[Federal Register Volume 61, Number 172 (Wednesday, September 4, 1996)]
[Rules and Regulations]
[Pages 46545-46547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22484]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 96F-0027]
Indirect Food Additives: Adjuvants, Production Aids, and
Sanitizers
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 bis(2,4-di-tert-
butyl-6-methylphenyl) ethyl phosphite as a processing stabilizer for
olefin polymers intended for use in contact with food. This action is
in response to a petition filed by Ciba-Geigy Corp.
DATES: Effective September 4, 1996; written objections and requests for
a hearing by October 4, 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: Vir D. Anand, Center for Food Safety
and
[[Page 46546]]
Applied Nutrition (HFS-216), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, 202-418-3081.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of February 9, 1996 (61 FR 5001), FDA announced that a food
additive petition (FAP 6B4492) had been filed by Ciba-Geigy Corp., 540
White Plains Rd., Tarrytown, NY 10591-9005, proposing that food
additive regulations be amended in Sec. 178.2010 Antioxidants and/or
stabilizers for polymers (21 CFR 178.2010) to provide for the safe use
of bis(2,4-di-tert-butyl-6-methylphenyl) ethyl phosphite as a
processing stabilizer for olefin polymers complying with 21 CFR
177.1520 intended for use in contact with food.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that the proposed use of the additive is safe,
that the additive will achieve its intended technical effect, and that
the regulations in Sec. 178.2010(b) 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 October 4, 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 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: Secs. 201, 402, 409, 721 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).
2. Section 178.2010 is amended in the table in paragraph (b) by
alphabetically adding a new entry for bis(2,4-di-tert-butyl-6-
methylphenyl) ethyl phosphite to read as follows:
Sec. 178.2010 Antioxidants and/or stabilizers for polymers
* * * * *
(b) * * *
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List of Substances Limitations
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* * * *
* * *
Bis(2,4-di-tert-butyl-6-methylphenyl) For use only:
ethyl phosphite (CAS Reg. No. 145650- 1. At levels not to exceed 0.3
60-8). percent by weight of olefin
polymers complying with Sec.
177.1520(c) of this chapter.
The finished polymers may only
be used 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 0.1
percent by weight of propylene
polymers complying with Sec.
177.1520(c) of this chapter,
items 1.1, 1.2, 1.3, 3.2b,
3.4, or 3.5, or 3.1a (where
the density of this polymer is
at least 0.85 gram per cubic
centimeter and less than 0.91
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.
[[Page 46547]]
3. At levels not to exceed 0.1
percent by weight of high-
density ethylene polymers
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 C (maximum
temperature 70 C) through G
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).
4. At levels not to exceed 0.01
percent by weight of low-
density ethylene polymers
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 0.001
inch.
* * * *
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* * * * *
Dated: August 22, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-22484 Filed 9-3-96; 8:45 am]
BILLING CODE 4160-01-F