or 3.6 (where the
density of each of these
polymers is at least 0.94 gram
per cubic centimeter), or 5.
The finished polymers may only
be used in contact with food
of the types identified in
Sec. 176.170(c) of this
chapter, Table 1, under
Categories III, IV-A, V, VI-C,
VII-A, and IX, and under
conditions of use B through H
described in Table 2 of Sec.
176.170(c) of this chapter;
provided that the finished
food-contact articles have a
volume of at least 18.9 liters
(5 gallons).
3. At levels not to exceed 0.02
percent by weight of ethylene
polymers and copolymers
complying with Sec.
177.1520(c) of this chapter,
items 2.1, 2.2, 2.3, 3.1a,
3.1b, 3.2a, 3.4, 3.5, or 3.6
(where the density of each of
these polymers is less than
0.94 gram per cubic
centimeter). The finished
polymers may only be used in
contact with food of the types
identified in Sec. 176.170(c)
of this chapter, Table 1,
under Categories III, IV-A, V,
VI-C, VII-A, and IX, and under
conditions of use B through H
described in Table 2 of Sec.
176.170(c) of this chapter;
provided that the average
thickness of such polymers in
the form in which they contact
food shall not exceed 50
micrometers (0.002 inch).
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Dated: May 11, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-14104 Filed 5-27-98; 8:45 am]
BILLING CODE 4160-01-F
